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  • ASH 2023 Tip Sheet From Sylvester Comprehensive Cancer Center

    ASH 2023 Tip Sheet From Sylvester Comprehensive Cancer Center

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    EMBARGOED

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

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

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

    Lymphomas

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

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

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

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

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

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

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

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

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

     

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

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

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

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

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

     

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

    EMBARGOED UNTIL Saturday, December 9, 2023: 5 PM

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

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

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

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

     

    Myelodysplastic Syndromes/Neoplasms

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

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

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

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

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

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

     

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

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

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

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

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

     

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

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

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

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

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

     

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

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

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

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

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

     

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

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

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

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

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

     

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

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

    First Presenter: Sana Chaudhry, Sylvester Comprehensive Cancer Center 

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

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

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

     

    Leukemias

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

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

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

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

     

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

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

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

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

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

     

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

    EMBARGOED UNTIL Monday, December 11, 2023: 4 PM

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

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

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

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

     

    Lung Cancer

    2649 Predictors and Timing of Venous Thromboembolism in Lung Cancer

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

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

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

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

     

    Myeloid Malignancies

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

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

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

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

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

     

    Multiple Myeloma

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

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  • Cell Therapy Appears Safe and Effective for Lymphoma in Remission

    Cell Therapy Appears Safe and Effective for Lymphoma in Remission

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    DOWNLOADABLE VIDEO HERE 

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

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

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

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

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

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

    Background

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

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

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

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

    Targeted Therapies for Mutations

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

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

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

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

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

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

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

    On the Horizon

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

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

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

    Disclosures

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

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    ASH Presentation Title:

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

    Presentation Date/Time:

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

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  • True Progression or Pseudoprogression in Glioblastoma Patients?

    True Progression or Pseudoprogression in Glioblastoma Patients?

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    Newswise — MIAMI, FLORIDA (STRICTLY EMBARGOED UNTIL SEPT. 29, 2023 AT 5PM ET) – Is it true progression or pseudoprogression in tumor growth?

    That’s the critical question for radiation and medical oncologists treating patients with glioblastoma, the most common and aggressive form of brain cancer. Distinguishing between these types of progression is vitally important for treatment management.

    “Knowing if it’s true progression, indicative of a poor response to treatment, or pseudoprogression, a favorable response that may look worse due to swelling or tumor necrosis, is essential for clinicians,” said Eric Mellon, MD, PhD, a radiation oncologist and researcher with Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. “That knowledge can guide us in adjusting current treatment in real time.”

    He and his research colleagues are presenting results from two recent studies on this topic at ASTRO 2023, the annual meeting of the American Society for Radiation Oncology, Oct. 1-4, in San Diego.

    One study was designed to determine if daily monitoring of tumor changes during a course of radiation therapy could result in early prediction of treatment response. The MRI-guided linear accelerator systems, known as MR-linac, that deliver radiation therapy allow for this type of monitoring and detection of patterns within these volume changes. 

    Sylvester researchers used sophisticated analytical and machine learning tools, including a linear fitting model to test their prediction theory on a prospective cohort of glioblastoma patients undergoing chemoradiation for their cancers.

    “The model was trained to predict between no progression, pseudoprogression and true progression, and the results were cross-validated,” explained Kaylie Cullison, an MD/PhD student who is conducting her PhD research in Mellon’s Sylvester laboratory, is the study’s first author, and will present the data at ASTRO 2023. 

    Of the 28 patients analyzed in the study, 11 had no tumor growth on first diagnostic MRI after treatment (no progression), five were found to have pseudoprogression based on long-term stability of MRI findings, and 12 had true progression determined by continuing tumor growth beyond six months, tissue sampling showing active malignancy or rapid death.

    The model achieved an overall accuracy of 86%, when predicting three outcome classes (no progression, true progression and pseudoprogression), and an accuracy of 93% when predicting between no progression versus any kind of progression.

    “We identified patterns of tumor behavior during therapy that were indicative of differences in growth patterns between true progression and pseudoprogression,” said Mellon, co-leader of Sylvester’s Neuro-Oncology Site Disease Group who leads numerous clinical trials for brain tumors. “These volume changes during treatment may be early markers of treatment response.”

