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.

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10.2147/TCRM.S122480

Publication Info

Affronti, Mary Lou, Sarah Woodring, James E Herndon, Frances McSherry, Katherine B Peters, Henry S Friedman, Annick Desjardins, Waynette Freeman, et al. (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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Scholars@Duke

Affronti

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 Tisch Brain Tumor Center in the Duke Cancer Institute.

Dr. Affronti has been a part of Duke’s oncology clinical and research community for almost three and a half decades, and has been associated with DUSON since 1989 in a variety of roles, including clinical associate, guest lecturer, preceptor, and clinical instructor. She was instrumental in developing the oncology curriculum for DUSON nurse practitioner students. In 2005, she was honored by the Friends of Nursing at Duke with the Evelyn Morgan Award for Excellence in Oncology Nursing. Dr. Affronti’s DNP capstone on adherence to antiemetic guidelines in patients with malignant glioma, received the Outstanding Capstone Doctoral Project Award in 2013, was published in Supportive Care in Cancer and was cited in a 2016 New England Journal of Medicine Antiemetic Review Article. Dr. Affronti was the Recipient of the Southern Nursing Research Society Clinical Research Award in 2018.

Dr. Affronti has been developing and leading therapeutic and supportive care research while seeing patients as a nurse practitioner, and is continuing both her clinical and research activities at the Brain Tumor Center. She has a strong interest in the development and testing of therapies and supportive care for primary brain tumors as a currently a co-principal or principal investigator on many Phase II clinical trials at the Duke Brain Tumor Center.

Herndon

James Emmett Herndon

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).


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