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Showing 6601 - 6650FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
On January 3, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand the use of a single booster dose to include use in individuals aged 12 to 15 years; shorten the time between the completion of primary...
MRD Response–Adapted Therapy in Patients Receiving Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone Plus AHCT for Newly Diagnosed Multiple Myeloma
In the phase II MASTER trial reported in the Journal of Clinical Oncology, Luciano J. Costa, MD, PhD, and colleagues found that daratumumab, carfilzomib, lenalidomide, and dexamethasone (Dara-KRd) induction; autologous hematopoietic cell transplantation (AHCT); and measurable residual disease (MRD) ...
European Genome-Wide Association Study of Genetic Variants in Alcohol-Related Hepatocellular Carcinoma
In a case-control genome-wide association study among persons of European ancestry reported in The Lancet Oncology, Trépo et al identified common genetic variants associated with the risk of alcohol-related hepatocellular carcinoma (HCC). Study Details The study involved a discovery cohort of 2,107 ...
Balstilimab Plus Zalifrelimab for the Second-Line Treatment of Advanced Cervical Cancer
In a phase II trial reported in the Journal of Clinical Oncology, David M. O’Malley, MD, and colleagues found that the PD-1 inhibitor balstilimab and the CTLA-4 inhibitor zalifrelimab—both investigational agents—produced durable responses as second-line treatment for patients with recurrent or...
Andrew Matthews, MD, on AML: CPX-351 vs Venetoclax/Azacitidine for Initial Therapy
Andrew Matthews, MD, of the Abramson Cancer Center, University of Pennsylvania, discusses findings from a retrospective study at an academic institution, which showed there was no statistically significant difference in overall survival between induction with CPX-351 and venetoclax/azacitidine for...
Polatuzumab Vedotin-piiq Plus R-CHP vs R-CHOP for Previously Untreated Patients With DLBCL
In the phase III POLARIX trial reported in The New England Journal of Medicine, Tilly et al found that polatuzumab vedotin-piiq plus R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) significantly improved progression-free survival vs R-CHOP (rituximab, cyclophosphamide, doxorubicin, ...
New National Study Finds Oropharyngeal Cancer Incidence and Mortality Is Rising in the United States
Oropharyngeal cancer incidence among men is continuing to rise rapidly in nearly all 50 U.S. states and among women living in states in the Midwest and Southeast regions, according to a new study published by Damgacioglu et al in JAMA Otolaryngology–Head & Neck Surgery. In addition, the...
Hepatic Arterial Infusion Chemotherapy vs Sorafenib for Advanced Hepatocellular Carcinoma
In a Chinese phase III trial (FOHAIC-1) reported in the Journal of Clinical Oncology, Lyu et al found that hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin; HAIC-FO) significantly prolonged overall survival vs sorafenib in patients with advanced...
Second-Line Tisagenlecleucel vs Standard of Care in Aggressive B-Cell Lymphoma
As reported in The New England Journal of Medicine by Bishop et al, the phase III BELINDA trial showed no improvement in event-free survival with second-line tisagenlecleucel vs standard of care including salvage chemotherapy and autologous hematopoietic stem cell transplantation (HSCT) in patients ...
Lisa A. Carey, MD, on HR-Positive and HER2-Negative Advanced Breast Cancer: Overall Survival by Subtype Across Three MONALEESA Studies
Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill and the Lineberger Comprehensive Cancer Center, discusses findings from a pooled analysis of the MONALEESA-2, -3, and -7 trials. Among the findings was a consistent overall survival benefit with ribociclib plus endocrine therapy...
Breast Cancer Index May Predict Benefit of Extended Endocrine Therapy in Certain Patients With Hormone Receptor–Positive Disease
New data were presented at the 2021 San Antonio Breast Cancer Symposium demonstrating that the Breast Cancer Index (BCI) may predict preferential recurrence-prevention benefit from extended endocrine therapy and may also predict the overall benefit/risk and likelihood of improved health outcomes...
Molecular Analysis Advances Risk Profiling and Assessment of Immunotherapy Response in Smoldering Myeloma
Molecular and genetic research has advanced the categorization of different risk groups in patients with smoldering myeloma. Notable presentations at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition included reports on biomarkers to predict response to immunotherapy in...
Personalized Therapy vs Physician’s Choice of Treatment for Patients With Residual Triple-Negative Breast Cancer After Neoadjuvant Chemotherapy
In a phase II trial reported in the Journal of Clinical Oncology, Schneider et al found that genomically directed therapy did not improve 2-year disease-free survival vs treatment of physician’s choice in patients with residual triple-negative breast cancer following neoadjuvant chemotherapy. Study ...
Effect of Bupropion vs Placebo on Sexual Desire in Postmenopausal Female Cancer Survivors
In a phase II trial (NRG-CC004) reported in the Journal of Clinical Oncology, Barton et al found that bupropion, a dopaminergic agent, did not improve sexual desire vs placebo as measured by the Female Sexual Function Index (FSFI) desire subscale among postmenopausal women with low desire scores...
