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Showing 2051 - 2100Build Back Better Act Passes in the House, Moves to Senate
On November 19, 2021, the Build Back Better Act passed the U.S. House of Representatives with a vote of 220–213. The legislation contains significant health-care provisions, some of which are outlined below. Drug Pricing—The legislation contains prescription drug pricing reforms designed to address ...
The Oncology Center of Excellence Encourages Submissions of Applied Regulatory Science Research Proposals
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, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD,...
Daratumumab in Front-Line Treatment of Newly Diagnosed Transplant-Ineligible Multiple Myeloma: Questions Emerge From MAIA Trial
In the past decade, use of immunotherapy has arisen as a novel adjunct to multiple myeloma therapy. Daratumumab is the first anti-CD38 monoclonal antibody to be approved by the U.S. Food and Drug Administration (FDA), in November 2015, for use in treating relapsed or refractory multiple myeloma.1...
Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
On November 22, 2021, sirolimus protein-bound particles for injectable suspension (albumin-bound) was approved for treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.1 Supporting Efficacy Data Approval was supported by findings in the...
Final Analysis of PALLAS Trial: No Benefit of Adjuvant Palbociclib Plus Endocrine Therapy in Early Breast Cancer
The final protocol-defined analysis of the phase III PALLAS trial confirmed the negative results of the second interim analysis, showing no benefit of palbociclib plus endocrine therapy in the adjuvant breast cancer setting. Michael Gnant, MD, of the Medical University of Vienna, reported these...
The Cancer Research Institute in Morocco: A Center of Excellence Illustrating Progress in Africa in the Age of Global Oncology
The enthusiasm behind the open access initiative sprang from the need for scientific research that is accessible to everyone worldwide. Open knowledge based on open access also aimed to increase good research practices such as reproducibility and transparency.1 This movement was launched by...
Expert Point of View: Hope S. Rugo, MD, FASCO
Invited discussant of the KEYNOTE-355 trial, Hope S. Rugo, MD, FASCO, one of the coauthors of the study, had presented the survival data at the 2021 European Society of Medical Oncology (ESMO) Annual Congress.1 The San Antonio presentation was a more in-depth evaluation of survival by different...
NCCN Guidelines for Prostate Cancer: Panel Clarifies Role of Active Surveillance for Low-Risk Prostate Cancer
In October 2021, the National Comprehensive Cancer Network (NCCN) prostate caycer panel modified its guidelines (NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines®]) for low-risk prostate cancer to remove the word “preferred option” for active surveillance, giving equal weight to...
I Don’t Know Why I Got Young-Onset Colorectal Cancer
Throughout my adolescence and early adulthood, I had been plagued with digestive issues, including bouts of gastritis and constipation, which seemed normal for me and wasn’t too concerning. But by the time I turned 30, in 2015, the acid reflux I had been experiencing became so frequent and...
Study Examines Rates of Breast and Colorectal Cancer Screening Among Rural Women
Women who live in urban areas and those residing in rural areas are screened for breast cancer at similar rates, but rural women are screened for colorectal cancer at significantly lower rates than their urban counterparts, research published by Shete et al in JAMA Network Open showed. The...
ASH Recognizes Choosing Wisely Champions at 63rd Annual Meeting
The American Society of Hematology (ASH) recognized three Choosing Wisely Champions—individuals working to tackle the overuse of hematology tests and treatments—at the 63rd ASH Annual Meeting & Exposition, held December 11–14 in Atlanta. Choosing Wisely is an initiative that seeks to advance a...
Positive Practice Changes After the COVID-19 Pandemic: From the Advanced Practice Provider Perspective
The COVID-19 pandemic may have changed some aspects of health care forever. At the 2021 JADPRO Live Virtual event, a panel discussion focused on how several cancer centers faced challenges, and what changes the participants view as positive.1 JADPRO Live is an annual educational conference for...