    Next steps, according to Mellon and Cullison, include automating real-time tumor monitoring by using a deep-learning solution for volume delineation on daily treatment scans.

    Their other study, conducted simultaneously with the above one, sought to determine the predictive value of weekly delta-radiomic features extracted from MR-linac systems used for treating glioblastoma patients.

    Whereas radiomics focus on quantitative features extracted from medical images to correlate with various biological features and clinical endpoints for cancer diagnosis, prognosis and clinical decisions, delta radiomics extend that analysis by examining feature variation at different time points, usually before and after therapy.

    In this case, however, the acquisition time points were during therapy. Sylvester researchers deployed supervised machine learning with a sophisticated classification model to predict true progression or pseudoprogression outcomes. Their model included 41 variables – 39 tumor texture features plus lesion volume and mean lesion intensity – per time point to generate the predictions.

    Of the 10 most prognostic features, 90% happened during an early time point, suggesting that prognostic changes in the underlying tumor microenvironment occur within the first 15 treatment sessions (or first half of treatment).

    “Our findings support the theory that delta-radiomic features from MR-linac radiotherapy can predict treatment response during therapy, which is earlier than current methods,” concluded Mellon. “And doing so would allow physicians to intensify current treatment for poorly responding patients.”       

    Mellon and Cullison say future research should include a larger patient cohort and the use of MR-linac systems with multiparametric MRI to further test the model’s prognostic value.

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  • ASTRO 2023 Session Shines Spotlight on Physician Burnout

    ASTRO 2023 Session Shines Spotlight on Physician Burnout

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    Newswise — MIAMI, FLORIDA (EMBARGOED UNTIL SEPT. 29, 2023, AT 5 PM ET, 2023) – Physician burnout was already a trending topic within the medical community before 2020, when the COVID-19 pandemic brought national attention to the issue.

    Typical stressors such as long hours, poor work-life balance, frustrating insurance denials and cumbersome medical documentation were compounded by new challenges from a novel, deadly virus that killed millions worldwide and necessitated a paradigm shift in care delivery.

    The side effects were widespread and readily apparent. By late 2021, research by the American Medical Association, Mayo Clinic and Stanford Medicine found that the prevalence of burnout among physicians was almost 63%, up from less than 40% the previous year. Additionally, research has repeatedly shown that occupational burnout among physicians is considerably higher than with the overall U.S. workforce.    

    So, where do things stand now? A panel of experts will delve into this topic at ASTRO 2023, the annual meeting of the American Society of Radiation Oncology, Oct. 1-4, in San Diego. The discussion, titled “Getting It All Done – Practical Strategies at All Career Stages,” occurs on Monday, Oct. 2, from 8-9 a.m., in Room 2.

    Crystal Seldon Taswell, MD, radiation oncologist and researcher with Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, will co-moderate the panel discussion with Leah Katz, MD, from Columbia University College of Physicians and Surgeons.  

    Seldon Taswell and Katz will provide background on the extent of burnout within radiation oncology and medicine in general. They also will discuss the curriculum gap for residents regarding time management, balancing clinical and research work and learning boundaries for better work-life balance in an always-connected world.

    “Radiation oncology and other specialties do an excellent job of teaching resident physicians the clinical side of the job,” said Seldon Taswell, who specializes in treating breast and musculoskeletal cancers. “But often, there is a curriculum void in teaching the intangibles that ensure proper work-life integration and professional satisfaction.” 

    Seldon Taswell noted that the ASTRO panel discussion was purposely designed to offer practical strategies for practicing physicians at different stages of their careers. Panelists are:

    • Sara Beltran Ponce, MD, radiation oncology resident and mother, sharing her personal time-management tips and ways to support physician-parents.

     

    • Matt Katz, MD, physician and parent, explaining how to navigate work-life balance through various career changes and pursue academic interests in a private-practice setting.

     

    • Anthony D’amico, MD, PhD, veteran radiation oncologist and professor, offering insights into building core values into daily routines and mentoring residents/attendings as they seek balance in their lives.

     

    • Christina Henson, MD, early-career physician and parent, discussing how she navigates clinical care, research and resident teaching, as well as the challenges for women in medicine.

