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  • Inovação em IA da Mayo Clinic traz expectativa para a detecção precoce de câncer de pâncreas

    Inovação em IA da Mayo Clinic traz expectativa para a detecção precoce de câncer de pâncreas

    Newswise — ROCHESTER, Minnesota — Existe uma estimativa de que o câncer de pâncreas se tornará a segunda causa principal de morte provocada por câncer até 2030. Com um prognóstico desolador, aproximadamente 70 por cento dos pacientes morrem no primeiro ano de diagnóstico. Infelizmente, 40 por cento dos cânceres de pâncreas não são detectados nos exames de tomografia computadorizada (TC), então, eles avançam para um estágio incurável.

    Esse cenário cria uma barreira crítica, a “última fronteira” para os esforços de detecção precoce, e para maioria dos pacientes, inclusive aqueles com alto risco que passam pela triagem ativa, o exame de imagem detecta o câncer em um estágio onde a cura é improvável. Isso faz com que o exame de imagem se torne a última fronteira na busca da detecção precoce do câncer.

    Em um avanço recente, os pesquisadores do Centro de Câncer da Mayo Clinic usaram o conjunto de dados de exames de imagens mais extenso do mundo para construir um modelo de inteligência artificial (IA) versátil que demonstrou o potencial de detecção autônoma do câncer de pâncreas em tomografias computadorizadas onde a intervenção cirúrgica ainda pode gerar a cura.

    “Aqui é onde o estudo surge como um farol de otimismo”, explica Ajit H. Goenka, médico radiologista na Mayo Clinic, pesquisador principal e autor correspondente. “Ele soluciona o desafio da última fronteira ao detectar o câncer em um estágio no qual ele ainda está além do escopo de especialistas.”

    O grupo desenvolveu um modelo de IA altamente preciso, treinado no maior e mais diverso conjunto de dados de tomografia computadorizada, com mais de 3 mil pacientes, para a detecção de câncer completamente automatizada, inclusive os tumores pequenos e outros de difícil detecção. Publicado na Gastroenterology, a revista da Associação Americana de Gastroenterologia, o estudo não só se baseia no trabalho recente do grupo sobre modelos de detecção precoce baseados em radiômica, como também destaca a posição da Mayo Clinic como um farol de inovação para as soluções de cuidados em saúde com o uso de IA.

    O mais importante é que o modelo poderia detectar o câncer visualmente imperceptível a partir dos pâncreas com aparências normais em exames de imagens pré-diagnósticas de tomografia computadorizada, ou seja, as imagens obtidas em 3 a 36 meses antes do diagnóstico clínico, substancialmente precoces, em média 438 dias, antes do diagnóstico clínico.

    “Essas descobertas sugerem que a IA tem o potencial de detectar cânceres ocultos em pessoas assintomáticas, permitindo o tratamento cirúrgico em um estágio no qual a cura ainda é possível”, explica o Dr. Goenka. 

    Finalmente, o modelo permaneceu confiável e preciso entre os diversos grupos e variações de pacientes no equipamento de varredura e técnicas de exame de imagem. Essa resiliência é fundamental para a utilidade do modelo em um amplo conjunto de cenários médicos no mundo real.

    Ao lidar com um interesse principal no cenário de cuidados em saúde com o uso de IA, a equipe também desconstruiu um processo de tomada de decisão da IA para garantir transparência e reconhecer que a confiança e controle de qualidade são essenciais para a aceitação clínica mais ampla da IA.

    “Devemos esse progresso aos esforços engenhosos da Estrutura para Tecnologia de Software em IA, equipe liderada pelo Dr. Panagiotis Korfiatis e complementada pela nossa equipe de bolsistas de pesquisa e analistas de ciência de dados excepcionalmente brilhantes”, explica o Dr. Goenka. “Eles dedicaram meses de preparação meticulosa para o nosso envio inicial e investiram um esforço significativo para responder astutamente às consultas incisivas do painel de analistas internacionais.”

    “Estamos apenas no começo, mas estamos preparados para lidar com os desafios relativos à detecção precoce de câncer e potencializar as capacidades da IA e do exame de imagem molecular de próxima geração em consonância com os biomarcadores moleculares”, acrescenta o Dr. Goenka.

    A Mayo Clinic já iniciou as etapas para a validação clínica e os modelos estão sendo submetidos a processos regulatórios. Com o apoio do Centro de Câncer da Mayo Clinic, a equipe está pronta para realizar ensaios de triagem prospectivos financiados por benfeitores. As descobertas a partir desses ensaios refinarão e reforçarão a efetividade prática de suas abordagens inovadoras.

    Seus esforços interdisciplinares envolvem coautores especialistas em radiologia (Dra. Garima Suman, Dr. Nandakumar Patnam Gopal Chetty, bacharel em medicina e cirurgia, Dra. Kamaxi H. Trivedi, bacharel em medicina e cirurgia, Dra. Aashna M. Karbhari, bacharel em medicina e cirurgia, Dr. Sovanlal Mukherjee, Dr. Cole J. Cook, mestre em ciências, Dr. Jason R. Klug, Dr. Naveen Rajamohan, Dra. Hala A. Khasawneh, Dr. Joel G. FletcherDra. Candice W. Bolan e Kumar Sandrasegaran, bacharel em medicina e cirurgia), cirurgia (Dr. Mark J. Truty, mestre em ciências) e gastroenterologia (Dr. Shounak Majumder e Dr. Suresh T. Chari).

    A pesquisa relatada neste comunicado de imprensa recebeu apoio do Instituto Nacional do Câncer dos Institutos Nacionais de Saúde com os números de subvenção R01CA272628 e R01CA256969, assim como da Fundação de Caridade Centene e Programa de Pesquisa para o Câncer de Pâncreas Campeões do Otimismo da Fundação Funk Zitiello. O conteúdo é de responsabilidade exclusiva dos autores e não representa necessariamente as opiniões oficiais dos Institutos Nacionais de Saúde.

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    Sobre a Mayo Clinic
    Mayo Clinic é uma organização sem fins lucrativos comprometida com a inovação na prática clínica, educação e pesquisa, fornecendo compaixão, conhecimento e respostas para todos que precisam de cura. Visite a Rede de Notícias da Mayo Clinic para obter outras notícias da Mayo Clinic.

    Mayo Clinic

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  • 75,000 Kaiser Permanente Workers Strike, Demand Better Pay | Entrepreneur

    75,000 Kaiser Permanente Workers Strike, Demand Better Pay | Entrepreneur

    On Wednesday, more than 75,000 unionized employees of nonprofit health provider Kaiser Permanente initiated the largest healthcare worker strike in the country’s history, CNN reported. The strike is scheduled to continue until Saturday.

    The 75,000 employees are represented by eight unions across five states (Washington, Virginia, Colorado, California, Oregon, and the District of Columbia) and account for 40% of Kaiser Permanente’s workforce.

    The employees on the picket line include nurses, dietary workers, receptionists, optometrists, and pharmacists. The strike was prompted by the expiration of union contracts on September 30. Negotiations with Kaiser continued up until the strike’s commencement, but didn’t reach a resolution, James Santos, a field coordinator for the coalition of Kaiser unions in Virginia, told CNN.

    The workers are fighting for better pay and benefits, as well as looking to resolve disputes over staffing levels.

    Striking Kaiser Permanente workers march in front of the Kaiser Permanente San Francisco Medical Center on Wednesday in San Francisco, California. Justin Sullivan | Getty Images.

    The issue of understaffing has led to safety concerns and burnout, Caroline Lucas, executive director of the Coalition of Kaiser Permanente Unions, told CNBC.

    “We continue to have front-line health-care workers who are burnt out and stretched to the max and leaving the industry,” Lucas told the outlet. “We have folks getting injured on the job because they’re trying to do too much and see too many people and work too quickly. It’s not a sustainable situation.”

    The strike is temporary, and employees plan to return to work on October 7, unless a further strike is called in November if no agreement is reached, per CNN.

    Entrepreneur has reached out to Kaiser Permanente for comment.

    Kaiser Permanente operates under a different model from traditional fee-for-service healthcare providers — where members pay dues to access Kaiser’s services, whereas for-profit providers charge a fee per each visit or service. While the strike may affect some patient care, the organization has taken precautions to minimize disruptions.

    “Our hospitals and emergency departments will remain open. Our facilities will continue to be staffed by our physicians, trained and experienced managers, and staff, and in some cases we will augment with contingent workers,” Kaiser Permanente told CNN in a statement.

    Related: After Losing Work in the Writer’s Strike, He Turned His ‘Weird Niche Hobby’ Into a Side Hustle That Brings in Hundreds of Dollars Per Sale

    Madeline Garfinkle

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  • New robot could help diagnose breast cancer early

    New robot could help diagnose breast cancer early

    Newswise — A device has been created that could carry out Clinical Breast Examinations (CBE).

    The manipulator, designed by a team at the University of Bristol and based at the Bristol Robotics Laboratory, is able to apply very specific forces over a range similar to forces used by human examiners and can detect lumps using sensor technology at larger depths than before.

    This could revolutionise how women monitor their breast health by giving them access to safe electronic CBEs, located in easily accessible places, such as pharmacies and health centres, which provide accurate results.    

    Precision, repeatability and accuracy are of paramount importance in these tactile medical examinations to ensure favourable patient outcomes. A range of automatic and semi-automatic devices have been proposed to aid with optimising this task, particularly for difficult to detect and hard to reach situations such as during minimally invasive surgery.

    The research team included a mix of postgraduate and undergraduate researchers, supervised by Dr Antonia Tzemanaki from Bristol Robotics Laboratory. Lead author George Jenkinson explained: “There are conflicting ideas about how useful carrying out Clinical Breast Examinations (CBE) are for the health outcomes of the population.

    “It’s generally agreed upon that if it is well performed, then it can be a very useful and low risk diagnostic technique.

    “There have been a few attempts in the past to use technology to improve the standard to which healthcare professionals can perform a CBE by having a robot or electronic device physically palpate breast tissue. But the last decade or so of technological advances in manipulation and sensor technology mean that we are now in a better position to do this.

    “The first question that we want to answer as part of this is whether a specialised manipulator can be demonstrated to have the dexterity necessary to palpate a realistic breast size and shape.”

    The team created their manipulator using 3D printing and other Computerised Numerical Control techniques and employed a combination of laboratory experiments and simulated experiments on a fake (silicone) breast and its digital twin, both modelled on a volunteer at the Simulation and Modelling in Medicine and Surgery research group at Imperial College London.

