December 25, 2021 (View All Issues)
Solving the Conundrum of Young-Onset Colorectal Cancer
Although research so far has failed to uncover the root causes of the development of young-onset colorectal cancer, what is certain is that although colorectal cancer rates are declining in older adults, they are on a steady rise in people younger than age 50, especially those between the ages of...
Diversity in Clinical Trials Career Development Program
The Bristol Myers Squibb Foundation, the National Medical Fellowships, and the American Association for Cancer Research (AACR) recently announced the first group of 52 physicians selected for its Diversity in Clinical Trials Career Development Program.
The 52 physicians selected by an independent...
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 ...
UC Davis Brain Surgeon Appointed to Co-lead Cancer Center Biomedical Technology Program
Professor and neurosurgical oncologist Orin Bloch, MD, FAANS, has been appointed as the new co-leader of UC Davis Comprehensive Cancer Center’s Biomedical Technology Program effective December 1. Dr. Bloch is replacing Chief of Nuclear Medicine Ramsey Badawi, PhD, who is stepping down from the role ...
Addition of First-Line Veliparib to Chemotherapy in Advanced Squamous Cell NSCLC: No Survival Benefit in Current Smokers, but Potential Benefit Among Biomarker-Selected Patients
In a phase III trial reported in the Journal of Clinical Oncology, Suresh S. Ramalingam, MD, of Winship Cancer Institute, Emory University School of Medicine, and colleagues found that the addition of the PARP inhibitor veliparib to platinum-based chemotherapy did not improve overall survival in...
2021 FDA Approvals of Drugs for Cancer Treatment
Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to many novel drugs and new indications for older therapeutic agents used in oncology and hematology.
NOVEMBER
Pafolacianine for Ovarian Cancer Lesions: On November 29, pafolacianine (Cytalux), an imaging drug,...
Creating a More Equitable Health-Care System for Patients With Cancer
When President Richard M. Nixon signed the National Cancer Act into law on December 23, 1971, he said: “I hope in the years ahead, we will look back on this action today as the most significant action taken during my administration.” The increased financial investment and focus on cancer research...
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...
More Than Two Dozen SABCS Presenters Receive Research Scholarships
Several of the researchersand scientists at the 42nd annual San Antonio Breast Cancer Symposium (SABCS), held December 10–14, attended the event on the basis of scholarships awarded through SABCS and its cosponsor, the American Association of Cancer Research (AACR). The goal of the scholarships is...
Impact of Time of Day of Immune Checkpoint Inhibitor Infusion on Overall Survival in Patients With Metastatic Melanoma
In a single-institution study reported in The Lancet Oncology, Qian et al found that the administration of immune checkpoint inhibitors after 4:30 PM was associated with poorer overall survival vs infusion earlier in the day in patients with metastatic melanoma.
As stated by the investigators,...
Changes in PSA Screening After 2017 USPSTF Guidance Revision
In a study reported in JAMA Oncology, Michael S. Leapman, MD, and colleagues found that prostate-specific antigen (PSA) screening for prostate cancer has increased since the 2017 publication of the U.S. Preventive Services Task Force (USPSTF) draft guidance endorsing individual decision-making for...
Study Examines Treatment-Related Regret Among Men With Localized Prostate Cancer
In a prospective cohort study (CEASAR) reported in JAMA Oncology, Wallis et al found that patient expectations of treatment efficacy and adverse effects were associated with treatment-related regret at 5 years after diagnosis in men with localized prostate cancer.
As stated by the investigators,...
Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy
Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...
Measurable Residual Disease Kinetics: A Potential New Tool in CLL
Achieving undetectable measurable residual disease (MRD) is an important milestone in the treatment of patients with chronic lymphocytic leukemia (CLL) as well as those with other hematologic malignancies undergoing treatment. Now a small phase II study, presented at the 2021 American Society of...
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...
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...
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...
ORIENT-31: Novel Four-Drug Regimen Evaluated in EGFR-Mutated NSCLC
A four-drug combination of the anti–PD-1 antibody sintilimab, the bevacizumab biosimilar IBI305, plus pemetrexed and cisplatin chemotherapy significantly improved progression-free survival compared with chemotherapy alone in patients with advanced nonsquamous non–small cell lung cancer (NSCLC) with ...
COSMIC-312: Cabozantinib Plus Atezolizumab Improves Progression-Free Survival in Advanced Hepatocellular Carcinoma
The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...
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...
