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  • Teenagers need better reproductive health education to tackle parenthood fears

    Teenagers need better reproductive health education to tackle parenthood fears

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    Newswise — Nearly half of teenagers are worried about having children and many lack knowledge about their reproductive health, find two new studies by UCL researchers.

    The studies, published in Human Fertility and Health Education Journal, used survey results from 931 students in England aged 16 to 18, collected between May 2021 and July 2022.

    The Human Fertility paper found that a majority of students (64%) still wanted to have children in the future – with nearly half (49%) desiring to have two children.

    However, 45% of all participants said that they had concerns about future parenthood –expressing their fears about their ability to have healthy offspring and the lives their children might lead.

    When asked what their concerns were, the teenagers responded that fear, self-doubt, health and wellbeing, financial burdens, hinderance to personal aspirations and non-inclusive LGBTQ+ education all played a part in their anxieties.

    For example, some students’ desire to have children was influenced by climate change, while others who identified within the LGBTQ+ community felt that the Relationships and Sex Education (RSE) they received at school lacked inclusivity.

    Meanwhile, the students who did not want children in the future (36%) cited reasons including: negative associations with pregnancy and childbirth; parenthood apprehension; raising a child in a world with an uncertain future; considering alternative routes to parenthood; and finding children a nuisance.

    One female participant said: “The state of the world is in a shambles. Governments are corrupt. The environment is deteriorating … it would be cruel to put a child through any of our problems, especially since they are not getting better.”

    Senior author, Professor Joyce Harper (UCL EGA Institute for Women’s Health), said: “Sadly, a number of female students expressed a lack of interest in future parenthood due to their fears about pregnancy and childbirth.

    “Shortcomings in fertility education in schools also meant that students were left feeling both ill-informed and negative towards their own fertility and ability to have children.”

    Until recently, sex education in the UK focused on puberty, menstruation, sexually-transmitted infections including HIV/AIDS, contraception and abortion.

    Guidance in England about sex education remained unchanged for almost 20 years until in September 2020 a new Relationships Education curriculum became compulsory for all primary schools (5-11 year-olds) in England.

    Additionally, a compulsory RSE curriculum was brought in for secondary schools (11-18-year-olds) and included the need to teach reproductive health.

    However, the second paper, published in Health Education Journal, found there were still significant gaps in young people’s education – and that teenagers are not being taught about key reproductive issues such as endometriosis, infertility and the impact of lifestyle on fertility.

    Over half (65%) of the students rated the sex education they’d received as adequate or below and half (49%) said they did not know when a woman was most fertile.

    When asked how their education could be improved, students suggested making the curriculum more inclusive and relevant, alongside providing honest, transparent and non-judgemental teaching and boosting sex positivity.

    One female participant responded: “All we’ve done in school is go over and over having safe sex and talked about periods which whilst is important is barely scratching the surface of things people need to know about. If miscarriage and infertility were better taught, then that could reduce the guilt and embarrassment people who struggle with it would feel.”

    While a male teen added: “Make the education a bit more ‘real world’ in the sense that [currently] it can be difficult to apply current knowledge to what is needed in life.”

    Professor Harper added: “It is not surprising that we take so long to diagnose conditions such as endometriosis and polycystic ovary syndrome (PCOS) when pupils are not taught about these conditions. It seems we are afraid to talk about a ‘normal’ and ‘abnormal’ menstrual cycle.

    “With regards to fertility education, most teenagers told us they want children in the future but at school we concentrate on teaching them how not to get pregnant, not how to have a healthy pregnancy.

    “The menopause is now included in the Department for Education curriculum and it needs to be taught.

    “This is why the International Reproductive Health Education Collaboration* that I co-founded has developed a number of educational resources, including a teacher’s guide which will be available, for free, very soon.”

    The research team hope that the study will contribute to the improvement of sex and reproductive health education for students in England.

    Notes to editors

    For more information or to speak to the researchers involved, please contact: Poppy Tombs, UCL Media Relations. T: +44 (0)20 3108 9440, E: [email protected]

    *For more information about the International Reproductive Health Education Collaboration, please visit: www.eshre.eu/IRHEC

    Rina Biswakarama, Katherine Maslowski, Michael J. Reiss, Joyce Harper. “Poor intentions of 16-18-year-olds in England: a survey of school students” will be published in Human Fertility on 13th February at 00:01 UK time.

    The DOI for this paper will be: https://doi.org/10.1080/14647273.2024.2310639

    Katherine Maslowski, Rina Biswakarma, Michael J Reiss and Joyce Harper. “What have 16-to-18-year-olds in England learned about reproductive health? A survey of school students” will be published in Health Education Journal on 13th February at 00:01 UK time.



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    University College London

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  • The Complete Library of Charles Darwin revealed for the first time

    The Complete Library of Charles Darwin revealed for the first time

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    Newswise — Charles Darwin – arguably the most influential man of science in history, accumulated a vast personal library throughout his working life. Until now, 85 per cent of its contents were unknown or unpublished. 

    This year, coinciding with Darwin’s 215th birthday, The Complete Work of Charles Darwin Online, the scholarly project helmed by Dr John van Wyhe at the National University of Singapore (NUS) Department of Biological Sciences, has released an online 300-page catalogue detailing Darwin’s complete personal library, with 7,400 titles across 13,000 volumes and items including books, pamphlets and journals. Previous lists only had 15 per cent of his whole collection. Darwin’s library has also been virtually re-assembled with 9,300 links to copies of the works freely available online.

    “This unprecedentedly detailed view of Darwin’s complete library allows one to appreciate more than ever that he was not an isolated figure working alone but an expert of his time building on the sophisticated science and studies and other knowledge of thousands of people. Indeed, the size and range of works in the library makes manifest the extraordinary extent of Darwin’s research into the work of others,” said Dr van Wyhe.

    Discovering Darwin’s complete library

    After his death in 1882, much of Darwin’s library was preserved and catalogued, but many other items were dispersed or lost, and details of the vast majority of the contents have never been published until now. For many years, scholars have referred to Darwin’s library as containing 1,480 books, based on those that survive in the two main collections, the University of Cambridge and Down House.

    Over 18 years the Darwin Online project has identified thousands of Darwin’s obscure references in his own catalogues and lists of items such as pamphlets and journals that were originally in his library. Each reference required its own detective story to discover the publications that Darwin had hurriedly recorded. In addition, missing details such as author, date or the source of clippings in thousands of records from older catalogues have been identified for the first time.

    A major source of information that helped to reveal the original contents is the 426-page handwritten “Catalogue of the Library of Charles Darwin”, compiled from 1875. Painstaking comparison of its abbreviated entries revealed 440 unknown titles that were originally in the library. An inventory of his home made after his death recorded 2,065 bound books and an unknown number of unbound volumes and pamphlets. In the drawing room, 133 titles and 289 volumes of mostly unscientific literature were recorded. Amazingly, the legacy duty valuer estimated that the “Scientific Library that is books relating to Science” was worth only 30 pounds and 12 shillings [about £2,000 today] Indeed, all the books were valued at only66 pounds and 10 shillings [about £4,400 today]. Today any book that belonged to Darwin is worth a great deal to collectors.

    Other sources of information that helped to build Darwin’s complete library were lists of pamphlets, Darwin’s reading notebooks, Emma Darwin’s diaries, the Catalogue of books given to the Cambridge Botany School in 1908 and the 30 volumes of the Darwin Correspondence. Items that still exist but were never included in the lists of Darwin’s library include his unbound materials at Cambridge University Library, books now in other institutional collections, private collections and books sold at auctions over the past 130 years. Combining these and many other sources of evidence allowed Darwin’s library to be reconstructed.

    For example, Darwin’s copy of an 1826 article by the ornithologist John James Audubon: ‘Account of the habits of the Turkey Buzzard (Vultura aura), particularly with the view of exploding the opinion generally entertained of its extraordinary power of smelling’ was sold in 1975. Darwin had investigated this point during the voyage of the Beagle and recorded reading a critic of Audubon in the lost Galapagos notebook. In 2019, a copy of Elizabeth Gaskell’s 1880 novel Wives and daughters appeared at auction. A note in it records: “This book was a great favourite of Charles Darwin’s and the last book to be read aloud to him.”

    Understanding Darwin’s library

    Most of the works in Darwin’s library are, unsurprisingly, on scientific subjects, especially biology and geology. Yet, the library also included works on farming, animal breeding and behaviour, geographical distribution, philosophy, psychology, religion, and other topics that interested Darwin, such as art, history, travel and language. Most of the works are in English, but almost half are in other languages, especially German, French and Italian as well as Dutch, Danish, Spanish, Swedish and Latin.

    Some of the hundreds of books not previously known to be in Darwin’s library include Sun Pictures, a 1872 coffee table book showcasing photographs of artworks. Another book that the we did not know that the Darwins purchased was a copy of the popular science book on gorillas that was all the rage just after Origin of species was published: Paul Du Chaillu’s Explorations and adventures in equatorial Africa. Of the thousands of shorter items were also found in Darwin’s library, such as an issue of a German scientific periodical sent to him in 1877 that contained the first published photographs of bacteria and another article amusingly entitled The hateful or Colorado grasshopper. In his complete library, Darwin’s eclectic sources are there for all to see.

    Click to view The Complete Library of Charles Darwin

    Click to view Introduction to the Library by John van Wyhe



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    National University of Singapore (NUS)

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  • Scientists Pinpoint Growth of Brain’s Cerebellum as Key to Evolution of Bird Flight

    Scientists Pinpoint Growth of Brain’s Cerebellum as Key to Evolution of Bird Flight

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    **EMBARGOED UNTIL 7:01 P.M. ET TUESDAY, JAN 30**

    Evolutionary biologists at Johns Hopkins Medicine report they have combined PET scans of modern pigeons along with studies of dinosaur fossils to help answer an enduring question in biology: How did the brains of birds evolve to enable them to fly?

    The answer, they say, appears to be an adaptive increase in the size of the cerebellum in some fossil vertebrates. The cerebellum is a brain region responsible for movement and motor control.

    The research findings are published in the Jan. 31 issue of the Proceedings of the Royal Society B.

    Scientists have long thought that the cerebellum should be important in bird flight, but they lacked direct evidence. To pinpoint its value, the new research combined modern PET scan imaging data of ordinary pigeons with the fossil record, examining brain regions of birds during flight and braincases of ancient dinosaurs.

    “Powered flight among vertebrates is a rare event in evolutionary history,” says Amy Balanoff, Ph.D., assistant professor of functional anatomy and evolution at the Johns Hopkins University School of Medicine and first author on the published research.

    In fact, Balanoff says, just three groups of vertebrates, or animals with a backbone, evolved to fly: extinct pterosaurs, the terrors of the sky during the Mesozoic period, which ended over 65 million years ago, bats and birds.

    The three species are not closely related on the evolutionary tree, and the key factors or factor that enabled flight in all three have remained unclear.

    Besides the outward physical adaptations for flight, such as long upper limbs, certain kinds of feathers, a streamlined body and other features, Balanoff and her colleagues designed research to find features that created a flight-ready brain.

    To do so, she worked with biomedical engineers at Stony Brook University in New York to compare the brain activity of modern pigeons before and after flight.

    The researchers performed positron emission tomography, or PET, imaging scans, the same technology commonly used on humans, to compare activity in 26 regions of the brain when the bird was at rest and immediately after it flew for 10 minutes from one perch to another. They scanned eight birds on different days.

    PET scans use a compound similar to glucose that can be tracked to where it’s most absorbed by brain cells, indicating increased use of energy and thus activity. The tracker degrades and gets excreted from the body within a day or two.

    Of the 26 regions, one area — the cerebellum — had statistically significant increases in activity levels between resting and flying in all eight birds. Overall, the level of activity increase in the cerebellum differed by more than two standard statistical deviations, compared with other areas of the brain.

    The researchers also detected increased brain activity in the so-called optic flow pathways, a network of brain cells that connect the retina in the eye to the cerebellum. These pathways process movement across the visual field.

    Balanoff says their findings of activity increase in the cerebellum and optic flow pathways weren’t necessarily surprising, since the areas have been hypothesized to play a role in flight.