    The simulations allowed the team to perform thousands of palpations and test lots of hypothetical scenarios such as calculating the difference in efficiency when using two, three, or four sensors at the same time. In the lab, they were able to carry out the experiments on the silicone breast to demonstrate the simulations were accurate and to experimentally discover the forces for the real equipment.

    George added: “We hope that the research can contribute to and complement the arsenal of techniques used to diagnose breast cancer, and to generate a large amount of data associated with it that may be useful in trying to identify large scale trends that could help diagnose breast cancer early.

    “One advantage that some doctors have mentioned anecdotally is that this could provide a low-risk way to objectively record health data. This could be used, for example, to compare successive examinations more easily, or as part of the information packet sent to a specialist if a patient is referred for further examination.”

    As a next step, the team will combine CBE techniques learned from professionals with AI, and fully equip the manipulator with sensors to determine the effectiveness of the whole system at identifying potential cancer risks.

    The ultimate goal is that the device and sensors will have the capability to detect lumps more accurately and deeper than it is possible only from applying human touch. It could also be combined with other existing techniques, such as ultrasound examination.

    “So far we have laid all of the groundwork,” said George. “We have shown that our robotic system has the dexterity necessary to carry out a clinical breast examination – we hope that in the future this could be a real help in diagnosing cancers early.”

    This research was a part of project ARTEMIS, funded by Cancer Research UK and supported by EPSRC.

     

    Papers:

    ‘A robotIc Radial palpatIon mechaniSm for breast examination (IRIS)’ by George Jenkinson et al which was presented at the RO-MAN conference.

    University of Bristol

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  • Computer model predicts who needs lung cancer screening

    Computer model predicts who needs lung cancer screening

    Newswise — A machine learning model equipped with only data on people’s age, smoking duration and the number of cigarettes smoked per day can predict lung cancer risk and identify who needs lung cancer screening, according to a new study publishing October 3rd in the open access journal PLOS Medicine by Thomas Callender of University College London, UK, and colleagues.

    Lung cancer is the most common cause of cancer death worldwide, with poor survival in the absence of early detection. Screening for lung cancer among those at highest risk could reduce lung cancer deaths by nearly a quarter, but the ideal way to determine the high-risk population has been unclear. The current standard-of-care model of lung cancer risk requires 17 variables, few of which are routinely available in electronic health records.

    In the new study, researchers used data on 216,714 ever-smokers from the UK Biobank cohort and 26,616 ever-smokers participating in the US National Lung Screening Trial to develop new models of lung cancer risk.

    A machine learning model used three predictors — age, smoking duration and pack-years — to calculate people’s odds of both developing lung cancer and dying of lung cancer over the next five years. The researchers tested the new model on a third set of data, from the US Prostate, Lung, Colorectal and Ovarian Screening Trial. The model predicted lung cancer incidence with an 83.9% sensitivity and lung cancer deaths with an 85.5% sensitivity. All versions of the model had a higher sensitivity than the currently used risk prediction formulas at an equivalent specificity.

    Callender adds, “We know that screening for those who have a high chance of developing lung cancer can save lives. With machine learning, we’ve been able to substantially simplify how we work out who is at high risk, presenting an approach that could be an exciting step in the direction of widespread implementation of personalised screening to detect many diseases early.”

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    PLOS

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  • Surgical Scorecards May Cut Cost of Surgical Procedures Without Impacting Outcomes

    Surgical Scorecards May Cut Cost of Surgical Procedures Without Impacting Outcomes

    Key takeaways 

    • A tool for evaluating the overall cost of a surgical procedure, called a scorecard, helps reduce costs of surgical procedures between 5% and 20% without adversely affecting clinical outcomes.  
    • Further implementation of scorecards may move surgeons toward energy-efficient operating rooms, which are the largest hospital producer of emissions and waste.   

    Newswise — CHICAGO (October 3, 2023): Surgical scorecards, a tool that gives direct feedback to surgeons about their procedure costs in the operating room, may significantly reduce costs without impacting clinical outcomes, according to a studypublished in the Journal of the American College of Surgeons(JACS). 

    The surgical scorecard is a novel approach to addressing operating room costs. It is commonly delivered to the surgeon in the form of an email receipt, report card, or informational session summarizing the cost of their own surgical items, staffing, and the time used for any procedure in the operating room, as well as how those costs compare to colleagues’ costs and similar operations performed.   

    “The reality is that healthcare in the United States is exorbitantly expensive, and despite this increased spending, Americans don’t have better health outcomes than our high income country neighbors,” said lead study author Wesley Dixon, MD, an internal medicine resident physician at Brigham and Women’s Hospital in Boston, Massachusetts. “Our results show that scorecard implementation is one of many different methods that can be used to lower health-care costs, particularly operating room costs, which comprise a significant proportion of health-care spending. Using different cost saving interventions together can reduce overall U.S. health care spending without compromising patient care.”   

    Study design 

    The researchers carried out a scoping review, which synthesizes all available study results based on keyword searches, by scanning research databases such as PubMed, Embase, and Web of Science to gather more information about surgical scorecards and their impact on cost reduction. 

    Twenty-one studies published between 2011 and 2022 were included, spanning eight subspecialties and 30 procedures. Through a literature search, key elements of cost such as “surgical supplies,” “implants,” “wasted supplies,” and “operative time” were identified.  

    The data was then analyzed according to the impact of scorecards on the percentage change in cost per operation – from before the intervention to after the intervention, and the impact on patient outcomes, which included operative time, postoperative length of stay, complication rates, readmission rates, and mortality.   

    Key findings 

    • Of 30 total scorecard interventions measured across 21 studies, 16 out of 30 (53%) interventions showed surgical procedure cost reductions between 5% and 20%.  
    • For 11 studies, cost reduction was attributed to reduced use of specific high cost items. Cost savings can come from using less expensive alternatives or wasting fewer supplies (opened but unused during the operation).  
    • The most common surgical subspecialties included in the review were orthopedic and general surgery. A wide variety of procedures were included, but the most common were adult and pediatric laparoscopic appendectomy.  

    Making hospitals more energy efficient 

    “The biggest knowledge gap we identified in this study is that there is essentially no research connecting surgical scorecards to surgeons with environmental or emissions data related to the operating room,” Dr. Dixon said.  

    “Operating rooms contribute around 50% of hospital waste and are much more energy-intensive than the rest of the hospital, adding to the overall carbon footprint. Therefore, some of these data-driven feedback mechanisms that include carbon-related data would be a major step towards making the hospital a more energy-efficient place.” 

    A limitation of the study is that a large part of scorecard use nationwide is implemented as part of quality improvement initiatives and those results are not always published. Therefore, the results of this scoping review might underrepresent the true impact of surgical scorecards.  

    Study coauthors are Allan Ndovu; Millis Faust, MD; Tejas Sathe, MD; Christy Boscardin, PhD; Garrett R. Roll, MD, FACS; Kaiyi Wang, MS; and Seema Gandhi, MD. 

    The study authors have no disclosures. 

    This study is published as an article in press on the JACS website. 

    Citation: Cost-Saving in the Operating Room: A Scoping Review of Surgical Scorecards. Journal of the American College of Surgeons. DOI:10.1097/XCS.0000000000000846 

    # # # 

    About the American College of Surgeons 

    The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 88,000 members and is the largest organization of surgeons in the world. “FACS” designates that a surgeon is a Fellow of the American College of Surgeons. 

    American College of Surgeons (ACS)

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  • KEEP Announces Nationwide Launch, Transforming Home Safety and Medication Management

    KEEP Announces Nationwide Launch, Transforming Home Safety and Medication Management

    Today, KEEP Labs, the pioneering company in innovative storage solutions, is thrilled to announce the greatly anticipated launch of its groundbreaking product, KEEP, the world’s first smart storage device for medication and all life’s remedies.

    Since its inception in 2020, KEEP has been at the forefront of blending cutting-edge technology with stylish design, working to revolutionize the way we store, manage and monitor medication in the home. The nationwide launch marks a significant milestone in making this innovative solution accessible to households across North America.

    Rooted in its commitment to safety and innovation, WIFI and Bluetooth connected KEEP offers a modern solution for secure, discreet, and intelligent storage at home. Designed with a blend of style and functionality, KEEP ensures medications and other essentials are stored away from curious hands while appearing as a sleek piece of home decor. The KEEP companion app allows for secure biometric opening, real-time alerts for tampering or unauthorized movement, customizable LED display, medication management and passive adherence tracking.

    For the past three years we have worked hard to get this lifesaving product to market. It was not easy, but through talking to customers we were able to understand what both homes and healthcare needed and were able to build just that”, says Philip Wilkins, Co-Founder, KEEP Labs. “After selling out a 15,000 unit pre-order campaign we knew we had to keep going. Today is a very proud day for all of us at KEEP and brings us closer to our mission to create a safer and more responsible home and world for our children.

    KEEP addresses a growing need in today’s homes, where multiple generations often live together, and guests frequently visit. The company provides secure storage for medications, cannabis, vitamins, and other sensitive items. Traditional storage methods either lack security or are inconvenient, leading to potential misuse, theft, or accidental ingestion, especially by children or curious teenagers. Additionally, there’s a desire for storage solutions that blend seamlessly with modern home decor, rather than standing out or looking clinical.

    Beyond the physical product, KEEP Health elevates the mission by offering a comprehensive medication adherence and analytics platform. This platform, a harmonious integration of cutting-edge hardware and software, is tailored to serve life sciences companies, patient support programs, and pharmacy networks.

    KEEP Health tackles the medication non-adherence challenge in healthcare, which leads to suboptimal treatment outcomes, increased hospitalizations, and higher healthcare costs. Life sciences companies, patient support programs, and pharmacy networks often lack real-time insights into patient medication habits at home. Without timely data, it’s challenging to intervene effectively, offer tailored support, or understand the effectiveness of different patient support strategies. KEEP is the first product to capture real-time data on medication usage passively in patient homes, which empowers proactive intervention and tailored support. 

    The launch of KEEP brings a new era of safety and convenience to households across North America. KEEP comes in two minimalistic colorways; chalk white and slate black, $299 at www.discoverkeep.com. 

    About KEEP Labs

    KEEP Labs is a Canadian tech company founded by two dads who were looking for a smart way to store prescription medication at home. Originally focused on harm reduction, KEEP Lab’s introductory product, KEEP, is a TIME Best Invention of 2020 and CES 2020 Innovation Honoree. KEEP Health is the first medication adherence and analytics platform for global life sciences companies, patient support programs and pharmacy networks that integrates both hardware and software for all dosage forms, providing deeper insight into the patient journey at home.

