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Showing 6251 - 6300Osimertinib 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...
FDA Grants Priority Review for Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer
On September 29, Roche announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application and granted Priority Review for pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, for adjuvant treatment of...
Addition of Cetuximab to Concurrent Chemoradiation in Esophageal Cancer
The phase III NRG Oncology RTOG 0436 trial has shown no survival benefit of adding cetuximab (Erbitux) to paclitaxel/cisplatin and radiation therapy in patients with esophageal cancer treated without surgery. These results were reported by Mohan Suntharalingam, MD, MBA, of the Marlene and Stewart...
Nivolumab Approved in Japan for Unresectable Advanced or Recurrent Gastric Cancer That Has Progressed After Chemotherapy
On September 22, Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved nivolumab (Opdivo) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. This approval was based on the phase III ...
Pooled Analysis Safety Profile of Combination Immunotherapy for Advanced Melanoma
In a retrospective study reported in the Journal of Clinical Oncology, Sznol et al have provided a pooled safety profile of combination nivolumab (Opdivo) and ipilimumab (Yervoy) treatment in patients with advanced melanoma. Study Details The study included data from 448 patients from a phase Ib...
Addition of MET Inhibitor to First-Line Chemotherapy in Advanced Gastric Cancer
The phase III RILOMET-1 trial showed no survival benefit of adding the MET inhibitor rilotumumab to first-line epirubicin, cisplatin, and capecitabine in patients with advanced MET-positive gastric or gastroesophageal junction adenocarcinoma. These results were reported in The Lancet Oncology by...
Adjuvant Nivolumab vs Ipilimumab in Resected Stage III or IV Melanoma
The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Jeffrey Weber and colleagues in The New England Journal of Medicine. Study Details In the ...
Adding Sorafenib to Transarterial Chemoembolization in Hepatocellular Carcinoma
As reported in The Lancet Gastroenterology & Hepatology by Tim Meyer, MBBS, of the University College London, and colleagues, the UK phase III TACE 2 trial has shown no progression-free survival benefit with the addition of sorafenib (Nexavar) to transarterial chemoembolization in patients...
FDA Expands Approval of Ipilimumab to Pediatric Patients 12 Years and Older
On July 24, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use now to include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of...
ASTRO 2017: Accelerated Breast Radiation Therapy Following Mastectomy Can Shorten Treatment Time While Maintaining Tumor Control
Radiation therapy following mastectomy for intermediate-stage, high-risk breast cancer can be shortened from 5 to 3 weeks while maintaining tumor control rates in the breast and surrounding region that are equivalent to conventional treatment, according to research presented by Sun et al at the...
Shrinivas Rathod, MD, on NSCLC: Quality-of-Life Outcomes From an IAEA Trial
Shrinivas Rathod, MD, of the University of Manitoba, discusses phase III study results on optimization of treatment of advanced non–small cell lung cancer using radiation therapy and chemotherapy (Abstract 223).
ASTRO 2017: Patients With Breast Cancer Find Radiation Therapy Experience Better Than Expected
A new survey finds breast cancer patients’ actual radiation therapy experiences largely exceeded their expectations. The survey, which addressed the fears and misconceptions regarding radiation therapy for breast cancer, found that more than three-fourths of the breast cancer patients...
ASTRO 2017: Aggressively Reduced Radiation Therapy May Benefit Some Patients With HPV-Related Throat Cancer
For certain patients with oropharyngeal cancer caused by the human papillomavirus (HPV), an aggressive reduction of radiation therapy after surgery may provide cancer control while simultaneously reducing post-treatment side effects, improving quality of life, and lowering treatment costs,...
Adjuvant Therapy for Localized or Locally Advanced Renal Cell Carcinoma
As reported in the Journal of Clinical Oncology by Motzer et al, the phase III PROTECT trial showed no significant disease-free survival benefit for adjuvant pazopanib at 600 mg vs placebo after nephrectomy in patients with localized or locally advanced renal cell carcinoma at high risk of relapse. ...
ASTRO 2017: GOG-249 Confirms Adjuvant Pelvic Radiation as Standard of Care for High-Risk, Early-Stage Endometrial Cancer
In a new phase III trial report from the National Clinical Trial Network group, NRG Oncology, recurrence-free and overall survival rates for women with stage I–II high-risk endometrial cancer were not superior following adjuvant vaginal cuff brachytherapy plus chemotherapy when compared with...
Tamim Niazi, MDCM, on Prostate Cancer: Results From a Trial on Dose Escalation
Tamim Niazi, MDCM, of McGill University, discusses phase III study findings on hypofractionated, dose-escalation radiation therapy for high-risk adenocarcinoma of the prostate (Abstract 281).