    “We know from research and physician surveys, in particular, that poor work-life integration is a critical driver of professional burnout,” explained Seldon Taswell. “This phenomenon can lead to higher rates of depression, drug and alcohol abuse, divorce and suicidal thoughts among physicians.”

    She added that professional burnout has potentially harmful effects on patient care, including increased medical errors, decreased patient satisfaction and strained relationships among physician colleagues.

    “Physician well-being goes hand-in-hand with the health and wellness of patients and our healthcare system in general,” Seldon Taswell said. “I look forward to participating in this important conversation at ASTRO 2023 to ensure physician wellness remains in the national spotlight.”     

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  • Sylvester Research: Socioeconomic status linked with outcomes and survival in patients treated for non-small cell lung cancer

    Sylvester Research: Socioeconomic status linked with outcomes and survival in patients treated for non-small cell lung cancer

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    Newswise — MIAMI, FLORIDA (Sept. 22, 2023) – Researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine found an association between “social determinants of health” and outcomes and survival in patients undergoing surgery and treatment for non-small cell lung cancer.

    The findings are based on a statistical scoring system the researchers developed that consolidates and analyzes several measures of socioeconomic status and related factors.

    “We believe our social determinants of health scoring system is the first to provide a composite perspective on many of the nonmedical factors that affect outcomes in patients receiving treatment for non-small cell lung cancer,” said Dao Nguyen, M.D., Sylvester Thoracic Cancers Group co-leader. He said the study focused on patients with stage 2 or stage 3 NSCLC, with surgically confirmed metastasis to regional lymph nodes within the chest cavity.

    Ideally, Nguyen said, patients with these cancers should receive ‘multimodal’ care – chemotherapy, immunotherapy and, in some cases, radiotherapy – and this high level of expertise and care may best be provided by specialized, comprehensive centers like Sylvester, a National Cancer Institute-designated center.

    But studies have shown that better or worse outcomes result from more than just medical and surgical treatments. Socioeconomic disadvantages, for example, have been associated with lower-quality care and suboptimal outcomes. Social determinants of health, or SDH, include income, wealth, education, geographical location, access to specialized care and other nonmedical factors that influence health outcomes.

    “Our analysis shows that SDH scores can identify patients who are at increased risk even if they undergo adequate initial treatment. Our research also may help point the way toward improving strategies and care for patients with lung cancer who are socioeconomically disadvantaged,” said Nguyen, a thoracic surgeon who treats and studies lung and other cancers and is the senior author of an article published online ahead of print in The Journal of Thoracic and Cardiovascular Surgery.

    Nguyen and colleagues analyzed data from 11,274 patients with locally advanced NSCLC in the National Cancer Database (NCDB), a registry provided by the American College of Surgeons and the American Cancer Society. Patients with locally advanced disease make up about one-third of the NSCLC population. In the study sample, average patient age was about 68, and 57% of patients were female. Eighty-four percent of patients in the sample were non-Hispanic white, 8.8% were Black, 3.0% were Hispanic, and 3.3% were Asian.

    The researchers quantified results based on the medical research term “textbook oncological outcome,” which considers several metrics and translates to the most desirable or optimal outcome for patients undergoing surgery to remove a primary cancer. These factors include complete resection, adequate lymph node removal, timely initiation of other therapies when needed, and short hospital stay. Textbook outcomes also are reflected in statistics on mortality, re-intervention, readmission, and major complications.

    The Sylvester study aimed to determine the rate of achieving ideal outcomes in relation to social determinants of health scores, the association between these scores and optimal outcomes, and the association between SDH and overall survival.

    The researchers focused on income, place of residence, level of education, and location of hospitals in proximity to patient residence. Other variables of interest included patient demographics, types of treatment facilities, surgical volumes at treatment facilities (representing experience and expertise), and whether patients had other medical conditions or diseases in addition to NSCLC.