    Source: KEEP Labs

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  • ISPOR Announces 2023 Health Economics and Outcomes Research Award Honorees

    ISPOR Announces 2023 Health Economics and Outcomes Research Award Honorees

    Newswise — Lawrenceville, NJ, USA—October 3, 2023—ISPOR—The Professional Society for Health Economics and Outcomes Research announced today the recipients of its 2023 Health Economics and Outcomes Research (HEOR) Scientific and Leadership Awards.

    ISPOR Scientific Awards are designed to foster and recognize excellence and outstanding achievement in HEOR and its Leadership Awards recognize excellence and outstanding leadership in the field. The Society will be hosting an HEOR Awards Celebration at ISPOR Europe 2023 on Monday, 13 November to recognize the honorees.

    The 2023 HEOR Award honorees include:

    Avedis Donabedian Lifetime Achievement Award This award recognizes honorees for their outstanding, life-long contribution to the improvement of health outcomes. The 2023 honoree is:

    • Charles Phelps, PhD; University Professor and Provost Emeritus, University of Rochester; Pittsford, NY, USA

    Marilyn Dix Smith Leadership Award This award recognizes a leader who has shown consistent, broad, and meaningful direction to the Society. The 2023 honoree is:

    • Shelby D. Reed, PhD; Professor, Duke University; Durham, NC, USA

    Bernie O’Brien New Investigator Award This award is given to an individual who has shown evidence of exceptional promise based on their emerging body of technical and scholarly work in the field of HEOR. The 2023 honoree is:

    • Jessica Roydhouse, PhD; Select Foundation Senior Research Fellow in Health Services Research, Menzies Institute for Medical Research, University of Tasmania; Tasmania, Australia

    LMIC Health Economics and Outcomes Research Excellence Award This award recognizes individuals in low- and middle-income countries (LMICs) with demonstrated outstanding HEOR achievements. The 2023 honoree is:

    • Bach Xuan Tran, PhD; Vice Head of Department of Health Economics, Hanoi Medical University; Hanoi, Vietnam

    Award for Excellence in Health Economics and Outcomes Research Methodology This award recognizes honorees for their outstanding research in the field of HEOR methodology. The 2023 honoree is:

    • “Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions;” Shirley V Wang, PhD; Associate Professor, Brigham and Women’s Hospital, Harvard Medical School; Boston, MA, USA, [Nat Commun. 2022; 13(1): 5126]

    Award for Excellence in Health Economics and Outcomes Research Application This award recognizes honorees for their outstanding practical application of HEOR in healthcare decision making. The 2023 honoree is:

    • “Developing and validating a machine-learning algorithm to predict opioid overdose in Medicaid beneficiaries in two US states: a prognostic modelling study;” Wei-Hsuan Lo-Ciganic, PhD; Associate Professor, University of Florida Department of Pharmaceutical Outcomes & Policy; Gainesville, FL, USA, [Lancet Digit Health. 2022; 4(6): e455–e465]

    Value in Health Paper of the Year Award The outstanding research paper for Value in Health is:

    • “The History and Future of the ‘ISPOR Value Flower’: Addressing Limitations of Conventional Cost-Effectiveness Analysis;” Peter J Neumann, ScD; Director, Center for the Evaluation of Value and Risk in Health, Tufts Medical Center; Professor, Tufts University School of Medicine; Boston, MA, USA, [Value Health. 2022; 25(4): 558–565]

    Value in Health Regional Issues Excellent Article Award The excellent article honored for Value in Health Regional Issues is:

    • “Developing a New Region-Specific Preference-Based Measure in East and Southeast Asia;” Takeru Shiroiwa, PhD; National Institute of Public Health Center for Outcomes Research and Economic Evaluation for Health; Saitama, Japan, [Value Health Reg Issues. 2022; 32: 62-69]

     
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    ABOUT ISPOR
    ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
    Website  | LinkedIn  | Twitter (@ispororg)  |  YouTube  |  Facebook  |  Instagram  

    ABOUT VALUE IN HEALTH
    Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2022 impact factor score is 4.5 and its 5-year impact factor score is 6.2. Value in Health is ranked 8th of 87 journals in health policy and services, 21st of 105 journals in healthcare sciences and services, and 69th of 380 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
    Website  | Twitter (@isporjournals)
     

    ABOUT VALUE IN HEALTH REGIONAL ISSUES
    Value in Health Regional Issues (ISSN 2212-1099) is ISPOR’s online, MEDLINE®-indexed journal that publishes articles on health-related topics that impact the health policies and populations in the following regions: 1) Asia; 2) Central and Eastern Europe, Western Asia, and Africa; and 3) Latin America. Value in Health Regional Issues is indexed in PubMed/MEDLINE®, the Web of Science, and many other top scientific databases. The journal’s 2022 impact factor score is 2.0.
    Website  |  Twitter (@isporjournals)

    ISPOR–The Professional Society for Health Economics and Outcomes Research

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  • Liquid biopsy may help identify which patients with non-small cell lung cancer will benefit most from radiation

    Liquid biopsy may help identify which patients with non-small cell lung cancer will benefit most from radiation

    Newswise — SAN DIEGO, October 2, 2023 — A novel liquid biopsy test may help determine which patients with non-small cell lung cancer that has spread beyond the lungs are most likely to benefit from targeted, high-dose radiation, rather than drug-based therapy, a new study suggests. Findings will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting and published in npj Precision Oncology

    The study found that a liquid biopsy test – which identifies tumor DNA circulating in the blood – can help distinguish if a patient’s cancer has spread to just a few tumor sites or spread more widely. This indicator would help physicians determine which type of treatment would be most effective for each patient.

    “Our findings suggest the level of circulating tumor DNA, rather than the number of tumors themselves, is a more precise measure of disease burden,” said senior study author Aadel Chaudhuri, MD, PhD, an assistant professor of radiation oncology at the Siteman Cancer Center of Washington University School of Medicine in St. Louis.

    Non-small-cell lung cancer (NSCLC) accounts for about 84% of all lung cancers, which are the leading cause of cancer death in the U.S. and worldwide. Patients diagnosed with NSCLC who have widespread metastatic disease, where cancer spreads past a person’s lungs and lymph nodes, generally cannot be cured, said Dr. Chaudhuri. But some patients with oligometastatic disease – where the cancer has spread to just a few sites – experience long periods of cancer-free survival when treated with high-dose radiation targeted to the individual tumor sites.

    Identifying which patients with oligometastatic disease will benefit from this type of focused radiation treatment has been challenging, said Dr. Chaudhuri.

    Tumor tissue biopsy – long considered the gold standard for analyzing solid tumors – only examines the site where the tissue sample was taken, and imaging tests also have limitations for detecting micro-metastatic disease, Dr. Chaudhuri explained. Likening a visible tumor to an iceberg, he said it’s difficult for imaging tests to show “if the disease is just the part of the iceberg that’s visible above the water, or if there’s substantially more micro-metastatic disease beneath the surface.”

    Liquid biopsy tests can detect elements of solid tumor cancers in blood, urine or cerebrospinal fluid. Blood tests are the most widely used type of liquid biopsy and can identify circulating tumor DNA (ctDNA), circulating tumor cells (CTC), circulating RNA and other biomarkers that signal the presence of cancer.

    “Liquid biopsy,” said Dr. Chaudhuri, “could help us know if there is micro-metastatic disease.”

    Dr. Chaudhuri and his colleagues previously used liquid biopsy technology to monitor the status of patients with colorectal cancer, bladder cancer and peripheral nerve tumors.

    In the current study, a real-world, multi-institutional analysis, the researchers analyzed data from 2016 to 2022 for 309 patients with oligometastatic NSCLC who received radiation therapy following liquid biopsy. Oligometastatic disease was defined in this study as metastatic disease in at least one, and up to five, organ systems. Patients were an average of 64.7 years old.

    Patients with detectable ctDNA prior to radiation therapy had worse overall survival than those whose blood showed no detectable ctDNA prior to treatment. For those whose blood showed traces of ctDNA, median overall survival was 16.8 months, compared to 25 months for patients with no ctDNA detected prior to treatment (p=0.030, HR=1.65, CI=1.05–2.61).

    Likewise, progression-free survival was worse for those whose blood showed traces of ctDNA prior to radiation therapy. Median progression-free survival was 5.4 months for patients with detectable ctDNA, compared to 8.8 months for those with no detectable ctDNA prior to treatment (p=0.004, HR=1.57, CI=1.15–2.13). These findings were corroborated by multivariate models that included eight additional clinical and genomic parameters.

    The findings suggest that patients with no or low levels of detectable ctDNA are most likely to benefit from radiation therapy, whereas those with higher detectable levels of ctDNA are more likely to need systemic therapy, such as chemotherapy or immunotherapy, Dr. Chaudhuri said.

    “When you have a detectable ctDNA level, you have a higher burden of disease. Our findings indicate that we can use this biomarker to support patient-centered treatment decisions in the oligometastatic cancer setting,” he said.

    ###

    See this study presented:

    • News Briefing: Tuesday, October 3, 9:00 a.m. Pacific time. Details here. Register here.
    • Scientific Presentation: Monday, October 2, 11:25 a.m. Pacific time, San Diego Convention Center. Email [email protected] for access to the livestream or recording.
    • Abstract Title: Circulating tumor DNA for early risk stratification of oligometastatic lung cancer (Abstract 149)

    Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage. View our meeting press kit at www.astro.org/annualmeetingpress.

    ABOUT ASTRO

    The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. Radiation therapy contributes to 40% of global cancer cures, and more than a million Americans receive radiation treatments for cancer each year. For information on radiation therapy, visit RTAnswers.org. To learn more about ASTRO, visit our website and media center and follow us on social media.

    American Society for Radiation Oncology (ASTRO)

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  • Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

    Nobel Prize in medicine awarded to two scientists whose work enabled creation of mRNA vaccines against COVID-19

    STOCKHOLM (AP) — Two scientists won the Nobel Prize in medicine on Monday for discoveries that enabled the development of effective mRNA vaccines against COVID-19.

    The award was given to Katalin Karikó, a professor at Sagan’s University in Hungary and an adjunct professor at the University of Pennsylvania, and Drew Weissman, who performed his prizewinning research together with Karikó at the University of Pennsylvania.

    “Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the panel that awarded the prize said.

    Thomas Perlmann, secretary of the Nobel Assembly, announced the award and said both scientists were “overwhelmed” by news of the prize when he contacted them shortly before the announcement.

