In a UK-based phase III noninferiority trial (QUARTZ) reported in The Lancet, Mulvenna et al found that use of whole-brain radiotherapy in addition to optimal supportive care including dexamethasone was associated with little additional benefit in non–small cell lung cancer (NSCLC) patients...
I am writing to ask the ASCO community for help in addressing a policy decision by the Nuclear Regulatory Commission (NRC) that requires oncologists to take a 700-hour course (on the full range of nuclear medicines) to give one medicine to their patients: prepackaged radioimmunotherapy. It’s...
The multikinase inhibitor regorafenib (Stivarga) prolonged progression-free survival vs placebo in patients with previously treated advanced gastric carcinoma, in a phase II trial reported in the Journal of Clinical Oncology by Nick Pavlakis, MBBS, PhD, of the University of Sydney, Australia, and...
Low-dose oral cyclophosphamide plus methotrexate maintenance therapy yielded no disease-free survival benefit in women with hormone receptor–negative early breast cancer, according to the phase III International Breast Cancer Study Group (IBCSG) 22-00 trial. Some evidence of benefit was observed in ...
In an analysis of National Cancer Data Base data reported in the Journal of the National Cancer Institute, Bhatia et al found that adjuvant radiotherapy was associated with a survival benefit in patients with stage I and II but not stage III Merkel cell carcinoma, with no benefit of adjuvant...
In a pivotal phase II study reported in The Lancet Oncology, Stephan Stilgenbauer, MD, of Ulm University, Germany, and colleagues found that the BCL2 inhibitor venetoclax (ABT-199) produced a high response rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) with the 17p ...
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the first-line treatment of patients with advanced non–small...
As reported in The Lancet Oncology, Moran et al developed a classifier of cancer type based on microarray DNA methylation signatures (EPICUP assay), which has showed promise in diagnosing cancers of an unknown primary. Study Details The tumor type classifier was developed in a training set of...
In a phase II trial reported in The Lancet Oncology by Anas Younes, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, treatment with the anti–PD-1 (programmed cell death protein 1) immune checkpoint inhibitor nivolumab (Opdivo) produced response in two-thirds of patients with...
Clinical trials focused on older adults with cancer were featured prominently at the 2016 ASCO Annual Meeting. There was a plenary session in glioblastoma, a clinical symposium on immunotherapy, and multiple educational lectures highlighting the growing literature and unique challenges in the...
In a phase III trial reported in The New England Journal of Medicine, Peter Johnson, MD, of the Cancer Research UK Centre, University of Southampton, and colleagues found similar efficacy with continued ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) vs omission of bleomycin (AVD) after...
Assessment of minimal residual disease was associated with improved prediction of outcome in responders, as well as complete responders, in patients with chronic lymphocytic leukemia (CLL) who respond to treatment. Kovacs et al reported these findings, which are based on an analysis of two phase...
In a phase III trial (EURAMOS-1) reported in The Lancet Oncology, Marina et al found no improvement in event-free survival by adding postoperative ifosfamide/etoposide to cisplatin, doxorubicin, and methotrexate in patients with newly diagnosed high-grade osteosarcoma who responded poorly to...
The number of docetaxel cycles completed was associated with improved overall survival among men with metastatic castration-resistant prostate cancer receiving docetaxel, prednisone, and lenalidomide (Revlimid; DPL) or docetaxel/prednisone (DP), in the phase III Mainsail trial. de Morrée et...
For at least the past quarter of a century, radiobiologists and radiation oncologists have debated the role of hypofractionation (fewer total fractions with a higher dose per fraction) for prostate cancer. The debate stems from the unique radiobiology of prostate cancer and the best means to...
In June 2016, the European Hematology Association Congress convened in Copenhagen, Denmark. The educational and scientific program highlighted state-of-the-art clinical practice and the latest findings in hematology research. The ASCO Post brings its readers brief summaries of some of the important ...
Outcomes for adults with high-grade and aggressive non-Hodgkin lymphomas (NHLs) appear to be better when these patients are treated with pediatric-inspired protocols, according to Mitchell S. Cairo, MD, Chief of the Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Maria...