    “In this cohort, we found that socioeconomic status – indicated by SDH score – has an important association with both textbook outcomes and survival,” said Ahmed Alnajar, M.D., the paper’s first author. “Significant socioeconomic disadvantage was associated with a 21% decrease in textbook outcomes and a 32% decrease in overall survival when compared to a patient subgroup that was not disadvantaged. Vulnerable patient population groups living in areas with limited income, limited education, rural locations, and areas with limited access to specialized cancer care settings are at increased risk of poor outcomes and long-term mortality.”

    Among highlights from the article:

    • In this study, patients living in rural areas had a 30% decreased likelihood of overall survival and long-term outcomes.
    • Having access to only community hospitals adversely affected survival.
    • Having surgery performed in a high-volume hospital decreased mortality risk by 31% and increased textbook outcome likelihood by 93%, compared to having surgery completed in a low-volume hospital.
    • Black patients were 31% less likely to achieve optimal, textbook outcomes than were white patients.
    • The authors say policymakers should ensure equitable access to surgery and multimodality therapy to be sure all patients receive the best care. They also say surgeons and other care providers can strategically allocate resources and target interventions to counter the effects of SDH inequities.

    Authors: In addition to Nguyen and Alnajar, Karishma Kodia, M.D., and Nestor Villamizar, M.D., contributed from Sylvester and the University of Miami Miller School of Medicine. Syed Razi, M.D., contributed from Hackensack Meridian Health in Edison, New Jersey.

    Funding: This work received no external funding.

    Conflicts of interest: The authors declare no conflicts of interest or disclosures.

    Publication: The Journal of Thoracic and Cardiovascular Surgery, “The Impact of Social Determinants of Health on Textbook Oncological Outcomes and Overall Survival in Locally Advanced Non-Small Cell Lung Cancer.”

    DOI: 10.1016/j.xjon.2023.09.013

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  • Sylvester Researcher Earns Prestigious Columbia University Award

    Sylvester Researcher Earns Prestigious Columbia University Award

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    Newswise — MIAMI, FLORIDA (Sept. 20, 2023) – A researcher with Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine has been selected to receive a prestigious honor from Columbia University.

    Glen N. Barber, PhD, Sylvester’s internationally known cell biologist who chairs UM’s Department of Cell Biology, will be awarded the 2023 Louisa Gross Horwitz Prize from Columbia for outstanding contributions to basic research in biology and biochemistry.

    Barber is the first UM faculty member to receive this award, and more than 50% of previous honorees have gone on to win the Nobel Prize. The award, which carries a $10,000 prize was presented to Barber and fellow recipient, James Chen, at a recognition dinner in New York City.

    Barber is being honored for his transformational research discovery known as STING (stimulator of interferon genes), a pivotal pathway controlling immune responses to infections and inflammation that also plays a vitally important role in triggering anti-tumor T-cell activity.   

    Since making the discovery in 2008, Barber and his team have conducted extensive research into STING signaling and made significant discoveries that have spawned efforts to design novel drugs that target this pathway for new treatments of various diseases such as inflammatory bowel disease, systemic lupus and, more recently, leukemia and other cancers.

    “This award is a tremendous honor for which I am both humbled and grateful,” Barber said. “I will be accepting it on behalf of many colleagues, past and present, whose contributions have been invaluable to our collective success.”

    The Louisa Gross Horwitz prize was established at the bequest of the late S. Gross Horwitz and is named to honor his mother, the daughter of academic trauma surgeon Samuel D. Gross. The prize was first awarded in 1967. 

    Read more about this award on the InventUm Blog.  

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  • Study: Race, Ethnicity May Play a Role in Cause of Liver Cancer

    Study: Race, Ethnicity May Play a Role in Cause of Liver Cancer

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    Newswise — MIAMI, FLORIDA (EMBARGOED UNTIL SEPT. 5, 2023 AT 8 P.M. ET) – A new analysis of liver cancer has identified racial and ethnic differences and emerging trends for this highly fatal disease. The study,  conducted by researchers with Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and collaborating organizations, also identified potential targeted interventions to improve control and prevention. 

    Their extensive review, published Sept. 6 in the journal Clinical Gastroenterology and Hepatology, examined 14,420 confirmed cases of hepatocellular carcinoma (HCC), the most common form of liver cancer, diagnosed between 2010 and 2018. Data was culled from Florida’s statewide cancer registry and two other public sources.