    The Nobel Prize in physiology or medicine was won last year by Swedish scientist Svante Paabo for discoveries in human evolution that unlocked secrets of Neanderthal DNA which provided key insights into our immune system, including our vulnerability to severe COVID-19.

    The award was the second in the family. Paabo’s father, Sune Bergstrom, won the Nobel Prize in medicine in 1982.

    Nobel announcements continue with the physics prize on Tuesday, chemistry on Wednesday and literature on Thursday. The Nobel Peace Prize will be announced Friday and the economics award on Oct. 9.

    The prizes carry a cash award of 11 million Swedish kronor ($1 million). The money comes from a bequest left by the prize’s creator, Swedish inventor Alfred Nobel, who died in 1896.

    The prize money was raised by 1 million kronor this year because of the plunging value of the Swedish currency.

    The laureates are invited to receive their awards at ceremonies on Dec. 10, the anniversary of Nobel’s death. The prestigious peace prize is handed out in Oslo, according to his wishes, while the other award ceremony is held in Stockholm.

    Corder reported from The Hague, Netherlands.

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  • Stock Plays for October: 3 to Watch, According to J.P. Morgan

    Stock Plays for October: 3 to Watch, According to J.P. Morgan

    The stock market is entering October a little battered and bruised after September’s selloff. However, that also offers opportunities and


    J.P. Morgan


    analysts have some ideas for where to invest at the start of t…

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  • Atopic dermatitis: Viruses offer new treatment

    Atopic dermatitis: Viruses offer new treatment

    Newswise — Up to 15 percent of children and five percent of adults are affected by the chronic inflammatory skin disease atopic dermatitis. Despite advanced therapy measures, the severe itching and eczema, especially on the elbows or knees, cause great distress to the patients. In the course of a study conducted at MedUni Wien a research team led by Wolfgang Weninger, Head of the Department of Dermatology, has discovered a new approach: bacteriophages, which colonize the skin as viral components of the microbiome and can drive the development of innovative atopic dermatitis therapies. The research results were recently published in the scientific journal Science Advances.

    Until now, the importance of bacteriophages (“bacteria eaters”, also called phages) in the human body has been known primarily from analyses of the intestine. In the search for innovative therapeutic measures for atopic dermatitis (AD), the MedUni Vienna research team has now investigated the interaction of phages and bacteria in the skin for the first time. After all, it has long been known that the progression of AD is accompanied by massive changes in the skin microbiome. The microbiome is the sum of all microorganisms on the skin and has been primarily investigated for its bacterial constituents. It has been unknown whether viruses also contribute to the nature of the bacterial microbiome in healthy and diseased skin. Phages are viruses of different types and functions whose sole aim is to infect bacteria, thereby either destroying them – or stimulating them to multiply.

    New phages identified
    “In our study, we discovered previously unknown phages in the microbiome of the skin samples of AD patients, which help certain bacteria to grow faster in different ways,” note first authors Karin Pfisterer and Matthias Wielscher from the Department of Dermatology at MedUni Vienna. The resulting shift in the balance between phages and bacteria was not detected in the comparative samples from healthy individuals and may be one explanation for the overpopulation of the skin microbiome with bacteria called Staphylococcus aureus found in AD. These findings contribute significantly to a better understanding of the skin bioflora in AD patients and pave the way for the development of new targeted therapeutic interventions: By identifying and culturing phages specialized for Staphylococcus aureus, a promising new option is available.

    Specialists for targeted therapy
    Bacteriophages are found not only in the body, but in every habitat populated by bacteria. There are 1031 different phage species, which makes a number with 31 zeros. One of their characteristics is that they prove to be extremely specific when it comes to choosing their target of infection: Most phages specialize in a particular genus, and in many cases in only a single species of bacteria. While that makes it a challenge for scientists to identify the type of phage needed for a particular purpose, it also enables them to use them in a targeted manner. Bacterial viruses do not make any difference between antibiotic-resistant and other bacteria, thus they are being researched as possible weapon in the fight against multi-resistant pathogens. Further studies are now planned to confirm phage therapy for topical use in atopic dermatitis.

    Medical University of Vienna (MedUni Wien)

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  • Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result

    Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result

    By Adria Calatayud

    Novartis said an interim analysis from a phase 3 trial to evaluate its investigational iptacopan drug in patients with kidney disease nephropathy achieved positive results, meeting its primary goal.

    The Swiss pharmaceutical company said Monday that an analysis of study data at nine months showed a clinically meaningful and statistically significant reduction in protein in urine. The company said this demonstrated superiority of iptacopan relative to placebo in reducing protein in urine.

    The safety profile of the drug was consistent with previously reported data, Novartis said.

    Novartis said it plans to review the trial’s interim results with the U.S. Food and Drug Administration to enable a potential regulatory submission for accelerated approval.

    The study will now continue to assess the iptacopan’s ability to slow disease progression over two years, the company said. Results from the primary goal at the end of the study are expected in 2025.

    Write to Adria Calatayud at adria.calatayud@dowjones.com

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  • Precision medicine navigators increase genomic testing rates for Black patients with prostate cancer

    Precision medicine navigators increase genomic testing rates for Black patients with prostate cancer

    Newswise — SAN DIEGO, October 1, 2023 — The presence of a clinical navigator to act as a liaison between people with prostate cancer and the health care system greatly increases the likelihood that patients, especially Black patients, will receive advanced testing that can help predict the severity of their disease and guide treatment, a new study suggests.

    The study showed patients seen by a precision medicine navigator were substantially more likely to receive genomic testing than those not seen by the navigator. Black patients, whose genomic testing rates traditionally are much lower than white patients, experienced a six-fold increase if they were seen by a navigator. Findings will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting

    “Black patients with prostate cancer in the U.S. have disparately worse clinical outcomes compared to other racial groups,” said lead study author Alexander J. Allen, MD, a radiation oncology resident physician at the University of Maryland Medical Center in Baltimore. “Our findings suggest hiring a precision medicine navigator who specializes in genetic testing can improve the rates of Black patients receiving these tests, which could potentially reduce health disparities and improve outcomes.”

    Research shows Black patients are 76% more likely to be diagnosed with prostate cancer than white patients and 120% more likely to die from it. This disparity stems from many factors, including lower rates of early prostate cancer screening that result in more aggressive cancers by the time Black patients are diagnosed.

    Genomic testing is used to gauge the likelihood that a cancer will metastasize, or spread beyond the prostate, within the next five to 10 years; the most common form of this test is called Decipher, which analyzes RNA markers in tumor tissue samples. Research presented at ASTRO’s 2021 Annual Meeting suggested genomic testing may be better at predicting the risk for metastases than conventional prostate cancer tests, such as the Gleason score and prostate-specific antigen (PSA) levels. Dr. Allen said oncologists use the results of all three tests to guide treatment decisions.

    “Genomic testing provides additional information that can alter a patient’s treatment plan,” he said. “For example, if Gleason scores and PSA levels suggest a patient has an intermediate risk for metastases, but the genetic analysis categorizes them at high risk because of the biological makeup of the tumor, then you might intensify treatment.”

    Precision medicine navigators are people whose job is focused entirely on identifying patients eligible for genomic testing and then making sure the tests are completed – a task Dr. Allen said is much more complicated than it sounds.

    “Obtaining genetic tests in a clinical setting is complex and requires knowledge of the submission requirements,” he said. After working with health care providers to identify which patients are eligible, the navigator helps the patient fill out requisition forms and coordinates the submission of biopsy tissue samples to the appropriate genomic testing company.

    In this study, researchers compared how frequently patients with prostate cancer in a large health care system received genetic testing from the seven months prior to the arrival of a precision medicine navigator (PMN) to the seven months following the creation of that position. Of the 693 patients studied, 44.9% (n=311) were treated prior to the arrival of the PMN and 55.1% (n=382) were treated after the PMN began work. The median age in both groups was 68 years, and racial distributions were similar (60% white, 35.1% and 34% Black, 3.2% and 3.7% Asian/Pacific Islander and 1.3% and 2.1% Latino). There were no significant differences between the two groups in disease severity, type of insurance coverage or type of facility in which they were treated.

    Black patients seen by the PMN were six times more likely to receive testing than those not seen by a PMN. Following the arrival of the PMN, the proportion of Black patients referred for genomic testing rose from 19% to 58%. Genomic testing rates also rose for lower-income patients (from 20% to 64%), those on Medicare and Medicaid (from 20% to 68.5%) and people who were being treated at community hospitals (from 6% to 77%), after the introduction of the PMN.

    “We thought there would be some increase but did not expect the testing rates to grow so substantially,” Dr. Allen said. He also said that genomic testing results altered treatment plans for many patients who received them. “The most common way treatments were altered based on genomic testing results was in whether or not patients with intermediate risk disease were given hormone blocking therapy,” in which hormones are suppressed to stop them from fueling cancer cell growth.

    Dr. Allen said the next step for his team is to design a study that investigates whether the increased rates of genomic testing ultimately lead to better patient outcomes. “We theorize that if patients are treated differently based on this new genome-based risk stratification, outcomes will improve.”

    But making sure genomic testing is available to all patients who might benefit will be key to helping lessen racial disparities in prostate cancer going forward, he said. Precision medicine navigators are not funded through traditional business models, suggesting that novel funding mechanisms may need to be initiated to decrease disparities.

    “As precision medicine becomes more mainstream, it has the potential to alleviate disparities,” said Dr. Allen. “But if there are no measures taken to ensure access to these tools, we could just be maintaining or even worsening the health inequities that we have today.”

    ###

    See this study presented:

    • News Briefing: Monday, October 2, 11:00 a.m. Pacific time. Details here. Register here.
    • Scientific Presentation: Sunday, October 1, 4:55 p.m. Pacific time, San Diego Convention Center. Email [email protected] for access to the live stream or recording.
    • Abstract Title: A precision medicine navigator can mitigate inequities associated with utilization of genomic tests in Black men with prostate cancer (Abstract 122)

    Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage. View our meeting press kit at www.astro.org/annualmeetingpress.

    This study was funded by an anonymous donation to the University of Maryland Precision Radiation Oncology Initiative.

    ABOUT ASTRO

    The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. Radiation therapy contributes to 40% of global cancer cures, and more than a million Americans receive radiation treatments for cancer each year. For information on radiation therapy, visit RTAnswers.org. To learn more about ASTRO, visit our website and media center and follow us on social media.