    What was new in their research was linking the cerebellum findings of flight-enabled brains in modern birds to the fossil record that showed how the brains of birdlike dinosaurs began to develop brain conditions for powered flight.

    To do so, Balanoff used a digitized database of endocasts, or molds of the internal space of dinosaur skulls, which when filled, resemble the brain.

    Balanoff identified and traced a sizable increase in cerebellum volume to some of the earliest species of maniraptoran dinosaurs, which preceded the first appearances of powered flight among ancient bird relatives, including Archaeopteryx, a winged dinosaur.

    Balanoff and her team also found evidence in the endocasts of an increase in tissue folding in the cerebellum of early maniraptorans, an indication of increasing brain complexity.

    The researchers cautioned that these are early findings, and brain activity changes during powered flight could also occur during other behaviors, such as gliding. They also note that their tests involved straightforward flying, without obstacles and with an easy flightpath, and other brain regions may be more active during complex flight maneuvers.

    The research team plans next to pinpoint precise areas in the cerebellum that enable a flight-ready brain and the neural connections between these structures.

    Scientific theories for why the brain gets bigger throughout evolutionary history include the need to traverse new and different landscapes, setting the stage for flight and other locomotive styles, says Gabriel Bever, Ph.D., associate professor of functional anatomy and evolution at the Johns Hopkins University School of Medicine.

    “At Johns Hopkins, the biomedical community has a wide-ranging set of tools and technology to help us understand evolutionary history and link our findings to fundamental research on how the brain works,” he adds.

    In addition to Balanoff and Bever, other authors of the study are Elizabeth Ferrer of the American Museum of Natural History and Samuel Merritt University; Lemise Saleh and Paul Vaska of Stony Brook University; Paul Gignac of the American Museum of Natural History and University of Arizona, M. Eugenia Gold of the American Museum of Natural History and Suffolk University; Jesús Marugán-Lobón  of the Autonomous University of Madrid; Mark Norell of the American Museum of Natural History; David Ouellette of Weill Cornell Medical College; Michael Salerno of the University of Pennsylvania; Akinobu Watanabe of the American Museum of Natural History, New York Institute of Technology College of Osteopathic Medicine, and Natural History Museum of London; and Shouyi Wei of the New York Proton Center.

    Funding for the research was provided by the National Science Foundation.



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    Johns Hopkins Medicine

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  • New Research Highlights Superior Long-Term Survival with Multi-Arterial Coronary Artery Bypass Grafting Over Single Arterial Grafting

    New Research Highlights Superior Long-Term Survival with Multi-Arterial Coronary Artery Bypass Grafting Over Single Arterial Grafting

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    Newswise — SAN ANTONIO (January 27, 2024) ─ A new study presented at The Society of Thoracic Surgeons’ 2024 Annual Meeting in San Antonio, Texas, examines the ongoing controversy surrounding the choice between multi-arterial grafting (MAG) and single arterial grafting (SAG) in coronary artery bypass grafting (CABG) for multivessel coronary revascularization.

    The research, spanning from 2008 to 2019 and involving over one million patients undergoing isolated CABG with more than two bypass grafts, found that multi-arterial grafting CABG is associated with superior long-term survival compared to single arterial grafting, establishing it as the preferred surgical strategy for multivessel revascularization. 

    “Multiple small studies have demonstrated a survival benefit of multi-arterial grafting. We wanted to know if this survival benefit of multi-arterial grafting observed in single-center studies would translate to a large national cohort,” said the study’s lead author, Joseph Sabik III, MD, University Hospitals.  “Using the STS Adult Cardiac Surgery Database, we were able to demonstrate that it does.”

     At 10 years, MAG demonstrated improved unadjusted (HR 0.59, 95% CI 0.58-0.61) and adjusted (HR 0.86, 95% CI 0.85-0.88) survival rates compared to SAG. A center volume of 10 or more MAG cases per year was associated with survival benefits. 

    MAG’s survival advantage over SAG was found in various subgroups, including stable coronary disease, acute coronary syndrome, and acute infarction. Notably, MAG showed superior survival for patients with a BMI less than 40, whereas patients with a BMI of 40 or higher had superior survival with SAG. Survival outcomes were equivalent between MAG and SAG for patients aged 80 years or older, and those with severe heart failure, renal failure, peripheral vascular disease, or obesity.

    Patient data was collected from the STS Adult Cardiac Surgery Database and linked to the National Death Index for comprehensive longitudinal survival analysis. Risk-adjustment measures, including inverse probability weighting and multivariable modeling, were implemented to ensure accurate comparisons.

    These findings have significant implications for clinicians and cardiac surgeons when deciding on the most appropriate multivessel revascularization approach.

    “The survival benefit of multi-arterial grafting was observed in nearly all patients, except in those 80 or older and in those with co-morbidities graded as severe, where multi and single-arterial grafting resulted in similar survival. The only patients where single arterial grafting resulted in better survival were severely obese,” said Dr. Sabik. 

     

    This research not only contributes valuable insights to the ongoing debate but also provides evidence-based guidance for healthcare professionals in optimizing patient outcomes during CABG procedures.

    ###

    Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 7,700 cardiothoracic surgeons, researchers, and allied healthcare professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The Society’s mission is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy.



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    The Society of Thoracic Surgeons

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  • Subcutaneous Nivolumab as Effective as IV for Renal Cell Carcinoma — With Much Faster Treatment Time

    Subcutaneous Nivolumab as Effective as IV for Renal Cell Carcinoma — With Much Faster Treatment Time

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    • Subcutaneous formula slashes treatment time to under 5 minutes
    • Broad impact seen for greater access to and experience with treatment
    • Study has implications for treatment of many cancer types

    Newswise — SAN FRANCISCO — Subcutaneous injection of the immunotherapy nivolumab (brand name Opdivo) is noninferior to intravenous delivery and dramatically reduces treatment time in patients with renal cell carcinoma, as seen in the results of a large phase 3 clinical trial reported today at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco, California. Saby George, MD, FACP, Professor of Oncology and Medicine and Director of Network Clinical Trials at Roswell Park Comprehensive Cancer Center, will deliver an oral abstract summarizing the findings of “A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants with Previously Treated Clear Cell Renal Carcinoma That Is Advanced or Has Spread (CheckMate-67T)” (NCT04810078).

     “The burden of treatment felt by cancer patients is tremendous. If nivolumab can be given as a subcutaneous injection instead of an intravenous infusion, their treatment experience will be significantly improved,” says Dr. George, who is the presenting author, a member of the clinical trial steering committee and site principal investigator at Roswell Park. “Instead of one hour in an infusion chair, they will get the injection done in five minutes.”

    He points to the high demand for infusion chair appointments at most cancer centers, which can result in treatment delays of a week or more.

    “If nivolumab becomes available subcutaneously, we can administer it in the clinic instead of sending patients to infusion centers,” he says. That outcome could simultaneously speed treatment time for patients receiving nivolumab and shorten wait times for patients who still need to receive treatment in an infusion center.

    The availability of injectable nivolumab could also reduce health disparities. “One of the major problems is access to treatment,” says Dr. George, noting that some patients live a long distance from an infusion center and do not have a way to get there. “Patients who don’t live near an infusion center could get treatment closer to home, at a clinic, and that could improve access and help reduce disparities.”

    Sponsored by Bristol Myers Squibb, the drug’s manufacturer, the clinical trial began in May 2021, randomizing 495 patients at 73 centers in 17 countries. Roswell Park was one of only three participating sites in the U.S. and the only one in New York State.

    Patients in the study had advanced or metastatic renal cell carcinoma, had received no more than two prior treatments with systemic therapies and no prior immunotherapy. They were randomized 1:1 to receive nivolumab either subcutaneously or intravenously. Nivolumab is FDA-approved and the standard-of-care treatment for those patients.

    The study’s primary objective was to evaluate the pharmacokinetics of subcutaneous vs. intravenous delivery — how the body interacted with the nivolumab, including whether blood levels of the drug were comparable in the two groups over time. Those measures included the daily average concentration of the drug in the blood over 28 days (Cavgd28) and the concentration of the drug at the end of the dosing cycle (Cminss). Both measures were noninferior to intravenous nivolumab, as evidenced in pharmacokinetic measures and overall response rate.

    The objective response rate for the subcutaneous group — the percentage of patients who achieved a complete or partial response, measured by blinded independent central review — proved noninferior to the intravenous group, at 24.2% vs. 18.2%, respectively. Median progression-free survival stood at 7.23 months for the subcutaneous group vs. 5.65 months for the IV group. The safety profile was similar for both groups.

    More than 80,000 new cases of renal cell carcinoma are diagnosed in the U.S. each year.

    Because nivolumab is already FDA-approved for more than 20 indications across multiple malignancies, CheckMate-67T will likely serve as a gateway to additional studies evaluating the effectiveness of the subcutaneous formula in other patient populations.

    “This is a groundbreaking achievement for patients and physicians, and will definitely make treatment easier for patients,” says Dr. George.

    ASCO GU Presentation Details

    Abstract LBA360: “Subcutaneous nivolumab (NIVO SC) vs. intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T.”

    Time/date: Saturday, Jan. 27, 2024, 8:47 a.m. PST, Moscone West, Level 3, Ballroom

    ###

    From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email [email protected].



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    Roswell Park Comprehensive Cancer Center

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  • STS Announces Late-Breaker Research to Be Presented at the 2024 Annual Meeting

    STS Announces Late-Breaker Research to Be Presented at the 2024 Annual Meeting

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    Newswise — SAN ANTONIO (January 27, 2024) — The Society of Thoracic Surgeons has released late-breaking research scheduled for presentation at the 2024 Annual Meeting taking place January 27 – 29 in San Antonio. The conference, healthcare’s leading scientific and educational convening specializing in cardiothoracic surgery, has a rich history of showcasing clinical trials with a strong foundation of detailed methodology and trusted data collection governed by ethical clinical principles.

    The event’s late-breaking trial sessions focus on studies anticipated to significantly influence advances in cardiothoracic patient care. In this fast-paced healthcare landscape, surgeons look for the latest evidence to identify new therapies or preventive measures and help inform the most effective treatment decisions.  

    Key late-breaking studies selected for presentation include:

    Longitudinal Follow-up of Elderly Patients After Esophageal Cancer Resection in the Society of Thoracic Surgeons General Thoracic Surgery Database

    The study defines characteristics associated with long-term survival following esophagectomy for cancer in the Medicare population, using the STS General Thoracic Surgery Database linked to Centers for Medicare and Medicaid Services data. The analysis included 4,798 patients from 207 STS sites who underwent esophagectomy between 2012-2019. The researchers found that Medicare patients undergoing esophagectomy for cancer exhibit identifiable predictors for long-term survival and readmission. The absence of pathologic T and N downstaging increases the risk for long-term mortality and readmission.

    These findings suggest opportunities to enhance clinical practice and improve outcomes for Medicare patients undergoing esophagectomy for cancer.

    Cardiac Surgery after Transcatheter Aortic Valve Replacement: Trends and Outcomes

    The researchers set out to document trends and outcomes in cardiac surgery following transcatheter aortic valve replacement (TAVR), a topic gaining importance as reports of subsequent cardiac operations and early TAVR explantations increase. Using the Society of Thoracic Surgeons Adult Cardiac Surgery Database, the study covers adult patients who underwent cardiac surgery after an initial TAVR from January 2012 to March 2023.

    The findings underscore the escalating need for both aortic and non-aortic valve cardiac surgeries following TAVR. They note a substantial increase in the frequency of these surgeries, emphasizing the importance of understanding outcomes. The observed elevated risk in these cases, as indicated by mortality and stroke rates, calls for careful consideration, particularly given the expanding use of TAVR across a broader range of age and risk profiles. The study suggests the need for ongoing assessment and longitudinal evidence to inform decision-making in the evolving landscape of TAVR applications.

    The STS 2023 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation: Key Takeaways and How Do They Differ from the ACC/AHA Atrial Fibrillation Clinical Practice Guidelines?

    The Society of Thoracic Surgeons’ 2023 clinical practice guidelines for the surgical management of atrial fibrillation (AF) incorporates the latest evidence for surgical ablation (SA) and left atrial appendage occlusion (LAAO) across various clinical scenarios. It emphasizes the evolving role of surgical ablation and left atrial appendage occlusion in managing atrial fibrillation.