    By the Numbers

    According to statistics from the National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC), HCC accounts for almost 80 percent of all liver cancers. About 25,000 new cases are diagnosed annually, and its incidence has increased 48% since 2000. The disease is highly fatal, with a five-year survival rate of only 18%.

    Despite these numbers, however, most studies looking at the extent and demographic breakdown of the disease have been limited in scope, resulting in a clear knowledge gap.

    “To date, studies examining the burden of this cancer have been hospital-based, failing to consider the underlying population at risk, thereby limiting epidemiological information,” explained Paulo Pinheiro, MD, PhD, a Sylvester cancer epidemiologist and the study’s corresponding author. “Hospital studies are subject to selection bias due to referral and health insurance patterns, which tend to limit the overall impact on marginalized populations.”

    Pinheiro, who is also a professor of epidemiology, noted that liver cancer disproportionately affects people of low socioeconomic status, as well as immigrants, veterans and incarcerated populations, which are difficult to capture in clinical studies because they have limited access to healthcare.

    “Consequently, we need truly inclusive population data to establish causes and patterns for this disease, especially if we are to develop effective prevention and control efforts for those most vulnerable,” he said.

    Pinheiro and colleagues sought to overcome potential biases by using data from three independent, population-based sources: Florida’s cancer registry; its public health agency; and its hospitals’ discharge records. The researchers deployed novel linkages among these data sources to estimate incidence and trends by cause.

    Additionally, they leveraged the vast diversity of Florida’s population to focus on patterns in detailed racial-ethnic groups, such as Central Americans, Cubans, Dominicans, Mexicans, Puerto Ricans and South Americans, instead of Hispanic/Latino only, and African American, Haitian and West Indian instead of just Non-Hispanic Black.

    Previous studies done by Pinheiro and collaborators at Sylvester and researchers elsewhere have shown that 90% of all liver cancers are caused by hepatitis B or hepatitis C viral infections, fatty liver disease and alcohol-related liver disease. However, many of those studies had limitations or did not dig deeper into the most common causes specific to racial-ethnic groups.

    For this study, the researchers expanded on past findings by including more years of data – nine in this study versus only two (2014-15) previously – and conducting a far more comprehensive analysis of the data, adding linkages for chronic viral hepatitis biomarkers, performing trend assessments and refining subgroups for Black, Hispanic and Asian populations.

    Results

    Key findings from the study included:

    • Race and birthplace affect causes of liver cancer, with clear differences for various groups.
    • Differences in liver-cancer causes reflect the socioeconomic factors associated with each racial-ethnic group.
    • Black, Asian and Hispanic populations have marked differences by subgroup – Cubans, Haitians, Chinese, Japanese, for example – and social factors, which influence major causes of liver cancer.
    • For men and women combined in 2018, hepatitis C infection and fatty-liver disease accounted for 36% and 35% of all liver cancers, respectively.

    Additionally, the research revealed some unexpected findings, including:

    • A three-fold difference in rates between Puerto Rican and Cuban men – with Puerto Rican men being higher – proof that grouping all Hispanics together can obscure major differences across ethnicity.
    • Filipinos have higher rates of fatty liver-related cancer, similar to Hispanics.
    • Liver cancer from hepatitis B infections is not only the leading cause among Asians, but also Haitian-born Black men.
    • Liver cancer causes that are increasing – fatty liver and alcohol-related – are both more prevalent among Hispanics.
    • Conversely, causes that are declining – primarily Hepatitis C – are more prevalent in U.S.-born populations, like Whites and Blacks.

    The researchers also noted that declines in liver cancer from hepatitis C since 2015 are likely due to the advent of direct-acting antivirals, while increasing incidence of liver cancer from fatty liver disease reflect rising rates of obesity and diabetes in the general population.

    Next Steps

    “Moving forward, we need to reinforce the importance of screening all adults in Florida – and nationwide – for hepatitis C and B viral infections, especially if they are in a high-risk group identified by the study,” Pinheiro said. “There is a cure for hep C and an effective control for hep B.”