    American Society for Radiation Oncology (ASTRO)

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  • Short-course radiation as effective as standard treatment for patients who opt for breast reconstruction after mastectomy

    Short-course radiation as effective as standard treatment for patients who opt for breast reconstruction after mastectomy

    Newswise — SAN DIEGO, October 1, 2023 — In a first-of-its-kind study, people with breast cancer who underwent implant-based breast reconstruction immediately following a mastectomy reported that getting fewer, higher doses of radiation was just as effective as standard radiation, did not increase side effects and saved them time and money. There also was a small improvement in quality of life for women under 45 who received the shortened treatment regimen.

    The FABREC study is the first prospective randomized study comparing quality-of-life and clinical outcomes following accelerated versus conventional radiation therapy specifically for patients with post-mastectomy implant- or tissue-based breast reconstruction. Findings will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting.

    “Both the accelerated and standard courses of treatment were equally effective at preventing the cancer from returning and had the same level of side effects. But with shortening the treatment from five weeks to three, patients experienced fewer treatment disruptions, a lower financial burden and other meaningful improvements to their lives,” said senior study author Rinaa Punglia, MD, MPH, FASTRO, an associate professor of radiation oncology at Dana-Farber Brigham Cancer Center in Boston.

    Breast cancer is the second most diagnosed cancer for women in the U.S. About 40% of people with breast cancer have mastectomies and of that group, 62% undergo immediate reconstruction. Reconstruction using tissue expanders or breast implants has grown in popularity in recent years.

    Roughly one-third of patients who get mastectomies also need radiation therapy to the chest wall and lymph nodes, to help prevent their cancer from returning. While standard radiation therapy generally occurs over a period of five weeks, research has shown a shorter course of treatment can be just as effective at preventing the cancer from returning in women who have undergone breast-conserving surgery. Prior research also shows the shorter regimen does not increase side effects and can improve quality of life for these patients.

    FABREC is the first study to compare the shorter and longer courses of post-mastectomy radiation specifically for people who had their breasts reconstructed immediately following mastectomy. Investigators also compared results for people under 45 years old to those 45 and older.

    “Our main goal was to look at patient-reported outcomes, especially in terms of patient well-being,” said lead study author, Julia Wong, MD, FASTRO, also an associate professor of radiation oncology at Dana-Farber Brigham Cancer Center. “We often focus on cancer outcomes, but there are a lot of quality-of-life issues involved in having a mastectomy and reconstructive surgery, a combination a lot of patients are now choosing. We have to look at how these treatments affect patients.”

    The multi-center trial involved 400 participants treated at 16 U.S. health centers who underwent mastectomies followed by immediate breast reconstruction using a tissue expander or implant. Patients were randomly assigned to receive either conventional radiation consisting of 25 fractions across five weeks (50 Gy total; n=201) or hypofractionated radiation consisting of 16 fractions across roughly three weeks (42.56 Gy total; n=199).

    All patients were diagnosed with stage 0 to 3 breast cancer with tumors of any size but not growing into the chest wall or skin. The median age was 47 years. Patients completed questionnaires about their physical well-being and quality of life at baseline and at six, 12 and 18 months following treatment. Median follow-up was 40.4 months.

    Patients in both groups reported similar levels of physical well-being six months after treatment, the primary endpoint of the study (p=0.71). There were some differences between the groups at baseline, including higher energy levels reported by those randomized to receive hypofractionated radiation (p=0.02). Dr. Punglia said this finding likely reflects their positive reactions to the shortened treatment.

    “In our protocol, patients could complete their baseline questionnaire either before or after randomization, as long as it was before they started radiation. And so, patients could be aware of their treatment arm when they answered the questions,” she said. “It seems patients felt more energetic because they knew they would be done with treatment faster.”

    Treatment breaks, which are associated with worse outcomes in breast cancer, were significantly fewer (2.7% vs. 7.7% with conventional treatment, p=0.03) and shorter with the accelerated treatment (average 2.8 days vs. 3.3 with conventional treatment, p=0.03). Patients who needed unpaid time off work also reported taking 50 fewer hours of unpaid leave (73.7 hours vs.125.8 hours, p=0.046).

    There were small improvements in quality-of-life scores among younger patients treated with hypofractionated radiation. Patients younger than 45 reported feeling less bothered by treatment-related side effects (p=0.045) with the accelerated treatments. They also reported better physical well-being (p=0.049).

    There were no differences in the rates of recurrence or side effects between the two groups. Two people (one in each arm) experienced a local recurrence, and 23 (12 in the conventional arm, 11 in the hypofractionated arm) had cancer return to distant sites. Four patients (two in each arm) died during the study period; all were diagnosed with distant metastases.

    The overall rates of chest wall toxicity were lower in both arms than rates previously reported with implant-based reconstruction, said Dr. Wong. Twenty patients in the hypofractionated group and 19 in the conventional group had toxicity in the chest wall area. The analysis found several factors predicted chest wall toxicity on univariate analysis, including higher body mass index (HR=1.02, p=0.003), having a post-operative infection (HR=3.14, p=0.01), whether lymph nodes needed to be dissected (HR=2.07, p=0.03), having more lymph nodes removed (HR=1.05, p=0.01), having a tissue expander versus an implant (HR=3.32, p=0.04), and using preoperative endocrine therapy (HR=2.99, p=0.001).

    Though they had hoped to see more dramatic results, the researchers were happy that delivering higher doses of radiation in less time did not increase side effects. “In fact, overall, the rates of chest wall toxicity were lower in both arms than what’s been seen historically, which is likely because of improvements over time in technique,” said Dr. Wong.

    ###

    See this study presented:

    • News Briefing: Monday, October 2, 11:00 a.m. Pacific time. Details here. Register here.
    • Scientific Presentation: Clinical Trials Session, Sunday, October 1, 10:20 a.m. Pacific time, San Diego Convention Center. Email [email protected] for access to the live stream or recording.
    • Abstract Title: Patient-reported and toxicity results from the FABREC study: A multicenter randomized trial of hypofractionated vs. conventionally fractionated postmastectomy radiation therapy after implant-based reconstruction (LBA 05)

    Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage. View our meeting press kit at www.astro.org/annualmeetingpress.

    ABOUT ASTRO

    The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. Radiation therapy contributes to 40% of global cancer cures, and more than a million Americans receive radiation treatments for cancer each year. For information on radiation therapy, visit RTAnswers.org. To learn more about ASTRO, visit our website and media center and follow us on social media.

    American Society for Radiation Oncology (ASTRO)

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  • High-dose radiation offers new treatment option for older patients with inoperable kidney tumors

    High-dose radiation offers new treatment option for older patients with inoperable kidney tumors

    Newswise — SAN DIEGO, October 1, 2023 — Older adults diagnosed with kidney tumors that are not suitable for surgery may benefit from targeted, high-dose radiation, a new study from Australian and Dutch researchers suggests.

    A multi-institutional phase II study – TransTasman Radiation Oncology Group (TROG) FASTRACK II – found 100% local control and cancer-specific survival for longer than three years among patients who were treated non-invasively for inoperable kidney cancer with stereotactic ablative body radiotherapy (SABR). Findings will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting.

    Previous smaller, single institution studies showed promise for stereotactic radiation treatments with patients whose kidney tumors are inoperable, yet FASTRACK II is the first study to test SABR’s efficacy in a large, multi-institutional clinical trial.

    “Our study demonstrated that a novel treatment delivered in an outpatient setting is able to achieve unprecedented efficacy for patients with inoperable kidney cancer,” said lead study author Shankar Siva, PhD, a radiation oncologist at the Peter MacCallum Cancer Centre and a professor at the University of Melbourne in Australia. “There’s an unmet need for curing this type of cancer, and our findings point to the potential of radiation therapy to address that need.”

    As the population ages, the incidence of kidney cancer in older adults is increasing globally, with the greatest increase in people over 70, who also have lower rates of survival. Worldwide, kidney cancer is the sixth most diagnosed cancer in men and 10th in women. Surgery has been the standard of care, either to remove the tumor and surrounding margins or to remove the entire kidney and surrounding tissue.

    Yet many older people with renal cell carcinoma have unique challenges that make it difficult to treat them surgically, said Dr. Siva. “People might have other medical issues such as high blood pressure or diabetes, things that place them at higher risk for complications from surgery. They may have tumors in areas that are difficult to operate on, or where surgery may lead to dialysis.”

    He said, “our research clearly defines a new population of patients who will benefit from stereotactic radiation. These patients often don’t have other viable treatment options, so we are excited to see that radiation therapy can be effective for them.”

    SABR, also known as stereotactic body radiation (SBRT), can shrink or destroy tumors by targeting them directly with high doses of radiation delivered in a small number of outpatient sessions.

    In this non-randomized, prospective study, Dr. Siva and his colleagues treated 70 patients who were diagnosed with inoperable, high-risk kidney tumors or who declined surgery for their renal cell cancer. The median patient age was 77 years (range 47-91), and patients had a single lesion.

    Participants in the trial were treated with SABR in one or three sessions at seven Australian centers and one in the Netherlands. Treated tumors were relatively large, said Dr. Siva, on average 4.7 centimeters. Patients with tumors smaller than 4 cm received a single fraction of radiation (n=23), and those with tumors larger than 4 cm received three fractions (n=47).

    None of the patients experienced a local progression of their kidney cancer during the trial lifetime (median follow-up 43 months), nor did any patients die from cancer. Overall survival was 99% one year after SBRT and 82% at three years. One patient experienced a distant recurrence of their cancer.

    Side effects were relatively modest, with no grade 4 or 5 toxicities observed. Seven patients (10%) experienced grade 3 adverse events, most commonly abdominal pain (3 patients). 51 patients (73%) had a grade 1-2 treatment-related event, and 11 patients (16%) experienced no adverse events.

    Kidney function was assessed by measuring patients’ estimated glomerular filtration rate (eGFR); the average eGFR declined by 10.8 mLs/min at one year and 14.6 mLs/min at two years after treatment, indicating mild-to-moderate kidney stress. Only one patient required dialysis following treatment. Overall, said Dr. Siva, there was a modest drop in kidney function and that plateaued after two years.

    Dr. Siva attributed the high efficacy rate and the ability to preserve kidney function to rigorous quality control, as well as the effectiveness of stereotactic radiation. He also said the findings of this phase II trial justify designing a randomized phase III trial to compare stereotactic radiation to surgery as the primary treatment modality for patients with operable kidney cancer.

    “Given a choice between the two, I believe a lot of patients would opt for non-invasive radiation,” he said.

