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FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

Stephen M. Hahn, MD, Commissioner at the U.S. Food and Drug Administration (FDA), recently issued a statement regarding an important step that researchers and medical product sponsors can take to make sure clinical trials for medical products are more inclusive of multiple populations. “We have...

health-care policy

Medicaid Expansion May Be Linked to Lower Mortality Rates for Three Major Types of Cancer

In states that have expanded Medicaid availability as part of the Affordable Care Act (ACA), mortality rates for three major types of cancer are significantly lower than in states that have not expanded Medicaid availability, according to a recent study by researchers at Dana-Farber Cancer...

A Daughter of Immigrants Chooses a Challenging but Rewarding Career in Surgical Oncology

Nationally recognized oncologic surgeon Sandra L. Wong, MD, MS, FASCO, FACS, was born and raised in Stockton, California, a city on the San Joaquin River, in California’s Central Valley. “My parents were both immigrants, but unlike the stereotypical picture of hard-driving immigrant parents who...

head and neck cancer

Study Shows Equivalence of Sentinel Node Biopsy vs Neck Node Dissection in Operable Oral or Oropharyngeal Cancer

In the French phase III Senti-MERORL trial reported in the Journal of Clinical Oncology, Renaud Garrel, MD, PhD, of the University Hospital Center of Montpellier, France, and colleagues, found that sentinel node biopsy was equivalent to neck lymph node dissection in 2-year neck node...

covid-19

What Is ‘Quality Oncology Care’ During the COVID-19 Pandemic?

My patient with metastatic colon cancer was sitting across from me after being absent for several months. His cancer had been under excellent control on chemotherapy, but now he was having worse pain and shortness of breath. Despite our calls, he had not kept his appointments. We were 6 feet apart, ...

William Dameshek, MD, Helped Take Hematology From a Minor Medical Discipline to a Major Scientific Field

Although William Dameshek, MD, is renowned for his work in hematology, especially in advancing the understanding of myeloproliferative disorders and their interrelatedness, his early interest in medicine was instead focused on such diverse diseases as hyperthyroidism and typhus fever. Born on May...

prostate cancer

Darolutamide Improves Overall Survival in Nonmetastatic, Castration-Resistant Prostate Cancer: ARAMIS Trial

As reported in The New England Journal of Medicine by Karim Fizazi, MD, of the Institut Gustave Roussy, University of Paris-Saclay, Villejuif, and colleagues, the phase III ARAMIS trial has shown significantly prolonged overall survival with darolutamide vs placebo in men with nonmetastatic...

leukemia
immunotherapy

Dasatinib/Blinatumomab Produces High Rates of Molecular Response and Survival in Philadelphia Chromosome–Positive ALL

In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Robin Foà, MD, of Sapienza University of Rome, and colleagues, found that first-line induction and consolidation treatment with dasatinib and blinatumomab produced a high rates of molecular response as...

multiple myeloma

Ixazomib Maintenance in Patients With Newly Diagnosed Multiple Myeloma Who Did Not Receive ASCT

As reported in the Journal of Clinical Oncology by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, Greece, and colleagues, the phase III TOURMALINE-MM4 trial has shown that postinduction maintenance with ixazomib prolonged progression-free survival vs placebo in...

The US Oncology Network Welcomes Two More Practices

The US Oncology Network, the largest organization of its kind dedicated to advancing local cancer care and better patient outcomes, continues to expand its reach into local communities by welcoming Alliance Cancer Specialists and Northwest Oncology. The addition of these two independent and...

breast cancer

Final Efficacy Results From ExteNET Trial of Neratinib in Subgroup of Patients With HR-Positive, HER2-Positive Early Breast Cancer

In an analysis from the phase III ExteNET trial reported in Clinical Breast Cancer, Arlene Chan, MD, of the Breast Cancer Research Centre of Western Australia and Curtin University, Perth, and colleagues, found significant improvements in efficacy outcomes with administration of neratinib vs...

lung cancer

First-Line Atezolizumab Improves Overall Survival vs Chemotherapy in Certain Patients With Metastatic NSCLC

As reported in The New England Journal of Medicine by Roy S. Herbst, MD, PhD, of Yale School of Medicine, and colleagues, the phase III IMpower110 trial has shown significantly prolonged overall survival with first-line atezolizumab vs platinum-based chemotherapy in metastatic non–small cell lung...

breast cancer

Addition of Abemaciclib to Endocrine Therapy Improves Invasive Disease–Free Survival in High-Risk Early Breast Cancer

As reported in the Journal of Clinical Oncology by Stephen R.D. Johnston, MD, PhD, of the Royal Marsden NHS Foundation Trust, London, and colleagues, an interim analysis in the phase III monarchE trial has shown that adjuvant abemaciclib plus endocrine therapy significantly improved invasive...