    Colleague and co-author Patricia D. Jones, MD, a Sylvester liver-cancer specialist, agreed.  “Cancer Control efforts should begin by expanding screening programs to the most vulnerable groups noted in the study,” she said. “Similar efforts are critically needed to disseminate educational materials informed by this granular data to the healthcare providers who care for these vulnerable groups.”

    Pinheiro, who has been studying liver cancer for many years, noted that its epidemiology by demographics is quite complex and, until now, often puzzling. “With this study, we have shined some light on this deadly disease.”

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    Contributing Authors

    The complete list of authors is included with the manuscript.

     

    Conflicts of Interest

    The authors declare no conflicts of interest.

     

    Funding

    This research was supported by the Bankhead Coley Research Program of the state of Florida. Supplemental funding was provided by Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

     

    DOI: doi.org/10.1016/j.cgh.2023.08.016

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  • Sylvester Research: Remnants of ancient retrovirus may drive aggressiveness and resilience of malignant brain cancers

    Sylvester Research: Remnants of ancient retrovirus may drive aggressiveness and resilience of malignant brain cancers

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    Newswise — MIAMI, FLORIDA (EMBARGOED UNTIL JULY 3, 2023 AT NOON ET) – The median length of survival after diagnosis of glioblastoma is 14 months, but some of these brain tumors are more aggressive and resistant to treatment than others, and a new study from Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine suggests reactivation of an ancient retrovirus may be at least partly to blame.

    “Our lab found that an evolutionary dormant retrovirus from 6 million years ago – HML-2, a subtype of HERV-K– contributes to brain tumor formation. We demonstrated for the first time that this virus, when reactivated, plays a role in defining the stem-cell state of high-grade gliomas, promoting an aggressive form of cancer,” said neurosurgeon Dr. Ashish Shah, first author of a paper in the Journal of Clinical Investigation.

    Cancer stem cells, a subpopulation of cells in cancers, drive tumor initiation and development and influence how aggressive and resistant to treatment a cancer will be. This study, conducted by researchers from Sylvester, Georgetown University and the National Institutes of Health, found that HML-2 altered stem cell programming by activating a gene-regulating protein called OCT4. HML-2 was previously implicated in the genesis and development of other cancers, but this is believed to be the first study showing the virus’ effects in gliomas and describing the molecular and cellular mechanisms involved.

    “Our results suggest that HML-2 fundamentally contributes to the glioblastoma stem-cell niche, the microenvironment that supports stem cells and determines their fate,” said Dr. Avindra Nath, clinical director of the Division of Intramural Research at the National Institute of Neurological Disorders and Stroke at the National Institutes of Health.

    “We conducted a comprehensive translational investigation of HML-2 expression in glioblastoma and its role in maintaining the cancer stem cell phenotype,” said Nath, the article’s senior author. Results were based on analyses of patient-derived glioblastoma cells and mouse model studies.

    The team’s findings give researchers targets for developing therapies; and in their work, an anti-retroviral drug significantly reduced HML-2 activity and reduced tumor stem-cell markers, said Shah, director of clinical trials and translational research and principal investigator in the Section of Virology and Immunotherapy at Sylvester Comprehensive Cancer Center’s Brain Tumor Initiative (BTI).

    “Targeting the glioblastoma stem cell niche is an attractive option to prevent alterations in stem cells and reduce tumor recurrence and treatment resistance,” he said.

    HML-2, a subtype of HERV-K, is one of many human endogenous retroviruses (HERVs), ancestral relics of retroviral infections that occurred throughout history and led to the integration of viral sequences into the human genome. HERVs, making up about 8% of the human genome, are usually silent – unable to cause infection – but scientists have recently discovered that some can be reactivated in certain cancers.

    Authors from the University of Miami include first author Shah, Vaidya Govindarajan, Dr. Jay Chandar, Deepa Seetharam, PhD, Jelisah Desgraves, Dr. Michael Ivan, and Dr. Ricardo Komotar. A full list of authors and affiliations is available in the article.

    Funding: The work was funded in part by the Intramural Program of the National Institute of Neurological Disorders and Stroke, National Institutes of Health, the Neurosurgery Research and Education Foundation, and the Florida Center for Brain Tumor Research.

