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Showing 7001 - 7050Clinical Trials Actively Recruiting Patients With Acute Lymphoblastic Leukemia
Phase I Study Title: Phase Ib Study of Nivolumab and Dasatinib in Patients With Relapsed/Refractory Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Study Type: Phase I/interventional/single-group assignment Study Sponsor and Collaborators: Northwestern University, National...
Breaking the ‘Conspiracy of Silence’
A new study1 showing that just 1 in 20 terminally ill patients with cancer has sufficient understanding about the prognosis or purpose of treatment is highlighting the need for improvements in both the way oncologists communicate prognosis with their patients and in the development of educational...
Why Patients’ Understanding of Their Prognosis Often Differs From Their Oncologists’
A recent study1 published in the Journal of Clinical Oncology (see “Breaking the ‘Conspiracy of Silence’” in this issue of The ASCO Post) found that just 1 in 20 patients with advanced, incurable cancer has sufficient understanding of his or her prognosis or life expectancy. Now, another new study ...
I-SPY 2: Separating Contenders From Pretenders in Breast Cancer
With the expansion of our understanding of signaling pathways in normal cells and how they are co-opted or corrupted in malignancy, the number of potential antitumor agents to be tested has exploded, exposing the limitations of traditional antineoplastic drug development and challenging us to...
Comparison of Second-Line Treatments in Advanced Pancreatic Cancer After Gemcitabine-Based Chemotherapy
In the Canadian phase III PANCREOX trial reported in the Journal of Clinical Oncology, Gill et al found no benefit of modified FOLFOX6 (infusional fluorouracil [5-FU], leucovorin, and oxaliplatin) vs infusional 5-FU/leucovorin as second-line treatment in patients with advanced pancreatic cancer who ...
Neoadjuvant Veliparib/Carboplatin and Neratinib ‘Graduate’ From Adaptive Randomization I-SPY 2 Trial in Early Breast Cancer
As reported by Hope S. Rugo, MD, and John W. Park, MD, both of the University of California, San Francisco, and colleagues in The New England Journal of Medicine, the multiarm adaptive randomization phase II I-SPY 2 trial has shown that the addition of veliparib/carboplatin and the addition of...
FDA Grants Priority Review to Pembrolizumab Supplemental Biologics License Application for First-Line Treatment of Advanced NSCLC
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 cell lung cancer...
Lung Cancer Specialist Shares Clinical Pearls for Managing Stage IIIA Non–Small Cell Lung Cancer
Clinicians face a number of questions in evaluating and treating patients with stage IIIA non–small cell lung cancer (NSCLC). One expert in the field, Rafael Santana-Davila, MD, reviewed key issues in managing this disease in the Journal of Oncology Practice (JOP). The ASCO Post asked Dr....
Continuation of Docetaxel May Improve Survival in Metastatic Castration-Resistant Prostate Cancer
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) or docetaxel/prednisone, in the phase III Mainsail trial. de Morrée et al reported this ...
FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL
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 (CLL). The application, which...
Everolimus in Advanced HER2-Positive Breast Cancer With PIK3CA Mutation, PTEN Loss, or Hyperactive PI3K Pathway
In an analysis of the phase III BOLERO-1 and -3 trials reported in the Journal of Clinical Oncology, Fabrice André, MD, of Institut Gustav-Roussy, Paris, France, and colleagues found that the addition of everolimus (Afinitor) to trastuzumab (Herceptin) and chemotherapy was associated with a...
Novel Agents on the Horizon in Lymphoma
Attendees at the 2016 Pan Pacific Lymphoma Conference held July 18–22 in Koloa, Hawaii, got a peek at early data for a number of novel agents in the treatment of various lymphoma subtypes. The ASCO Post captured these findings. Denintuzumab Mafodotin in Diffuse Large B-Cell Lymphoma Denintuzumab...
Reducing Drug Costs by Increasing Science-Driven Drug Discovery
For several years now, the American health-care system has been undergoing a transformation. Innovative ideas are being explored, new systems continue to be created, and millions of lives have been impacted. As health-care providers and research engines, academic institutions have an opportunity...
Immune Checkpoint Inhibitors March to First-Line Treatment in Advanced NSCLC
For the majority of patients who are diagnosed with advanced-stage non–small cell lung cancer (NSCLC), platinum-based doublets have been the standard of care for over 30 years. Recently, the immune checkpoint inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) demonstrated superior survival ...
‘Encouraging Survival Outcomes’ Reported With Combined Nivolumab and Ipilimumab in Advanced Melanoma
Hodi et al found “encouraging survival outcomes” with the addition of nivolumab to ipilimumab in patients with previously untreated unresectable stage III or IV melanoma, according to 2-year overall survival data in the phase II CheckMate 069 trial. These results were reported in The...
