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Showing 6851 - 6900Phase III Trial Finds No Survival Benefit of Adding Ipilimumab to Etoposide/Platinum in Extensive-Stage SCLC
The addition of the anti–CTLA-4 (cytotoxic T-lymphocyte–associated protein 4) checkpoint inhibitor ipilimumab (Yervoy) to etoposide/platinum did not improve overall survival in the first-line treatment of patients with extensive-stage small cell lung cancer (SCLC), according to a phase...
Actively Recruiting Clinical Trials Focused on the Role of Obesity in Cancer
Study Title: A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors Study Type: Pilot/interventional/single-group assignment Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute Purpose: To study whether the...
Ribociclib Receives FDA Breakthrough Therapy Designation for Treatment of Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ribociclib in combination with letrozole for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib...
Is Post-Transplantation Cyclophosphamide Disruptive Technology?
There was a time when transplantation across human leukocyte antigen (HLA) barriers was fraught with so much difficulty that many thought it was impossible and we should stop trying. However, most patients do not have an HLA-matched sibling donor, and death was therefore certain if they had a...
Reduced-Intensity Related-Donor Haploidentical vs HLA-Matched Sibling-Donor Hematopoietic Cell Transplantation in Lymphoma
In an analysis of the observational database of the Center for International Blood and Marrow Transplant Research reported in the Journal of Clinical Oncology, Nilanjan Ghosh, MD, PhD, of Levine Cancer Institute, Carolinas Healthcare System, Charlotte, North Carolina, and colleagues found that...
The Complexities of Care for Older Cancer Survivors
Integrated care, a focus on prevention and screening, and acknowledgment of comorbidities on the impact of treatment all play a critical role in the cancer survivorship of older patients, according to Martine Extermann, MD, PhD, a medical oncologist at Moffitt Cancer Center in Tampa, Florida....
More Focus Needed on Chemotherapy-Induced Nausea as a Cluster of Symptoms
Management of chemotherapy-induced vomiting has improved with the use of antiemetics, but chemotherapy-induced nausea remains a major clinical problem, according to Alex Molassiotis, RN, PhD, Professor and Head of the School of Nursing at The Hong Kong Polytechnic University. And, he added, the...
Anti–Interleukin-1 Alpha Antibody MABp1 Improves Outcomes Significantly Over Placebo in Advanced Colorectal Cancer
A novel anti–interleukin-1 alpha (IL-1α) antibody has shown a significant impact on symptoms and a high level of safety and tolerability in patients with advanced colorectal cancer, according to phase III data presented by Hickish et al at the European Society for Medical Oncology’s 18th World...
Chemoradiotherapy After Surgery for Gastric Cancer Shows Similar Outcomes to Postoperative Chemotherapy
Postoperative treatment intensification with chemoradiotherapy does not achieve better outcomes when compared with postoperative chemotherapy in patients with gastric cancer who have already undergone preoperative chemotherapy, according to phase III data presented by Marcel Verheij, MD, PhD, et...
Phase III RESORCE Study Data Show Regorafenib Improves Overall Survival in Previously Treated Patients With Unresectable Liver Cancer
Results from the phase III RESORCE trial show that regorafenib (Stivarga) tablets achieved a median overall survival improvement in patients with unresectable hepatocellular carcinoma that progressed after treatment with sorafenib (Nexavar) tablets. The study, presented by Jordi Bruix, MD, et al...
Anti–PD-L1 Immunotherapy Shows Response in Microsatellite-Stable Metastatic Colorectal Cancer in Combination With MEK Inhibition
Anti–PD-L1 (programmed death ligand 1) immunotherapy may achieve a response in patients with microsatellite-stable metastatic colorectal cancer if combined with a MEK inhibitor, according to phase I data presented at the European Society for Medical Oncology (ESMO) 18th World Congress on...
Neoadjuvant Veliparib/Carboplatin and Neratinib ‘Graduate’ From Adaptive Randomization I-SPY 2 Trial in Early Breast Cancer
As reported by Rugo et al and Park et al in The New England Journal of Medicine, the adaptive randomization phase II I-SPY 2 trial has shown that the addition of veliparib/carboplatin and the addition of neratinib to standard neoadjuvant therapy have met criteria predictive of success in a phase...
