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Showing 6051 - 6100FDA 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 ...
Regorafenib in Hepatocellular Carcinoma Previously Treated With Sorafenib
On April 27, 2017, the indications for regorafenib (Stivarga) were expanded to include treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data The new approval was based on the finding of improved overall survival...
Small Steps Forward in Brain Tumor Therapy
SOME RECENT ADVANCES in the treatment of brain tumors are promising, but others are less so, according to Jeffrey J. Olson, MD, Professor of Neurosurgery at Emory University, Atlanta. At the 2017 Debates and Didactics in Hematology and Oncology Conference, held in Sea Island, Georgia, and...
Is Complete Lymphadenectomy Still Standard of Care in Melanoma?
DOES COMPLETE lymph node dissection for sentinel node–positive melanoma still have a role in the management of this disease? That’s debatable. Although it does not improve overall survival over observation alone, complete lymphadenectomy may have other benefits, according to a dialogue at the...
Update on Nonimmunotherapy Advances in Endometrial, Cervical, and Ovarian Cancers
AT THE 12TH ANNUAL New Orleans Summer Cancer Meeting, Thomas Herzog, MD, Deputy Director of the University of Cincinnati Cancer Institute and Professor of the Division of Gynecologic Oncology at the University of Cincinnati College of Medicine, delivered an update on nonimmunotherapy advances in...
Expert Point of View: Johan Vansteenkiste, MD, PhD
FORMAL DISCUSSANT of this trial, Johan Vansteenkiste, MD, PhD, Head of the Respiratory Oncology Unit at the University Hospital KU Leuven, Belgium, was enthusiastic about the PACIFIC trial results. “We had an earthquake of immunotherapy in lung cancer this past year at ESMO. After an earthquake,...
PD-L1 Inhibitor Consolidation Therapy for NSCLC: New Standard of Care?
THE PROGRAMMED CELL DEATH ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) improved progression-free survival by 11.2 months compared with placebo in patients with locally advanced, unresectable stage III non–small cell lung cancer (NSCLC) whose disease did not progress following standard treatment ...
New Response Evaluation Criteria for Lymphoma Clinical Trials: RECIL 2017
New criteria for evaluating response in lymphoma clinical trials—RECIL 2017—have been developed by an International Working Group with the aim of harmonizing criteria with the RECIST criteria used for solid tumors.1 The new criteria were reported by Anas Younes, MD, of Memorial Sloan Kettering...
Expert Point of View: Reinhard Dummer, MD, and Jeffrey Weber, MD, PhD
ASSUMING THE regimens evaluated in COMBI-AD and CheckMate 238 are both approved by the U.S. Food and Drug Administration for the treatment of high-risk resected melanoma, clinicians may be faced with a tough choice. ESMO experts and the study’s investigators weighed in on this issue in a lively...
Significant Improvement in Outcomes Reported With Adjuvant Therapy for Melanoma
FOR PATIENTS with malignant melanoma, the significant improvement in outcomes with targeted agents and antibodies against the programmed cell death protein 1 (PD-1) has now been observed in the adjuvant setting. Two landmark studies presented at the European Society for Medical Oncology (ESMO) 2017 ...
Tibetan Yoga Practice May Improve Sleep Quality for Patients With Breast Cancer Undergoing Chemotherapy
Participating in twice-weekly practice of Tibetan yoga may reduce sleep disturbances and improve sleep quality in breast cancer patients receiving chemotherapy, according to a study published by Chaoul et al in Cancer. The study, led by researchers from The University of Texas MD Anderson Cancer...
Positive Results from Phase III MURANO Trial Evaluating Venetoclax in Combination With Rituximab in Relapsed/Refractory CLL
The phase III MURANO study of venetoclax (Venclexta) tablets in combination with rituximab (Rituxan) met its primary endpoint. Results showed that the combination prolonged progression-free survival in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) compared with bendamustine...
Overall Survival With Nivolumab/Ipilimumab, or Nivolumab Alone, vs Ipilimumab in Advanced Melanoma
Overall survival outcomes in the phase III CheckMate 067 trial indicate improved survival with nivolumab (Opdivo)/ipilimumab (Yervoy) vs ipilimumab and with nivolumab vs ipilimumab in patients with previously untreated advanced melanoma. These findings were reported in The New England Journal of...
First-Line Gemcitabine/Docetaxel vs Doxorubicin in Advanced Soft-Tissue Sarcoma
In the UK-Swiss phase III GeDDiS trial, the combination of gemcitabine and docetaxel did not significantly improve progression-free survival vs doxorubicin in first-line treatment of locally advanced or metastatic soft-tissue sarcoma. Findings were reported in The Lancet Oncology by Seddon et al....
ESMO 2017: KEYNOTE-045: Updated Results Support Pembrolizumab as Second-Line Treatment in Advanced Urothelial Cancer
Mature results from the KEYNOTE-045 trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract LBA37_PR) confirmed significantly longer survival in patients with advanced urothelial cancer who received the checkpoint inhibitor pembrolizumab after initial...
ESMO 2017: KEYNOTE-040 Evaluates Pembrolizumab in Head and Neck Cancer
Immunotherapy with the checkpoint inhibitor pembrolizumab (Keytruda) may be a better option than standard treatments for patients whose head and neck cancer has spread or recurred after an initial round of chemotherapy, according to results of the KEYNOTE-040 trial presented at the European Society ...
ESMO 2017: MONARCH 3: Abemaciclib as Initial Therapy Improves Outcome in Endocrine-Sensitive Advanced Breast Cancer
The results of the MONARCH 3 trial, presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract 236O_PR), showed that adding the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib to endocrine therapy improved progression-free survival compared to endocrine...
ESMO 2017: NOR-CAYACS Trial: Factors That May Limit Work Ability of Young Adult Cancer Survivors
Factors that may limit the ability of young adult cancer survivors to work were reported at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract 1110PD_PR). Late side effects can occur months or years after cancer treatment. In patients diagnosed with cancer in young...
ESMO 2017: PACIFIC Trial: Durvalumab Improves Progression-Free Survival in Stage III Lung Cancer
Durvalumab improves progression-free survival in patients with locally advanced, unresectable stage III lung cancer, according to late-breaking results from the phase III PACIFIC trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract LBA1_PR) and...
Posttransplantation Cyclophosphamide-Based Haploidentical HCT in Hodgkin Lymphoma
In a European analysis reported in the Journal of Clinical Oncology, Martínez et al found similar survival outcomes with post-transplantation cyclophosphamide-based haploidentical allogeneic hematopoietic cell transplantation (HCT) vs conventional HLA-matched sibling donor or HLA-matched...
