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Showing 6001 - 6050Carfilzomib May Be a Strong Candidate for Salvage Therapy in Relapsed/Refractory Multiple Myeloma—but Questions Remain
WITH THE INCLUSION of proteasome inhibitors and immunomodulatory agents first into salvage and then as components of first-line, consolidation, and maintenance regimens, response rates, depth of response, and median progression-free and overall survival have all improved for patients suffering...
Carfilzomib Improves Overall Survival vs Bortezomib in Relapsed/Refractory Multiple Myeloma
AT A PRESPECIFIED interim analysis, the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, as reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian...
Regional Radiation Therapy Reduces Risk of Regional Recurrence in Node-Positive Cutaneous Melanoma
IN A LARGE single-institution study reported in the Journal of the National Comprehensive Cancer Network, Tobin Strom, MD, and colleagues found that regional radiotherapy was associated with a reduced risk of regional recurrence in patients with node-positive cutaneous melanoma, including those...
No Progression-Free Survival Benefit With First-Line Nivolumab vs Chemotherapy in Advanced PD-L1–Positive NSCLC
AS REPORTED BY David P. Carbone, MD, PhD, of The Ohio State University Comprehensive Cancer Center, Columbus, and colleagues in The New England Journal of Medicine, the phase III CheckMate 026 trial has shown no progression-free survival benefit for first-line nivolumab (Opdivo) vs platinum-based...
Phase III Trial Shows No Survival Benefit to Adding First-Line Ipilimumab to Chemotherapy in Advanced Squamous NSCLC
IN A PHASE III trial reported by Ramaswamy Govindan, MD, of Washington University School of Medicine, and colleagues in the Journal of Clinical Oncology, the addition of first-line ipilimumab (Yervoy) to paclitaxel/carboplatin did not improve overall survival in patients with advanced squamous...
Nivolumab/Ipilimumab in Patients With Advanced Melanoma Who Did or Did Not Discontinue Induction Treatment due to Adverse Events
IN A RETROSPECTIVE pooled analysis of the CheckMate 069 and 067 studies reported in the Journal of Clinical Oncology, Dirk Schadendorf, MD, of the University Hospital Essen and the German Cancer Consortium, and colleagues found little difference in the efficacy of combined nivolumab (Opdivo) and...
Tremelimumab in Previously Treated Advanced Malignant Mesothelioma
In the randomized phase IIB DETERMINE trial, the cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) inhibitor tremelimumab did not improve overall survival vs placebo as second- or third-line treatment of relapsed malignant mesothelioma. These findings were reported in The Lancet Oncology by...
Nivolumab Treatment Beyond Disease Progression in Advanced Melanoma
In a retrospective analysis reported in JAMA Oncology, Georgina V. Long, MBBS, PhD, of the Melanoma Institute Australia, North Sydney, and colleagues found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response...
Expert Point of View: Markus Joerger, MD, PhD, and Domenica Lorusso, MD, PhD
PRESS CONFERENCE MODERATOR Markus Joerger, MD, PhD, of St. Gallen Cancer Center, Switzerland, indicated that prior to the current study, it was unclear whether chemotherapy followed by surgery would be superior to chemoradiotherapy. “I think we all agree that it has been confirmed as the standard...
Expert Point of View: Alexander Eggermont, MD, PhD
BASED ON THE RESULTS of COMBI-AD1 and CheckMate 238,2 invited discussant Alexander Eggermont, MD, PhD, Professor of Oncology at Gustave Roussy in Paris, commented: “It’s a good day for melanoma!” In COMBI-AD, treatment with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist)...
CheckMate 238: Nivolumab Shows Benefit as Adjuvant Melanoma Treatment
IN THE TREATMENT of malignant melanoma, immune checkpoint inhibitors are no longer just for metastatic disease, and the best type may be agents targeting the programmed cell death protein 1 (PD-1), according to results of CheckMate 238, presented at the European Society for Medical Oncology (ESMO)...