    Compared to the 2017 clinical practice guidelines, this latest version emphasizes SA in first-time, non-emergent cardiac surgery and its long-term benefits, an extension of the recommendation to perform SA in all patients with AF undergoing first-time, non-emergent cardiac surgery. Further guidance is provided for patients with structural heart disease and AF who are considered for transcatheter valve repair or replacement.

    The recommendations highlight the importance of a multidisciplinary team, comprehensive assessment, and long-term follow-up, with specific attention to diverse clinical scenarios. The Class I recommendation for LAAO and expanded use of SA signify the growing confidence in these interventions based on recent evidence.

    Impact of Surgical Factors on Event-Free Survival in the Randomized, Placebo-Controlled, Phase 3 Trial of Perioperative Pembrolizumab For Early-Stage Non-Small-Cell Lung Cancer

    New findings from the KEYNOTE-671 research study, focused on resectable early-stage non-small-cell lung cancer (NSCLC), have unveiled a significant breakthrough in the treatment landscape.

    The study, titled “Impact of Surgical-Related Data on Event-Free Survival in KEYNOTE-671,” demonstrated that neoadjuvant therapy with pembrolizumab plus chemotherapy did not delay surgery. Neoadjuvant pembrolizumab plus chemotherapy with adjuvant pembrolizumab provided meaningful improvement in EFS compared with neoadjuvant chemotherapy alone for resectable early-stage NSCLC regardless of clinical nodal status, baseline disease stage, or type of surgery.

    Note to editors: Abstracts are available upon request.

    # # #

    Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 7,700 cardiothoracic surgeons, researchers, and allied healthcare professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The Society’s mission is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy.

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    The Society of Thoracic Surgeons

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  • Live animal transport regulations not ‘fit for purpose’, major international study finds

    Live animal transport regulations not ‘fit for purpose’, major international study finds

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    Newswise — A ‘fitness check’ of regulations in five countries meant to protect animals during transportation, has deemed that they all fall short of fully protecting animals during transport. Findings from this interdisciplinary work involving animal welfare scientists and a law lecturer which compared animal transport rules designed to protect the billions of livestock that are transported on lengthy journeys in Australia, Canada, New Zealand, EU (including UK) and US, highlights serious failures.

    The study, published in Royal Society Open Science today [Wednesday 24 January], and involving researchers from the Universities of Bristol, Essex and British Columbia (Canada), is the first comprehensive fitness check of live animal transportation regulations in five English-speaking Western countries to assess whether the regulatory framework for a policy sector is fit for purpose.

    Live animal transport, which affects most farm animals at some point during their lifetime, is a stressful experience whereby animals are often subjected to long transport times during which they are prevented from drinking, eating and resting. For example, in Canada some animals can be transported for 36 hours without feed, water and rest.

    Researchers investigated four major risk factors associated with live animal transportation – fitness for transport, journey duration, climatic conditions and space allowances – and explored how regulations were structured to prevent animal welfare issues.

    Results from this research showed that all countries could improve and draw key future directions for new policies. For instance, no countries adopt maximum journey duration for all animals, meaning that animals can sometimes be transported for days. Not all countries mandate regular rest stops for long journeys but those that do often mandate rest stop times that are too short to allow meaningful recovery. Updating the transport regulations using the most recent science would be an important step towards improved animal welfare during transport, bringing the livestock industries more in line with societal values.

    The team also considered recent and proposed changes to the regulations. These included reviewed changes that have been announced but not yet been translated into legislation or different options that are being considered. For instance, last month (December 2023), a Bill including a ban on the export of livestock for slaughter and fattening from Great Britain (i.e., England, Scotland and Wales, but not Northern Ireland) was introduced in Parliament but may only target a minority of animals being exported.

    Dr Ben Lecorps, study co-author and Animal Welfare Lecturer in the Bristol Veterinary School, said: “Our findings indicate that regulations are often insufficient or too vague to ensure they are fit for purpose. All studied countries fall short in guaranteeing adequate protection to livestock during transport. Whilst this does not mean that all animals transported will experience serious harms, major risk factors such as excessively long journeys, or journeys during hot weather, are not being addressed to a satisfactory level.”

    Dr Eugénie Duval, study co-author and Lecturer in Law at the Essex Law School, added: “Even if they do not necessarily reflect the latest scientific evidence, some regulations are more specific than others. If we were to take the best from each regulatory framework (e.g. fitness for transport in Canada; providing species-specific thresholds for the temperature inside vehicles in the EU) and apply some of the propositions made by some countries (e.g. a ban of export outside the EU borders: proposition of some EU Member States), the ensuing regulations would be a major step closer to safeguarding animal welfare during transportation.”

    The study was funded by a grant awarded to ED and MvK by the Humane Slaughter Association and the Hans Sigrist Research Prize awarded to MvK by the Hans Sigrist Stiftung Foundation.

    Paper

    ‘Are regulations addressing farm animal welfare issues during live transportation fit for purpose? A multi-country jurisdictional check’ by Eugénie Duval, Benjamin Lecorps, Marina A.G. von Keyserlingk in Royal Society Open Science [open access]

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    University of Bristol

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  • Many Close Relatives of People with Alcohol Use Disorder Experience Similar Cognitive Weaknesses, Manifesting as Social and Emotional Struggles

    Many Close Relatives of People with Alcohol Use Disorder Experience Similar Cognitive Weaknesses, Manifesting as Social and Emotional Struggles

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    Many people with a family history of alcohol use disorder (AUD) struggle with certain cognition issues that often accompany AUD itself, even if they don’t themselves drink dangerously, according to a novel study. The findings suggest that these issues may be markers of vulnerability for the condition. A family history of AUD—having one or more first-degree relatives with the disorder—increases the risk of developing it, owing to genetic and environmental factors. Differences in cognitive functioning, especially in executive function (EF) and social cognition (SC), may predispose people to AUD and be amplified by chronic drinking. EF involves mental flexibility, inhibiting responses, and working memory, among other processes. SC facilitates social interactions through theory of mind (understanding others’ mental states), emotion recognition, and empathy. Research on healthy people with a family history of AUD has identified EF and SC differences in their neural networks, though little is known about SC processes in this population or whether those neural differences also manifest behaviorally. A better understanding of EF and SC as vulnerability markers may help identify people at risk for AUD. For the study in Alcohol: Clinical & Experimental Research, investigators in France explored behavioral SC in people without AUD who have first-degree relatives with the disorder and assessed the cognitive impact of SC and EF difficulties.

    Researchers worked with 120 adults, of whom 60 had a father or sibling with AUD but did not themselves drink dangerously. The two groups—with and without a family history of AUD—were matched for age, sex, and education level. The participants were assessed for intellectual functioning, psychiatric conditions, problematic drinking, nicotine dependence, depressive symptoms, anxiety, and childhood trauma. They underwent neuropsychological tasks evaluating their EF and theory of mind (a key component of SC) and self-reported impulsivity, alexithymia (“emotional blindness”), and empathy. The investigators used statistical analysis to compare the EF and SC profiles of participants with and without family histories of AUD as groups and individually.

    In tests, the participants with family histories of AUD showed lower resistance to interference—or difficulties suppressing automatic responses and impaired attentional control—EF issues. They also demonstrated weaknesses in theory of mind. (Other differences between groups dissipated after controlling for age, anxiety, and depressive symptoms.) Some participants with AUD relatives had mainly EF difficulties, others predominantly theory of mind. Individual analyses showed EF or SC weaknesses in 53% of people with a family history of AUD; of these, six out of ten struggled with one outcome, the others with more. Those with impaired theory of mind revealed diminished emotional arousal, fantasy, empathy, and perspective-taking. Overall, the findings suggest that EF and SC may drive AUD vulnerability through separate cognitive mechanisms. The participants with close AUD relatives had higher rates of past suicide attempts, anxiety disorders, and childhood trauma than those without such family histories; these mental health symptoms may increase the risk of heavy drinking. The variability in findings was consistent with previous studies suggesting heterogeneous cognitive manifestations in people with AUD as well as in close relatives without the disorder.

    This is the first known study to highlight SC difficulties in a behavioral task measuring theory of mind among healthy close relatives of people with AUD and extends our understanding of the breadth of socioemotional issues affecting this population. Cognitive vulnerabilities involving EF or SC appear to represent a continuum. Despite these risk factors, many people with family histories of AUD likely have protective resiliency factors. More research is needed to examine the relative roles of EF and theory of mind in the development of AUD and to identify people with higher clinical and cognitive vulnerability to AUD, facilitating prevention.

    Patterns of executive functions and theory of mind in adults with a family history of alcohol use disorder: Combined group and single-case analyses. F. Schmid, A. Henry, F. Benzerouk, S. Barrière, J. Gondrexon, A. Kaladjian, F. Gierski. (pp xxx)

    ACER-23-5740.R2

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    Research Society on Alcoholism

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  • Endless biotechnological innovation requires a creative approach

    Endless biotechnological innovation requires a creative approach

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    BYLINE: Laura Thomas

    Newswise — Scientists working on biological design should focus on the idiosyncrasies of biological systems over optimisation, according to new research.

    In a study, published today in Science Advances, researchers from the Universities of Bristol and Ghent have shown how exploring the unknown may be the crucial step needed to realise the continual innovation needed for the biotechnologies of the future.

    Recognising the role of open-endedness in achieving this goal and its growing importance in fields like computer science and evolutionary biology, the team mapped out how open-endedness is linked to bioengineering practice today and what would be required to achieve it in the lab.

    For success, algorithms used for biological design should not solely focus on moving toward a specific goal – such as better yield ­– but also consider the creation and maintenance of novelty and diversity in the solutions that have been found.

    Dr Thomas Gorochowski, co-author and Royal Society University Research Fellow in the School of Biological Sciences at Bristol, explained: “When we try to design a complex biological process, it’s often tempting to just tweak something that partially works rather than take the risk of trying something completely new.

    “In this work we highlight that in these situations the best solutions often come from unexpected directions, because we don’t always fully understand how everything works. With biology, there are lots of unknowns and so we need a vast and diverse toolkit of building blocks to ensure we have the best chance of finding the solution we need.”

    Professor Michiel Stock, lead author from Ghent University, added: “Biological systems have a natural capacity for innovation that has led to the overwhelming biodiversity we see in nature today.

    “Our own attempts to engineer biology, in contrast, lack this creativity – they are far more rigid, less imaginative, and often doesn’t make the best use of what biology is capable of.

    “With all life around us originating from the open-ended process of evolution, wouldn’t it be awesome if we could harness some of that power for our own biological designs.”

    The ability to create new biotechnologies is becoming increasingly important for tackling global challenges spanning the sustainable production of chemicals, materials and food, to advanced therapeutics to combat emerging diseases. Fueling this progress are innovations in how biology can be harnessed in new ways. This work supports this goal by offering a fresh direction for new research and design approaches.

    The study was made possible due to a travel grant from the FWO Flanders and funding from the Royal Society, BBSRC and EPSRC.

    Paper:

    ‘Open-endedness in synthetic biology: a route to continual innovation for biological design’ by Michiel Stock and Thomas E. Gorochowski in Science Advances (DOI: https://doi.org/10.1126/sciadv.adi3621)

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    University of Bristol

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  • Amnesia Caused by Head Injury Reversed in Early Mouse Study

    Amnesia Caused by Head Injury Reversed in Early Mouse Study

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    Newswise — WASHINGTON – A mouse study designed to shed light on memory loss in people who experience repeated head impacts, such as athletes, suggests the condition could potentially be reversed. The research in mice finds that amnesia and poor memory following head injury is due to inadequate reactivation of neurons involved in forming memories.

    The study, conducted by researchers at Georgetown University Medical Center in collaboration with Trinity College Dublin, Ireland, is reported January 16, 2024, in the Journal of Neuroscience.

    Importantly for diagnostic and treatment purposes, the researchers found that the memory loss attributed to head injury was not a permanent pathological event driven by a neurodegenerative disease.  Indeed, the researchers could reverse the amnesia to allow the mice to recall the lost memory, potentially allowing cognitive impairment caused by head impact to be clinically reversed.