    ###

    See this study presented:

    • News Briefing: Tuesday, October 3, 9:00 a.m. Pacific time. Details here. Register here.
    • Scientific Presentation: Sunday, October 1, 9:50 a.m. Pacific time, San Diego Convention Center. Email [email protected] for access to the livestream or recording.
    • Abstract Title: TROG 15.03/ANZUP international multicenter phase II trial of focal ablative stereotactic radiotherapy for cancers of the kidney (FASTRACK II) (Abstract 5)

    Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage. View our meeting press kit at www.astro.org/annualmeetingpress.

    ABOUT ASTRO

    The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. Radiation therapy contributes to 40% of global cancer cures, and more than a million Americans receive radiation treatments for cancer each year. For information on radiation therapy, visit RTAnswers.org. To learn more about ASTRO, visit our website and media center and follow us on social media.

    American Society for Radiation Oncology (ASTRO)

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  • Sexual activity and vaginal dilation associated with fewer side effects after cervical cancer treatment

    Sexual activity and vaginal dilation associated with fewer side effects after cervical cancer treatment

    Newswise — SAN DIEGO, October 1, 2023 — People who engage in sexual activity or vaginal dilation after chemoradiation treatment for cervical cancer are at lower risk for long-term side effects, according to a new study from researchers in Austria. Findings of the EMBRACE study will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting

    “Curing cancer is always our first priority,” said lead study author Kathrin Kirchheiner, MSc, PhD, a clinical psychologist in the department of radiation oncology at the Medical University of Vienna. “But with a growing number of relatively young cervical cancer survivors, the prevention and management of side effects becomes increasingly important to ensure a better quality of life.”

    “I hope this research helps to reduce the taboo around sexual health and makes it easier for clinicians to discuss these issues with their patients.”

    Cervical cancer is the fourth most common cancer among women globally. Patients are diagnosed most often around age 50. Standard non-surgical treatment for patients whose cancer has spread to the surrounding tissue or organs involves a combination of radiation therapy, chemotherapy and brachytherapy – inserting radioactive implants directly into the tumor.

    Advances in brachytherapy, such as the use of MRI imaging to pinpoint tumor size and location, along with the ability to deliver precise doses of radiation, have greatly improved tumor control and cure rates in recent years. The five-year survival rate for people with locally advanced cervical cancer is 74%.

    Delivering high doses of radiation to tumors near the vagina, however, can lead to vaginal stenosis – a shortening or narrowing of the vagina – and long-term changes in vaginal tissue that can complicate gynecological examinations or cause pain during intercourse. Physicians often recommend regular and ongoing vaginal dilation to mitigate these side effects and prevent scar tissue from forming, but few studies have quantified its impact.

    EMBRACE is a multi-institutional, prospective, observational study that measured physician-reported vaginal side effects and patient-reported outcomes among 1,416 people with locally advanced cervical cancer. In this sub-cohort of 882 patients, Dr. Kirchheiner and her colleagues compared side effects for people who were sexually active or used vaginal dilators on a regular basis in the years after treatment to those who did not follow this routine.

    In the five years following treatment, patients were seen for a median of 11 follow-up visits with gynecological exams to assess vaginal side effects. They also filled out questionnaires on quality of life, sexual activity and vaginal dilation. Questionnaires were completed at baseline, every three months in the first year, every six months in the second and third years and annually thereafter. The median age of patients was 49 years old.

    Regular vaginal dilation and/or sexual activity – defined as the patient reporting the practice during half or more of their follow-ups – was reported by 64% of patients and was significantly associated with lower risk for moderate grade 2 or higher vaginal shortening and narrowing five years after treatment (p≤0.001).  

    Patients who reported both dilation and intercourse had the lowest risk of grade ≥2 vaginal stenosis (18%), followed by those who were sexually active but did not use vaginal dilators (23%) and those who used dilators but were not sexually active (28%). Patients who did not engage in regular dilation or intercourse were most likely to experience moderate stenosis (37%).

    Analyses also showed that regular sexual activity and/or vaginal dilation was associated with an increased risk for other – but mild – vaginal symptoms, such as grade ≥1 dryness and bleeding.

    This is not surprising, said Dr. Kirchheiner, as vaginal dryness is more likely to be noticed as a lack of lubrication in patients engaging in some form of penetrative activity, and that minor bleeding during or after dilation or intercourse can often be caused by irritation of the vaginal lining.

    “Minor vaginal dryness and bleeding can be managed with lubricants, moisturizer and/or hormone replacement therapy,” she said. “The risk of having these minor side effects should not stop patients from dilating or having sexual intercourse, as these activities may help prevent a more serious, and irreversible, condition.”

    Among people who reported regular sexual activity and/or vaginal dilation, 72% experienced grade ≥1 vaginal dryness, compared to 67% of those who reported none or infrequent dilation/intercourse (p=0.028). Grade ≥1 vaginal bleeding occurred in 61% of patients who reported frequent sexual activity and/or vaginal dilation, compared to 34% of those who did not (p≤0.001).

    While the study’s findings point to a promising option for patients to maintain sexual health following cervical cancer treatment, Dr. Kirchheiner emphasized that this study was observational and therefore can only report correlations. Questions remain regarding the degree to which vaginal dilation and/or sexual intercourse effectively prevent shortening and narrowing, or if the development of vaginal symptoms interferes with the likelihood that patients are able to engage in these activities.

    “In clinical reality, both causal pathways likely will contribute and interact in a vicious circle. However, as we cannot and should not randomize patients in a clinical trial into groups with and without regular dilation, our findings support both clinical experience and the standard of care.”

    Next steps for this area of research, said Dr. Kirchheiner, include considering the role of sexual arousal, such as increased blood flow in the pelvic area, on tissue healing and vaginal health, given the slight advantage of intercourse over dilators in their observational study.

    Yet studies on sexual health following cancer treatment can be difficult to complete, she noted. “Sexual health is a highly individual and sensitive topic to address, both in research and in survivorship care, and it deserves a respectful and comprehensive approach.”

    ###

    See this study presented:

    • News Briefing: Monday, October 2, 11:00 a.m. Pacific time. Details here. Register here.
    • Scientific Presentation: Sunday, October 1, 9:40 a.m. Pacific time, San Diego Convention Center. Email [email protected] for access to the live stream or recording.
    • Abstract Title: Association between regular vaginal dilation and/or sexual activity and long-term vaginal morbidity in cervical cancer survivors (Abstract 4)

    Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage. View our meeting press kit at www.astro.org/annualmeetingpress.

    ABOUT ASTRO

    The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. Radiation therapy contributes to 40% of global cancer cures, and more than a million Americans receive radiation treatments for cancer each year. For information on radiation therapy, visit RTAnswers.org. To learn more about ASTRO, visit our website and media center and follow us on social media.

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  • Liquid biopsies can rapidly detect residual disease following cervical chemoradiation, study finds

    Liquid biopsies can rapidly detect residual disease following cervical chemoradiation, study finds

    Newswise — SAN DIEGO, October 1, 2023 — Two liquid biopsy tests that look for the presence of human papillomavirus (HPV) in the blood accurately identified patients with a high risk of cervical cancer recurrence after the completion of chemoradiation, a new study confirms. Findings will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting

    The study compared two novel tests – a digital polymerase chain reaction (dPCR) test and a sequencing test for genetic material from HPV, the main cause of cervical cancer – and found they were equally effective at identifying residual disease in the blood of patients who recently completed radiation and chemotherapy for cervical cancer. Earlier detection allows for earlier treatment of residual disease and potentially better survival rates. 

    “These non-invasive tests can detect residual disease following chemoradiation treatment earlier than imaging or a clinical exam,” said lead study author Kathy Han, MD, a radiation oncologist at the Princess Margaret Cancer Center at the University of Toronto. “We can detect very minimal disease, before it grows bigger, which potentially will enable us to intervene earlier and improve outcomes for people with cervical cancer.”

    Roughly 11,500 new cases of cervical cancer are diagnosed annually in the U.S., and an estimated 4,000 Americans die from the disease each year. Approximately 30-40% of patients with cervical cancer develop tumor recurrence following chemoradiation, and currently, residual disease is often detected too late to improve survival rates.

    Tissue biopsy has long been considered the gold standard for identifying tumors, but it requires an invasive procedure to sample enough tumor tissue to be visualized on imaging, and it provides a snapshot only of a specific tumor region. Liquid biopsies can detect microscopic components of tumors in bodily fluids such as blood or urine, providing a less invasive option to assess malignancy. Blood tests are the most widely used type of liquid biopsy and can identify circulating tumor DNA (ctDNA), circulating RNA and other markers that signal the presence of cancer, including HPV.

    Because these tests can detect fragments of the HPV virus that remain in the blood following chemoradiation but before tumors recur, “liquid biopsies provide insight before tissue biopsy becomes possible,” said Dr. Han. “If we can predict who might be at higher risk of recurrence, it may be a signal to clinicians to make sure these patients are followed more closely.”

    In a previous, pilot study, Dr. Han and her team collected blood samples from 20 patients with cervical cancer before and after chemoradiation treatment. Using digital polymerase chain reaction (dPCR) tests, they found people with detectable HPV ctDNA at the end of chemoradiation had worse outcomes than those with no detectable HPV ctDNA.

    This new study sought to validate those findings in a larger sample of patients, using both dPCR and more sophisticated HPV sequencing tests. To do so, researchers prospectively enrolled 70 patients from four Canadian centers; all participants were diagnosed with HPV-positive cervical cancer and treated with chemoradiation. Patients were followed for a median of 2.2 years.

    Patients gave blood samples before treatment; they also received blood tests immediately after treatment, between four to six weeks post-treatment and 12 weeks post-treatment. Patients with detectable HPV ctDNA in their blood at each of these three timepoints had substantially worse progression-free survival rates than those with no detectable HPV in their blood.

    Specifically, 53% of patients with detectable HPV ctDNA immediately following chemoradiation were progression-free two years later, compared to 87% of patients without detectable HPV ctDNA immediately after treatment. The difference was even more pronounced at the 12-week mark; patients with detectable HPV ctDNA three months following chemoradiation had a 26% two-year progression-free survival rate, compared to 85% for those without.

    “We were happy to see that we could validate our initial results,” said Dr. Han. “We were surprised, however, to find no significant differences between the digital PCR test and the HPV sequencing test. Even though HPV sequencing was more sensitive than digital PCR, both approaches returned similar results after treatment.”

    In recent years, advances in technology have accelerated the use of liquid biopsies, which are believed to hold great potential for non-invasive cancer screening in high-risk populations. However, the tests are not yet widely available.