Adjuvant BRAF/MEK Inhibition Improves Survival in Resectable Melanoma
FOR PATIENTS with locally advanced, resectable melanoma harboring BRAF mutations, adjuvant treatment with BRAF/ MEK inhibition significantly improves overall survival, results of the COMBI-AD trial have shown. The study was presented at the European Society for Medical Oncology (ESMO) 2017...
Expert Point of View: Luis Paz-Ares, MD
FORMAL DISCUSSANT of the ALEX and ALUR trials, Luis Paz-Ares, MD, Professor of Medicine at the Hospital Universitario 12 de Octubre, Madrid, said that the ALEX trial is “good news” for patients. “Importantly, 40% had baseline metastases. Disease progression was nicely controlled with alectinib...
Alectinib Yields Favorable Results in Phase III Trials of ALK-Positive NSCLC
RESULTS OF TWO separate phase III trials confirm the activity of alectinib (Alecensa) in the central nervous system (CNS) in patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC). Results lend support for alectinib as the better first-line treatment option over...
Abiraterone or Docetaxel: Which Is Optimal for Hormone-Sensitive High-Risk Prostate Cancer?
ABIRATERONE ACETATE (Zytiga) plus prednisone and docetaxel have moved up from the castrate-resistant metastatic setting to earlier in the course of disease as treatment of high-risk hormone-sensitive prostate cancer in men who are initiating androgen-deprivation therapy, based on level 1 evidence...
Positive Early Data on Second-Line Ramucirumab/Docetaxel in Platinum-Refractory Advanced Urothelial Cancer
RAMUCIRUMAB (CYRAMZA) added to docetaxel improved progression-free survival and almost doubled the overall response rate compared with docetaxel alone in patients with advanced or metastatic urothelial cancer that has progressed on platinum-based chemotherapy. These results of the phase III RANGE...
Expert Point of View: Paul Harari, MD
COMMENTING ON THIS STUDY, ASTRO President Paul Harari, MD, was enthusiastic about the results. Dr. Harari is the Jack Fowler Professor and Chairman of the Department of Human Oncology at the University of Wisconsin School of Medicine and Public Health and Associate Director of the University of...
Cutting Radiation Exposure by 50% Appears Safe and Effective in HPV-Positive Head and Neck Cancer
AGGRESSIVE REDUCTION in radiation therapy appears to be a potential win-win situation for patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma, according to the results of a phase II trial presented at the 2017 Annual Meeting of the American Society for...
Expert Point of View: Brian G. Czito, MD, and Benjamin Movsas, MD
BRIAN G. CZITO, MD, a radiation oncologist at Duke Cancer Institute in Durham, North Carolina, commented on the study presented by Iyengar et al at the 2017 American Society for Radiation Oncology Annual Meeting. “This study of focal high-dose radiation in stage IV patients with limited...
Consolidative Radiation Therapy: New Paradigm for Limited Metastatic NSCLC?
ADDING CONSOLIDATIVE RADIATION therapy to maintenance chemotherapy had a robust effect on preventing disease progression compared with maintenance chemotherapy alone in patients with limited metastatic non–small cell lung cancer (NSCLC), according to a late-breaking study presented at the 2017...
IASLC 2017: First-Line Pembrolizumab Increases Overall Survival vs Chemotherapy in Metastatic NSCLC With High Levels of PD-L1
Updated overall survival findings from the phase III KEYNOTE-024 trial evaluating pembrolizumab (Keytruda) as a first-line monotherapy in patients with non–small cell lung cancer (NSCLC) whose tumors express high levels of programmed cell death ligand 1 (PD-L1) were presented at the...
IASLC 2017: Treatment Based on BRCA1 Level Does Not Increase Survival of Stage II/III NSCLC Node-Positive Resected Patients
New research shows that treating stage II and III non–small cell lung cancer (NSCLC) node-positive resected patients with customized chemotherapy based on their specific BRCA1 expression levels, as opposed to providing the standard treatment, did not increase overall survival rates among...