Jeffrey D. Bradley, MD, on NSCLC: Results of the RTOG 0617 Trial
Jeffrey D. Bradley, MD, of Washington University School of Medicine, discusses long-term phase III findings on standard-dose vs high-dose conformal chemoradiation therapy with or without cetuximab for stage III non–small cell lung cancer (Abstract 227).
ASTRO 2017: RTOG 0617: Long-Term Survival Rates Improve Previous Estimates for Locally Advanced Lung Cancer
Long-term results of a phase III clinical trial indicate that survival rates for patients receiving chemoradiation for unresectable, locally advanced non–small cell lung cancer (NSCLC) may be more than twice as high as previous estimates. At 5 years following treatment with a standard dose of ...
Marcus E. Randall, MD, on Endometrial Cancer: Results From a Gynecology Oncology Group Study
Marcus E. Randall, MD, of the University of Kentucky, discusses phase III study findings on pelvic radiation therapy vs vaginal cuff brachytherapy followed by paclitaxel/carboplatin chemotherapy in patients with high-risk, early stage endometrial cancer (Abstract LBA1).
ASTRO 2017: Adding Radiation to Maintenance Chemotherapy May Benefit Patients With Limited Metastatic NSCLC
For patients with limited metastatic non–small cell lung cancer (NSCLC), adding radiation therapy before maintenance chemotherapy may curb disease progression when compared to maintenance chemotherapy alone, according to a randomized phase II clinical trial reported by Iyengar et al. at the...
Addition of Motesanib to Paclitaxel/Carboplatin in East Asian Patients With Advanced NSCLC
The phase III MONET-A trial has shown that the addition of the multikinase/vascular endothelial growth factor receptor inhibitor motesanib to paclitaxel and carboplatin did not significantly improve progression-free survival in East Asian patients with stage IV/recurrent nonsquamous non–small ...
Adjuvant Dabrafenib and Trametinib in Resected Stage III BRAF-Mutated Melanoma
The phase III COMBI-AD trial has shown a significant improvement in relapse-free survival with the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) vs placebo as adjuvant therapy in patients with resected stage III melanoma with BRAF V600E or V600K ...
ASTRO 2017: Biomarker Blood Test Predicts Survival Following Localized Lung Cancer Treatment
A new study demonstrates that a blood test to detect cancer may predict treatment outcomes for patients with localized non–small cell lung cancer (NSCLC) and afford physicians additional lead time to personalize treatment for recurrent disease. Patients in the study with detectable levels of...
Adding Midostaurin to Chemotherapy in AML With FLT3 Mutation
In a phase III trial (Cancer and Leukemia Group B 10603 [RATIFY]/Alliance) reported in The New England Journal of Medicine, Stone et al found that the addition of midostaurin (Rydapt) to standard chemotherapy improved overall survival in patients with newly diagnosed acute myeloid leukemia (AML)...
Tumor-Infiltrating Lymphocytes in African Americans and European Americans With Triple-Negative Breast Cancer
Triple-negative breast cancer is a highly aggressive breast cancer that lacks hormone receptors and overexpression of human epidermal growth factor receptor 2 (HER2/neu), and, therefore, there are no targeted treatments available for the cancer. Triple-negative breast cancer afflicts African...
Preexisting Dementia and Survival in Older Patients With Stage III Colon Cancer
A pre-existing diagnosis of dementia was associated with increased risk of death for older patients with advanced colon cancer; however, some of the effects of dementia on survival could be mediated by receipt of chemotherapy, according to results of a study published by Chen et al in Cancer...
Adjuvant Nivolumab vs Ipilimumab in Resected Stage III or IV Melanoma
The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Weber and colleagues in The New England Journal of Medicine. Study Details In the...
Durvalumab Consolidation After Chemoradiotherapy in Stage III NSCLC
As reported by Antonia et al in The New England Journal of Medicine, an interim analysis of the phase III PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1) inhibitor durvalumab (Imfinzi) vs placebo as consolidation in patients with unresectable...
Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL
On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2 Supporting Efficacy Data APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL...
Duration Studies in Oncology Have Often Been Poorly Designed and Analyzed
The ASCO Post is pleased to introduce “At Microphone 1,” an occasional column written by Steven E. Vogl, MD, of Bronx, New York. When he’s not in his clinic, Dr. Vogl can generally be found at major oncology meetings, and often at the microphone where he stands ready with important questions for...
No Improvement in Melanoma-Specific Survival With Completion Dissection vs Observation for Sentinel-Node Metastasis
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...
Sarcoma Management Is Slowly Evolving
THE BACKBONE treatment for soft-tissue sarcomas has long been anthracycline-based, but new approaches are coming. These novel strategies were discussed at the 2017 Debates and Didactics in Hematology and Oncology Conference in Sea Island, Georgia, by Melinda L. Yushak, MD, MPH, Assistant Professor ...