    The Georgetown investigators had previously found that the brain adapts to repeated head impacts by changing the way the synapses in the brain operate. This can cause trouble in forming new memories and remembering existing memories. In their new study, investigators were able to trigger mice to remember memories that had been forgotten due to head impacts.

    “Our research gives us hope that we can design treatments to return the head-impact brain to its normal condition and recover cognitive function in humans that have poor memory caused by repeated head impacts,” says the study’s senior investigator, Mark Burns, PhD, a professor and Vice-Chair in Georgetown’s Department of Neuroscience and director of the Laboratory for Brain Injury and Dementia.

    In the new study, the scientists gave two groups of mice a new memory by training them in a test they had never seen before. One group was exposed to a high frequency of mild head impacts for one week (similar to contact sport exposure in people) and one group were controls that didn’t receive the impacts. The impacted mice were unable to recall the new memory a week later.

    “Most research in this area has been in human brains with chronic traumatic encephalopathy (CTE), which is a degenerative brain disease found in people with a history of repetitive head impact,” said Burns. “By contrast, our goal was to understand how the brain changes in response to the low-level head impacts that many young football players regularly experience.”

    Researchers have found that, on average, college football players receive 21 head impacts per week with defensive ends receiving 41 head impacts per week. The number of head impacts to mice in this study were designed to mimic a week of exposure for a college football player, and each single head impact by itself was extraordinarily mild.

    Using genetically modified mice allowed the researchers to see the neurons involved in learning new memories, and they found that these memory neurons (the “memory engram”) were equally present in both the control mice and the experimental mice.

    To understand the physiology underlying these memory changes, the study’s first author, Daniel P. Chapman, Ph.D., said, “We are good at associating memories with places, and that’s because being in a place, or seeing a photo of a place, causes a reactivation of our memory engrams. This is why we examined the engram neurons to look for the specific signature of an activated neuron. When the mice see the room where they first learned the memory, the control mice are able to activate their memory engram, but the head impact mice were not. This is what was causing the amnesia.”

    The researchers were able to reverse the amnesia to allow the mice to remember the lost memory using lasers to activate the engram cells. “We used an invasive technique to reverse memory loss in our mice, and unfortunately this is not translatable to humans,” Burns adds. “We are currently studying a number of non-invasive techniques to try to communicate to the brain that it is no longer in danger, and to open a window of plasticity that can reset the brain to its former state.”

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    In addition to Burns and Chapman the authors include Stefano Vicini at Georgetown University and Sarah D. Power and Tomás J. Ryan at Trinity College Dublin, Ireland.

    This work was supported by the Mouse Behavior Core in the Georgetown University Neuroscience Department and by the National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS) grants R01NS107370 & R01NS121316. NINDS also supported F30 NS122281 and the Neural Injury and Plasticity Training Grant housed in the Center for Neural Injury and Recovery at Georgetown University (T32NS041218). Seed funding is from the CTE Research Fund at Georgetown.

    The authors report having no personal financial interests related to the study.

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    Georgetown University Medical Center

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  • Count of neurosurgeon density reflects global unmet needs

    Count of neurosurgeon density reflects global unmet needs

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    Newswise — Rolling Meadows, IL (January 16, 2024) How many neurosurgeons are needed worldwide? Recent reports have suggested that a neurosurgeon ratio of approximately 1 neurosurgeon per 65,000 individuals may not be adequate. Investigators from Harvard Medical School attempted to systematically provide the most accurate count of neurosurgeon density around the world, as well the number in each country. Using data collected from 99.5% of all countries and 96.2% of all additional territories, states, and disputed regions, the authors report that there are approximately 72,967 neurosurgeons globally, representing a pooled density of 0.93 neurosurgeons per 100,000 individuals, and a median national density of 0.44 neurosurgeons per 100,000 individuals. The study detailing these findings was published today in the Journal of Neurosurgery (https://thejns.org/doi/10.3171/2023.9.JNS231615). 

    The authors used contacts with national and regional neurosurgery societies, their own personal contacts, bibliometric and Google searches, and World Bank and United Nations data to obtain perhaps the most accurate count of global neurosurgeon density to date. There were wide disparities in the neurosurgery workforce and access to resources in different WHO regions and World Bank income categories. The African region, with 0.11 neurosurgeons per 100,000 individuals, and the Southeast Asia region, with 0.34 per 100,000 individuals, had the lowest neurosurgeon density, while the Western Pacific region (WPR) had the highest density, with 1.58 per 100,000 individuals. The authors found that there were 29 countries, 14 territories, and 1 independent state with no neurosurgeons at all, representing almost 36 million individualswithout access to a neurosurgeon. Among these 29 countries, 21 were low- and middle-income countries (LMICs; 72.4%), and most were located in the WPR (n = 10, 34.5%) or African region (n = 9, 31.0%). 

    The greatest growth in the number of neurosurgeons from 2016 to 2022 was in the Southeast Asia region (33.0% per year), while the slowest growth was in the African region (2.0% per year); 15 countries in the African region had a decrease in their neurosurgery densities, and 7 of these 15 countries were in West Africa. Some of the strongest predictors of annual relative growth in neurosurgery density included the presence of a national neurosurgery society, development aid, and national gross domestic product. 

    “We were excited to find that the neurosurgery workforce is growing worldwide, but the growth in LMICs has been disproportionately slow,” said Dr. Saksham Gupta, the lead author of the study. “The number of neurosurgeons in many LMICs remains insufficient to manage their countries’ needs, and neurosurgeons in LMICs have fewer resources to provide subspecialized care. These imbalances will negatively affect population health in LMICs and could contribute to burnout amongst already overworked LMIC neurosurgeons.” 

    In a related companion article (https://thejns.org/doi/10.3171/2023.9.JNS231616), the authors also attempted to determine the global density of neurosurgeon trainees. They estimated there were 1261 training programs with 10,546 neurosurgery trainees worldwide. The Southeast Asia (0.04 per 100,000 people) and African (0.05 per 100,000 people) regions had the lowest pooled trainee density, and there were no training programs in 22.4% of high-income countries (HICs) and in 35.2% of LMICs. Surveys of African young neurosurgeons and trainees highlighted some of the educational limitations that most trainees face, which included low exposure to educational conferences, the inability to attend national and international research conferences, and low access to cadaver laboratories.

    Regarding solutions to correct these imbalances, Gupta stated, “Collaboration between LMICs and HICs as well as between LMICs themselves is key and will help new perspectives flourish and best practices spread. Furthermore, there have been several impressive educational efforts, including but certainly not limited to Dr. Rutka’s work with the Ukraine Pediatric Fellowship Program, Dr. Baticulon’s work in the Philippines, the World Federation of Neurosurgical Societies (WFNS)—sponsored training center in Rabat, and numerous Foundation for International Education in Neurological Surgery courses and partnerships. Education is the bedrock of neurosurgery, and we should continue supporting existing educational tools (such as cadaver laboratories, weekend courses, year-long fellowships) while promoting emerging teaching modalities (webinars, high-fidelity dissection models, and open-access operative videos).”

    Articles:  Gupta S, Gal ZT, Athni TS, Calderon C, Callison WÉ, Dada OE, Lie W, Qian C, Reddy R, Rolle M, Baticulon RE, Chaurasia B, Dos Santos Rubio EJ, Esquenazi Y, Golby AJ, Pirzad AF, and Park KB, on behalf of the WFNS Global Neurosurgery Committee, EANS Global and Humanitarian Neurosurgery Committee, and CAANS Executive Leadership Committee. Mapping the global neurosurgery workforce. Part 1: Consultant neurosurgeon density. Journal of Neurosurgery. Published online January 16, 2024; DOI: 10.3171/2023.9.JNS231615. Mapping the global neurosurgery workforce. Part 2: Trainee density. Journal of Neurosurgery. Published online January 16, 2024; DOI: 10.3171/2023.9.JNS231616.

    Disclosures: The authors report no conflict of interest concerning the materials or methods used in these studies or the findings specified in these papers.

    Funding: Mr. Athni was supported by the National Institute of General Medical Sciences, NIH, under grant no. T32GM144273.

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    The global leader for cutting-edge neurosurgery research for more than 75 years, the Journal of Neurosurgery (www.thejns.org) is the official journal of the American Association of Neurological Surgeons (AANS) representing over 12,000 members worldwide (www.AANS.org).

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    Journal of Neurosurgery

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  • Research sheds new light on Moon rock formation, solving major puzzle in lunar geology

    Research sheds new light on Moon rock formation, solving major puzzle in lunar geology

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    Newswise — The study, published today in Nature Geoscience, reveals a key step in the genesis of these distinctive magmas.  A combination of high temperature laboratory experiments using molten rocks, together with sophisticated isotopic analyses of lunar samples, identify a critical reaction that controls their composition.

    This reaction took place in the deep lunar interior some three and a half billion years ago, involving exchange of the element iron (Fe) in the magma with the element magnesium (Mg) in the surrounding rocks, modifying the chemical and physical properties of the melt.  

    Co-lead author Tim Elliott, Professor of Earth Sciences at the University of Bristol, said: “The origin of volcanic lunar rocks is a fascinating tale involving an ‘avalanche’ of an unstable, planetary-scale crystal pile created by the cooling of a primordial magma ocean. 

    “Central to constraining this epic history is the presence of a magma type unique to the Moon, but explaining how such magmas could even have got to the surface, to be sampled by Space missions, has been a troublesome problem. It is great to have resolved this dilemma.”

    Surprisingly high concentrations of the element titanium (Ti) in parts of the lunar surface have been known since the NASA Apollo missions, back in the 1960s and 1970s, which successfully returned solidified, ancient lava samples from the Moon’s crust. More recent mapping by orbiting satellite shows these magmas, known as ‘high-Ti basalts’, to be widespread on the Moon.

    “Until now models have been unable to recreate magma compositions that match essential chemical and physical characteristics of the high-Ti basalts. It has proven particularly hard to explain their low density, which allowed them to be erupted some three and a half billion years ago,” added co-lead author Dr Martijn Klaver, Research Fellow at the University of Münster Institute of Mineralogy.

    The international team of scientists, led by the Universities of Bristol in the UK and Münster in Germany managed to mimic the high-Ti basalts in the process in the lab using high-temperature experiments.  Measurements of the high-Ti basalts also revealed a distinctive isotopic composition that provides a fingerprint of the reactions reproduced by the experiments.

    Both results clearly demonstrate how the melt-solid reaction is integral in understanding the formation of these unique magmas. 

    Paper

    ‘Titanium-rich basaltic melts on the Moon modulated by reactive flow processes’ by Martijn Klaver et al in Nature Geoscience

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    University of Bristol

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  • Few older adults use direct-to-consumer health services; many who do don’t tell their regular provider

    Few older adults use direct-to-consumer health services; many who do don’t tell their regular provider

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    Newswise — Only a small percentage of older Americans have jumped on the rising trend of getting health care services and prescriptions directly from an online-only company, rather than seeing their usual health care providers in person or via telehealth, a new poll finds.

    But that could change rapidly, the University of Michigan survey suggests.

    In all, 7.5% of people between the ages of 50 and 80 have used at least one direct-to-consumer health care service from an online-only provider, according to the new findings from the National Poll on Healthy Aging.

    Of those who did use such a service, most said they were driven by convenience. More than 60% of them received a prescription, mostly for a one-time treatment. But only one-third of them told their regular health care provider about the prescription.

    People in their pre-Medicare years of 50 to 64 were more than twice as likely as adults over 65 to have used direct-to-consumer, or DTC, online health services (10% vs. 4%). Meanwhile, 47% of those over 65 said they had never heard of such companies.

    Looking to the future, nearly a third of all older adults, and more than 42% of those age 50 to 64, said they’d be interested in using such services in the future.

    The poll is based at the U-M Institute for Healthcare Policy and Innovation, and supported by AARP and Michigan Medicine, U-M’s academic medical center.

    For the DTC survey, the poll team worked with members of U-M’s Center for Value-Based Insurance Design, who are interested in how cost and convenience influence people’s health care decisions and the continuity of care delivery.

    A rapidly growing sector spurs concerns

    The rise of DTC sites and subscription-based apps that promise convenient online access to providers who can evaluate symptoms, make diagnoses and prescribe medicines has received a lot of attention, especially amid a national crunch in availability of primary care providers and timely appointments.

