A Phase II single-arm trial of palonosetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in malignant glioma patients receiving multidose irinotecan in combination with bevacizumab.
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PURPOSE: Given that the prognosis of recurrent malignant glioma (MG) remains poor, improving quality of life (QoL) through symptom management is important. Meta-analyses establishing antiemetic guidelines have demonstrated the superiority of palonosetron (PAL) over older 5-hydroxytryptamine 3-receptor antagonists in chemotherapy-induced nausea and vomiting (CINV) prevention, but excluded patients with gliomas. Irinotecan plus bevacizumab is a treatment frequently used in MG, but is associated with low (55%) CINV complete response (CR; no emesis or use of rescue antiemetic) with commonly prescribed ondansetron. A single-arm Phase II trial was conducted in MG patients to determine the efficacy of intravenous PAL (0.25 mg) and dexamethasone (DEX; 10 mg) received in conjunction with biweekly irinotecan-bevacizumab treatment. The primary end point was the proportion of subjects achieving acute CINV CR (no emesis or antiemetic ≤24 hours postchemotherapy). Secondary end points included delayed CINV CR (days 2-5), overall CINV CR (days 1-5), and QoL, fatigue, and toxicity. MATERIALS AND METHODS: A two-stage design of 160 patients was planned to differentiate between CINV CR of 55% and 65% after each dose of PAL-DEX. Validated surveys assessed fatigue and QoL. RESULTS: A total of 63 patients were enrolled, after which enrollment was terminated due to slow accrual; 52 patients were evaluable for the primary outcome of acute CINV CR. Following PAL-DEX dose administrations 1-3, acute CINV CR rates were 62%, 68%, and 70%; delayed CINV CR rates were 62%, 66%, and 70%, and overall CINV CR rates were 47%, 57%, and 62%, respectively. Compared to baseline, there was a clinically meaningful increase in fatigue during acute and overall phases, but not in the delayed phase. There were no grade ≥3 PAL-DEX treatment-related toxicities. CONCLUSION: Data suggest that PAL-DEX is effective in preventing CINV in MG patients, which ultimately maintains the QoL of patients with glioma.
chemotherapy-induced nausea and vomiting
Published Version (Please cite this version)10.2147/TCRM.S122480
Publication InfoAffronti, Mary Lou; Woodring, Sarah; Herndon, James E; McSherry, Frances; Peters, Katherine B; Friedman, Henry S; ... Vredenburgh, James J (2017). A Phase II single-arm trial of palonosetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in malignant glioma patients receiving multidose irinotecan in combination with bevacizumab. Ther Clin Risk Manag, 13. pp. 33-40. 10.2147/TCRM.S122480. Retrieved from https://hdl.handle.net/10161/16098.
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Mary Louise Affronti
Clinical Professor in the School of Nursing
Dr. Mary Lou Affronti is a Professor who joined the Duke University School of Nursing faculty in February 2014. She earned both her DNP and her MSN at DUSON, and additionally earned a Master’s degree in Health Science in Clinical Research from the Duke University School of Medicine. She holds a Clinical Associate faculty appointment in the Duke University Medical Center Department of Surgery /Neurosurgery. She is also Primary Investigator and Adult Nurse Practitioner at the Preston Robert
Henry Seth Friedman
James B. Powell, Jr. Distinguished Professor of Pediatric Oncology, in the School of Medicine
Overview: Our laboratory is pursuing a comprehensive analysis of the biology and therapy of adult and childhood central nervous system malignancies, particularly high-grade medulloblastoma, glioma, and ependymoma. Laboratory Studies: Active programs, using human adult and pediatric CNS tumor continuous cell lines, transplantable xenografts growing subcutaneously and intracranially in athymic nude mice and rats, and as well as in the subarachnoid space of the ath
James Emmett Herndon II
Professor of Biostatistics & Bioinformatics
Current research interests have application to the design and analysis of cancer clinical trials. Specifically, interests include the use of time-dependent covariables within survival models, the design of phase II cancer clinical trials which minimize some of the logistical problems associated with their conduct, and the analysis of longitudinal studies with informative censoring (in particular, quality of life studies of patients with advanced cancer).
Katherine Barnett Peters
Associate Professor of Neurosurgery
Dr. Katy Peters, MD Ph.D. FAAN is an associate professor of neurology and neurosurgery at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. Her academic medical career started at Stanford University School of Medicine, receiving an MD and Ph.D. in Cancer Biology. After completing a neurology residency at Johns Hopkins University and a fellowship in cognitive neurosciences, Katy joined the PRTBTC as a neuro-oncology fellow. In 2009, she became a faculty member at
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