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Showing 1001 - 1050FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
On February 27, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of COVID-19. The EUA allows the Janssen COVID-19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older. The FDA...
EMPOWER-Lung 1: First-Line Cemiplimab-rwlc vs Platinum-Doublet Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 50%
As reported in The Lancet by Sezer et al, the phase III EMPOWER-Lung 1 trial has shown improved overall and progression-free survival with cemiplimab-rwlc vs platinum doublet chemotherapy among patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 50% of tumor cells...
Endoscopic Nasopharyngectomy vs IMRT for Previously Treated, Resectable, Locally Recurrent Nasopharyngeal Carcinoma
In a Chinese phase III trial reported in The Lancet Oncology, Liu et al found that endoscopic nasopharyngectomy was associated with improved overall survival vs intensity-modulated radiotherapy (IMRT) in patients with resectable locally recurrent nasopharyngeal carcinoma who had received prior...
Medicare Physician Fee Schedule Conversion Factor Updated to Reflect 2021 Federal Funding Package
The Centers for Medicare & Medicaid Services (CMS) announced a revised Medicare Physician Fee Schedule conversion factor of $34.8931 for 2021. This represents a 3.3% reduction from the 2020 conversion factor of $36.0869. CMS updated the conversion factor as a result of a provision in the $1.4...
In Case You Missed It: Brief Highlights From ASH 2020
In case you missed these while attending the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, below is a sampler of highlights that were not included in our first round of meeting coverage. Many of these reports are on early-phase clinical trials of agents that may raise...
IASLC Honors Pan-Chyr Yang, MD, PhD, for Contributions to Lung Cancer Prevention
Pan-Chyr Yang, MD, PhD, Chair Professor at the National Taiwan University Hospital and Academician of Academia Sinica, Taiwan, received the Joseph W. Cullen Prevention/Early Detection Award from the International Association for the Study of Lung Cancer (IASLC) at the virtual IASLC 2020 World...
Ongoing Surveillance and Efforts to Reduce Smoking and Obesity Needed to Lower Cancer Survivors’ Risks of New Cancers
The risk of developing or dying of a new primary cancer, particularly those cancers associated with smoking and obesity, was greater among survivors of adult-onset cancers than the expected risk in the general population, according to an analysis of data from more than 1.5 million cancer...
The CARG-BC Score: Novel Tool for Predicting Chemotherapy Toxicity in Early-Stage Breast Cancer
As reported in the Journal of Clinical Oncology, Allison Magnuson, DO, of the University of Rochester Medical Center & Wilmot Cancer Institute, and Mina S. Sedrak, MD, MS, of the City of Hope National Medical Center, along with colleagues, have developed a novel risk tool—the Cancer and Aging...
Genome-Edited Donor-Derived Anti-CD19 CAR T-Cell Therapy Is Active in B-Cell Acute Lymphoblastic Leukemia
Pooled results of two phase I studies, reported in The Lancet by Reuben Benjamin, MBBS, of the Department of Haematological Medicine, King’s College Hospital, London, and colleagues, indicate that the genome-edited donor-derived allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell product...
How the COVID-19 Pandemic Can Help Improve Cancer Research
The ripple effects of the coronavirus pandemic have been felt in every area of health care. In our medical specialty, oncology, clinical trials of new treatments were upended by COVID-19. In the early months of the pandemic, widespread interruptions in trial enrollment prevented some patients...
Updated Findings Bolster the Use of Checkpoint Inhibitors in Treatment of Liver Cancer
Although optimal regimens are still being determined, checkpoint inhibition has clearly established itself in the treatment of hepatocellular carcinoma, as judged by the number of abstracts on the topic at the 2021 Gastrointestinal Cancers Symposium. The ASCO Post brings readers short summaries of ...
Responses to Anti–PD-1/PD-L1 Immunotherapy in Patients With MSS Solid Tumors and High Tumor Mutational Burden
In a single-institution study reported in JAMA Oncology, Valero et al found that response rates to anti–PD-1 or anti–PD-L1 treatments in patients with microsatellite-stable (MSS) solid tumors were generally higher among those with high tumor mutational burden (TMB) defined as ≥ 10...
