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Showing 7601 - 7650Patient-Centered Initiatives at the FDA
OCE Insights is a periodic 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 first installment, Vishal Bhatnagar, MD, Acting Associate Director of Patient Outcomes; Bellinda King-Kallimanis, PhD, Senior...
Canadian Cancer Organizations Team Up to Focus on New Approach to Metastatic Breast Cancer
At a press conference at McGill University, Stand Up To Cancer Canada (SU2C Canada), the Canadian Cancer Society (CCS), and the Canadian Institutes of Health Research (CIHR) announced the launch of the SU2C Canada Metastatic Breast Cancer Dream Team to pursue the development of a new drug...
Current Controversies in Lymphoma: From the Role of Liquid Biopsy to Ways to Improve Upon Standard Chemotherapy
Two topics that hematologists are currently grappling with were addressed at the 2019 Debates and Didactics Conference in Sea Island, Georgia, sponsored by Emory University Winship Cancer Institute, by Editor-in-Chief of The ASCO Post, James O. Armitage, MD, FASCO.1 They focus on the emerging role ...
AACR Cancer Progress Report 2019 Released
Today, the American Association for Cancer Research (AACR) released the AACR Cancer Progress Report 2019, which highlights how research largely supported by federal investments in the National Institutes of Health (NIH) is spurring improvements in public health and innovations across the spectrum...
FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved by the FDA in 2018 for patients with nonmetastatic castration-resistant prostate cancer. TITAN Trial...
ASTRO 2019: Patterns of Disease Progression in Patients With Unresectable Stage III NSCLC: Analysis of the PACIFIC Trial
Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, presented an update of the landmark PACIFIC trial at the 61st Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Abstract LBA-6). In earlier reports from the randomized phase III trial, Antonia et al had evaluated...
FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis
The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...
Targeting an Important Tumor Vulnerability With Maintenance Olaparib in Germline BRCA-Mutated Pancreatic Cancer
In the POLO trial, which is discussed in this issue of The ASCO Post, Golan and colleagues evaluated the potential benefit of maintenance olaparib after disease stability or response to a minimum of 4 months of platinum-based chemotherapy in patients with metastatic pancreatic cancer and a...
FDA Issues Drug Safety Communication on Lung Inflammation Due to Treatment With CDK4/6 Inhibitors
On September 13, the U.S. Food and Drug Administration (FDA) issued a drug safety communication warning that palbociclib, ribociclib, and abemaciclib—used to treat some patients with advanced breast cancer—may cause rare but severe inflammation of the lungs. The agency approved new warnings about...
FDA Pipeline: Breakthrough Therapy Designation in Lung Cancer, Orphan Drug Designations in Myeloma and Soft-Tissue Sarcoma
Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to tepotinib for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations, and Orphan Drug designations to novel chimeric antigen receptor T-cell therapies in both multiple myeloma ...
WCLC 2019: Video-Assisted Thoracic Surgery vs Open Surgery in Lung Cancer
Video-assisted thoracic surgery was associated with lower in-hospital complications and a shorter length of stay compared with open surgery among British patients who were diagnosed with early-stage lung cancer, according to research presented by Lim et al at the International Association for the...
WCLC 2019: Selpercatinib in RET Fusion–Positive NSCLC
Patients with RET fusion–positive non–small cell lung cancer (NSCLC) comprise up to 2% of all NSCLC cases, but there are no targeted therapies currently approved for patients with this form of lung cancer. Selpercatinib (also known as LOXO-292) is an oral and highly selective investigational drug...
WCLC 2019: KEYNOTE-024 Survival Update Shows Benefit With Pembrolizumab vs Chemotherapy in Advanced NSCLC
First-line pembrolizumab monotherapy provides durable long-term overall survival benefit compared to chemotherapy in patients with advanced non–small cell lung cancer (NSCLC), according to data from the KEYNOTE-024 trial presented by Martin Reck, MD, PhD, at the International Association for the...