    Such companies include Amazon Clinic, Sesame, Roman, BetterHelp, Rosy, Lemonaid, Hims & Hers, and don’t require a referral or health insurance. Drug companies and membership-based organizations including Weight Watchers and Costco have also started offering access to such direct services.

    But the trend has raised concern because of the potential for patients to receive care and prescriptions from providers who don’t know their full health history, don’t have access to their full medical records, and may not check for potentially dangerous interactions between medications.

    One-third of those who had used a DTC service said their primary care provider wasn’t aware they had done so. If they received a new prescription through an encounter with a DTC health service, one-third said their regular primary care provider was not made aware of the new medication they were prescribed. The majority of those who received prescriptions through a DTC service said it was for a one-time treatment.

    “These compelling findings have important implications for patient safety and continuity of care,” said Mark Fendrick, M.D., director of VBID and IHPI member who is a primary care physician at Michigan Medicine. “With rapid growth in this sector of health care predicted for this year and beyond, all providers, insurers and regulators need to pay more attention to how patients are using these services and why, and the impact on care quality and safety.” Fendrick is a professor of internal medicine in the Division of General Medicine at the U-M Medical School.

    His colleague Nicole Hadeed, M.D., who also worked on the poll and is a clinical assistant professor, notes that while the number of poll participants who said they had used DTC services was relatively small, the analysis gives clues that should inform further research.

    Types of care received

    Nearly half of those who had used a DTC service said it has been for general health care such as treatment of allergies, sinus infections, pink eye or acid reflux, though again there was a clear divide between the 50-64 and 65-80 age groups.

    Overall, nearly 12% said they’d used a service for mental health reasons, but the proportion was much higher (50%) among respondents who said they considered their mental health to be fair or poor and had used a DTC service of any kind.

    As for other types of care, 15% had sought help from a DTC service for a sexual health issue, 9% had used it for skin care, 6% had used it for weight management, nearly 5% had used it for hair loss and a similar percentage had used it for pain management.

    Convenience topped the list of reasons for choosing a DTC service, with 55% saying this drove their decision. But lack of access to their regular health care provider, not having a regular health care provider, or needing a service when their health provider was not open or available were each cited by around 20%. Discomfort discussing a sensitive health topic with a provider – often cited in marketing by such companies – was only mentioned by 10% of those who had turned to a DTC service.

    “For both patients and providers, these findings drive home the importance of open dialogue and transparency about the potential uses, benefits and risks of these services – and the importance of maintaining contact for ongoing primary care,” said Jeffrey Kullgren, M.D., M.P.H., M.S., director of the poll and a primary care provider at the VA Ann Arbor Healthcare System who is also an associate professor at the Medical School.

    More than 55% of the poll respondents who had used a direct-to-consumer service said the overall quality of care they get from their primary care provider is better than what they received from a DTC provider.

    Fendrick and Hadeed wrote about the potential long-term change to primary care use from telehealth services in a piece published early in the COVID-19 pandemic in the American Journal of Managed Care.

    And in fact, 58% of poll respondents who had used a DTC service had started doing so in 2020, 2021 or 2022.

    The rapid pivot during the pandemic to vaccination in pharmacies, and not just primary care clinics, has also changed how people think about alternate ways of getting care that might be closer to home or have more flexible hours.

    However, Fendrick notes, pharmacies share information about vaccination with insurance companies and statewide immunization registries that primary care providers can access.

    “Patients will increasingly seek care online because of the convenience it can provide, especially for those willing to pay the cost out of pocket,” said Fendrick. “Its use will likely be boosted by the rapidly increasing number of online vendors and the national shortage of primary care clinicians. The recent launch of a telemedicine platform offering home delivery for the new highly popular weight loss drugs is a noteworthy example of this trend.”

    He added, “Given a likely expansion of online care, it is critical that individuals inform their usual clinician and that we providers consistently ask our patients regarding their use. Similar to my routinely asking patients about which supplements, vitamins and over-the-counter medications they’re taking, it should become standard practice for me to inquire about prescriptions or diagnoses they’ve received online, as it might influence their care.”

    The poll was a nationally representative survey conducted by NORC at the University of Chicago for IHPI and administered online and via phone in July and August 2023 among 2,657 adults aged 50 to 80. In all, 168 respondents reported having used a DTC health care service. The sample was subsequently weighted to reflect the U.S. population. Read past National Poll on Healthy Aging reports and about the poll methodology.

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    Michigan Medicine – University of Michigan

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  • About 22 high school age adolescents died each week from overdoses in 2022, driven by fentanyl-laced prescription pills

    About 22 high school age adolescents died each week from overdoses in 2022, driven by fentanyl-laced prescription pills

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    BYLINE: Enrique Rivero

    EMBARGOED FOR USE UNTIL:

    7:30 A.M. (ET) ON JANUARY 6, 2024

     

    About 22 high school age adolescents died each week from overdoses in 2022, driven by fentanyl-laced prescription pills

    Newswise — An average of 22 adolescents 14 to 18 years of age died in the U.S. each week in 2022 from drug overdoses, raising the death rate for this group to 5.2 per 100,000– driven by fentanyl in counterfeit pills, new research finds.

    Adolescent overdoses had more than doubled among this group between 2019 and 2020, and have since intensified to such an extent that the death count equals a high school classroom each week, and is now the third largest cause of pediatric deaths behind firearm-related injuries and motor vehicle collisions. 

    The increase is, however, not due to more illicit drug use – which has in fact fallen over the years; for example, excluding cannabis, the rate of any illicit drug use among just 12th graders had fallen from about 21% to 8% in the 20 years since 2002. Instead, the increase is the result of drugs becoming deadlier due to fentanyl, which is increasingly found in counterfeit oxycodone, benzodiazepines and other prescription pills that fall into the hands of adolescents.

    But educators, physicians, and mental health practitioners can be instrumental in helping to stem this tide through pointed questions and guidance about drug use and the dangers that counterfeit pills present, the researchers write in a paper published in the New England Journal of Medicine. In addition, policymakers can focus on “hotspot” counties, most in western states, with particularly high overdose deaths.

    “Teenagers are likely to be unaware of just how high-risk experimenting with pills has become, given the recent rise in counterfeit tablets” said study co-author Joseph Friedman, a researcher at UCLA. “It’s often impossible to tell the difference with the naked eye between a real prescription medication obtained from a doctor and a counterfeit version with a potentially deadly dose of fentanyl. It’s urgent that teenagers be given accurate information about the real risks, and strategies to keep themselves and their friends safe.” 

    The researchers found that adolescent overdoses were occurring at double the national average in Arizona, Colorado and Washington State between 2020 and 2022. They identified 19 hotspot counties – that is, those with at least 20 overdose deaths and death rates higher than the national average, with Maricopa County in Arizona and Los Angeles County having the most fatal overdoses at 117 and 111, respectively, during this period. 

    The other 17 counties are Orange County, California (61 deaths), Cook County, Illinois (56), San Bernardino County, California (54), King County, Washington (52), Riverside County, California (41), San Diego County, California (36), Tarrant County, Texas (35), Clark County, Nevada (31), Kern County, California (30), Pima County, Arizona (29), Adams County, Colorado (25), Denver County, Colorado (24), Jackson County, Missouri (24), Santa Clara County, California (24), Bernalillo County, New Mexico (23), Davidson County, Tennessee (21), and Marion County, Indiana (21). 

    In addition, American Indian and Alaska Native adolescents had 1.82 times the overdose rates of whites between 2020 and 2022. And adolescents are overall likelier to use the pill form of the drug rather than powder, which was previously the main fentanyl source. For instance, while 0.3% of high school seniors in 2022 reported using heroin, which comes in powder form, 5% reported nonmedical use of prescription pills the same year.

    The researchers provide the following recommendations to combat these trends:

    • Pediatricians, other primary care physicians, and mental health practitioners should ask their adolescent patients if they or their peers were approached either in person or via social media about buying pills, or if they have used them without prescriptions
    • Educators, along with parents, can discuss with adolescents the dangers associated with counterfeit pills; these efforts should be especially prioritized in hotspot locations
    • Clinicians, educators and parents can highlight the Safety First curriculum that emphasizes abstinence from drugs and provides information about risk reduction for those who do experiment with drugs, such as where to find and how to use the overdose-reversal agent naloxone
    • Finally, naloxone should be available in schools, which should also adopt “no-questions-asked” pill-disposal programs as well as provide anonymous mechanisms such messaging services that students can use to ask about counterfeit pills and substance use without risk of punishment or embarrassment.

    “Fentanyl has rapidly become a leading cause of death in American teens,” said Dr. Scott Hadland, chief of adolescent medicine at Mass General for Children and senior author on the paper. “Policymakers, clinicians, families and communities need to partner together to address this worsening public health threat.”

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    University of California, Los Angeles (UCLA), Health Sciences

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  • ‘Long flu’ has emerged as a consequence similar to long COVID

    ‘Long flu’ has emerged as a consequence similar to long COVID

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    BYLINE: Kristina Sauerwein

    Newswise — Since the COVID-19 pandemic began, extensive research has emerged detailing the virus’s ability to attack multiple organ systems, potentially resulting in a set of enduring and often disabling health problems known as long COVID. Now, new research from Washington University School of Medicine in St. Louis and the Veterans Affairs St. Louis Health Care System indicates that people hospitalized with seasonal influenza also can suffer long-term, negative health effects, especially involving their lungs and airways.

    The new study comparing the viruses that cause COVID-19 and the flu also revealed that in the 18 months after infection, patients hospitalized for either COVID-19 or seasonal influenza faced an increased risk of death, hospital readmission, and health problems in many organ systems. Further, the time of highest risk was 30 days or later after initial infection.

    “The study illustrates the high toll of death and loss of health following hospitalization with either COVID-19 or seasonal influenza,” said senior author Ziyad Al-Aly, MD, a clinical epidemiologist at Washington University. “It’s critical to note that the health risks were higher after the first 30 days of infection. Many people think they’re over COVID-19 or the flu after being discharged from the hospital. That may be true for some people. But our research shows that both viruses can cause long-haul illness.”

    The findings are published Dec. 14 in The Lancet Infectious Diseases.

    The statistical analysis spanned up to 18 months post-infection and included a comparative evaluation of risks of death, hospital admissions and 94 adverse health outcomes involving the body’s major organ systems.

    “A review of past studies on COVID-19 versus the flu focused on a short-term and narrow set of health outcomes,” said Al-Aly, who treats patients within the VA St. Louis Health Care System and is an assistant professor of medicine at Washington University. “Our novel approach compared the long-term health effects of a vast array of conditions. Five years ago, it wouldn’t have occurred to me to examine the possibility of a ‘long flu.’ A major lesson we learned from SARS-CoV-2 is that an infection that initially was thought to only cause brief illness also can lead to chronic disease. This revelation motivated us to look at long-term outcomes of COVID-19 versus flu.

    “We wanted to know whether and to what degree people with flu also experience long-term health effects,” Al-Aly said. “The big answer is that both COVID-19 and the flu led to long-term health problems, and the big aha moment was the realization that the magnitude of long-term health loss eclipsed the problems that these patients endured in the early phase of the infection. Long COVID is much more of a health problem than COVID, and long flu is much more of a health problem than the flu.”

    However, the overall risk and occurrence of death, hospital admissions, and loss of health in many organ systems are substantially higher among COVID-19 patients than among those who have had seasonal influenza, Al-Aly said. “The one notable exception is that the flu poses higher risks to the pulmonary system than COVID-19,” he said. “This tells us the flu is truly more of a respiratory virus, like we’ve all thought for the past 100 years. By comparison, COVID-19 is more aggressive and indiscriminate in that it can attack the pulmonary system, but it can also strike any organ system and is more likely to cause fatal or severe conditions involving the heart, brain, kidneys and other organs.”

    The researchers analyzed de-identified medical records in a database maintained by the U.S. Department of Veterans Affairs, the nation’s largest integrated health-care delivery system. They evaluated information involving 81,280 patients hospitalized for COVID-19 at some point from March 1, 2020, through June 30, 2022, as well as 10,985 patients hospitalized for seasonal influenza at some point from Oct. 1, 2015, through Feb. 28, 2019.