On August 2, 2016, PharmaMar announced the start of a pivotal phase III ATLANTIS study evaluating the efficacy and safety of lurbinectedin (PM1183), a novel synthetic tetrahydroisoquinoline that targets active transcription. The study is evaluating lurbinectedin combined with doxorubicin vs...
In an analysis reported in the Journal of Clinical Oncology, Press et al found notable discrepancies between recent ASCO–College of American Pathologists (ASCO-CAP) changes in the recommendations for evaluation of HER2 amplification by fluorescent in situ hybridization (FISH) and FISH scores...
In a post hoc analysis of the German phase III FIRE-3 trial reported in The Lancet Oncology, Stintzing et al found that first-line FOLFIRI (fluorouracil, leucovorin, irinotecan) plus cetuximab (Erbitux) was associated with improved overall survival vs FOLFIRI plus bevacizumab (Avastin) in an...
In a Chinese phase III trial reported in The Lancet, Zhang et al found that gemcitabine/cisplatin improved progression-free survival vs fluorouracil/cisplatin in patients with recurrent or metastatic nasopharyngeal carcinoma. Study Details In the open-label trial, 362 patients from 22 sites in...
Approximately 20% of patients with follicular lymphoma will relapse within 2 years of diagnosis. Although the optimal management of these patients has not been established, clinicians may be guided by data from recent clinical trials, according to Nathan H. Fowler, MD, Associate Professor and...
Two recent European phase III trials with different study designs focused on hypofractionated vs conventional radiotherapy in localized prostate cancer. Investigators in the CHHiP trial1 showed that the hypofractionated approach is noninferior to standard fractionation, with no increase in side...
In a pooled analysis reported in the Journal of Clinical Oncology, Meignan et al found that higher baseline total metabolic tumor volume measured by 18F-fluorodeoxyglucose (18F-FDG) positron-emission tomography–computed tomography (FDG PET-CT) was associated with poorer outcome in patients...
Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia...
In the phase III CASTOR trial reported in The New England Journal of Medicine, Palumbo et al found that adding the anti-CD38 antibody daratumumab (Darzalex) to bortezomib (Velcade) and dexamethasone markedly improved progression-free survival among patients with relapsed or relapsed and refractory...
In a phase III trial (MINDACT) reported in The New England Journal of Medicine, Cardoso et al found that adjuvant chemotherapy may be avoidable in women with early-stage breast cancer who are at high clinical risk but low genomic risk as determined by the 70-gene signature assay (MammaPrint)....
Radiation for prostate cancer typically requires 40 to 45 daily treatments, given over 8 to 9 weeks. Long fractionation schemes are chosen for most cancers, because they allow for tumor killing while reducing the potential for injury to normal tissue. However, the radiobiology of prostate cancer...
In a phase III noninferiority trial (NRG Oncology RTOG 0415) reported in the Journal of Clinical Oncology, W. Robert Lee, MD, MS, Med, of Duke University Medical Center, and colleagues found that hypofractionated radiotherapy was not inferior to conventional radiotherapy in disease-free survival...
The U.S. Food and Drug Administration (FDA) has approved an extended-release version of granisetron (Sustol) for the prevention of chemotherapy-induced nausea and vomiting, according to a news release by Heron Therapeutics, the drug’s manufacturer. Granisetron is an extended-release, injectable...
As reported in The Lancet Oncology by Zielinski et al, the final results of the phase III TURANDOT trial showed that overall survival with first-line bevacizumab (Avastin)/capecitabine was noninferior vs bevacizumab/paclitaxel in per-protocol analysis among patients with advanced HER2-negative...
The Cancer Moonshot initiative is bringing together scientists, oncologists, patient advocates, and representatives of the biopharmaceutical industry with renewed collaborative focus and the ambitious objective of consolidating 10 years of cancer research in 5 years. Achieving this outcome will...
In a phase III trial reported in The New England Journal of Medicine, Hagop M. Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that treatment with the antibody-drug conjugate inotuzumab ozogamicin resulted in a greater complete remission rate and improved ...
In a phase III trial (CALGB 40503/Alliance) reported in the Journal of Clinical Oncology, Maura N. Dickler, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that the addition of bevacizumab (Avastin) to first-line endocrine therapy with letrozole improved progression-free...
