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skin cancer
immunotherapy

Interim Radiographic Assessment for Adaptive Dosing of Combination Immunotherapy in Advanced Melanoma

In the phase II ADAPT-IT trial reported in the Journal of Clinical Oncology, Michael A. Postow, MD, and colleagues showed that findings on interim computed tomography (CT) allowed patients to avoid the third and fourth doses of combination nivolumab/ipilimumab for the treatment of advanced...

thyroid cancer

Apatinib for Advanced Radioactive Iodine–Refractory Differentiated Thyroid Cancer

In an interim analysis of the Chinese phase III REALITY trial reported in JAMA Oncology, Lin et al found that apatinib, a highly selective VEGFR2 inhibitor, significantly prolonged progression-free survival vs placebo in patients with progressive, locally advanced or metastatic, radioactive...

lung cancer

Comparison of Efficiency of USPSTF vs PLCO Criteria in Determining Eligibility for Lung Cancer Screening

In an interim analysis of a prospective cohort study reported in The Lancet Oncology, Tammemägi et al found that the Prostate Lung Colorectal and Ovarian Cancer Screening Trial 2012 risk prediction model (PLCOm2012) may be more efficient than U.S. Preventive Services Task Force 2013 (USPSTF2013)...

leukemia
immunotherapy

Pretreatment Disease Burden and Outcomes With Commercial Tisagenlecleucel in Pediatric/Young Adult B-Cell ALL

In an analysis from the Pediatric Real-World Chimeric Antigen Receptor Consortium reported in the Journal of Clinical Oncology, Schultz et al found that pretreatment high disease burden was associated with poorer outcomes in pediatric and young adult patients who received commercial...

immunotherapy

Patrick Hwu, MD, and Mary Dean, JD, CAE, on What’s Ahead for Cancer Immunology and SITC

Patrick Hwu, MD, of Moffitt Cancer Center and President of the Society for Immunotherapy of Cancer (SITC), and Mary Dean, JD, CAE, SITC Executive Director, discuss the organization’s mission, strides made in cancer immunology, meeting the challenge of immunoresistance, and the new SITC app for...

lymphoma
genomics/genetics

Joe Schroers-Martin, MD, on Follicular Lymphoma: Precursor Mutations May Be Detectable Years Before Diagnosis

Joe Schroers-Martin, MD, of Stanford University, discusses his latest study findings, which show that follicular lymphoma driver mutations are detectable in blood and saliva years prior to a clinical diagnosis. These data build on previous work and suggest that researchers may be able to stratify...

covid-19

NCCN Updates Recommendations on COVID-19 Vaccination and Preexposure Prophylaxis

Today, the National Comprehensive Cancer Network® (NCCN®) published significant updates to the expert consensus recommendations on vaccination and preexposure prophylaxis of COVID-19 for people with cancer. The NCCN Advisory Committee on COVID-19 Vaccination and Preexposure Prophylaxis meets...

global cancer care

Study Examines Global Cancer Burden From 2010 to 2019

Cancer deaths rose to 10 million and new cases jumped to over 23 million globally in 2019, according to a new study from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington School of Medicine published in JAMA Oncology. At the start of the decade in 2010, total...

covid-19

Study Finds Fully Vaccinated Patients With Cancer and Breakthrough COVID-19 Infection Remain at High Risk for Severe Outcomes

A study evaluating the clinical characteristics and outcomes of fully vaccinated patients with cancer who had breakthrough COVID-19 infections indicated they remained at high risk for hospitalization and death. The report, published by Schmidt et al in Annals of Oncology, showed that fully...

genomics/genetics
immunotherapy

Association of HLA-A*03 With Outcomes of Immune Checkpoint Inhibition for Advanced Cancers

In a study reported in The Lancet Oncology, Naranbhai et al found that the presence of HLA-A*03 was associated with poorer outcomes in patients receiving immune checkpoint inhibitors for advanced cancers. As stated by the investigators, “Predictive biomarkers could allow more precise use of immune...

leukemia

Association of Response Rate and Event-Free Survival With Overall Survival in Newly Diagnosed AML: FDA Analysis

In a trial-level analysis of randomized studies submitted to the U.S. Food and Drug Administration (FDA) reported in the Journal of Clinical Oncology, Norsworthy et al found that complete remission rate was moderately correlated, and event-free survival was strongly correlated, with overall...

breast cancer

Long-Term Outcomes According to Residual Cancer Burden After Neoadjuvant Chemotherapy for Breast Cancer