    Patients represented multiple ages, races and sexes.

    Regarding both viruses, patient vaccination status did not affect results. Those in the COVID-19 cohort were hospitalized during the pre-delta, delta and omicron eras.

    During the overall 18-month study period, patients who had COVID-19 faced a 50% higher risk of death than those with seasonal influenza. This corresponded to about eight more deaths per 100 persons in the COVID-19 group than among those with the flu.

    Although COVID-19 showed a greater risk of health loss than seasonal influenza, infection with either virus carried significant risk of disability and disease. The researchers found COVID-19 exhibited increased risk of 68% of health conditions examined across all organ systems (64 of the 94 adverse health outcomes studied), while the flu was associated with elevated risk of 6% of health conditions (six of the 94) – mostly in the respiratory system.

    Also, over 18 months, COVID-19 patients experienced an increased risk of hospital readmission as well as admission to an intensive care unit (ICU). For every 100 persons in each group, there were 20 more hospital admissions and nine more ICU admissions in COVID-19 than flu.

    “Our findings highlight the continued need to reduce the risk of hospitalization for these two viruses as a way to alleviate the overall burden of health loss in populations,” Al-Aly said. “For both COVID-19 and seasonal influenza, vaccinations can help prevent severe disease and reduce the risk of hospitalizations and death. Optimizing vaccination uptake must remain a priority for governments and health systems everywhere. This is especially important for vulnerable populations such as the elderly and people who are immunocompromised.”

    In both COVID-19 and the flu, more than half of death and disability occurred in the months after infection as opposed to the first 30 days, the latter of which is known as the acute phase.

    “The idea that COVID-19 or flu are just acute illnesses overlooks their larger long-term effects on human health,” Al-Aly said. “Before the pandemic, we tended to belittle most viral infections by regarding them as somewhat inconsequential: ‘You’ll get sick and get over it in a few days.’ But we’re discovering that is not everyone’s experience. Some people are ending up with serious long-term health issues. We need to wake up to this reality and stop trivializing viral infections and understand that they are major drivers of chronic diseases.”

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  • ASH 2023 Tip Sheet From Sylvester Comprehensive Cancer Center

    ASH 2023 Tip Sheet From Sylvester Comprehensive Cancer Center

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    EMBARGOED

    Newswise — Many physician-scientists and other researchers from Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine will be making oral or poster presentations or participating in panel discussions at the American Society of Hematology’s 2023 annual meeting in San Diego, Dec. 9-12.

    Below is an EMBARGOED summary highlighting several presentations involving Sylvester physicians and other staff members.

    Please note that all information is strictly embargoed until the date and time of each presentation. 

    Lymphomas

    984 Limited Duration Loncastuximab Tesirine with Rituximab Induces High Complete Metabolic Response Rate in High-Risk Relapsed/Refractory Follicular Lymphoma — a Phase 2 Study

    EMBARGOED UNTIL Monday, December 11, 2023: 5:45 PM, Grand Hall C

    Presenting Author: Juan Pablo Alderuccio, MD, Sylvester Comprehensive Cancer Center

    Intro: No standard-of-care exists for treatment of relapsed/refractory follicular lymphoma (FL) with worse prognosis in those demonstrating progression of disease within 24 months from frontline immunochemotherapy. Loncastuximab tesirine (loncastuximab) is an antibody-drug conjugate comprising a monoclonal antibody. The authors report results of a single-institution, investigator-initiated study evaluating this combination for the first time to treat FL. Conclusion: A limited duration program combining loncastuximab with rituximab in patients with FL is well tolerated and highly effective for high-risk patients or those with high disease burden.

    615 Chimeric Antigen Receptor (CAR) T Cell Infusion for Large B Cell Lymphoma in Complete Remission: A Center for International Blood & Marrow Transplant Research (CIBMTR) Analysis

    EMBARGOED UNTIL Sunday, December 10, 2023: 5:00 PM

    Presenting Author: Trent Wang, DO, MPH, Sylvester Comprehensive Cancer Center

    Intro: There are limited reported outcomes of patients with large B-cell lymphoma (LBCL) who are infused with CD19 CAR-T cells while being in radiographic or metabolic complete remission (CR). The authors hypothesize that these patients in complete remission before CAR-T infusion may have favorable progression-free survival with lower toxicity.

    Conclusion: CAR-T cell in LBCL patients who are CR after receiving two or more lines of prior therapy is a reasonable consolidation option, with a subset of patients remaining progression-free at two years. Their 9% rate of non-relapse mortality highlights the importance of continued follow-up.

     

    1032 Five Year Outcomes of Patients with Large B-Cell Lymphoma Treated with Standard-of-Care Axicabtagene Ciloleucel: Results from the US Lymphoma CAR-T Cell Consortium

    EMBARGOED UNTIL Monday, December 11, 2023: 5:45 PM

    Presenting Author: Jay Y. Spiegel, MD, FRCPC, Sylvester Comprehensive Cancer Center

    Intro: Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 CAR T-cell therapy that induces durable responses in patients with relapsed or refractory large B-cell lymphoma. The authors previously reported outcomes for axi-cell patients treated with standard-of-care therapy, including 42% who were ineligible for the ZUMA-1 trial. Now, they update outcomes for this cohort at 58 months.  

    Conclusion: This multicenter, retrospective study showed similar five-year results to the ZUMA-1 trial, despite including patients ineligible for that trial due to comorbidities. It supports the curative potential of axi-cel therapy but highlights the risk for non-relapse mortality in this group.

     

    383 Risk of Transformation by Frontline Management in Follicular Lymphoma and Marginal Zone Lymphoma: A US Population-Based Analysis

    EMBARGOED UNTIL Saturday, December 9, 2023: 5 PM

    Presenting Author: Jorge A. Florindez, MD, University of North Carolina School of Medicine

    Sylvester Authors: Izidore S. Lossos, MD, and Juan Pablo Alderuccio, MD

    Intro: Some patients with follicular or marginal zone lymphoma experience high-grade transformation (HGT) into diffuse large B-cell lymphoma. This study used population-based data to assess incidence and risk factors for HGT, post-HGT overall survival and lymphoma-specific survival across subtypes with treatment or surveillance as initial strategies.  

    Conclusion: Frontline treatment was associated with lower risk for HGT in follicular lymphoma, with advanced stage and female gender identified as risk factors. For other lymphomas, initial treatment neither diminished HGT risk nor improved survival afterward. 

     

    Myelodysplastic Syndromes/Neoplasms

    998 Data-Driven Harmonization of 2022 WHO and ICC Classifications of Myelodysplastic Syndromes/Neoplasms (MDS): A Study By the International Consortium for MDS (icMDS)

    EMBARGOED UNTIL Monday, December 11, 2023: 4:45 PM

    Presenting Author: Luca Lanino, MD, Humanitas Clinical and Research Center, Milano, Italy

    Sylvester Authors: Mikkael A. Sekeres, MD, Justin Taylor, MD and Stephen D. Nimer, MD

    Intro: Significant discrepancies still exist between WHO and ICC classifications of myelodysplastic syndromes/neoplasms, despite their recent inclusion of gene mutations and chromosomal abnormalities to enhance diagnosis and clinical decision-making. These differences potentially cause inconsistent practices within the clinical setting. This study for the International Consortium for MDS adopted a data-driven model to develop a harmonization road map for these classifications.

    Conclusion: The study demonstrated the value of this approach based on advanced statistical methods to generate harmonized MDS classifications.

     

    750 Bromodomain and Extra-Terminal Inhibitor INCB057643 (LIMBER-103) in Patients with Relapsed or Refractory Myelofibrosis and Other Advanced Myeloid Neoplasms: A Phase 1 Study

    EMBARGOED UNTIL Monday, December 11, 2023: 11:45 AM

    Presenting Author: Justin Watts, MD, Sylvester Comprehensive Cancer Center

    Intro: Bromodomain and extra-terminal (BET) proteins regulate expression of critical oncoproteins associated with myelofibrosis (MF) and other blood-cancer malignancies, including B-lymphoma-2. This ongoing Phase 1, dose-escalation study is evaluating the safety and tolerability of a BET inhibitor as monotherapy and in combination with ruxolitinib.

    Conclusion: Monotherapy and combination therapy with ruxolitinib were generally well-tolerated, except for the largest monotherapy amount that caused two dose-limiting toxicities. Dose-finding for both therapies is ongoing to determine the recommended expansion dose.

     

    1872 Olutasidenib Alone or in Combination with Azacitidine Induces Durable Complete Remissions in Patients with mIDH1 Myelodysplastic Syndromes/Neoplasms (MDS)

    EMBARGOED UNTIL Saturday, December 9, 2023: 5:30-7:30 PM, Halls G-H (San Diego Convention Center)

    Senior Author: Justin M. Watts, MD, Sylvester Comprehensive Cancer Center (Presenting author is Jorge Cortes, MD, Georgia Cancer Center, Augusta)

    Intro: Olutasidenib, a small molecule drug that targets a mutation involved in certain cancers and is approved for relapsed and refractory acute myeloid leukemia (AML), was studied in 22 patients with a specific type of myelodysplastic syndromes/neoplasms (MDS).

    Conclusion: In this subgroup of patients in a Phase 1/2 study, the drug – used both alone and in combination with another drug – induced durable remissions in patients with intermediate-, high-, or very high-risk MDS, and the treatment had a tolerable and manageable safety profile.

     

    1860 Correlation between Peripheral Blood and Bone Marrow Somatic Mutations Among Patients with Suspected or Established Myelodysplastic Syndromes from the National MDS Study

    EMBARGOED UNTIL Saturday, December 9, 2023: 5:30-7:30 PM, Halls G-H (San Diego Convention Center)

    Senior Author: Mikkael A. Sekeres, MD, Sylvester Comprehensive Cancer Center (Presenter: Amy E. DeZern, MD, Johns Hopkins University)

    Intro: Myelodysplastic syndromes (MDS) – disorders of blood cells in the bone marrow – may result from mutations in stem cells responsible for blood cell creation. Screening and monitoring of some diseases can be accomplished by assessing mutations in peripheral blood, from a basic blood draw, but because the ability to detect and monitor mutations involved with MDS and related conditions is less certain, guidelines often require invasive bone marrow evaluations instead.

    Conclusion: This study, which included 36 patients, compared results from peripheral blood and bone marrow studies and found that peripheral blood can be used to reliably identify somatic (non-hereditary) mutations in patients with suspected or established MDS and related conditions.

     

    4613 Impact of Type of Hypomethylating Agent (HMA) Used on Outcomes of Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) – A Large, Multicenter, Retrospective Analysis

    EMBARGOED UNTIL Monday, December 11, 2023: 6-8 PM, Halls G-H (San Diego Convention Center)

    Sylvester Co-Authors: Mikkael A. Sekeres, MD, and Namrata Sonia Chandhok, MD, Sylvester Comprehensive Cancer Center (Presenting Author: Jan Philipp Bewersdorf, MD, Memorial Sloan Kettering Cancer Center)

    Intro: This multicenter analysis aimed to provide a better understanding of treatment options for patients with cancers of blood cells in the bone marrow – higher-risk myelodysplastic syndromes/neoplasms (HR-MDS). Two drugs, azacitidine and decitabine, both hypomethylating agents, or HMA, provide the foundation of mainstay, frontline treatments for HR-MDS, but they have not been compared directly in randomized trials.

    Conclusion: This study, involving 1,223 patients, with 919 patients included in the survival analysis, found no significant difference in overall survival or overall responses between the two groups of patients treated with the drugs.

     

    44 Altered RNA Export in SF3B1 Mutants Increases Sensitivity to Nuclear Export Inhibition 

    EMBARGOED UNTIL Saturday, December 9, 2023: 9:45 AM 

    First Presenter: Sana Chaudhry, Sylvester Comprehensive Cancer Center 

    Senior Author: Justin Taylor, MD, Sylvester Comprehensive Cancer Center 

    Intro: About half of MDS patients carry genetic alterations, known as somatic mutations, in spliceosome genes, with SF3B1 being the most commonly mutated one. However, no successful therapy exists to target this pathway. The authors hypothesized that XPO1 inhibition may preferentially affect these mutant cells via splicing, and that high-risk MDS patients with this mutation would have a better response to rational drug combinations with next-generation XPO1 inhibitors. 