One-Third of Cancer Survivors Reported Worry About Health-Care Disruptions Early in the COVID-19 Pandemic
A new study published by Corinne Leach, MPH, MS, PhD, and colleagues in the Journal of Psychosocial Oncology reported that early in the COVID-19 pandemic in the United States, one-third of cancer survivors worried about treatment and cancer care disruptions. Using a mixed-methods approach,...
Addition of Andecaliximab to mFOLFOX6 in First-Line Treatment of HER2-Negative Advanced Gastric Cancer
As reported in the Journal of Clinical Oncology by Manish A. Shah, MD, and colleagues, the phase III GAMMA-1 trial showed no improvement in overall survival with the addition of andecaliximab to modified oxaliplatin, leucovorin, and fluorouracil (mFOLFOX6) in the first-line treatment of...
MRI-Targeted Biopsy vs Systematic Transrectal Ultrasonography Biopsy for Detection of Disease in Men at Risk for Prostate Cancer
In a Canadian phase III trial reported in JAMA Oncology, Klotz et al found that multiparametric magnetic resonance imaging (MRI) with targeted biopsy was noninferior to systematic 12-core transrectal ultrasonography biopsy in detecting International Society of Urological Pathology grade group 2...
Addition of Second-Line Pegilodecakin to FOLFOX in Metastatic Pancreatic Cancer: SEQUOIA Trial
In the phase III SEQUOIA trial reported in the Journal of Clinical Oncology, J. Randolph Hecht, MD, and colleagues found that the addition of pegilodecakin—a pegylated recombinant human interleukin (IL)-10—to FOLFOX (leucovorin, fluorouracil [5-FU], and oxaliplatin) did not improve overall survival ...
Transplant May Improve Survival in Older Patients With High-Risk Myelodysplastic Syndrome
Stem cell transplants are not frequently offered to older patients with high-risk myelodysplastic syndromes (MDS). According to a study from the Blood and Marrow Transplant Clinical Trials Network (BMTCTN 1102), these patients may indeed achieve a survival benefit from stem cell transplant. As...
Treatment With LOXO-305 Results in Durable Efficacy in Heavily Pretreated Patients With CLL/SLL
Despite the marked efficacy of ibrutinib, acalabrutinib, and venetoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), treatment failure can occur through the development of resistance. In addition, patients in whom Bruton’s tyrosine kinase (BTK) inhibitors and BCL2...
Nivolumab/Ipilimumab vs Chemotherapy as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma: CheckMate 743 Trial
As reported in The Lancet by Paul Baas, MD, and colleagues, a prespecified interim analysis in the phase III CheckMate 743 trial has shown improved overall survival with first-line nivolumab/ipilimumab vs platinum-based chemotherapy in patients with unresectable malignant pleural mesothelioma. The...
mFOLFIRINOX or Gemcitabine/Nab-paclitaxel for Resectable Pancreatic Cancer: Improved Overall Survival?
In a phase II trial reported in JAMA Oncology, Davendra P.S. Sohal, MD, MPH, and colleagues found that neither of two perioperative chemotherapy regimens was associated with improved overall survival in patients with resectable pancreatic ductal adenocarcinoma compared with historical rates in...
COVID Virus–Specific T Cells: Potential Treatment of Severe COVID-19 Infection Under Study
It may be possible to exploit T cells from healthy volunteers who have recovered from COVID-19 as a treatment for this viral infection. Researchers at the Center for Cell and Gene Therapy at Baylor College of Medicine have designed an off-the-shelf COVID virus–specific T-cell product (called...
Study Examines Pregnancy Outcomes in Breast Cancer Survivors
Breast cancer survivors of child-bearing age appear to have a more difficult time becoming pregnant than the general population, and when they do become pregnant, they have a higher risk of preterm labor and need for cesarean section. Fortunately, most women deliver healthy babies, but they are...
First-Line Lorlatinib Improves Progression-Free Survival vs Crizotinib in Advanced ALK-Positive NSCLC
As reported in The New England Journal of Medicine by Alice T. Shaw, MD, PhD, Global Head of Translational Clinical Oncology at Novartis Institutes for BioMedical Research,* and colleagues, an interim analysis of the phase III CROWN trial has shown that first-line lorlatinib significantly improved...
Patients With Lymphoma Receiving B-Cell–Depleting Therapies May Be at Greater Risk for Persistent COVID-19 Infection
B-cell–depleting immunotherapy may cause B-cell aplasia and impair the body’s immune response. A retrospective, multicentric French study of patients with lymphoma and persistent COVID-19 infection has found that those treated with B-cell–depleting therapies within the previous 12 months had nearly ...