WCLC 2019: Declaration From IASLC on Tobacco Cessation After Cancer Diagnosis
The International Association for the Study of Lung Cancer (IASLC) used the platform of the 2019 World Conference on Lung Cancer (WCLC) to call attention to the importance of tobacco cessation after cancer diagnosis and urged all physicians to screen patients with cancer for tobacco use and...
WCLC 2019: Final Overall Survival Results of IMpower131 Trial in Advanced Squamous NSCLC
Patients with stage IV squamous non–small cell lung cancer (NSCLC) with high programmed cell death ligand 1 (PD-L1) expression treated with atezolizumab and chemotherapy experienced longer overall survival rates than those treated with chemotherapy alone. The data from the IMpower131 trial were...
WCLC 2019: BioMILD Trial of Blood MicroRNA Plus Low-Dose CT to Reduce CT Repeats in Lung Cancer Screening
Researchers from Milan reported that using a blood microRNA assay accompanied by low-dose computed tomography (CT) screening is safe and effective in screening patients for lung cancer. The results were shared at the International Association for the Study of Lung Cancer (IASLC) 2019 World...
WCLC 2019: Autoantibody Diagnostic Test Followed by CT Imaging May Improve Diagnosis, Reduce Mortality in Lung Cancer
A combination of the EarlyCDT-Lung Test followed by computed tomography (CT) imaging in Scottish patients at risk for lung cancer resulted in a significant decrease in late-stage diagnosis of lung cancer and may decrease lung cancer–specific mortality, according to research presented at...
Michael Kenneth Keng, MD, on an ASCO Quality Training Program: 5-Year Review
Michael Kenneth Keng, MD, of the University of Virginia, gives a status update on this international program, and discusses future initiatives which include coaching mentorship and publishing articles on quality care (Abstract 7).
Cary P. Gross, MD, on Creating and Implementing Clinical Pathways: Where is the Patient’s Voice?
Cary P. Gross, MD, of Yale School of Medicine, discusses the challenges of implementing pathways and guiding patient decision-making on treatment.
Joseph O. Jacobson, MD, on Suffering, Systems, and Safety: The Joseph V. Simone Award Lecture
Joseph O. Jacobson, MD, of Dana-Farber Cancer Institute, and this year’s recipient of the award for excellence in quality cancer care, discusses the need for quality improvement (QI) to encompass systems of care, the role of QI in preventing suffering, how poor quality affects patient safety, and...
Nadine Housri, MD, on Online Tumor Boards: A New Resource for Practicing Oncologists
Nadine Housri, MD, of the Yale School of Medicine, talks about a new paradigm in sharing knowledge from tumor board discussions at NCI-designated comprehensive cancer centers, with community oncologists on themednet.org. Currently, thoracic, breast, and GI cancers are included, with plans to expand ...
Matthew B. Schabath, PhD, on Addressing Cultural Barriers to Equality in Oncology Among Sexual and Gender Minorities
Matthew B. Schabath, PhD, of H. Lee Moffitt Cancer Center and Research Institute, discusses the disparities in cancer care among members of the LGBTQ community and the need to collect more data in order to close that gap.
Angela M. Stover, PhD, on Patient-Reported Outcome Performance Measures for Oncology Practice
Angela M. Stover, PhD, of the University of North Carolina at Chapel Hill, discusses ASCO’s initiative to develop patient-based performance measures for assessing and managing symptoms. The measures have made substantial differences in reducing nausea, constipation, and insomnia (Abstract 173).
Lauren M. Hamel, PhD, on Race and Doctor-Patient Behavior
Lauren M. Hamel, PhD, of Wayne State University/Karmanos Cancer Institute, discusses her findings on the ways in which nonverbal behavior between doctors and patients of the same or different races can affect their relationship, quality of communication, and ultimately, perhaps outcomes as well...
Mallika Sharma, MPH, on Eliminating Prior Authorizations, Anxiety, Delay in Care, Higher Costs
Mallika Sharma, MPH, of Seattle Cancer Care Alliance, discusses her findings that, by doing away with the many prior authorization denials based on administrative errors, providers may offer higher-value care by eliminating unnecessary anxiety among patients, administrative burdens, and increased...