After several dose-finding phase I and II studies in a variety of B-cell malignancies, the potential clinical role of the newer anti-CD20 monoclonal antibody obinutuzumab (Gazyva) remained unclear. These early trials tested low and high doses as well as weekly and every-3-week schedules of...
In the phase III GADOLIN trial reported in The Lancet Oncology, Laurie H. Sehn, MD, Chair, British Columbia Cancer Agency Lymphoma Tumor Group, and Clinical Associate Professor at the University of British Columbia, Vancouver, and colleagues, found that adding the anti-CD20 antibody obinutuzumab...
For diffuse large B-cell lymphoma, does the dose of rituximab (Rituxan) matter? Are there patient characteristics that determine outcomes as well as the optimal dose? These questions were explored at the 2016 Pan Pacific Lymphoma Conference by Matthew A. Lunning, DO, Assistant Professor of...
As reported by Alexi A. Wright, MD, MPH, of Dana-Farber Cancer Institute, and colleagues in the Journal of Clinical Oncology, ASCO and the Society of Gynecologic Oncology (SGO) have released a clinical practice guideline on neoadjuvant therapy for patients with newly diagnosed stage IIIC or IV...
ASCO has published an adaptation of the 2015 Cancer Care Ontario (CCO) clinical practice guideline on adjuvant chemotherapy for early-stage breast cancer.1 There were several areas of controversy that the guideline attempts to address. Should Anthracyclines Be Standard of Care? The guideline...
As reported in the Journal of Clinical Oncology by Neelima Denduluri, MD, and colleagues, ASCO has adapted a Cancer Care Ontario (CCO) clinical practice guideline on selection of optimal adjuvant chemotherapy for HER2-negative and adjuvant targeted therapy for HER2-positive breast cancer.1 The...
In patients with relapsed/refractory acute lymphoblastic leukemia (ALL), the antibody-drug conjugate inotuzumab ozogamicin produced significantly more complete remissions and was a better bridge to transplant than treatment by physician’s choice, according to the final results of a phase III trial...
As reported by Ascierto et al in The Lancet Oncology, longer-term follow-up in the pivotal phase III coBRIM trial confirmed the benefit of adding cobimetinib to vemurafenib (Zelboraf) in first-line treatment of BRAF V600–mutant unresectable stage IIIC or IV melanoma. Study Details In the...
Robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy yielded similar domain-specific quality-of-life or pathologic outcomes at 12 weeks in men with newly diagnosed, clinically localized prostate cancer, according to the results of a randomized phase III trial reported ...
Heron Therapeutics, Inc, announced on August 10, 2016, that the U.S. Food and Drug Administration (FDA) has approved granisetron (Sustol) extended-release injection. Granisetron is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention ...
In a phase III noninferiority trial (NRG Oncology RTOG 0415) reported by Lee et al in the Journal of Clinical Oncology, W. Robert Lee, MD, MS, Med, of Duke University Medical Center, and colleagues found that hypofractionated radiotherapy was not inferior to conventional hypofractionated...
Bristol-Myers Squibb Company announced last week that CheckMate-026, a phase III trial investigating the use of nivolumab (Opdivo) as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non–small cell lung cancer (NSCLC)...
According to the European phase III PENELOPE trial reported in the Journal of Clinical Oncology, Christian Kurzeder, MD, of Kliniken Essen-Mitte, Essen, Germany, et al found that adding pertuzumab (Perjeta) to investigator’s choice chemotherapy did not improve progression-free survival in women...
Patients with previously treated advanced renal cell carcinoma receiving nivolumab (Opdivo) in the phase III CheckMate 025 trial had improved health-related quality of life compared with those receiving everolimus (Afinitor), as reported by David Cella, PhD, of Northwestern University, Chicago, et...
As reported by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, et al in The Lancet Oncology, the final results of the phase III METEOR trial indicate significantly improved overall survival with cabozantinib (Cabometyx) vs everolimus (Afinitor) in patients with advanced renal cell carcinoma...
The U.S. Food and Drug Administration (FDA) approved Epclusa (sofosbuvir at 400 mg/velpatasvir at 100 mg) on June 28, 2016, to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis (decompensated cirrhosis),...