Expert Point of View: W. Robert Lee, MD
Formal discussant W. Robert Lee, MD, of Duke University School of Medicine, Durham, North Carolina, placed himself firmly in the camp supporting hypofractionation as a new standard of care. “We now have three large noninferiority trials with different eligibility criteria and different regimens....
ASCO Plenary Studies: Assessing the ‘Value’ of New Treatments
At the 2016 ASCO Annual Meeting, studies presented at the Plenary Session gave attendees new treatment strategies to employ back home. But in the emerging push to contain the cost of new cancer treatments, do the four interventions fit within the new “value framework” for oncology? Deborah Schrag, ...
No Improvement in Outcome Reported With Longer Wait Between Radiochemotherapy and Surgery in Rectal Cancer
Pathologic complete response rate was not improved by increasing the interval between neoadjuvant chemoradiotherapy and surgery from 7 to 11 weeks in patients with rectal cancer, according to the French phase III GRECCAR-6 trial reported by Lefevre et al in the Journal of Clinical Oncology. In...
Is Nivolumab Active in Classical Hodgkin Lymphoma After Failure of Autologous SCT and Brentuximab Vedotin?
Treatment with the anti–PD-1 (programmed cell death protein 1) immune checkpoint inhibitor nivolumab (Opdivo) produced response in two-thirds of patients with classical Hodgkin lymphoma after failure of both autologous stem cell transplantation (SCT) and brentuximab vedotin (Adcetris),...
Poorer Outcome in Favorable-Histology Wilms Tumor Associated With Chromosome 1q Gain Reported in U.S. Study
The Children’s Oncology Group found that chromosome 1q gain is associated with poorer event-free and overall survival in patients with favorable-histology Wilms tumor. Gratias et al reported these findings in the Journal of Clinical Oncology. Study Details The study involved analysis of...
FDA Grants Breakthrough Therapy Designation for Daratumumab in Combination With Standard of Care for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the immunotherapy daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have ...
Gene-Expression Signature Assay Identifies High-Risk Stage II Colon Cancer
In an analysis reported in the Journal of Clinical Oncology, Niedzwiecki et al found that the ColDx gene-expression signature assay identified high-risk stage II colon cancer among patients in the phase III Alliance C9581 trial. This assay has been shown to be independently prognostic for...
Olanzapine Combination Reduces Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy
In a phase III trial reported by Navari et al in The New England Journal of Medicine, the addition of the antipsychotic agent olanzapine vs placebo to dexamethasone, aprepitant, or fosaprepitant, and a 5-hydroxytryptamine type 3–receptor antagonist reduced nausea and improved antiemetic...
Clinical Trials Actively Recruiting Patients With Acute Myeloid Leukemia
Phase I/II Study Title: A Phase I-II Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First-Relapse AML Study Type: Phase I/II/interventional/parallel assignment Study Sponsor and Collaborators: Yale University,...
Mindfulness-Based Stress-Reduction Program May Reduce Psychological and Physical Symptoms in Breast Cancer Survivors
A mindfulness-based stress-reduction program for breast cancer survivors was associated with psychological and physical symptom benefits during and at 6 weeks after intervention, according to a randomized trial reported in the Journal of Clinical Oncology by Cecile A. Lengacher, RN, PhD, of the...
New ASTRO Clinical Practice Statement Updates Treatment Standard for Rectal Cancer
The American Society for Radiation Oncology (ASTRO) recently issued a new clinical practice statement, “Appropriate Customization of Radiation Therapy for Stage II and III Rectal Cancer: An ASTRO Clinical Practice Statement Using the RAND/UCLA Appropriateness Method.” An executive...
ASCO 2016 Guidelines for the Treatment of Pancreatic Cancer: Why Another Guideline?
The 5-year survival rate of those diagnosed with pancreatic cancer remains stubbornly fixed around 5%. Even in the 20% of cases in which surgical resection is undertaken for curative intent, the 5-year survival rate after surgery is 20% to 30%. As we make progress in other cancers with decreasing...
Can Self-Administered Acupressure Reduce Fatigue in Breast Cancer Survivors?
Self-administered relaxing acupressure and stimulating acupressure were both associated with reduced persistent fatigue vs usual care in breast cancer survivors, according to a randomized clinical trial reported by Zick et al in JAMA Oncology. However, only relaxing acupressure had significant...