Grace C. Hillyer, EdD, MPH, on Enrolling Patients in Clinical Trials: Improving Clinician-Patient Communication
Grace C. Hillyer, EdD, MPH, of Columbia University Mailman School of Public Health, discusses the many barriers to enrolling patients in clinical trials, most notably different attitudes toward and perceptions about research studies among clinicians vs patients. Her findings point to the need for...
Elena Martinez, PhD, MPH, on Diversity in Precision Oncology
Elena Martinez, PhD, MPH, of Moores Cancer Center at the University of California, San Diego, discusses the challenges of ensuring diversity in precision oncology and potential solutions to address the challenges.
Oncology Communications Online: Pause and Think Before Hitting ‘Send’
The emergence of online technologies over the past few decades has fundamentally changed the way society communicates and shares information. This sea change has also had profound influence on the practice of medicine, from real-time information-sharing among colleagues, to having instant access...
Ryan Huey, MD, on the Financial Toxicity of Early-Phase Clinical Trials
Ryan Huey, MD, of The University of Texas MD Anderson Cancer Center, discusses his findings that showed the large financial burden on lower-income patients enrolled in phase I trials (Abstract 8).
Cristina Merkhofer, MD, MHS, on NSCLC: Survival Impact of Taking Part in a Clinical Trial
Cristina Merkhofer, MD, MHS, of Fred Hutchinson Cancer Research Center, discusses study results showing that for patients with metastatic non–small cell lung cancer at her institution, enrolling in a therapeutic drug clinical trial was associated with a 47% lower risk of death, compared with not...
Bernardo H.L. Goulart, MD, on Stage IV NSCLC: High Drug Costs May Affect Survival
Bernardo H. L. Goulart, MD, of Seattle Cancer Care Alliance, discusses his findings that high out-of-pocket costs for oral tyrosine kinase inhibitors may lower survival rates, shorten the duration of therapy, and reduce the number of prescriptions for patients with metastatic EGFR- or ALK-positive...
WCLC 2019: Screening Efficacy of PLCOm2012 vs USPSTF Criteria
Researchers reported that a prospective trial comparing two screening methods for patients at risk of developing lung cancer found that a model used by Canadian, Australian, and European public health organizations detected more cancers than the screening model used by the United States Preventive...
WCLC 2019: Survey Findings on Evidence-Based Guidelines for Molecular Testing in Lung Cancer
One-third of those who responded to a survey reported they are unaware of evidence-based guidelines that support the use of molecular testing in lung cancer, according to results from the International Association for the Study of Lung Cancer (IASLC) Global Survey on Molecular Testing in Lung...
2019 Lasker Awards for Basic and Clinical Medical Research and Public Service Announced
On September 10, The Lasker Foundation announced the winners of its 2019 Lasker Awards: Max D. Cooper, MD, of Emory University, and Jacques Miller, AC, FRS, FAA, of the Walter and Eliza Hall Institute of Medical Research, will receive the Albert Lasker Basic Medical Research Award; H. Michael...
WCLC 2019: CASPIAN Trial Finds Addition of Durvalumab to Chemotherapy Improves Overall Survival in Patients With Extensive-Stage SCLC
The addition of durvalumab to chemotherapy improved overall survival in patients with extensive-stage small cell lung cancer (SCLC), according to research presented at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) (Abstract PL02.11)....
WCLC 2019: Pooled Analysis of CheckMate 017 and 057: 5-Year Outcomes With Nivolumab vs Docetaxel in Previously Treated NSCLC
Pooled data on two clinical trials demonstrated patients with previously treated non–small cell lung cancer (NSCLC) treated with nivolumab had a greater than fivefold increase in 5-year overall survival rate compared to treatment with the chemotherapy docetaxel. Scott Gettinger, MD, of Yale...