Study Examines Possible Clinical Trial Bias From Undisclosed Censoring
New research published by Wilson et al in JNCCN–Journal of the National Comprehensive Cancer Network found that only 59% of oncology clinical trials studied provided adequately defined rules for censoring. The researchers examined published randomized control trials supporting U.S. Food and Drug...
Study Examines a Potential Approach to Mitigate CAR T-Cell Therapy Toxicity
Research demonstrating a novel approach that may reduce cytokine-release syndrome associated with chimeric antigen receptor (CAR) T-cell therapy was presented by Marcela Maus, MD, PhD, and colleagues at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1723)...
BELINDA Study: Second-Line Tisagenlecleucel Equivalent to Standard of Care for Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
In an analysis of the phase III BELINDA trial presented by Bishop et al during the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA-6), the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel was not found to improve event-free survival over the...
ZUMA-7 Primary Analysis: Second-Line Axicabtagene Ciloleucel Quadruples Event-Free Survival in Large B-Cell Lymphoma
In the primary analysis of the phase III ZUMA-7 trial, the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel led to a fourfold increase in event-free survival over the standard of care in the second-line treatment of relapsed or refractory large B-cell lymphoma, according to...
Study Identifies Factors for Severe COVID-19 Illness Among Patients With Acute Leukemia or MDS
In separate analyses of 257 patients with acute leukemia or myelodysplastic syndrome (MDS) who developed COVID-19 and are part of the American Society of Hematology (ASH) RC COVID-19 Registry for Hematology, both neutropenia and having active MDS or leukemia (vs being in remission) were found to...
Isatuximab/RVd Meets Primary Endpoint of MRD Negativity for Newly Diagnosed, Transplant-Eligible Patients With Multiple Myeloma
For the first-line treatment of newly diagnosed, transplant-eligible patients with multiple myeloma, the achievement of measurable residual disease (MRD) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to the standard three-drug induction regimen of...
Study Reveals Gaps in Code Status Discussions Among Patients With High-Risk AML
Oncologists and health-care professionals who treat patients with high-risk acute myeloid leukemia (AML) are missing important opportunities to have end-of-life discussions at earlier stages in the disease course, when patients are best able to discuss their options and preferences. These findings...
Antibody Response to COVID-19 Vaccination in Patients With Myeloid and Lymphoid Neoplasms
According to a German study by Rotterdam et al presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 218), about 15% of people with blood cancers and other blood disorders had no vaccination-related antibodies after receiving a COVID-19 vaccine....
ASH RC COVID-19 Registry for Hematology: Risk Factors for Hospitalization and Death Among Patients With Hematologic Malignancies Infected With COVID-19
Patients with blood cancers, particularly those with more advanced disease, are at increased risk for serious COVID-19 outcomes, including an elevated chance of severe illness or death from infection, according to an analysis of more than 1,000 patients in the ASH Research Collaborative (RC)...
Study Reveals Underrepresentation of AYA Hispanic Patients in a Large ALL Clinical Trial
A study of U.S. adolescent and young adult patients with acute lymphoblastic leukemia (ALL) found that Hispanic patients were significantly underrepresented in a large clinical trial compared with the general patient population. The study, presented by Muffly et al at the 2021 American Society of...
The National Cancer Act of 1971
On December 23, 1971, President Richard M. Nixon signed the National Cancer Act into law. At that time, cancer was the nation’s second leading cause of death; only about one of two people diagnosed with cancer survived at least 5 years—compared with two of three people diagnosed with the disease...
Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL
On October 1, 2021, the CD19-directed chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel was approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 The product is available only through a restricted program under a Risk Evaluation ...
Expect Questions on Use of Low-Dose Aspirin to Help Prevent Colorectal Cancer
Following a review of new data and additional analyses of previous data concerning colorectal cancer, the U.S. Preventive Services Task Force (USPSTF) “concluded the evidence is inadequate that low-dose aspirin use reduces colorectal cancer incidence or mortality.”1 Consequently, a draft...