    One of the challenges with making HPV ctDNA testing widely available for people with cervical cancer is the variety of HPV types that cause the disease, said Dr. Han, noting that 11 distinct HPV types were detected in their analysis. Yet Dr. Han said the HPV sequencing test was capable of detecting all 11 types with high accuracy and suggested that it could become a generalizable approach for HPV-positive cervical cancer.

    Expanding access to liquid biopsies is also necessary, said Dr. Han, and will be crucial for future research using liquid biopsies to identify patients at high-risk of recurrence and randomizing them to intensive versus standard treatment.

    ###

    See this study presented:

    • News Briefing: Monday, October 2, 11:00 a.m. Pacific time. Details here. Register here.
    • Scientific Presentation: Sunday, October 1, 8:00 a.m. Pacific time, San Diego Convention Center. Email [email protected] for access to the live stream or recording.
    • Abstract Title: Clinical validation of HPV ctDNA for early detection of residual disease following chemoradiation in cervical cancer (Abstract 105)

    Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage. View our meeting press kit at www.astro.org/annualmeetingpress.

    ABOUT ASTRO

    The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. Radiation therapy contributes to 40% of global cancer cures, and more than a million Americans receive radiation treatments for cancer each year. For information on radiation therapy, visit RTAnswers.org. To learn more about ASTRO, visit our website and media center and follow us on social media.

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  • Rapid Telehealth Consults Improve Care for Rural Patients With Stroke

    Rapid Telehealth Consults Improve Care for Rural Patients With Stroke

    Newswise — Minutes matter when a patient may have had a stroke, but being far from a physician with advanced training in neurology no longer needs to be a barrier to rapid diagnosis and intervention.

    Telestroke programs are designed to improve access to the limited number of specialists, regardless of the geographic isolation of patients who may have experienced a stroke. Telestroke, or stroke telemedicine, is a form of telehealth in which physicians with advanced training in stroke care use technology to provide immediate consultation to a local healthcare professional to recommend diagnostic imaging and treatment for patients with stroke at an originating site. Patients who present within 4.5 hours of when they were last known to be well may be eligible for thrombolytic drug therapy or endovascular intervention, often measured as door-to-needle time. 

    After launching a telestroke consultation program, Essentia Health, an integrated health system serving patients in Minnesota, Wisconsin and North Dakota, increased the percentage of patients receiving thrombolytics in less than 60 minutes and decreased the average door-to-needle time.

    Use of Telestroke to Improve Access to Care for Rural Patients With Stroke Symptoms” describes how Essentia Health’s program ensures that patients are evaluated rapidly to expedite decisions about their course of treatment. The article is published in the October issue of Critical Care Nurse (CCN).

    Essentia Health initiated the telestroke program in fall 2019, with coverage provided by a team of four interventional neurologists, three of whom work in the system’s Comprehensive Stroke Center in Fargo, North Dakota. In addition to this center, telestroke services are provided to five other acute stroke-ready hospitals throughout rural areas in the upper Midwest.

    Through the telestroke program, neurology consultations are available to all of the sites 24 hours a day, every day of the year, and can be used for both inpatient and emergency department stroke activations at each of the facilities.

    The team developed a tiered stroke alert algorithm and telestroke workflow chart to help healthcare professionals at rural sites determine eligibility for telestroke consultation to decide the treatment plan.

    The algorithm categorized strokes as level I to III according to the symptoms and time when the patient was last known to be well. Telestroke consults were most often used for patients with level I stroke alerts since they were within the timeframe when they may be eligible for thrombolytic drug therapy or endovascular intervention.

    Once staff members determine whether a telestroke consultation will be initiated, they refer to the step-by-step workflow chart, which specifies actions needed for each member of the multidisciplinary team.

    Co-author Chelsey Kuznia, BSN, RN, SCRN, is the stroke program manager for Essentia Health’s Comprehensive Stroke Center in Fargo, one of only two such facilities in North Dakota.

    “Regardless of the type of stroke, rapid diagnosis and intervention are critical for improving survival rates and reducing the long-term effects of stroke,” she said. “People living in rural areas not only have increased stroke risk factors, but they also face challenges to getting the advanced care they need in a timely way, which leads to higher rates of disability and death.”

    In 2022, telestroke connections for 42 patients were completed, with a stroke diagnosis confirmed in 25 of them (61%). Fourteen of the patients with confirmed stroke received thrombolytic therapy while others were not eligible, either because of patient-related contraindications or because more than 4.5 hours had elapsed since their last-known well time.

    Of the 25 patients with confirmed stroke, 18 (72%) were discharged home, while three were discharged to skilled nursing facilities, one to an inpatient rehabilitation unit, one to hospice and two died.

    The year prior to implementation of the telestroke program, 11 of 15 eligible patients (73%) received thrombolytic therapy in less than 60 minutes, with a mean door-to-needle time of 61 minutes. During the year after implementation, the results improved: 11 of 12 eligible patients (92%) received thrombolytic therapy in less than 60 minutes, and the mean door-to-needle time decreased to 38 minutes.

    As the American Association of Critical-Care Nurses’ bimonthly clinical practice journal for acute and critical care nurses, CCN is a trusted source of information related to the bedside care of critically and acutely ill patients. Access the article abstract and full-text PDF by visiting the CCN website at http://ccn.aacnjournals.org.

    About Critical Care Nurse: Critical Care Nurse (CCN), a bimonthly clinical practice journal published by the American Association of Critical-Care Nurses, provides current, relevant and useful information about the bedside care of critically and acutely ill patients. The award-winning journal also offers columns on traditional and emerging issues across the spectrum of critical care, keeping critical care nurses informed on topics that affect their practice in acute, progressive and critical care settings. CCN enjoys a circulation of about 130,000 and can be accessed at http://ccn.aacnjournals.org/.

    About the American Association of Critical-Care Nurses: For more than 50 years, the American Association of Critical-Care Nurses (AACN) has been dedicated to acute and critical care nursing excellence. The organization’s vision is to create a healthcare system driven by the needs of patients and their families in which acute and critical care nurses make their optimal contribution. AACN is the world’s largest specialty nursing organization, with about 130,000 members and nearly 200 chapters in the United States.

    American Association of Critical-Care Nurses, 27071 Aliso Creek Road, Aliso Viejo, CA 92656; 949-362-2000; www.aacn.org; facebook.com/aacnface; twitter.com/aacnme

    American Association of Critical-Care Nurses (AACN)

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  • High cure rate, low toxicity maintained with shortened radiation treatment for intermediate risk prostate cancer, study finds

    High cure rate, low toxicity maintained with shortened radiation treatment for intermediate risk prostate cancer, study finds

    Newswise — ARLINGTON, Va., September 29, 2023 — People with intermediate risk, localized prostate cancer can be treated as effectively using fewer and higher doses of radiation therapy delivered over five treatment sessions as they can with lower doses delivered over several weeks, a new phase III randomized trial suggests. The findings, which are the latest from a series of studies investigating the benefits of stereotactic body radiation therapy (SBRT) for people diagnosed with prostate cancer, will be presented Monday at the American Society for Radiation Oncology (ASTRO) Annual Meeting.

    The PACE B (Prostate Advances in Comparative Evidence) study found SBRT performed as well as standard treatment with moderately fractionated radiation for people whose prostate cancer had not spread, demonstrating a five-year 96% disease control rate, compared to 95% for conventional radiation.

    “The outcomes for patients in both study arms were better than we expected,” said principal investigator for the trial Nicholas van As, MD, a consultant clinical oncologist and Medical Director of The Royal Marsden NHS Foundation Trust and a professor at the Institute of Cancer Research in London. “To be able to sit with a patient and say, ‘We can treat you with a low toxicity treatment in five days, and your chance of keeping the cancer at bay for five years is 96%, it’s a positive conversation to have.”

    Prostate cancer is one of the most commonly diagnosed cancers in the U.S., second only to skin cancer for male patients. There are approximately 288,300 new cases each year, with rates rising roughly 3% each year since 2014. “As patient volumes rise, substantially reducing the number of times a patient needs to visit a cancer treatment center frees up valuable resources, allowing our radiation oncology teams to treat more patients in less time,” said Prof. van As.

    Most prostate cancers are diagnosed before the cancer has grown beyond the prostate gland. The primary treatment options for localized prostate cancer include active surveillance, radiation therapy or surgery to remove the prostate gland.

    SBRT is an advanced form of radiation therapy that shrinks or destroys tumors with fewer, higher doses of radiation delivered in a small number of outpatient sessions. This approach uses advanced imaging and treatment planning techniques to deliver radiation with pinpoint accuracy, minimizing damage to surrounding healthy tissue. Patients who choose radiation therapy for intermediate-risk prostate cancer typically receive treatment in 20 daily doses, or fractions, and up to 40, while SBRT is typically given in five or fewer outpatient treatment sessions.

    “There’s a lot of evidence now that prostate cancer actually responds better to a large fraction size given over a shorter period of time,” he said. “We’ve demonstrated now that the accelerated course is as effective as the protracted course.”

    PACE B was a multi-center, international phase III randomized controlled study to investigate whether SBRT was non-inferior to conventional radiation for treating people with intermediate risk, localized prostate cancer. Non-inferiority was measured by whether patients remained free of biochemical clinical failure (BCF), defined as an increase in PSA levels, distant metastases or other evidence the cancer was returning, or death from prostate cancer.

    Drawing from 38 centers across the UK and Canada, PACE B researchers enrolled 874 people who preferred radiation treatment or were unsuitable for surgery. The median age was 69.8 years old.

    Patients were randomly assigned to receive either SBRT (n=443) consisting of five fractions over one to two weeks (36.25 Gy total dose), or standard radiation (n=441) consisting of 39 fractions over 7.5 weeks (78 Gy) or 20 fractions over four weeks (62 Gy). None of the patients received hormonal therapy. Median follow-up was 73.1 months.

    Five years after treatment, people treated with SBRT had a BCF-event-free rate of 95.7% (93.2% – 97.3%), compared to 94.6% (91.9% – 96.4%) for those treated with conventional radiation, demonstrating that SBRT was non-inferior to CRT (90% CI, p-value for non-inferiority=0.007).

    Side effects were low in both groups, and not significantly different between treatment arms. At five years post-treatment, 5.5% of patients who received SBRT experienced grade 2 or higher side effects affecting the genital or urinary organs, compared to 3.2% in the conventional group (p=0.14). Only one person in each arm of the study experienced grade 2 or higher gastrointestinal side effects (p=0.99).

    “Standard radiation treatment is already highly effective and is very well tolerated in people with localized prostate cancer,” Prof. van As said. “But for a healthcare system and for patients, to have this treatment delivered just as effectively in five days as opposed to four weeks has huge implications.”