    Conclusion: The study provides insight on the mechanisms behind the increased effectiveness of XPO1 inhibition in SF3B1-mutant MDS and leukemia patients. These findings also may contribute to development of potentially beneficial drug combinations. 

     

    Leukemias

    The Future Paradigm of HMA + ven or Targeted Inhibitor Approaches: Sequencing or Triplet Combinations in AML Therapy

    EMBARGOED UNTIL Sunday, December 10, 2023: 4:30-5:45 PM, Room 6CF (San Diego Convention Center

    Presenting Author: Justin M. Watts, MD, Sylvester Comprehensive Cancer Center

    Description: This Education Session will review the transformation in AML therapy from traditional 7+3 for fit patients and hypomethylating agents for unfit patients to new standards of care and ongoing questions in the field. We will discuss the data regarding the development of hypomethylating agents plus venetoclax as the new standard of care for older patients and those not eligible for induction chemotherapy. There is growing interest in the use of HMA/Ven combinations for younger and fit patients and in specific subsets of AML; limited data in these patient populations and ongoing clinical trials will be reviewed. Resistance to HMA/Ven therapy remains a significant concern, and recent data regarding mechanisms of resistance and potential strategies to overcome ven resistance will be addressed. Given the FDA approval of several targeted agents in AML since 2017, there is a need to understand and optimize the use of these medications in combinations with traditional AML therapy. Questions regarding combinations, sequencing and management of toxicities will be discussed. Optimization of 7+3 chemotherapy in specific subsets of AML will be reviewed, including 7+3 based combinations with FLT3 inhibitors or gemtuzumab, as well as the use of CPX-351 in older patients with secondary AML and recent data in other AML patient populations. 

     

    2888 Olutasidenib for the Treatment of mIDH1 Acute Myeloid Leukemia in Patients Relapsed or Refractory to Hematopoietic Stem Cell Transplant, Prior mIDH1 Inhibitor, or Venetoclax

    EMBARGOED UNTIL Sunday, December 10, 2023: 6-8 PM, Halls G-H (San Diego Convention Center)

    Senior Author: Justin M. Watts, MD, Sylvester Comprehensive Cancer Center (Presenter: Jorge Cortes, MD, Georgia Cancer Center, Augusta)

    Intro: Olutasidenib, a small molecule drug approved for treatment of relapsed and refractory acute myeloid leukemia, targets a specific mutation that exists in these cancers. It is being studied in subsets of patients whose disease returned after treatment with stem cell transplant or the drugs ivosidenib (IVO) or venetoclax (VEN). The research team is conducting post-study analyses to better understand the response to olutasidenib in these poor-prognosis subgroups.

    Conclusion: Olutasidenib alone or in combination with a drug called azacitidine may induce complete remissions in patients with this type of AMD or myelodysplastic syndromes/neoplasms (MDS) that was relapsing or refractory to VEN, IVO or even hematopoietic stem cell transplant. This supports further study in larger groups of difficult-to-treat patients.

     

    918 Patient-Reported Outcomes in Acute Myeloid Leukemia Patients with FLT3-ITD Mutation Receiving Quizartinib Vs. Standard Chemotherapy: Results from the Quantum-First Trial – Clinically Relevant Abstract

    EMBARGOED UNTIL Monday, December 11, 2023: 4 PM

    Presenting Author: Esther Natalie Oliva, MD, U.O.C. Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy

    Senior Author: Mikkael A. Sekeres, MD, Sylvester Comprehensive Cancer Center

    Intro: QuANTUM-First, a global, Phase 3 clinical trial evaluated the safety and effectiveness of the novel oral inhibitor quizartinib in combination with standard first-line and consolidation chemotherapy, and as a maintenance monotherapy for adults with acute myeloid leukemia (AML). While quizartinib showed clinically meaningful improvements in overall survival, an exploratory endpoint assessed its impact on patient-reported outcomes. The authors report the first longitudinal results of these outcomes.

    Conclusion: Quizartinib showed improvement in overall survival without any detrimental impact on quality of life and symptoms when added to standard chemotherapy, followed by maintenance monotherapy in newly diagnosed AML patients.

     

    Lung Cancer

    2649 Predictors and Timing of Venous Thromboembolism in Lung Cancer

    EMBARGOED UNTIL Sunday, December 10, 2023: 6-8 PM, Halls G-H (San Diego Convention Center)

    Presenter: Thomas Plate IV, MD, Sylvester Comprehensive Cancer Center (all authors affiliated with Sylvester and/or University of Miami)

    Intro: Venous thromboembolism (VTE), the blockage of a blood vessel by a clot, is a common complication in lung cancer, and physicians often prescribe blood thinners for prevention, but there’s uncertainty about true incidence, risk factors and effects of treatments with various subtypes of lung cancer. Sylvester researchers analyzed data from their tumor registry to identify patients diagnosed with lung cancer between 2018 and 2022 and assess venous thromboembolism events and related factors.

    Conclusion: The retrospective study found an increased risk of VTE among patients treated for lung cancer and determined that the development of thrombosis was associated with a significantly decreased overall survival. Every subgroup of patients was at high risk of developing VTE. Statistical analyses showed that VTE and other factors including age, gender, cancer stage, and blood counts were significant predictors of death.

     

    Myeloid Malignancies

    1547 E7820, an Anti-Cancer Sulfonamide, in Combination with Venetoclax in Patients with Splicing Factor Mutant Myeloid Malignancies: A Phase II Clinical Trial

    EMBARGOED UNTIL Saturday, December 9, 2023: 5:30-7:30 PM, Halls G-H (San Diego Convention Center)

    Senior Author: Justin Taylor, MD, Sylvester Comprehensive Cancer Center (Additional Sylvester co-authors: Namrata Sonia Chandhok, MD, [co-first author] and Justin M. Watts, MD) (Presenting author: Jan Philipp Bewersdorf, MD, Memorial Sloan Kettering Cancer Center)

    Intro: Researchers at Sylvester and Memorial Sloan Kettering have studied the effects of an experimental drug, E7820, in patients with relapsing or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) that result from mutations in certain genes. Preclinical data from their work shows a synergy between E7820 and a drug called venetoclax.

    Conclusion: Based on preclinical data, the researchers plan to amend their current Phase 2 study to include a separate arm of E7820 in combination with venetoclax – a combination that has never been studied in human AML and MDS patients.

     

    Multiple Myeloma

    210 Efficacy and Safety of Daratumumab (DARA) Monotherapy in Patients with Intermediate-Risk or High-Risk Smoldering Multiple Myeloma (SMM): Final Analysis of the Phase 2 Centaurus Study EMBARGOED UNTIL Saturday, December 9, 2023: 3:15 PM, Harbor Ballroom (Manchester Grand Hyatt San Diego) Presenting Author: Ola Landgren, MD, Sylvester Comprehensive Cancer Center Intro: Smoldering multiple myeloma (SMM) is a precursor disorder to multiple myeloma (MM). Current guidelines recommend only active monitoring for SMM, with treatment beginning only when it progresses to MM, but therapeutic intervention at the earlier stage may help delay progression to MM. Investigators in this multicenter collaboration hypothesized that daratumumab (DARA), a monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action, could delay progression of SMM to MM. Preliminary results of the Phase 2 CENTAURUS study were previously reported. Here, the researchers present the final analysis. Conclusion: Findings from the final analysis continue to demonstrate the clinical activity of DARA monotherapy in patients with intermediate- or high-risk SMM after a median follow-up of approximately seven years. No new safety concerns were observed.

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  • Cell Therapy Appears Safe and Effective for Lymphoma in Remission

    Cell Therapy Appears Safe and Effective for Lymphoma in Remission

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    DOWNLOADABLE VIDEO HERE

    Newswise — MIAMI, FLORIDA (EMBARGOED UNTIL SUNDAY, DEC. 10, 2023 AT 8:00 P.M. ET) – A study led by researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine suggests that CAR-T immunotherapy remains a viable option for patients who have lymphoma that goes into remission before the cell therapy begins.

    While the study doesn’t answer the question of whether cell therapy in remission is the right choice, it does say that it’s not the wrong choice.

    “I don’t think it answers the question of: Should we give these patients cell therapy? But I think it answers the question that we can – that it’s safe and that it’s a reasonable strategy when you’re in that spot,” said Trent Wang, D.O., a Sylvester hematologist and cellular therapy specialist who will present study findings in an oral presentation at the 65th ASH Annual Meeting and Exposition, the American Society of Hematology’s conference taking place in San Diego, California, Dec. 9-12.

    Most patients receiving cell therapy, a form of immunotherapy that uses immune cells engineered to recognize and attack the patient’s cancer, desperately need it. For some, it comes after many other treatments have failed. But Wang noticed an odd phenomenon in the past few years when treating lymphoma patients with this form of therapy: Some of his patients went into complete remission before the cells ever touched their bodies.

    This uncommon scenario occurs during the process of getting to cell therapy, which in the case of Wang’s study uses a kind of engineered immune cell known as CAR-T cells. When a patient starts the process, there’s a waiting period of three to five weeks before they get the treatment. Insurance approval is needed, and the cells themselves need to be manufactured from the patient’s own cells. But many of these patients are very sick with their cancer, so physicians will often treat them with a short course of chemotherapy or other drugs to tamp down the symptoms.

    A small handful of these patients end up in remission during this waiting period treatment, the clinicians have found.

    “That prompted this dilemma: Now what are we supposed to do?” Wang said. “Should we change the plan or give the therapy anyway? We just didn’t have a lot of information on this scenario.”

    Wang said more often than not his team would proceed with the cell therapy in these cases, mainly to prevent yet another stretch of time where the patients’ cancer might come back again. But it didn’t feel like a very informed decision.

    Wang and his colleagues noticed that their patients who received the cells while in remission tended to fare well after their infusion. But they didn’t know if those results would hold up in an analysis of a larger group. They proposed a research study to the Center for International Blood & Marrow Transplant Research, a nationwide registry that tracks patients who have received transplants and/or cell therapies.

    The study included data from 134 patients in the registry who had gone into complete remission in the waiting period before receiving their cell therapy. To find that group, the scientists screened the records for more than 5,000 cell therapy patients.

    They found that this group of patients had a 43% probability of progression-free survival over the two years following their treatment, about the same percentage as patients in the registry who were not in remission when they received CAR-T. However, the patients in remission had very low levels of toxicities related to their cell therapies, namely an immune overreaction known as cytokine release syndrome and neurotoxicity, two side effects that can sometimes accompany CAR-T cell therapy.

    The study used data from patients treated with CAR-T cell therapy between 2015 to 2021, and current frequencies of specific cell therapy use are slightly different from those that were used in practice just a few years ago, Wang said. Next, the researchers want to explore the data paralleling more recent treatment trends.

    Authors: Wang, first author, and Antonio M. Jimenez Jimenez, M.D., last author, are Sylvester researchers. Co-authors include Kwang Wooahn, Ph.D., Manmeet Kaur, and Mehdi Hamadani, M.D., Medical College of Wisconsin; Mazyar Shadman, M.D., Fred Hutchinson Cancer Center, Seattle; Alex F. Herrera, M.D., City of Hope, Duarte, California; and Craig S. Sauter, M.D., Taussig Cancer Institute, Cleveland.

    Conflicts and disclosures: A full list of disclosures is included with the abstract.

    # # #

    Presentation Title: 615 Chimeric Antigen Receptor (CAR) T Cell Infusion for Large B Cell Lymphoma in Complete Remission: A Center for International Blood & Marrow Transplant Research (CIBMTR) Analysis 

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  • Landscape for AML Patients Evolving Rapidly as Research Discoveries Advance New Treatments

    Landscape for AML Patients Evolving Rapidly as Research Discoveries Advance New Treatments

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    Newswise — MIAMI, FLORIDA (EMBARGOED UNTIL DEC. 10, 2023, AT 7:30 P.M. ET) – The treatment landscape for acute myeloid leukemia (AML) is evolving rapidly, as research discoveries at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and other academic cancer centers advance new, more effective therapies for this aggressive blood cancer. 