    Conflicts of interest: The authors have no conflicts of interest to disclose.

    Publication: Journal of Clinical Investigation: Human Endogenous Retrovirus-K contributes to a unique stem-cell niche in glioblastoma.

    DOI: 10.1172/JCI167929

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  • New Research by Sylvester Cancer Shows Unmet Support Needs Can Lead to Worse Clinical Outcomes

    New Research by Sylvester Cancer Shows Unmet Support Needs Can Lead to Worse Clinical Outcomes

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    Newswise — MIAMI, FLORIDA (June 27, 2023) – Cancer patients with unmet supportive care needs are more likely to experience worse clinical outcomes, including more emergency department (ED) visits and hospitalizations, according to new research from Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

    The study, published June 21 in JAMA Network Open, also found that Black race, Hispanic ethnicity and factors such as anxiety, depression, pain, poor physical function and low health-related quality-of-life scores were associated with greater number of unmet needs, leading to increased risk for ED visits and hospitalizations.

    This retrospective analysis involved 5,236 patients treated at Sylvester’s various ambulatory cancer sites who used its My Wellness Check, an electronic health record-based system, that monitors patients’ emotional, physical and psychosocial needs.

    “This study, to our knowledge, is the most comprehensive assessment to date that links unmet supportive care needs to ED visits and hospitalizations among ambulatory oncology patients,” said Frank J. Penedo, PhD, Sylvester’s associate director for Cancer Survivorship and Translational Behavioral Sciences and corresponding author of the research. “It included a very diverse group of patients treated at our various cancer clinic locations and across multiple phases of the cancer care continuum.”

    Other key takeaways from this study included:

    • 940 or 18% of patients reported one or more unmet supportive care needs, with about a third of them noting two or more unmet needs.
    • Almost one quarter of patients with unmet support needs had ED visits, compared with 14% for those without unmet needs.
    • For hospitalizations, the differences were 23% and 14%, respectively.
    • Support for coping with cancer and financial concerns were the most reported unmet needs, followed by general cancer education and information.
    • Diverse representation with Hispanics comprising almost 48% of study patients while other racial groups included Blacks, Caucasians, Asians, American Indians, Native Alaskans, Native Hawaiians and other Pacific Islanders.

    “Our findings offer strong evidence that unmet supportive care needs are associated with unfavorable clinical outcomes, particularly higher risk for ED visits and hospitalizations,” Penedo said. “Addressing these unmet needs is crucial to improve clinical outcomes and particularly in racial and ethnic minority populations where the needs are greatest.”

    Authors

    The complete list of authors is noted in the research article.

    Funding

    This study was funded in part by grant P30 CA240139 from the National Cancer Institute. Sara Fleszar-Pavlovic, PhD, is funded by The Ruth L. Kirschstein NRSA Institution Research Training Grant (T32; 5T32CA251064-03) in Cancer Training in Disparities and Equity (C-TIDE).

    Conflicts of Interest Disclosure

    Penedo reported receiving personal fees from BlueNote Therapeutics outside the submitted work. No other disclosures were reported.

    DOI: 10.1001/jamanetworkopen.2023.19352

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  • Sylvester study identifies ‘marked disparities’ in federal cancer research funding

    Sylvester study identifies ‘marked disparities’ in federal cancer research funding

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    Newswise — MIAMI, FLORIDA (EMBARGOED UNTIL JUNE 8, 2023) – A research team at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine compiled and analyzed statistics from federal cancer research funding sources and found that funds tend to be allocated more heavily toward cancers that occur more often in non-Hispanic white people than in other racial and ethnic groups.

    The study found that funding across cancer sites is not concordant with lethality and that cancers with high incidence among racial/ethnic minorities receive lower funding, but the study’s authors say addressing these inequities could make a difference in cancer research disparities within a short time.

    “The results of this study are immediately actionable,” said Dr. Shria Kumar, a Sylvester gastroenterologist and the senior author of a paper in the June 8 Journal of the National Cancer Institute. “Agencies can evaluate their own recent funding distributions and those for upcoming cycles, then they can prioritize funding for cancers that disproportionately impact minorities to mitigate disparities and reduce cancer burden.”