Ola Landgren, MD, PhD, Joins Sylvester Comprehensive Cancer Center at University of Miami

Hematologic oncologist Ola Landgren, MD, PhD, was recently appointed the inaugural leader of a new research program, Experimental Therapeutics, at Sylvester Comprehensive Cancer Center at the University of Miami Health System and the Miller School of Medicine. Dr. Landgren, who was Chief of...

ACS Cancer Action Network Issues New Recommendations to Increase Access to Cancer Biomarker Testing

The American Cancer Society (ACS) Cancer Action Network has released new policy recommendations to increase the uptake of biomarker testing and to advance the use of precision medicine in cancer care. A recent report by the ACS Cancer Action Network and the LUNGevity Foundation found that although...

HCI Researcher Receives Awards for Community Contributions and Neuroendocrine Tumor Research

Heloisa Soares, MD, PhD, gastrointestinal and neuroendocrine tumor medical oncologist and researcher at Huntsman Cancer Institute (HCI) and Assistant Professor of Internal Medicine at the University of Utah, received two awards from external organizations honoring her contributions to the field of...

lung cancer
issues in oncology

Racial Disparities in Treatment of Common Lung Cancer Persist Despite Gains

Lung cancer continues to be the most deadly solid cancer in the world, despite the fact that survival rates have been improving over the past decade. However, Black patients have worse outcomes and shorter lifespans after being diagnosed with lung cancer. A study published in the Journal of...

UT Austin and MD Anderson Announce First Collaborative Projects in Improving Cancer Outcomes

The University of Texas (UT) MD Anderson Cancer Center, UT Austin Oden Institute for Computational Engineering and Sciences, and UT Austin Texas Advanced Computing Center (TACC) launched a new collaboration in oncologic data and computational science earlier this year. The strategic initiative...

Rutgers Awarded $1.5 Million FEMA Grant to Support Volunteer Firefighter Cancer Research and Prevention

The Rutgers School of Public Health has received a $1.5 million Federal Emergency Management Agency (FEMA) grant to support volunteer firefighter cancer research. This grant will enhance the research currently underway in collaboration with Rutgers Cancer Institute of New Jersey, which is geared...

issues in oncology

Understanding the Uniqueness of Cancer and Survival in Adolescents and Young Adults

Numerous studies over the past 4 decades have chronicled the lack of progress in improved outcomes for adolescents and young adults (AYAs)—defined by the National Cancer Institute as those ranging in age from 15 to 39—diagnosed with cancer compared with children and older adults diagnosed with the...

leukemia

Venetoclax in Combination Therapy for Untreated Acute Myeloid Leukemia

On October 16, 2020, venetoclax was granted regular approval for use in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or those with comorbidities precluding intensive induction...

MD Anderson Partners With Investment Fund to Generate Support for Investigational Therapies

In partnership with The University of Texas MD Anderson Cancer Center, The Focus Fund GP, LLC, has launched the “Cancer Focus Fund,” to provide investment support to investigational therapies in late preclinical development through to phase I and phase IB/II clinical trials. Along with the fund’s...

Colorectal Cancer Alliance Launches Comprehensive Campaign to Increase Screening Rates During COVID-19 and Beyond

The Colorectal Cancer Alliance, a national nonprofit committed to ending colorectal cancer, has launched a comprehensive marketing campaign. The effort will alert the public to the continued risk of colorectal cancer and the necessity of life-saving screening, which can be conducted safely during...

multiple myeloma

Update on Multiple Myeloma: Highlights From NCCN Virtual Congress on Hematologic Malignancies

New diagnostic criteria and modern imaging techniques, a wealth of new therapeutics, and an update on current thinking as to when to treat patients with smoldering myeloma were highlighted during the National Comprehensive Cancer Network (NCCN) 2020 Virtual Congress: Hematologic Malignancies™....

prostate cancer

A Urologic Surgeon Assesses the Current State of Prostate Cancer

Despite decades of research, multinational clinical trials, regular guideline updates by the U.S. Preventive Services Task Force, and coordinated efforts by ASCO and other major oncology organizations, the management strategy for prostate cancer remains controversial. To keep the oncology community ...