    “We’ve seen more progress during the past 10 years than the previous four decades combined,” said Justin M. Watts, M.D., Sylvester hematologist, associate professor of medicine, and Pap Corps Early Career Endowed Professor in Leukemia, “especially when it comes to treating older AML patients.”

    Watts, who serves as chief of the leukemia section at Sylvester, will highlight new drugs, such as Venetoclax plus Azacitidine, and new targeted therapies resulting from research advances when he leads an educational session at ASH 2023, the annual meeting of the American Society of Hematology in San Diego, Dec. 9-12.

    The session is designed to update community-based physicians who treat AML patients on current standards of care for using these new drugs sequentially or in triplet combinations with targeted inhibitors.  

    Background

    Acute myeloid leukemia is a cancer characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood-cell production. It’s one of the most common leukemia types in adults, although it’s fairly rare, accounting for about 1% of all cancers.

    It tends to afflict older adults, with 68 being the median age when first diagnosed, according to the American Cancer Society. Men are slightly more at risk than women.

    Typically, AML patients have been treated with intensive chemotherapy and a bone-marrow or stem-cell transplant. Those therapies are generally more effective in people under age 60. “We can cure about 60% of younger patients now, which is significantly better than just two decades ago,” said Watts. “But older patients, depending on their fitness level, don’t usually tolerate these treatments and historically less than 10 percent were cured, but this is now pushing 30% with the advent of venetoclax plus azacitidine and targeted inhibitors.”

    Until recently, next steps for these patients were limited to supportive care and blood transfusions, he added.

    Targeted Therapies for Mutations

    However, the outlook has improved, especially for older patients, with the emergence of new drugs and targeted inhibitors for the mutations driving AML, Watts says.

    “AML is almost always driven by mutations acquired over time,” he explained. “That’s why the risk of AML increases as we age.”

    Although there are hundreds of mutations that can cause this blood cancer, and most patients have more than one, there are five more common ones that are targetable: IDH1, IDH2, FLT3, NPM1 and MLL, Watts said. All of these now have approved therapies – or ones in development – thanks to ongoing research at Sylvester and other cancer centers.

    The results are encouraging. “We’re seeing very promising results in our studies and trials, combining Venetoclax, Azacitidine and targeted therapies, often as frontline therapy for AML,” he noted.

    Watts said the combination of Venetoclax and Azacitidine is producing good outcomes in about 52% of older patients, and the median survival is more than 2 years in these patients, with some patients living much longer.  

    Additionally, targeted therapies are proving effective, even in relapsed patients, and these treatments are also better tolerated than chemotherapy.

    Now, researchers like Watts and his colleagues must determine the best way to combine venetoclax and targeted therapies to produce the best outcomes. “That includes designing clinical trials to help us identify the optimal combinations for the right patients with specific mutations,” he explained, “and determining when we stop therapy for patients in a long remission.”

    On the Horizon

    Watts said that up to 50% of AML patients have a mutation for which there is no current targeted therapy. “We have to expand our targeted therapies to treat AML patients with harder to target mutations,” he explained, citing TP53 and RAS mutations as two common pathways for treatment resistance. “We currently have few approved therapies that are effective for these patients, especially if they are older.”

    Watts believes the future direction for AML treatment will involve targeted therapy combined with the “best backbone we have, possibly chemotherapy for younger patients or the drugs like venetoclax and azacitidine generating good results for older adults.”

    One of the biggest things that may come into play is immunotherapy, he said. “I can see us getting the immune system more involved in treating these blood cancers, as it has done with solid tumors and lymphoma.”

    Disclosures

    Dr. Watts serves on the consulting/advisory boards of Rigel, Servier, Celgene/BMS, Daiichi Sankyo, Aptose and Ativarre. He receives research funding from Takeda, Immune Systems Key Ltd, and Rigel.

    # # # 

    ASH Presentation Title:

    “The Future Paradigm of HMA + VEN or Targeted Inhibitor Approaches: Sequencing or Triplet Combinations in AML Therapy”

    Presentation Date/Time:

    Sunday, Dec. 10, 2023, 7:30 to 8:45 pm ET (4:30 to 5:45 pm PT)

    # # #

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  • ASH: Novel combination therapy significantly reduces spleen volume in patients with myelofibrosis

    ASH: Novel combination therapy significantly reduces spleen volume in patients with myelofibrosis

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    Newswise — SAN DIEGO ― Combining the JAK inhibitor ruxolitinib with the BCL-xL inhibitor navitoclax was twice as effective in reducing enlarged spleens – a major indicator of clinical improvement – compared with standard-of-care ruxolitinib monotherapy for adult patients with intermediate or high-risk myelofibrosis, a rare bone marrow cancer, according to results of the Phase III TRANSFORM-1 trial reported by researchers from The University of Texas MD Anderson Cancer Center.

    Data from the global, randomized, placebo-controlled clinical trial were presented today at the 2023 American Society of Hematology (ASH) Annual Meeting by Naveen Pemmaraju, M.D.,  professor of Leukemia. At the time of data cut-off, 63.2% of patients who received ruxolitinib and navitoclax achieved a spleen volume reduction of at least 35% within 24 weeks, compared to 31.5% of patients receiving ruxolitinib plus placebo, meeting the study’s primary endpoint.

    “By adding a second drug to an approved therapy, we were able to improve spleen volume reduction compared to the current standard of care. This is an important measurement of the clinical benefits of this novel drug combination because treatments can be less effective when the spleen remains enlarged,” Pemmaraju said. “If we can treat myelofibrosis earlier on in the disease course, we may have an opportunity to impact overall disease modificationimprove patient outcomes and reduce symptom burden.”

    Currently, there are few Food and Drug Administration-approved drugs for the treatment of myelofibrosis. Available options provide patients with spleen and symptom improvement, but a substantial unmet need remains for therapies that provide durable spleen size reduction and other longer-term clinical. Allogenic stem cell transplants are an effective treatment option, but not all patients qualify.

    This international trial enrolled 252 patients with intermediate or high-risk myelofibrosis and measurable spleen enlargement who had not received prior JAK inhibitor treatment. The trial randomized 125 patients to receive the navitoclax and ruxolitinib combination and 127 patients to receive ruxolitinib plus placebo. Most patients were male (57%) and the median age was 69.

    The trial met its primary endpoint of spleen volume reduction at 24 weeks. Spleen volume reduction at any time was achieved by 77% of patients on the combination arm and 42% of patients on the control arm. The median time to first spleen volume reduction response was 12.3 weeks with the combination and 12.4 weeks with monotherapy. At 24 weeks, there were no significant differences between the groups in a myeloproliferative neoplasm symptom assessment, a secondary endpoint of the study.

    Patients treated with the combination therapy, patients experienced side effects that were manageable and consistent with previous trials. The most common treatment-related side effects were thrombocytopenia, anemia, diarrhea and neutropenia. Serious adverse events were experienced by 26% of patients on the combination arm and 32% on the control arm.

    “This study marks a notable achievement in the field of myelofibrosis, as one of the first reported global Phase III frontline randomized combination clinical trials in our field,” Pemmaraju said. “This dataset now opens the door for additional research and investigation into combination therapies to treat myelofibrosis and, importantly, highlights a potential new era of investigating disease modification for patients. Additional data from the TRANSFORM-1 study is being evaluated.”

    The trial was funded by AbbVie. Pemmaraju receives research support from AbbVie. A full list of co-authors and their disclosures may be found here.

    Read this press release in the MD Anderson Newsroom.

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    University of Texas MD Anderson Cancer Center

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  • ASH: Targeted oral therapy reduced disease burden and improved symptoms for patients with rare blood disorder

    ASH: Targeted oral therapy reduced disease burden and improved symptoms for patients with rare blood disorder

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     Newswise — SAN DIEGO ― The targeted therapy bezuclastinib was safe and rapidly reduced markers of disease burden while also improving symptoms for patients with a rare blood disorder called nonadvanced system mastocytosis, according to results of the Phase II SUMMIT trial reported by researchers at The University of Texas MD Anderson Cancer Center.

    The findings, presented today at the 2023 American Society of Hematology (ASH) Annual Meeting, demonstrate that all participants treated with bezuclastinib achieved at least a 50% reduction in markers of disease burden and 63% reported their disease symptoms eased within 12 weeks. That number increased to 78% after an additional eight weeks of treatment, at which time all patients also reported an improvement in pain symptoms.

    “The era of targeted therapy offers hope, not just for alleviating symptoms but for getting to the root of the condition,” said principal investigator Prithviraj Bose, M.D., professor of Leukemia. “Bezuclastinib provides precision targeting without the typical central nervous system or bleeding side effects often associated with similar drugs.”

    Systemic mastocytosis (SM) is a rare disease marked by the buildup of malignant mast cells in the bone marrow and other tissues. These high levels of abnormal mast cells can lead to a multitude of symptoms due to the release of chemicals called mediators. SM can range from non-advanced (NonAdvSM) to advanced disease (AdvSM), with symptoms that can include brain fog and skin rashes to gut issues and life-threatening anaphylaxis.

    In up to 95% of patients, SM is driven by the KIT D816V gene mutation. Treatments targeting this mutated kinase have been used for AdvSM variants, but they are known to have off-target activity that can cause toxicities that restrict dosing and, therefore, limit efficacy.

    There are two variants within NonAdvSM: indolent systemic mastocytosis (ISM) and smoldering systemic mastocytosis (SSM). ISM, which affects the majority of patients with SM, is characterized mostly by symptoms related to mast cell degranulation and mediator release. SSM is identified by a higher mast cell burden, marked by high levels of blood enzymes like serum tryptase, but without resulting organ damage.

    Bezuclastinib is a potent type-1 tyrosine kinase inhibitor that blocks mutant KIT D816V activity while sparing other kinases, minimizing the potential for off-target side effects. In a separate, prior studies, the drug demonstrated minimal brain penetration in animals and no central nervous system toxicities in patients with AdvSM.

    The first part of the SUMMIT trial followed 20 patients with NonAdvSM for a median duration of seven months. The majority were female (75%) with a median age of 50. Seventy-five percent of patients had the KIT D816V mutation, and all had moderate-severe symptoms. Patients were treated with either 100 or 200 mg of bezuclastinib or with placebo. All patients continued to receive their baseline anti-mediator treatments throughout the trial.

    Researchers evaluated the efficacy of bezuclastinib through multiple patient-reported outcome measures and changes in markers of disease burden, such as serum tryptase, bone marrow mast cell percentage and KIT D816V mutation allele burden.

    Patients who received the 100 mg dose experienced a median reduction in symptoms of 48.5% after 12 weeks. During this period, none of the patients in the placebo group reported significant improvement in their overall symptoms. However, after transitioning those patients to bezuclastinib treatment, 67% reported an improvement in their symptoms after four weeks. 

    After 20 weeks, more patients observed greater improvements in dermatological symptoms (78%), gastrointestinal symptoms (33%) and cognitive symptoms (33%) compared to the 12-week mark.

    Adverse events generally were mild and reversible, with the most frequent being a change in hair color, nausea and peripheral edema. No serious adverse events related to bezuclastinib were reported in the 100 mg or 200 mg cohorts.

    “This drug may offer great promise in the treatment of non-advanced systemic mastocytosis,” Bose said. “As we move forward, our aspiration is to optimize the dosage while maintaining a robust safety profile.”

    To futher assess the drug’s efficacy in patients with NonAdvSM, next steps for the SUMMIT trial include comparing bezuclastinib against placebo once the optimal dose is determined. Part Ib of the trial will investigate 100mg and 150 mg daily doses that use a different formulation of the drug, and those results are expected in 2024, Bose explained.

    The SUMMIT trial was sponsored by Cogent Biosciences. Bose reports relationships with Cogent Biosciences, GSK, Novartis, Karyopharm, AbbVie, PharmaEssentia, Jubilant, Morphic, Kartos, Telios, Disc, Jassen, Geron, Ionis, Incyte, Bristol Myers Squibb, Sobi, MorphoSys, Blueprint and Sumitomo. A full list of co-authors and disclosures can be found with the abstract.

    Read this press release in the MD Anderson Newsroom.

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    University of Texas MD Anderson Cancer Center

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