Reclaiming a Complicated Genius Who Pursued Cancer With Single-Minded Fury
The Nobel Laureate Otto Warburg was regarded as one of the most significant biochemists of the 20th century, whose exhaustive research led to an understanding of cancer that remains significant to this day. Warburg was also one of the most despised figures in his homeland of Nazi Germany. As a...
Erudition and Assessment on the Longest War in the Modern Era
A little after noon on December 23, 1971, President Richard Nixon entered the White House state dining room. Before 137 esteemed guests from government, science, and industry, he signed the landmark National Cancer Act. It was, in short, a national commitment to conquer cancer. President Nixon...
Early Operation With General Anesthesia
The text and photograph here are excerpted from a four-volume series of books titled Oncology: Tumors & Treatment, A Photographic History, The Anesthesia Era 1845–1875 by Stanley B. Burns, MD, FACS, and Elizabeth A. Burns. The photograph appears courtesy of Stanley B. Burns, MD, and The Burns...
Last Hug
“Good evening, doc; I wanted to check on you and update you on my mom” read the text message on a late Thursday afternoon. I recognized the sender; it was not uncommon for me to share my cell phone number with patients and their families. Having been a caretaker of my own parents’ medical needs, I...
The History of Medical Oncology in Europe, 1955–1985
In part 1 of this two-part review, we looked at early pioneers in the field of medical oncology in Europe, as well as the development of international cooperative trials and the formation of European oncology societies (see related articles below). In part 2, we explore how the field of medical...
Three Investigators Named Winners of MSK Cancer Center’s 2021 Paul Marks Prize for Cancer Research
Memorial Sloan Kettering Cancer Center (MSK) is proud to announce three recipients of this year’s Paul Marks Prize for Cancer Research. The prize recognizes a new generation of leaders in cancer research who are making significant contributions to the understanding of cancer or are improving the...
Abemaciclib With Endocrine Therapy in Adjuvant Treatment of Early Breast Cancer
On October 12, 2021, abemaciclib was approved for use with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adults with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki67 score ≥ 20%, as determined by...
Asciminib for Philadelphia Chromosome–Positive Chronic Myeloid Leukemia
On October 29, 2021, the oral kinase inhibitor asciminib was granted accelerated approval for adults with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase previously treated with at least two tyrosine kinase inhibitors and regular approval for adults with...
Newer Cancer Therapies Offer Hope but Also May Confer Cardiac Risk
Since many different chemotherapeutic agents have been linked with cardiac adverse events, there is a growing need for strategies for the assessment and mitigation of treatment-induced cardiotoxicity. Moreover, the rapid rise of immunotherapies has added a new dimension to this clinical setting....
Mammen Chandy, MD, FRACP, FRACPA: A Pioneer in India’s Bone Marrow Transplantation Services
In this installment of the Living a Full Life series, guest editor Jame Abraham, MD, FACP, spoke with bone marrow transplant expert Mammen Chandy, MD, FRACP, FRACPA, Director of Tata Medical Center, in Kolkata, India. Dr. Chandy was instrumental in establishing the first sustained bone marrow...
Potential Impact of Nurse Navigation Program in Achieving Equitable Care and Outcomes in Patients With Aggressive Large B-Cell Lymphoma
In a single-institution study reported in the journal Cancer, and reviewed in the September 10, 2021, issue of The ASCO Post, Bei Hu, MD, and colleagues from Levine Cancer Institute/Atrium Health found that the use of a dedicated nurse navigation program aided in producing similar patterns of...
The History of Medical Oncology in Europe, 1955–1985
Our goal with this review of the pivotal years of oncology in Europe is to acknowledge the tremendous contributions of the early leaders in the field and to help young investigators learn from the past to better cope with the inevitable challenges of today and tomorrow. “On ne connaît pas...