Patients on Active Chemotherapy May Not Be at Increased Risk for COVID-19 Infection
Due to concerns that patients with cancer may be at higher risk for contracting the coronavirus—and may have more severe complications if infected—during the COVID-19 pandemic, hospitals and clinical practices have changed protocols to routine cancer care to reduce patients’ exposure to the virus....
Development and Performance of a Population-Based Benchmark Model for Use of Cancer Surgery in High-Income Countries
In a study reported in The Lancet Oncology, Perera et al developed a population-based benchmark model for guideline-recommended use of surgery for primary cancers in high-income countries. Actual use of surgery was often consistent with model predictions but sometimes varied markedly. Study ...
Two ADAURA Analyses Support the Use of Osimertinib in Patients With Surgically Resected NSCLC
Two presentations based on data from the ADAURA clinical trial advanced previous research that demonstrated improved disease-fee survival outcomes for patients with surgically resected non–small cell lung cancer (NSCLC) receiving osimertinib, while also maintaining quality of life. The data were...
Margetuximab-cmkb vs Trastuzumab in Heavily Pretreated Patients With HER2-Positive Breast Cancer: SOPHIA Trial
As reported in JAMA Oncology by Hope S. Rugo, MD, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs trastuzumab plus chemotherapy in patients with HER2-positive breast cancer who experienced disease...
WCLC Press Briefing Focuses on the Connection Between Lung Cancer and COVID-19
On February 27, 2020, the Journal of Thoracic Oncology published a case study that described two patients from Wuhan, China, who had recently underwent lung lobectomies for adenocarcinoma and were retrospectively found to have had COVID-19 at the time of surgery. Eleven months later, the lung...
Addition of Intraprostatic Focal Boost to External-Beam Radiotherapy in Localized Prostate Cancer
As reported in the Journal of Clinical Oncology by Kerkmeijer et al, the Dutch/Belgian phase III FLAME trial has shown that the addition of a focal boost to the intraprostatic lesion in patients receiving external-beam radiotherapy (EBRT) improved biochemical disease–free survival—without worsening ...
Hyperthermic Intraperitoneal Chemotherapy Plus Cytoreductive Surgery for Colorectal Cancer Metastases Does Not Improve Overall Survival
As reported in The Lancet Oncology by Quénet et al, the French phase III PRODIGE 7 trial has shown that the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery did not improve overall survival—and was associated with an increase in postoperative late...
Early Integration of Nutritional and Psychological Interventions for Previously Untreated Patients With Metastatic Esophagogastric Cancer
In a Chinese single-institution phase III trial reported in the Journal of Clinical Oncology, Lu et al found that early interdisciplinary supportive care with a focus on nutrition and psychological status was associated with improved overall survival vs standard care in previously untreated...
Preemptive Tocilizumab for Cytokine-Release Syndrome in Pediatric Patients With B-Cell ALL Receiving CAR T-Cell Therapy
In a single-institution study reported in the Journal of Clinical Oncology, Kadauke et al found that risk-adapted tocilizumab reduced the expected incidence of grade 4 cytokine-release syndrome in pediatric patients receiving CD19-directed chimeric antigen receptor (CAR) T-cell...
AAAS Announces Leading Scientists Elected as 2020 Fellows
Nearly 500 members of the American Association for the Advancement of Science (AAAS) have earned the lifetime distinction of AAAS Fellow. The Fellows are elected each year by their peers serving on the Council of AAAS, the organization’s member-run governing body. The title recognizes important...
Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations
On December 18, 2020, osimertinib was approved for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) with tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Supporting...
Venetoclax Added to Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma
As reported in The Lancet Oncology by Shaji K. Kumar, MD, of the Division of Hematology, Mayo Clinic, Rochester, and colleagues, the phase III BELLINI trial has shown that the addition of venetoclax to bortezomib/dexamethasone significantly prolonged progression-free survival in patients with...
Adding Entinostat to Exemestane Fails to Overcome Aromatase Inhibitor Resistance in Advanced Breast Cancer
The histone deacetylase inhibitor (HDAC) entinostat, added to exemestane, failed to overcome endocrine therapy resistance in advanced breast cancer, according to the E2112 phase III trial conducted by the ECOG-ACRIN Cancer Research Group. Results showed that overall survival was not improved by the ...