This Year’s FDA-ASCO Workshop Focused on Collection of Patient-Reported Tolerability Data From Clinical Trials

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Vishal Bhatnagar, MD, Associate Director for Patient Outcomes, Bellinda King-Kallimanis, PhD, Senior Staff...

New Leadership Elected to American Society of Hematology

The American Society of Hematology (ASH), the world’s largest professional society concerned with the causes and treatment of blood disorders, announced the election of four new members to its Executive Committee for terms beginning after the 2020 ASH Annual Meeting in December. Robert A. Brodsky,...

multiple myeloma
immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH

“Both KarMMa and CARTITUDE-1 trials presented during the ASCO20 Virtual Scientific Program showed exceptional results, not only in obtaining higher responses in the majority of patients but also in attaining high-quality responses,” said Ajay K. Nooka, MD, MPH, Associate Professor, Department of...

multiple myeloma
immunotherapy

Support Builds for Anti-BCMA CAR T-Cell Therapy in Multiple Myeloma

Based on early results in clinical trials, interest in the use of chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma has been high, especially for products targeting B-cell maturation antigen (BCMA). During the ASCO20 Virtual Scientific Program, further support for CAR T-cell...

Adam Bass, MD, Named Director, Center for Precision Cancer Medicine at Columbia University

Adam Bass, MD, a physician-scientist in the field of cancer genomics and gastrointestinal cancer, will join the Herbert Irving Comprehensive Cancer Center at Columbia University and NewYork-Presbyterian as the founding Director of the Center for Precision Cancer Medicine and Director of...

New Pediatric Neuro-Oncology Research Lab Established at Hackensack University Medical Center

New Jersey Brain and Spine has announced that Timothy Vogel, MD, PhD, Director of Pediatric Neurosurgery, has cofounded a new laboratory for pediatric neuro-oncology with Derek Hanson, MD, at the Center for Discovery and Innovation at Hackensack University Medical Center. Dr. Vogel also serves as ...

Expert Point of View: Fatima Cardoso, MD

The SOLAR-1 invited discussant, Fatima Cardoso, MD, Director of the Breast Unit at the Champalimaud Clinical Center in Lisbon and Chair of the ABC Global Alliance, commented: “The overall survival results, though numerically different by almost 8 months, unfortunately do not reach statistical...

breast cancer

Final Analysis of SOLAR-1: 8-Month Survival Benefit Misses Statistical Significance for Alpelisib

The statistically significant benefit of alpelisib in reducing disease progression, as reported at the European Society for Medical Oncology (ESMO) Congress 2 years ago, did not translate into a significant improvement in overall survival, although a numerical 8-month gain was observed in the final ...

AACR Announces Move to Virtual Meeting for 2021

The Annual Meeting of the American Association for Cancer Research (AACR) brings together key stakeholders in all areas of cancer research to make connections, build collaborations, and explore and expand the frontiers of integrative cancer science and medicine. After careful consideration of...

breast cancer

Growing Interest in Antiandrogens to Treat Male Breast Cancer

“There has been a lot of interest in the development of new antiandrogens” for clinical use in patients with breast cancer,” Anthony D. Elias, MD, reported in an update on male breast cancer at the 2020 Lynn Sage Breast Cancer Symposium, sponsored by the Robert H. Lurie Comprehensive Cancer Center...

lymphoma
immunotherapy

Pembrolizumab in Adult and Pediatric Classical Hodgkin Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 14, 2020, the approval of pembrolizumab was...

Expert Point of View: David Cameron, MD

“This study highlights an interesting difference between breast cancers that are detected at the time a woman attends a scheduled appointment as part of a national screening program and those that are diagnosed in the interval between screenings,” commented European Breast Cancer Conference...

breast cancer

Mode of Detection of High-Risk Breast Cancer Linked to Prognosis

Breast cancers detected between mammographic screenings carry a worse prognosis than those detected at the time of screening, even when tumor biology is similar, according to research presented at the 12th European Breast Cancer Conference (EBCC 12), which was held virtually this year.1 The 8-year...