In an analysis reported in The Lancet Oncology, Yau et al found that increasing residual cancer burden (RCB) after neoadjuvant chemotherapy was associated with poorer event-free survival across breast cancer subtypes. Study Details The study included patient-level data on RCB and other clinical and ...

multiple myeloma
covid-19

Nikhil C. Munshi, MD, PhD, on COVID-19 Vaccine Effectiveness in Patients With Multiple Myeloma

Nikhil C. Munshi, MD, PhD, of Dana-Farber Cancer Institute, discusses the findings from a large nationwide Veterans Affairs study, which showed that, for patients with multiple myeloma, the effectiveness of the COVID-19 vaccine is reduced, likely due to patients’ immunosuppression. Dr. Munshi...

breast cancer

Ann H. Partridge, MD, MPH, on SABCS Meeting Highlights: Expert Perspective

Ann H. Partridge, MD, MPH, of Dana-Farber Cancer Institute, discusses what she considers to be the most notable presentations at the 2021 San Antonio Breast Cancer Symposium. They include the focus on early-stage disease, especially in the TEXT/SOFT, RxPonder, and KEYNOTE-522 trials, as well as...

solid tumors
hematologic malignancies
covid-19

Study Finds Third COVID-19 Vaccine Dose Effectively Boosts Immunity for Patients With Solid Tumors

Nearly 100% of patients with solid tumors have antibodies effective against the SARS–CoV-2 delta variant after a third dose of COVID-19 vaccine, according to results published as a correspondence by Fendler et al in Cancer Cell. The new findings also highlight a proportion of patients with blood...

skin cancer
immunotherapy

Is a High-Fiber Diet Associated With Improved Survival and Treatment Response in Patients With Melanoma?

Patients with melanoma who reported eating more fiber-rich foods when they began treatment with immunotherapy survived longer without cancer growth than patients with insufficient dietary fiber intake, according to new research published by Spencer et al in Science. The benefit was most noticeable...

covid-19

FDA 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...

multiple myeloma

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) ...

hepatobiliary cancer
genomics/genetics

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 ...

gynecologic cancers
immunotherapy

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...

leukemia

Sangeetha Venugopal, MD, on Secondary AML: Impact of Front-Line Treatment Approach

Sangeetha Venugopal, MD, of The University of Texas MD Anderson Cancer Center, discusses a retrospective analysis of 562 patients with treated secondary acute myeloid leukemia and prior exposure to hypomethylating agents (HMAs). The results showed that an HMA plus venetoclax yielded significantly...

leukemia

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...

lymphoma
immunotherapy

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, ...

head and neck cancer

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...

issues in oncology

Eight Substances Added to the 15th Report on Carcinogens

Eight substances have been added to the Report on Carcinogens, bringing the total list to 256 substances that are known—or reasonably anticipated—to cause cancer in humans. The 15th Report on Carcinogens, which is a cumulative report mandated by Congress and prepared by the National Toxicology...

leukemia

Association of MRD Response and Prognosis in Patients With AML Treated With Venetoclax and Azacitidine

�In an analysis from the phase III VIALE-A study reported in the Journal of Clinical Oncology, Keith W. Pratz, MD, and colleagues found that among treatment-naive patients with acute myeloid leukemia (AML) who experienced complete remission after receiving treatment with venetoclax/azacitidine,...

hepatobiliary cancer

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...

lymphoma
immunotherapy

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 ...

breast cancer

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

Charles Coombes, MD, PhD, on Hormone Receptor–Positive HER2-Negative Breast Cancer: Use of Samuraciclib Plus Fulvestrant

Charles Coombes, MD, PhD, of Imperial College, London, discusses study results on samuraciclib, a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor–positive HER2-negative breast cancer. The combination of agents has...

breast cancer

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...

multiple myeloma
immunotherapy
genomics/genetics

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...

breast cancer
genomics/genetics

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 ...

breast cancer
gynecologic cancers
survivorship

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...

lung cancer

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...

hematologic malignancies
supportive care

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...

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...

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 ...

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...

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 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,...

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...

multiple myeloma
immunotherapy

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...

multiple myeloma
immunotherapy

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...

hepatobiliary cancer
immunotherapy

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...

hepatobiliary cancer
immunotherapy

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...

lung cancer
genomics/genetics

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...

lung cancer
genomics/genetics

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 ...

sarcoma

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...

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