Oral Taxanes Moving Forward in Metastatic Breast Cancer
Positive results have now been reported in phase III trials of two oral taxanes in the treatment of metastatic breast cancer. At the 2020 San Antonio Breast Cancer Symposium, treatment with tesetaxel and reduced-dose capecitabine resulted in an improvement in progression-free survival of about 3...
Relugolix for Advanced Prostate Cancer
On December 18, 2020, relugolix was approved for the treatment of adult patients with advanced prostate cancer. Relugolix is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to be approved in this setting.1,2 Supporting Efficacy Data Approval was based on findings in the...
Selinexor in Relapsed or Refractory Multiple Myeloma
On December 18, 2020, selinexor was approved for use in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy.1,2 Selinexor received accelerated approval in 2019 for use in combination with dexamethasone for...
Margetuximab-cmkb for Previously Treated Metastatic HER2-Positive Breast Cancer
On December 16, 2020, margetuximab-cmkb (margetuximab) was approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.1,2...
First-Line Nivolumab/Ipilimumab in Metastatic Uveal Melanoma
In a Spanish phase II trial reported in the Journal of Clinical Oncology, Piulats et al found that nivolumab/ipilimumab produced a “modest” improvement in overall survival vs historical rates achieved with chemotherapy as first-line treatment for patients with metastatic uveal melanoma ineligible...
Novel Risk Tool for Predicting Severe Toxicity in Older Patients Receiving Chemotherapy for Early-Stage Breast Cancer
As reported in the Journal of Clinical Oncology, Allison Magnuson, DO, and colleagues have developed a risk tool for predicting severe toxicity in patients aged 65 and older receiving chemotherapy for early-stage breast cancer. Study Details The prospective cohort study included 473 patients...
Bemarituzumab Plus Chemotherapy Improves Outcomes in Advanced Gastric/Gastroesophageal Junction Cancer
Gastric cancer has a new target: fibroblast growth factor receptor 2b (FGFR2b). Targeting FGFR2b with bemarituzumab plus chemotherapy led to clinically meaningful and statistically significant improvements in progression-free survival, overall survival, and response rates in the randomized phase II ...
Intensified Reduced-Intensity Conditioning for Allogeneic Stem Cell Transplantation in AML or MDS
In the phase II FIGARO trial reported in the Journal of Clinical Oncology, Craddock et al found that intensified reduced-intensity conditioning with fludarabine/amsacrine/cytarabine–busulfan (FLAMSA-Bu) did not improve outcomes following allogeneic stem cell transplantation vs standard...
Effect of COVID-19 Infection on Cancer Management
In a study reported in JCO Oncology Practice, Wu et al found that almost two-thirds of patients undergoing active cancer management who were diagnosed with COVID-19 over a 4-month period in 2020 had significant delays in planned management. Study Details The retrospective study involved data on...
Feasibility Study of Radical Cystectomy vs Intravesical BCG for High-Grade, Non–Muscle Invasive Bladder Cancer
As reported in the Journal of Clinical Oncology by Catto et al, the BRAVO-Feasibility study showed that recruitment of patients with high-grade, non–muscle invasive bladder cancer into a randomized trial comparing radical cystectomy vs intravesical bacillus Calmette-Guérin (BCG) proved difficult,...
Use of a Novel CAR T-Cell Therapy in Pediatric and Adult Patients With Advanced B-Cell ALL
Pooled results of two phase I studies, reported in The Lancet by Benjamin et al, indicate that the genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell product UCART19 is active and has a manageable toxicity profile in pediatric and adult patients with relapsed...
Integrated Palliative and Oncology Care for Patients Receiving Treatment for AML
In a study reported in JAMA Oncology, Areej El-Jawahri, MD, and colleagues found that integrated palliative and oncology care was associated with better quality of life vs usual care among patients receiving treatment for acute myeloid leukemia (AML). The investigators stated, “Patients with AML...
Gemogenovatucel-T Maintenance in Stage III/IV Ovarian Cancer
In the phase IIb VITAL trial reported in The Lancet Oncology, Rocconi et al found that front-line maintenance with the autologous tumor cell vaccine gemogenovatucel-T did not improve recurrence-free survival vs placebo in patients with stage III/IV ovarian cancer in clinical complete response after ...
