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01-05-2020 | Glioma | Original Article

Randomized open-label phase II trial of 5-day aprepitant plus ondansetron compared to ondansetron alone in the prevention of chemotherapy-induced nausea-vomiting (CINV) in glioma patients receiving adjuvant temozolomide

Authors: Mallika P. Patel, Sarah Woodring, Dina M. Randazzo, Henry S. Friedman, Annick Desjardins, Patrick Healy, James E. Herndon II, Frances McSherry, Eric S. Lipp, Elizabeth Miller, Katherine B. Peters, Mary Lou Affronti

Published in: Supportive Care in Cancer | Issue 5/2020

Abstract

Purpose

CINV remains a distressing side effect experienced by glioma patients receiving multi-day temozolomide therapy, in spite of guideline-based antiemetic therapy with selective serotonin-receptor-antagonists. Antiemetic research with aprepitant has routinely excluded glioma patients. In this randomized open-label phase II study, use of a nonstandard 5-day regimen of aprepitant for glioma patients was investigated.

Methods

One hundred thirty-six glioma patients receiving their first cycle of adjuvant temozolomide (150–200 mg/m²/day × 5 days every 28 days) were randomized to Arm-A (ondansetron 8 mg days 1–5 with aprepitant day 1: 125 mg, days 2–5: 80 mg) or Arm-B (ondansetron). Randomization was stratified by tumor grade and number of prior chemotherapy regimens. The primary endpoint was the percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescue medication over the 7-day study period. Secondary endpoints included CINV efficacy in the acute phase (≤ 24 h) and delayed phase (days 2–7), as well as safety and quality of life (QoL).

Results

Patients were 61% male, 97% white, 48% with KPS > 90%, 60% non-smokers, mean age 54, 92% with low alcohol use, and 46% with a CINV history. The CC was 58.6% (Arm-A) and 54.5% (Arm-B). Acute-complete response (CR) rates, defined as CC on day 1 in Arm-A and -B, were 97.1% and 87.9%, respectively (p = 0.056). Treatment-related toxicities were mild or moderate in severity.

Conclusions

Aprepitant plus ondansetron may increase acute-CR, may have benefit regarding CINV’s effect on QoL, and is safe for 5-day temozolomide compared to ondansetron. This study provides no evidence that aprepitant increases CC rate over ondansetron alone.

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Title: Randomized open-label phase II trial of 5-day aprepitant plus ondansetron compared to ondansetron alone in the prevention of chemotherapy-induced nausea-vomiting (CINV) in glioma patients receiving adjuvant temozolomide
Authors: Mallika P. Patel
Sarah Woodring
Dina M. Randazzo
Henry S. Friedman
Annick Desjardins
Patrick Healy
James E. Herndon II
Frances McSherry
Eric S. Lipp
Elizabeth Miller
Katherine B. Peters
Mary Lou Affronti
Publication date: 01-05-2020
Publisher: Springer Berlin Heidelberg
Keywords: Glioma
Nausea
Glioma
Vomiting
Glioma
Cytostatic Therapy
Published in: Supportive Care in Cancer / Issue 5/2020
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-019-05039-x

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