    Though he expected SBRT to be non-inferior to conventional radiation, Prof. van As said he was surprised at the level of disease control they were able to demonstrate. He attributed the high rates to improvements in image-guidance and technologies to deliver radiation in recent years.

    “One of the things this study demonstrated is that outcomes of high-quality radiation therapy are outstanding,” he said. “We’ve become much more precise at tracking and reaching the targets. We’re able to put high doses of radiation in the right place and avoid putting high doses in areas we don’t want it.”

    He cautioned the results could not be extrapolated to all people with prostate cancer. “Ninety percent of our patients were intermediate risk, but they were the better end of intermediate risk,” he said. “These results do not apply to people with higher-risk cancer.”

    Prof. van As’ team is also examining the use of SBRT for patients with higher risk disease. The PACE trials (NCT01584258) include three studies investigating the benefits of SBRT for people with localized prostate cancer. PACE A compared patient’s quality of life following SBRT or prostate surgery, finding fewer urinary and sexual side effects from SBRT but a higher risk for minor bowel problems. PACE C, which has completed accrual, investigates how well SBRT works for people with intermediate and high-risk prostate cancer who are also being treated with hormone therapy.

    In the meantime, Prof. van As said, people with intermediate risk prostate cancer should be given the option of SBRT as an alternative to longer courses of radiation or prostate surgery.

    ###

    Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage.

    See this study presented:

    • News Briefing: Tuesday, October 3, 9:00 a.m. Pacific time. Details here. Register here.
    • Scientific Presentation: Plenary session, Monday, October 2, 2023, 2:10 p.m. Pacific time, San Diego Convention Center. Email [email protected] for access to the live stream or recording.
    • Abstract Title: 5-Year Outcomes from PACE B: An International Phase III Randomized Controlled Trial Comparing Stereotactic Body Radiotherapy (SBRT) vs. Conventionally Fractionated or Moderately Hypofractionated External Beam Radiotherapy for Localized Prostate Cancer (LBA 03)

    View the press kit for the 2023 ASTRO Annual Meeting at www.astro.org/annualmeetingpress.

    ABOUT ASTRO

    The American Society for Radiation Oncology (ASTRO) is the largest radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. Radiation therapy contributes to 40% of global cancer cures, and more than a million Americans receive radiation treatments for cancer each year. For information on radiation therapy, visit RTAnswers.org. To learn more about ASTRO, visit our website and media center and follow us on social media.

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  • Embargoed Sylvester Comprehensive Cancer Center ASTRO 2023 Tip Sheet

    Embargoed Sylvester Comprehensive Cancer Center ASTRO 2023 Tip Sheet

    Newswise — ALL INFORMATION EMBARGOED UNTIL 5 P.M. E.T. ON SEPT. 29, 2023

    Panel Discussion

    Getting it All Done – Strategies for Coping With Professional Burnout

    Crystal Seldon Taswell, MD, Sylvester radiation oncologist and researcher, will co-moderate a panel discussion on physician burnout within radiation oncology and medicine. The discussion, titled “Getting It All Done — Practical Strategies at All Career Stages,” will include background on the extent of the problem, as well as the curriculum gap for residents regarding time management, balancing clinical and research work and learning boundaries for work-life balance in an always-connected world. Other speakers will explain how they navigate work-life balance, pursue career interests, build core values into daily routines, mentor residents and attendings and juggle multiple challenges among their clinical and academic careers and personal lives.

    Panel 05 – ASTRO/SWRO Joint Session

    Date/time/location – Monday, Oct. 2, 8-9 am, Room 2

    == 

    Oral Presentations

    Testosterone Recovery and Prostate Cancer Outcomes

    Alan Dal Pra, MD, director of the Radiation Oncology Clinical Research Program at Sylvester, and collaborators will present a secondary analysis of the NRG/RTOG 0534 SPPORT phase 3 trial in which patients were treated with salvage radiotherapy and short-term androgen suppression for rising PSA levels after radical prostatectomy. The trial was conducted in the U.S., Canada and Israel from 2008 to 2015. It showed improved outcomes with salvage radiotherapy to the prostate bed, pelvic lymph nodes and androgen suppression as opposed to prostate bed radiotherapy alone.

    Dal Pra and his team assessed the testosterone measurements of more than 1,000 patients enrolled in the SPPORT trial to investigate the impact of testosterone recovery on clinical outcomes. This study represents the largest study of testosterone dynamics in patients treated with salvage radiation and androgen suppression. Although testosterone is known to “feed” the growth of prostate cancer cells, the authors showed that a faster normalization of testosterone levels after treatment does not worsen patients’ outcomes. The results have potential clinical implications for using androgen suppression drugs that can provide a faster testosterone recovery. They may also shed light on a possible benefit of testosterone replacement therapies for some prostate cancer patients who experience significant side effects due to low testosterone levels after cancer treatment.

    Abstract: 55528

    Abstract title: Impact of Testosterone Recovery on Clinical Outcomes of Patients Treated With Salvage Radiotherapy and Androgen Suppression: A Secondary Analysis of the NRG/RTOG SPPORT Phase 3 Trial.

    SS 28 – GU 4

    Date/time: Oct. 3, 5:35-5:42 pm, Room 6B

     

    Predicting Tumor Response During Radiation Therapy for Glioblastoma Patients 

    Distinguishing between true progression and pseudoprogression of tumors after radiotherapy (RT) is critically important for treating patients with glioblastoma, the most common and aggressive form of brain cancer. New research to be presented by Kaylie Cullison, Eric Mellon, MD, PhD, and their Sylvester colleagues identified differences in tumor growth behavior for true progression and pseudoprogression, and these volume changes during treatment may be early markers of treatment response. Next steps, the researchers say, include automating real-time tumor volume monitoring by using a deep-learning solution for volume delineation on daily treatment scans.

    Title: “Pattern Analysis of Daily Lesion Volume Trajectories for Early Prediction of Glioblastoma Progression During MR-Linac Radiotherapy”

    Date/time/location: Oct. 3, 1:05-1:12 pm, Room 29

     

    Is It True Progression or Pseudoprogression of Tumor Growth?

    Cullison, Mellon and Sylvester colleagues also will present results from another study looking at the predictive value of weekly delta-radiomic features extracted from MRI-guided linear accelerator radiation therapy for determining true progression or pseudoprogression of tumors in glioblastoma patients. They concluded that these features may help distinguish between real and pseudoprogression, thereby allowing physicians to adapt or intensify treatment in real time.

    Title: “Prognostic Value of Weekly Delta-Radiomics During MR-Linac Radiotherapy of Glioblastoma”

    Date/time/location: Oct. 3, 5:35-5:40 pm, Room 7

    ==

    Poster Presentations

    AI Model for Beam Angle Selection Similar to Human Choices in Proton Therapy

    Beam angles can have a major impact on treatment of brain cancers with proton therapy, but manual beam selection can be a time-consuming, cumbersome task. Robert Kaderka, PhD, Sylvester researcher and assistant professor of radiation oncology with UM’s Miller School of Medicine, and collaborators will lead a poster session showing that an AI model for beam selection was comparable to human choices for a small group of patients receiving proton therapy. Kaderka says the results serve as “proof-of-concept” for an expanded study currently underway that will add the prediction of couch angles into the AI model.      

    Title: “AI Beam Angle Prediction in Proton Therapy for Brain Patients”

    PQA 07

    Date/time/location: Tuesday, Oct. 3, 4-5 pm, Hall B2

     

    Spectroscopic MRI May Better Detect Glioblastoma Invasion

    Conventional MRI may not fully capture the extent of disease in patients undergoing chemoradiation for primary glioblastoma, the most common and aggressive brain cancer. New research led by Jonathan Bell, MD, PhD, senior resident, Department of Radiation Oncology at Sylvester and others suggests that whole-brain spectroscopic MRI (sMRI) provides better visualization of invasive tumor cells and the potential to improve target delineation compared with conventional MRI.

    Title: Spectroscopic MRI Detects Occult Glioblastoma Radiation During Chemoradiation

    PQA 02

    Date/time/location: Monday, Oct. 2, 10:45 am-Noon, Hall B2

     

    Novel Nipple-Preservation Approach for Breast Cancer Patients

    Sylvester physician-scientist Crystal Seldon Taswell, MD, and collaborating researchers will present long-term results from a phase I study of a new approach to nipple-preserving therapy for patients with early-stage breast cancer or ductal carcinoma in situ who are not candidates for nipple-sparing mastectomy. The approach, which uses delayed radiotherapy after breast surgery, resulted in 100% nipple preservation without compromise of local control, as well as excellent patient-reported satisfaction with the treatment. Seldon Taswell believes study results support further exploration of this nipple preservation technique with broader patient-inclusion criteria.

    Title: Delayed Nipple-Areola Complex Radiotherapy After Nipple-Sparing Mastectomy and Immediate Reconstruction for Invasive Breast Cancer or DCIS: Long-Term Results of a Phase I Study

    PQA O3

    Date/time/location: Monday, Oct. 2, 3-4 pm, Hall B2

     

    Preventing Kidney Disease, Cholesterol Dysfunction from Cancer Treatment

    Radiation therapy alone or combined with chemotherapy reduces cholesterol metabolism, or efflux, and causes chronic kidney disease, often leading to dialysis or kidney transplantation. Researchers from Sylvester and UM’s Miller School of Medicine, led by Anis Ahmad, PhD, will present results from their laboratory study showing that LXR agonist treatment not only prevents cholesterol dysregulation, but also protects vital kidney cells and prevents chemotherapy- or radiotherapy-induced kidney injury.   

    Title: Role of ATP Binding Cassette Subfamily A Member 1 (ABCA1) in Chemoradiotherapy-Induced Renal Injury

    PQA 04

    Date/time/location: Monday, Oct. 2, 5-6 pm, Hall B2

    == 

    Miscellaneous

    Sylvester Physician to Moderate Scientific Session on Patient Safety

    Laura Freedman, MD, director of radiation oncology at Sylvester’s Deerfield Beach location, will co-moderate a scientific session addressing patient safety. The session will cover various safety issues in radiation oncology, including terminating treatment during radiation therapy, minimizing patient delays via insurance preauthorization, optimizing workup pathways to reduce radiotherapy wait times and improving quality of care provided to cervical cancer patients.

    SS 33 – Patient Safety 2

    Date/time/location: Wednesday, Oct. 4, 10:30-11:45 am, Room 2

     

    # # #

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