IASLC 2017: REVEL Trial Subgroup Analysis Further Clarifies Outcomes With Ramucirumab Plus Docetaxel in Advanced Non–Small Cell Lung Cancer
New subgroup analysis from the phase III REVEL trial of ramucirumab (Cyramza) in advanced non–small cell lung cancer (NSCLC) was presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan. Specifically, these...
PI3K Inhibition in Relapsed or Refractory Indolent Lymphoma
As reported in the Journal of Clinical Oncology by Dreyling et al, the phase II CHRONOS-1 trial has shown a high response rate and durable responses with the phosphatidylinositol 3-kinase (PI3K) inhibitor copanlisib (Aliqopa) in adults with relapsed or refractory indolent lymphoma who had received...
Immunotherapy for Previously Treated Advanced Gastric Cancer
In an Asian phase III trial (ONO-4538-12, ATTRACTION-2) reported in The Lancet, Kang et al found that nivolumab (Opdivo) produced an improvement in overall survival vs placebo in patients with advanced gastric or gastroesophageal junction cancer who had disease refractory to or who were intolerant...
FDA Grants Priority Review for Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma
On October 16, the U.S. Food and Drug Administration (FDA) determined the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted...
IASLC 2017: Combination of Lurbinectedin and Doxorubicin in Relapsed Small Cell Lung Cancer
The final efficacy and safety data obtained from a phase I/II trial combining lurbinectedin (PM1183) with doxorubicin in relapsed small cell lung cancer were presented during a Research Perspectives oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World...
Maintenance Therapy After ASCT in Younger Patients With Mantle Cell Lymphoma
In a French phase III trial, maintenance rituximab (Rituxan) improved event-free survival vs observation after autologous stem cell transplantation (ASCT) in younger patints with mantle cell lymphoma. These findings were reported by Le Gouill et al in The New England Journal of Medicine. Study...
Addition of EGFR Tyrosine Kinase Inhibitor to Chemotherapy in Resistant Non–Small Cell Lung Cancer
As reported by Mok et al in the Journal of Clinical Oncology, overall survival analysis of the phase III IMPRESS trial indicated a poorer outcome when adding gefitinib (Iressa) vs placebo to chemotherapy after disease progression on first-line gefitinib in epidermal growth factor receptor...
sNDA Submitted for Rucaparib as Maintenace Treatment for Patients With Platinum-Sensitive Recurrent Ovarian Cancer
On October 9, Clovis Oncology announced that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for rucaparib (Rubraca) as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer...
Results From the Phase III JUNIPER Trial Evaluating Abemaciclib in KRAS-Mutated, Advanced NSCLC
On October 10, Eli Lilly and Company announced that its phase III JUNIPER study evaluating abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non–small lung cancer (NSCLC) did not meet its primary endpoint of overall...
Osimertinib Granted Breakthrough Therapy Designation for First-Line Treatment of EGFR Mutation–Positive NSCLC
On October 9, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for osimertinib (Tagrisso) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung ...
Initial Treatment With CDK4/6 Inhibitor and Aromatase Inhibitor for Advanced Breast Cancer
As reported in the Journal of Clinical Oncology by Goetz et al, an interim analysis in the phase III MONARCH 3 trial has shown a significant progression-free survival benefit with the addition of the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio) to a nonsteroidal aromatase...
Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma
On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive ...
Nivolumab in Advanced DNA Mismatch Repair–Deficient or Microsatellite Instability–High Colorectal Cancer
THE PHASE II CHECKMATE 142 TRIAL has shown that nivolumab (Opdivo) produces durable responses in previously treated recurrent or metastatic DNA mismatch repair–deficient (dMMR)/ microsatellite instability–high (MSI-H) colorectal cancer. These study findings were reported in The Lancet Oncology...
Overview of the Phase III MSLT-II Trial
THE PHASE III MSLT- II TRIAL showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel-node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...