Overall Survival With Everolimus in Advanced Pancreatic Neuroendocrine Tumors in the RADIANT-3 Trial
As reported by Yao et al in the Journal of Clinical Oncology, the final overall survival analysis from the phase III RADIANT-3 trial showed a median survival of 44.0 months among patients with advanced pancreatic neuroendocrine tumors initially randomized to receive everolimus (Afinitor, Zortress)...
Joint Presence of Metabolic Syndrome and Obesity Seems to Be Associated With Poorer Survival in Early-Stage Colorectal Cancer
In a study in Kaiser Permanante patients reported in the Journal of Clinical Oncology, Cespedes Feliciano et al found that the joint presence of obesity and metabolic syndrome in those with early-stage colorectal cancer was associated with poorer overall and colorectal cancer–specific...
Decline in Circulating Tumor Cell Count and Treatment Outcome in Advanced Prostate Cancer
A drop in the number of cancer cells detected in a patient’s blood could be the best indicator yet as to whether treatment for prostate cancer is working. A new study, published by Lorente et al in European Urology, shows that a 30% decline in a patient’s numbers of circulating tumor...
Improved Quality of Life Reported With Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed Multiple Myeloma
As reported in the Journal of Clinical Oncology, Stewart et al found that treatment with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) was associated with improved health-related quality of life vs lenalidomide/dexamethasone (Rd) in relapsed multiple myeloma in the phase...
Little Benefit Reported With WBRT in NSCLC Patients With Brain Metastases Unsuitable for Resection or Stereotactic Radiotherapy
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...
Limited Access to Radioimmunotherapy in the Community Setting May Lead to Extinction of a Unique Lymphoma Treatment
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...
Regorafenib Increases Progression-Free Survival in Advanced Gastric Cancer
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...
Cyclophosphamide/Methotrexate Maintenance Shows No Benefit in Hormone Receptor–Negative Breast Cancer, but Subgroup May Benefit
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 ...
Study Suggests Benefit of Adjuvant Radiation Therapy but Not Chemotherapy in Some Patients With Merkel Cell Carcinoma
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...
Venetoclax Produces High Response Rate in Relapsed or Refractory CLL With 17p Deletion
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 ...
FDA Grants Priority Review to Pembrolizumab for First-Line Treatment of Advanced NSCLC
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...
DNA Methylation Assay May Improve Diagnosis of Cancer of an Unknown Primary
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...
Nivolumab Achieves Response in Most Patients With Classical Hodgkin Lymphoma After ASCT and Brentuximab Vedotin
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...
ASCO 2016: Geriatric Oncology Highlights
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...
Continued ABVD vs Omission of Bleomycin (AVD) After Negative Imaging Findings in Advanced Hodgkin Lymphoma
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...
Study Finds Minimal Residual Disease Assessment Improves Prediction of Outcome in CLL Responders
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...
Does Intensified Postoperative Chemotherapy for High-Grade Osteosarcoma Benefit Poor Responders to Preoperative Therapy?
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...
Continuation of Docetaxel May Improve Survival in Metastatic Castration-Resistant Prostate Cancer
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...
Hypofractionated Radiotherapy for Localized Prostate Cancer: A New Standard of Care?
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...
Roundup of Selected Abstracts in Multiple Myeloma, Acute and Chronic Leukemia, and Advanced Lymphoma
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 ...
For High-Grade and Aggressive Non-Hodgkin Lymphomas, Treat Adults Like Children
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...
Phase III Study Launches in Patients With Small Cell Lung Cancer
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...
Discrepancies Between Current ASCO-CAP Guidelines on HER2 Amplification Testing and Designations in BCIRG Trials
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...
Better Overall Survival Reported With FOLFIRI Plus Cetuximab vs Plus Bevacizumab in RAS Wild-Type Metastatic Colorectal Cancer
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...
Study Finds Gemcitabine/Cisplatin Improved Outcome vs Fluorouracil/Cisplatin in Recurrent or Metastatic Nasopharyngeal Carcinoma
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...
Early Relapse in Follicular Lymphoma: Clinical Trial Data May Guide Management Decisions
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...
European Studies Compare Conventional vs Hypofractionated Radiotherapy for Localized Prostate Cancer
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...
Higher Baseline Metabolic Tumor Volume May Predict Poorer Outcome in Patients With High Tumor Burden Follicular Lymphoma
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...
FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL
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...
Adding Daratumumab to Bortezomib/Dexamethasone Improves Progression-Free Survival in Relapsed/Refractory Multiple Myeloma
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...
Study Finds Chemotherapy May Be Avoidable in Women With Early Breast Cancer at High Clinical but Low Genomic Risk on 70-Gene Signature Assay
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)....
Hypofractionated Radiotherapy: Balancing Benefits vs Risks in Men With Localized Prostate Cancer
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...
Hypofractionated Radiotherapy Not Inferior to Conventional Radiotherapy in Low-Risk 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...
FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
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...
Overall Survival With Bevacizumab/Capecitabine Noninferior vs Bevacizumab/Paclitaxel in HER2-Negative Breast Cancer
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...
