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.
Abstract
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.
Type
Journal articleSubject
antiemetic guidelineschemotherapy
chemotherapy-induced nausea and vomiting
evidence-based practice
glioma
nausea
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https://hdl.handle.net/10161/16098Published Version (Please cite this version)
10.2147/TCRM.S122480Publication Info
Affronti, 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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
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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