Blood-Based Biomarker: Predicting Efficacy of Immunotherapy in Patients With Melanoma
IN WHAT APPEARS TO BE the largest blood-based biomarker study of a checkpoint inhibitor, an RNA transcript–based gene classifier was able to predict for melanoma patients’ response to tremelimumab. The study was recently published in the Journal for ImmunoTherapy of Cancer.1 “Our study, in many...
Expert Point of View: Nadia Harbeck, MD, PhD, and Sibylle Loibl, MD
NADIA HARBECK, MD, PhD, of the Breast Center at the University of Munich, Germany, said the findings of LORELEI are among a growing list of indications that “the future is bright for endocrine-based therapy.” Although the results were hypothesis-generating and not yet practice-changing, she...
Selective PI3K Inhibitor Boosts Effect of Letrozole in Neoadjuvant Setting
FOR THE first time, an inhibitor of the phosphoinositide 3-kinase (PI3K) pathway (taselisib) used in combination with endocrine therapy in the neoadjuvant setting improved response rates over endocrine therapy alone—with good tolerability—in women with early breast cancer, according to the phase...
Strong Showing for Rucaparib Maintenance Therapy for Platinum-Sensitive Ovarian Cancer
EVIDENCE CONTINUES to mount for the benefits of poly (ADP-ribose) polymerase (PARP) inhibition in ovarian cancer. Rucaparib (Rubraca) maintenance therapy after response to platinum-containing therapy significantly improved progression-free survival in patients with recurrent ovarian cancer compared ...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
Momelotinib vs Ruxolitinib in Janus Kinase Inhibitor–Naive Myelofibrosis
In the phase III SIMPLIFY-1 noninferiority trial reported in the Journal of Clinical Oncology, Mesa et al found that the selective Janus kinase (JAK) 1 and 2 inhibitor momelotinib was noninferior to ruxolitinib (Jakafi) in spleen response, but not symptom response, in JAK inhibitor–naive...
FDA Accepts sNDA for Lenvatinib for the Treatment of Hepatocellular Carcinoma
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
Nivolumab Plus Ipilimumab vs Sunitinib Alone as First-Line Therapy for Metastatic Renal Cell Carcinoma
A CHANGE IN PARADIGM may be on the horizon for the treatment of metastatic renal cell carcinoma. According to the results of CheckMate 214, the combination of ipilimumab (Yervoy) plus nivolumab (Opdivo) outperformed the standard of care—sunitinib (Sutent)—for first-line treatment, with improved...
MSLT-II Completion Lymph Node Dissection Trial: Practice Changing but Not Likely Practice Abandoning
PROBABLY THE MOST IMPORTANT advance in the treatment of newly diagnosed primary melanoma has been the incorporation of sentinel lymph node biopsy as part of initial surgical management. The routine use of sentinel lymph node biopsy, often termed “sentinel lymphadenectomy,” in appropriately...
Abemaciclib Plus Endocrine Therapy Extends Progression-Free Survival in First-Line Therapy for Advanced Breast Cancer
THE VALUE OF cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in advanced breast cancer became ever more certain with the announcement of interim data from MONARCH 3, which evaluated abemaciclib in combination with endocrine therapy as first-line therapy for hormone receptor–positive/HER2-negative...
Study Finds 'Standard Care' Treatments in Breast Cancer Clinical Trials Not Always Standard
Historically, randomized controlled trials have served as the state-of-the-art method for determining the efficacy and safety of new, innovative treatment regimens for patients with cancer and other diseases. It is imperative that such trials are carefully designed to ensure that they are...
European Commission Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma
On September 22, Roche announced that the European Commission has approved obinutuzumab (Gazyvaro in Europe; available in the United States as Gazyva) in combination with chemotherapy, followed by obinutuzumab maintenance in patients achieving a response, as a new treatment for previously untreated ...
Comparison of First-Line Treatments for EGFR-Mutant NSCLC
The phase III ARCHER 1050 trial has shown superior progression-free survival with the second-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor dacomitinib vs gefitinib (Iressa) in the first-line treatment of advanced EGFR-mutant non–small cell lung...