    The authors analyzed federal funding data to determine correlations between funding directed to cancer incidence and funding aimed at cancer mortality. They focused on National Cancer Institute funding for the 19 most common cancers, considering their respective “public health burdens,” a term that includes the incidence rate of the disease, the mortality rate, and person-years of life lost.

    Although previous studies of funding distribution have evaluated these three factors separately, the Sylvester team evaluated funding using a validated measure – funding-to-lethality (FTL) scores – that incorporates all three metrics and provides a composite, objective perspective on disease burden.

    “We were very surprised that correlation was stronger for incidence than mortality. It shows how complex and multifaceted funding allocation is, but it really underlines the need to look at it objectively, as we did here, and use it as a tool to mitigate cancer disparities, a common goal,” Kumar said.

    Breast and prostate cancer had the highest and second-highest FTL scores, while esophagus and stomach cancer ranked 18th and 19th. Kumar and colleagues noted that breast cancer research received approximately 50 times more funding than stomach cancer in 2018, even though estimated breast cancer deaths were only four times those of stomach cancer deaths.

    The authors also cited previously published statistics showing that cancers more frequently affecting non-Hispanic white people – such as breast cancer, leukemia and lymphoma – receive more funding than cancers with high incidence rates among racial and ethnic minorities – such as stomach, uterine and liver cancers.

    “In my research and in clinical practice, disparities in cancer are an unfortunate but well-known entity. I’m a gastroenterologist, and disparities are of paramount concern in my areas of expertise – stomach and colorectal cancer,” Kumar said. “Racial and ethnic disparities are well documented across the spectrum of cancer types, and this is of utmost importance. The White House’s Cancer Moonshot initiative has a focus on mitigating cancer disparities, and the NCI is very attuned to the impact that disparities have on our quest to improve cancer burden.”

    Specifics from the study:

    • There was a stronger correlation between FTL scores and race/ethnicity-specific cancer incidence, rather than mortality.
    • There was strong correlation between a cancer’s incidence among non-Hispanic white people and its FTL score, but this was not the case for other racial/ethnic groups, where there was only a weak to moderate correlation.
    • There was a moderate to strong correlation between a cancer’s mortality among non-Hispanic white people and its FTL score, but there was only a weak correlation for all other racial/ethnic groups.

    For the study, Kumar and her team obtained data from the NCI’s Surveillance, Epidemiology and End Results (SEER) database, the United States Cancer Statistics (USCS) database, and Funding Statistics between 2014 and 2018. For each year, they identified the incidence rate and mortality rate – both overall and by race/ethnicity – per 100,000 people for the 19 most common cancer sites, as well as NCI funding for each cancer.

    “Despite initiatives to bolster cancer research funding and to mitigate disparities in cancer outcomes, there are marked disparities in federally funded cancer research that do not correlate with lethality,” the authors said. “Our paper identifies discrepancies in funding by demographic groups and highlights the need to ensure that federal funds are equitably distributed. This is especially important given the discrepancies in cancer outcomes for minorities, particularly in the more underfunded cancers.”

    Additional authors: Dr. Shida Haghighat is the study’s first and corresponding author. Co-authors include Dr. Chunsu Jiang, Dr. Wael El-Rifai, Alexander Zaika, and Dr. David S. Goldberg. All authors are affiliated with the University of Miami Miller School of Medicine or Sylvester Comprehensive Cancer Center and the University of Miami Health System.

    Funding: Dr. Haghighat is supported by a National Institutes of Health training grant, T32 DK 116678-05.

    Disclosures: The authors declare no personal, professional or financial conflicts of interest.

    Journal: Journal of the National Cancer Institute: Urgent Need to Mitigate Disparities in Federal Funding for Cancer Research.

    DOI: https://doi.org/10.1093/jnci/djad097

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    PHOTO CAPTION/CREDIT:

    “Racial and ethnic disparities are well documented across the spectrum of cancer types, and this is of utmost importance,” said Dr. Shria Kumar. “The White House’s Cancer Moonshot initiative has a focus on mitigating cancer disparities, and the NCI is very attuned to the impact that disparities have on our quest to improve cancer burden.” Photo by Sylvester

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