Road to Successful Use of Real-World Evidence for Drug Development Is Long and Rocky
Friends of Cancer Research (Friends) has been a leader in the push for better and faster cancer drug development. Now it is tackling the use of real-world evidence in clinical trials. This is the report of a meeting on the subject that took place on June 16 in Washington, DC.1 Real-world evidence...
Quick Takes on Promising New Approaches to Treating Breast Cancer
At the 2016 ASCO Annual Meeting, researchers reported encouraging results for several new drugs and treatment strategies for breast cancer. The ASCO Post brings you brief summaries of a select few. Abemaciclib Trial The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib produced responses...
Selected Hematology Abstracts From the 2016 ASCO Annual Meeting
Here are several abstracts selected from the proceedings of the 2016 ASCO Annual Meeting, focusing on clinical trials on therapeutics in different types of leukemia, multiple myeloma, follicular lymphoma, and central nervous system (CNS) lymphoma. For full details of these study abstracts, visit...
App Triggers Earlier Detection of Relapse, May Help Improve Survival of Patients With Lung Cancer
Web-based applications have invaded mainstream culture and grabbed the attention of multitudes of people around the world. According to a study presented at the 2016 ASCO Annual Meeting, an app may also contribute to extending the lives of people with cancer and, at the same time, reduce...
Expert Point of View: Sunil Verma, MD
Sunil Verma, MD, Professor and Head of the Department of Oncology and Medical Director of the Tom Baker Cancer Centre of the University of Calgary in Canada, was the study’s formal discussant. He cited several limitations of the study: It was an open-label study, was initially a phase II study but ...
PHEREXA: Benefit for Second-Line Pertuzumab Questionable
In the second-line metastatic breast cancer setting, the addition of pertuzumab (Perjeta) to trastuzumab (Herceptin)/capecitabine did not significantly improve progression-free survival, results of the phase III PHEREXA trial showed.1 This is the first randomized trial to evaluate the efficacy of ...
Studies Suggest Bright Future for Combination Immunotherapy in Advanced Melanoma, but Questions Remain
Two studies presented at the 2016 ASCO Annual Meeting focused on the use of combination immunotherapy in the treatment of patients with advanced melanoma. Updated results from the phase III CheckMate 067 trial centered on the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) compared...
CMS Proposal for Part B Drug Payment: A Poorly Conceived Experiment
On March 11, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule in the Federal Register to test a change in reimbursement for Part B drugs.1 The first phase involves changing the 6% add-on to the average sales price (ASP) used to make drug payments under Part B to...
CNS-IPI for CNS Relapse in Diffuse Large B-Cell Lymphoma
As reported in the Journal of Clinical Oncology, Schmitz et al have developed and validated a risk score for CNS relapse—the Central Nervous System International Prognostic Index (CNS-IPI)—in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP (rituximab [Rituxan]...
No Survival Benefit for Cabozantinib Reported in Previously Treated Metastatic Castration-Resistant Prostate Cancer
Smith et al found no improvement in overall survival with cabozantinib (Cometriq) vs prednisone in patients with previously treated metastatic castration-resistant prostate cancer, in the phase III COMET-1 trial reported in the Journal of Clinical Oncology. Cabozantinib, which inhibits MET, VEGF...
Results of Two Practice-Changing Breast Cancer Trials Upheld
Results of two pivotal breast cancer trials reported at the 2016 ASCO Annual Meeting confirmed the practice-changing findings that resulted from earlier findings. PALOMA-2 The phase III PALOMA-2 trial confirmed results from the smaller, open-label phase II PALOMA-1 trial that led to the U.S. Food...
Patient-Oncologist Difference of Opinion About Advanced Cancer Prognosis Is Common, Study Shows
Misunderstandings about prognosis between patients with advanced cancer and their doctors was common, according to a study by Gramling et al in JAMA Oncology—and the vast majority of patients didn't know that their doctors held different opinions about how long they might live. “We've...
Long-Term Benefit of Lenalidomide/Dexamethasone Reported in High-Risk Smoldering Multiple Myeloma
As reported by Mateos et al in The Lancet Oncology, long-term follow-up in the phase III QuiRedex trial indicates continued benefit of lenalidomide (Revlimid)/dexamethasone vs observation in preventing disease progression in patients with high-risk smoldering multiple myeloma. Study Details In...