Erratum
In the August 10, 2019, issue of The ASCO Post, a photo on page 39, in an article about the National Comprehensive Cancer Network (NCCN) Policy Summit, was incorrectly identified as Terrell Johnson, MPA, an NCCN Policy and Advocacy Fellow. We regret the error and apologize to Mr. Johnson for the...
FDA Proposes New Required Health Warnings With Images for Cigarette Packages and Advertisements
On August 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule to require new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings, which feature photo-realistic...
Having Cancer as a Teenager Derailed My Life Course
In 1994, I was a normal, active 15-year-old, who loved cars, sports, and rock music, especially songs from my favorite group, The Clash. In fact, it was while jubilantly dancing alone in my room to one of their tunes that I vomited into my hands, an early symptom of acute myeloid leukemia (AML). I...
A Vigorous Life Through the Prism of Impending Death
“Live while you’re living, friends,” writes Julie Yip-Williams in her memoir, The Unwinding of the Miracle: A Memoir of Life, Death, and Everything That Comes After. It was The New York Times bestseller when she died of stage IV colon cancer at the age of 42. She is the most recent of several...
Not for the Squeamish: Surgery in the 19th Century
Imagine undergoing major surgery in a grimy operating room without any form of antisepsis. That was the grim reality in the 1800s, when the ruling theory was that damage from “bad air” was responsible for infections in surgical wounds. Hospitals simply aired out the surgical wards at midday to...
Florida Cancer Specialists Welcomes Luis Carrascosa, MD
Florida Cancer Specialists & Research Institute recently announced that radiation oncologist Luis Carrascosa, MD, has joined the statewide practice. Dr. Carrascosa has privileges at Ocala Regional Medical Center, West Marion Community Hospital, and AdventHealth Ocala. Dr. Carrascosa earned his ...
Doctor, Where Art Thou?
The ASCO Post is pleased to reproduce installments of the Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
Nakul Singhal, MD, and Nicole Carreau, MD, Join New York Cancer & Blood Specialists
Oncologist Nakul Singhal, MD, has joined New York Cancer & Blood Specialists (NYCBS) and will be accepting new patients at the Bayside and New Hyde Park locations. NYCBS also welcomes oncologist Nicole Carreau, MD. Prior to joining NYCBS, Dr. Singhal practiced at Hackensack Meridian Health...
Steven A. Rosenberg, MD, PhD, Awarded for His Pioneering Work in Immunotherapy
The Edogawa-NICHE Committee recently announced that the 2019-Edogawa NICHE Prize has been awarded to Steven A. Rosenberg, MD, PhD, for his work in developing effective adoptive immunotherapies and genetically modified T cells. Dr. Rosenberg’s research has significantly contributed to the...
Confronting the Criticisms Facing Watson for Oncology
Over the past 2 years, IBM’s Watson for Oncology cognitive computing system, which uses artificial intelligence (AI) algorithms to generate treatment recommendations, has come under fire for allegedly not delivering on expectations to provide state-of-the-art personalized treatment for patients...
MD Anderson to Expand Proton Therapy Center
The University of Texas MD Anderson Cancer Center recently unveiled plans to expand its Proton Therapy Center. The expansion will more than double the center’s size to more than 160,000 square feet. The estimated completion of the new building is November 2023. The $159 million expansion will...
FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence
Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multiyear research collaboration agreement focused on the use of real-world evidence to support regulatory decision-making. Syapse and the OCE will work with stakeholders across the FDA to...
American Cancer Society Names William G. Cance, MD, Chief Medical and Scientific Officer
William G. Cance, MD, has been selected as he Chief Medical and Scientific Officer of the American Cancer Society (ACS). Dr. Cance will lead the integration of the ACS Research and Cancer Control departments, unifying its intramural and extramural research; prevention and early detection; patient...
Firing Your Patient: How to Terminate a Treatment Relationship
Many clinicians are confused by the evolving opioid prescribing guideline issued by the Centers for Disease Control and Prevention (CDC) meant to stem the rising epidemic of opioid addiction and overdose in the United States.1 Many are also worried about regulatory oversight by the U.S. Drug...