MAIA Trial: Daratumumab Added to Lenalidomide Plus Dexamethasone Improves Overall Survival in Transplant-Ineligible Multiple Myeloma
As reported in The Lancet Oncology by Thierry Facon, MD, of the Centre Hospitalier Universitaire de Lille, and colleagues, a prespecified interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to...
FDA Approves Pembrolizumab for the Adjuvant Treatment of Stage IIB or IIC Melanoma
On December 3, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.
KEYNOTE-716
Efficacy was evaluated in KEYNOTE-716, a...
FDA Approves Maribavir for Posttransplant CMV
On November 23, the U.S. Food and Drug Administration (FDA) approved the antiviral maribavir (Livtencity) for adult and pediatric patients aged 12 years and older (and weighing at least 35 kg) with posttransplant cytomegalovirus (CMV) infection or disease that is not responsive (with or without...
FDA Approves Pafolacianine to Help Identify Ovarian Cancer Lesions
On November 29, the U.S. Food and Drug Administration (FDA) approved pafolacianine (Cytalux), a targeted fluorescent imaging agent intended to assist surgeons in identifying ovarian cancer lesions. The drug, which is indicated for use in adult patients with ovarian cancer and is administered in the ...
FDA Approves Triplet Therapy for Previously Treated Patients With Relapsed or Refractory Multiple Myeloma
On November 30, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with carfilzomib (Kyprolis) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of...
FDA Approves Rituximab Plus Chemotherapy for Several Pediatric Hematologic Malignancies
On December 2, the U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan) in combination with chemotherapy for pediatric patients (≥ 6 months to < 18 years old) with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma,...
ASH Recognizes Peter Marks, MD, PhD, With 2021 Outstanding Service Award
The American Society of Hematology (ASH) recognized Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA), for his outstanding commitment to hematology in overseeing the approval of therapeutics that improve the...
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...
Composite Biomarker Needed to Predict Benefit of Immunotherapy in Triple-Negative Breast Cancer
Although there is a biomarker that predicts response to the one approved immunotherapy agent for metastatic triple-negative breast cancer, “it is important to note there are no biomarkers of response to neoadjuvant immunotherapy in early-stage triple-negative breast cancer,” Elizabeth A....
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...
NYU Langone Opens Center Dedicated to Blood and Marrow Transplants
NYU Langone Health’s Laura and Isaac Perlmutter Cancer Center opened a new state-of-the-art center to treat people with hematologic malignancies, including leukemia, lymphoma, and multiple myeloma.
The new center, led by Samer Al-Homsi, MD, MBA, Clinical Professor in the Department of Medicine and ...
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,
Novel Vaccine Platform Plus Pembrolizumab May Boost Immune Response in Advanced HCC
A novel vaccine platform administered in combination with pembrolizumab appears to be safe and effective in patients with advanced hepatocellular carcinoma (HCC), according to data presented by Mark Yarchoan, MD, and colleagues at the Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting (
Eftilagimod Alpha Plus Paclitaxel May Improve Survival in HR-Positive, HER2-Negative Metastatic Breast Cancer: AIPAC Trial
The addition of the LAG-3 protein eftilagimod alpha to paclitaxel led to a significant improvement in overall survival in younger patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, according to data presented by Hans Wildiers, MD, and colleagues at the Society for ...
Sotigalimab Plus Nivolumab in Anti–PD-1/PD-L1–Refractory Melanoma
Immune checkpoint inhibitors have revolutionized the treatment of metastatic melanoma, but a significant number of patients still fail to respond to anti–PD-1 therapy. The novel combination of sotigalimab, an anti-CD40 monoclonal antibody, and the PD-1 inhibitor nivolumab could help address this...
Build 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...
ASCO Calls on Congress to Prevent Steep Medicare Cuts Before End of Year
“The Association for Clinical Oncology (ASCO) calls on Congress to pass legislation that will prevent devastating reimbursement cuts to Medicare services set to begin on January 1. Failure to do so will significantly compromise patient access to lifesaving cancer care during an ongoing and...
Cures 2.0 Bill May Increase Diversity in Clinical Trials, Expand Access to Telehealth, Invest in Research
Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) recently introduced new legislation intended to invest in research and deliver more cures to patients. The newly introduced 21st Century Cures 2.0 Act (Cures 2.0) is intended to build on the landmark 21st Century Cures Act, which was signed ...
Recruiting Practices to Help Test Performance Measures to Advance Oncology Quality of Care
ASCO is currently recruiting practices to participate in measures testing for a variety of efforts, including re-endorsing existing measures by the National Quality Forum (NQF). In addition to ensuring the highest level of quality care for individuals with cancer and advancing the specialty of...