World GI 2016: Anti–Interleukin-1 Alpha Antibody MABp1 Improves Outcomes Significantly Over Placebo in Advanced Colorectal Cancer
A novel anti–interleukin-1 alpha antibody has shown a significant impact on symptoms and a high level of safety and tolerability in patients with advanced colorectal cancer, according to phase III data presented by Hickish et al at ESMO’s 18th World Congress on Gastrointestinal Cancer...
World GI 2016: Chemoradiotherapy After Surgery for Gastric Cancer Shows Similar Outcomes to Postoperative Chemotherapy
Postoperative treatment intensification with chemoradiotherapy does not achieve better outcomes compared to postoperative chemotherapy in patients with gastric cancer who have already undergone preoperative chemotherapy, according to phase III data presented by Verheij et al at the ESMO 18th World...
World GI 2016: Anti–PD-L1 Immunotherapy Combined With MEK Inhibition Shows Response in Microsatellite-Stable Metastatic Colorectal Cancer
Anti–PD-L1 (programmed cell death ligand 1) immunotherapy may achieve a response in patients with microsatellite-stable metastatic colorectal cancer if combined with a MEK inhibitor, according to phase I data presented at the European Society for Medical Oncology (ESMO) 18th World Congress on ...
World GI 2016: Phase III RESORCE Study Data Show Regorafenib Improves Overall Survival in Previously Treated Patients With Unresectable Liver Cancer
Results from the phase III RESORCE trial show that regorafenib (Stivarga) tablets achieved a median overall survival improvement in patients with unresectable hepatocellular carcinoma (HCC) that progressed after treatment with sorafenib (Nexavar) tablets. The study, presented by Bruix et al during...
Updated Outcomes and Impact of Age in FIRST Trial in Multiple Myeloma
As reported by Hulin et al in the Journal of Clinical Oncology, the updated findings in the phase III FIRST trial continue to show improved progression-free and overall survival with continuous lenalidomide (Revlimid) plus low-dose dexamethasone (Rd) vs melphalan, prednisone, and thalidomide (MPT)...
Mixed Results With Hypofractionated vs Conventional Radiotherapy for Localized Prostate Cancer
Investigators of two European phase III trials have reached different conclusions on whether hypofractionated radiotherapy should replace conventional radiotherapy as a new standard of treatment in localized prostate cancer. The CHHiP trial findings favoring hypofractionation were reported by David ...
Neoadjuvant Chemotherapy May Render Advanced Ovarian Cancers Responsive to Immunotherapy
Although most patients with advanced ovarian cancer initially respond to platinum-based chemotherapy, they usually relapse. According to a study by Frances R. Balkwill, PhD, Professor of Cancer Biology at Barts Cancer Institute, Queen Mary University of London, United Kingdom, and colleagues...
Erika P. Hamilton, MD, Named Director of Breast and Gynecologic Cancer Research
Sarah Cannon has announced the promotion of Erika P. Hamilton, MD, to Director of the institution’s Breast and Gynecologic Cancer Research Program. Over the past 3 years, Dr. Hamilton has been instrumental in the growth and success of the program. “Erika has quickly become a recognized thought...
Complexities in the Diagnosis and Management of Amyloidosis
Question 1: What is the next best step for this patient? Correct Answer: C. Determination of amyloid subtype. Expert Perspective Amyloidosis encompasses a heterogeneous group of diseases bound by the characteristic deposition of amyloid fibrils in soft tissues and bone marrow, and it could be...
Routine Prophylactic vs Deferred Radiotherapy for Procedure-Tract Metastases in Malignant Pleural Mesothelioma
Prophylactic radiotherapy after surgery and large-bore pleural procedures did not result in significant reduction in the incidence of procedure-tract metastases in malignant pleural mesothelioma, according to the UK phase III SMART trial reported by Clive et al in The Lancet Oncology. Study...
Comparison of Chemotherapy Regimens After Negative Interim PET-CT in Advanced Hodgkin Lymphoma
In a phase III trial reported in The New England Journal of Medicine, Johnson et al found similar efficacy with continued ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) chemotherapy vs omission of bleomycin (AVD) after negative interim PET-CT (positron-emission tomography–computed...
Clinical Trials Actively Recruiting Patients With Cardiotoxicity Resulting From Treatment
Observational Study Title: Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors Study Type: Observational Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center Purpose: To study whether strain and...