Expert Point of View: Keerthi Gogineni, MD, MSHP

Keerthi Gogineni, MD, MSHP, Assistant Professor of Hematology and a medical oncologist at Emory University School of Medicine, Atlanta, commented on the long-term follow-up of the MINDACT trial presented at the 12th European Breast Cancer Conference. She noted that, for patients with early-stage...

breast cancer

MINDACT at 8.7 Years: Primary Findings Confirmed

Long-term analysis of the phase III MINDACT trial, with a median follow-up of 8.7 years, confirmed that the 70-gene signature MammaPrint assay can identify which patients with breast cancer can safely forgo adjuvant chemotherapy, reported Emiel Rutgers, MD, PhD, FRCS, a surgical oncologist at the...

Hairy Cell Leukemia Foundation and Leukemia & Lymphoma Society Join Forces

The Hairy Cell Leukemia Foundation (HCLF) and The Leukemia & Lymphoma Society (LLS) recently announced they are teaming up to support a research grants program of up to $10 million over 5 years. Their goal is to build a more comprehensive understanding of hairy cell leukemia, develop better...

Expert Point of View: Emiliano Calvo, MD, and Udai Banerji, MD

Press briefing moderator and meeting Co-Chair, Emiliano Calvo, MD, Director of the START Madrid Group and Director of Clinical Research at the START Madrid-Centro Integral Oncologico Clara Campal Hospital, stated: “Using drugs that are already approved and in worldwide use, and to be able to...

immunotherapy

Can Antihypertensives Improve Outcomes With Immunotherapy?

Angiotensin receptor blockers, commonly used to treat hypertension, may improve outcomes in patients treated with anti–PD-1/L1 agents, according to an observational study of almost 600 patients reported at the virtual 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.1 The...

Expert Point of View: Howard (Jack) West, MD, and William R. Sellers, MD

Howard (Jack) West, MD, Associate Clinical Professor in Medical Oncology at City of Hope Comprehensive Cancer Center, Duarte, California, was impressed with the data from the KRYSTAL-1 trial. “It’s great to see new data on another entrant into the space for patients with KRAS G12C...

lung cancer

KRAS Inhibitor Adagrasib Shows Activity in Non–Small Cell Lung Cancer

Another novel oral KRAS inhibitor—adagrasib (MRTX849)—has shown promise in early clinical trials, according to investigators of the KRYSTAL-1 study who reported findings at the virtual 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.1,2 The conference is jointly provided...

Daniel Sullivan, MD, Honored for Leadership in Quantitative Imaging Biomarkers

The Prevent Cancer Foundation recently honored Daniel C. Sullivan, MD, with the James L. Mulshine, MD Leadership Award for his work in founding and chairing the Quantitative Imaging Biomarkers Alliance (QIBA). The Quantitative Imaging Biomarkers Alliance is committed to attempting to transform...

Expert Point of View: Melina E. Marmarelis, MD, MSCE

Invited study discussant, Melina E. Marmarelis, MD, MSCE, of Abramson Cancer Center at the University of Pennsylvania, Philadelphia, noted that pembrolizumab has been evaluated in advanced mesothelioma in several clinical trials, with varying results. According to Dr. Marmarelis, this high...

immunotherapy

Use of Pembrolizumab in Advanced Pleural Mesothelioma: Results From KEYNOTE-158

The largest single-arm trial evaluating pembrolizumab in relapsed malignant pleural mesothelioma has demonstrated an “impressive” duration of response, according to a presentation during the virtual edition of the International Association for the Study of Lung Cancer (IASLC) 2020 North America...

Nagi S. El Saghir, MD, FACP, FASCO, Receives Lebanon’s National Cedar Medal Award

One of Lebanon’s highest national awards, the National Cedar Medal (Commander Rank), was recently bestowed upon Nagi S. El Saghir, MD, FACP, FASCO, in recognition of his extensive contributions to the fields of medicine, education, and science—and most particularly, for his efforts in the fight...

head and neck cancer

Stereotactic Radiosurgery May Delay Cognitive Deterioration vs Whole-Brain Radiotherapy for Multiple Brain Metastases

Stereotactic radiosurgery appears to be a new standard of care for patients with four or more nonmelanoma brain metastases, perhaps replacing whole-brain radiotherapy in this setting, according to a potentially practice-changing phase III study presented at the 2020 American Society for Radiation...

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