Postoperative Radiotherapy for Patients With Completely Resected Stage IIIA NSCLC and N2 Involvement
In the European phase III Lung ART trial reported in The Lancet Oncology, Le Pechoux et al found that three-dimensional (3D) conformal postoperative radiotherapy (PORT) did not improve disease-free survival vs no PORT in patients with stage IIIA N2 non–small cell lung cancer (NSCLC) who had...
Calcineurin Inhibitor–Free Chronic Graft-vs-Host Disease Interventions in Myeloablative HCT for Hematologic Malignancies
As reported in the Journal of Clinical Oncology by Luznik et al, the phase III Blood and Marrow Transplant Clinical Trial Network 1301 trial has shown no improvement in the composite outcome of chronic graft-vs-host disease or relapse-free survival with calcineurin inhibitor–free regimens in...
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,...
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...
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...
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...
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...
Expert Point of View: Ian Chau, MD
Invited discussant Ian Chau, MD, Consultant Medical Oncologist at The Royal Marsden Hospital in London and Surrey in the United Kingdom, said the findings from COSMIC-3121 are not mature enough to establish cabozantinib/atezolizumab as a new front-line option for advanced hepatocellular carcinoma...
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...
Expert Point of View: Myung-Ju Ahn, MD, PhD
Myung-Ju Ahn, MD, PhD, Professor in the Department of Hematology and Oncology at Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea, said the novel regimen of sintilimab, IBI305, and chemotherapy is a promising approach in EGFR-mutated nonsquamous non–small cell lung...
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 ...
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...
Expert Point of View: Matthew J. Ellis, MB, BChir, PhD, FACP
The final results of the phase III PALLAS trial1 are “deeply disappointing,” said session moderator Matthew J. Ellis, MB, BChir, PhD, FACP, Professor of Medicine and Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine. The results of the final primary analysis of PALLAS ...
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: Krish Patel, MD
Krish Patel, MD, Director of the Lymphoma Program at the Swedish Cancer Institute in Seattle and Interim Director of the Hematological Malignancies and Cellular Therapy Program, commented on the implications of Dr. Soumerai’s presentation. “We know that, in general, reaching [undetectable...
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...
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...
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...
Lynn M. Schuchter, MD, FASCO, Elected ASCO President for 2023–2024 Term
ASCO has elected Lynn M. Schuchter, MD, FASCO, a long-time member and volunteer, to serve as its President beginning in June 2023. Dr. Schuchter will take office as President-Elect immediately after the ASCO Annual Meeting in Chicago in June 2022. Seven new members were also elected to the ASCO...
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...
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...
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,...
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...
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...
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...
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...
First-Line Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma: Effect on Overall Survival
As reported in The Lancet Oncology by Thomas Yau, MD, and colleagues, the phase III CheckMate 459 trial has shown no improvement in overall survival with first-line nivolumab vs sorafenib in patients with advanced hepatocellular carcinoma. Study Details In the open-label trial, 743 patients not...
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...
Adjuvant T-DM1/Pertuzumab vs Taxane/Trastuzumab/Pertuzumab in High-Risk HER2-Positive Breast Cancer
In the phase III KAITLIN trial reported in the Journal of Clinical Oncology, Ian E. Krop, MD, and colleagues found that adjuvant ado-trastuzumab emtansine (T-DM1) plus pertuzumab did not improve invasive disease–free survival vs a taxane plus trastuzumab/pertuzumab, both following...
Association of CD123 Expression With High-Risk Disease Characteristics and Outcomes in Pediatric AML
In an analysis from the Children’s Oncology Group AAML1031 trial reported in the Journal of Clinical Oncology, Lamble et al found that increased CD123 expression was associated with high-risk genetic alterations and poorer treatment outcomes in pediatric patients with newly diagnosed acute myeloid...
Research From the 2021 ASH Annual Meeting & Exposition
The 2021 ASH Annual Meeting & Exposition took place from December 11 to 14. This week, we’re highlighting two studies featured as late-breaking abstracts at the meeting.
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...
WHO Launches a New Classification System for Pediatric Tumors, Incorporating Morphology, Immunohistochemistry Analysis, and Molecular Characteristics
A review article by Pfister et al published in Cancer Discovery summarizes the inaugural classification of pediatric tumors soon to be published by the International Agency for Research on Cancer as part of the new World Health Organization (WHO) Classification of Tumors series, including an online ...
CANDOR: Continued Progression-Free Survival Benefit With Carfilzomib, Dexamethasone, and Daratumumab vs Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma
In an updated analysis of the pivotal phase III CANDOR trial reported in The Lancet Oncology, Saad Z. Usmani, MD, and colleagues found that the addition of daratumumab to carfilzomib and dexamethasone (KdD) continued to show a large progression-free survival benefit in patients with relapsed or...