ASCO Releases New Guidelines on the Management of Adverse Events in Patients Treated With Immune Checkpoint Inhibitors and CAR T-Cell Therapy
ASCO has released new recommendations for the management of adverse events related to two immunotherapy modalities with increasing application in cancer care—immune checkpoint inhibitors and chimeric antigen receptor (CAR) T-cell therapy. The recommendations were published as two separate...
Atezolizumab in Adjuvant Therapy for PD-L1–Positive NSCLC
On October 15, 2021, atezolizumab was approved for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells, as determined by a U.S. Food and Drug Administration...
Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
On November 17, 2021, the immunotherapeutic agent pembrolizumab was granted approval for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.1 Supporting Efficacy Data...
Low-Dose Computed Tomography: A Window Into Early Lung Disease?
Lung health in adults has traditionally been defined as the absence of disease, but it may be time to rethink this paradigm, according to Ravi Kalhan, MD, MS, Director of the Northwestern Asthma and Chronic Obstructive Pulmonary Disease (COPD) Program at Northwestern University Feinberg School of...
Big Data and Vulnerable Populations: Addressing the Gap in Lung Cancer Screening
Recent advances in medical imaging have led to more accurate detection and management of early thoracic diseases such as lung cancer, chronic obstructive pulmonary disease (COPD), and cardiovascular disease—three of the top four leading causes of death in the United States. Unfortunately, if not...
Expert Point of View: Nabil F. Saba, MD, FACP
“It’s becoming more and more clear that increasing the cytotoxic effect of treatment and expecting to get a better outcome is an approach of the past,” said Nabil F. Saba, MD, FACP, the Lynne and Howard Halpern Chair in Head and Neck Cancer Research, Professor and Vice Chair ofHematology and...
Radiation Therapy for HPV-Related Oropharyngeal Squamous Cell Carcinoma: Prospects and Controversies
In the treatment of patients with human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma, neither cancer outcomes nor measurable quality of life have yet been shown to differ between surgery- and radiotherapy-based approaches, according to Sue S. Yom, MD, PhD, FASTRO, Professor of ...
Cleveland Clinic Researcher Receives NIH Director’s Pioneer Award
Michaela Gack, PhD, Scientific Director of Cleveland Clinic’s Florida Research and Innovation Center, has received a National Institutes of Health (NIH) Director’s Pioneer Award to support her research toward the development of broad-spectrum antiviral drugs. The grant is part of NIH’s High-Risk,...
Applying Research Data to Clinical Practice in Managing Head and Neck Cancer
The 2021 Winship Cancer Institute of Emory University Symposium: Updates in the Management of Head and Neck Cancer explored current paradigms for the multidisciplinary treatment of head and neck cancer.1 Moderated by Nabil F. Saba, MD, FACP, the Lynne and Howard Halpern Chair in Head and Neck...
How Medical Oncology Came to Be
For many, the way things are when you learn about them is assumed to be the way things have always been. For example, antibiotics are wonderful—but if you were practicing medicine when penicillin was discovered, it would have seemed like a miracle. For most of us, there have always been chemical...
Establishing a Health Equity Report Card to Eradicate Disparities in Cancer Care
Although enormous progress over the past 50 years in every aspect of cancer care, including prevention, screening, chemotherapy, targeted therapy, surgery, radiation therapy, and supportive care, has resulted in increases in lives saved—from 3 million in 1971 to 16.9 million in 2019—the burden of...
Elacestrant May Improve Outcomes for Postmenopausal Patients With Progressive ER-Positive HER2-Negative Metastatic Breast Cancer
The investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine monotherapy in the second- or third-line setting for postmenopausal...
Elacestrant May Improve Outcomes for Postmenopausal Patients With Progressive ER-Positive HER2-Negative Metastatic Breast Cancer
The investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly decreased the risk of death or disease progression and increased progression-free survival compared with standard-of-care endocrine therapy for postmenopausal patients with estrogen receptor...
