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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.

Publication ,  Journal Article
Patel, MP; Woodring, S; Randazzo, DM; Friedman, HS; Desjardins, A; Healy, P; Herndon, JE; McSherry, F; Lipp, ES; Miller, E; Peters, KB; Affronti, ML
Published in: Support Care Cancer
May 2020

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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Published In

Support Care Cancer

DOI

EISSN

1433-7339

Publication Date

May 2020

Volume

28

Issue

5

Start / End Page

2229 / 2238

Location

Germany

Related Subject Headings

  • Vomiting
  • Temozolomide
  • Quality of Life
  • Ondansetron
  • Oncology & Carcinogenesis
  • Nausea
  • Middle Aged
  • Male
  • Humans
  • Glioma
 

Citation

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Patel, M. P., Woodring, S., Randazzo, D. M., Friedman, H. S., Desjardins, A., Healy, P., … Affronti, M. L. (2020). 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. Support Care Cancer, 28(5), 2229–2238. https://doi.org/10.1007/s00520-019-05039-x
Patel, Mallika P., Sarah Woodring, Dina M. Randazzo, Henry S. Friedman, Annick Desjardins, Patrick Healy, James E. Herndon, et al. “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.Support Care Cancer 28, no. 5 (May 2020): 2229–38. https://doi.org/10.1007/s00520-019-05039-x.
Patel MP, Woodring S, Randazzo DM, Friedman HS, Desjardins A, Healy P, Herndon JE, McSherry F, Lipp ES, Miller E, Peters KB, Affronti ML. 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. Support Care Cancer. 2020 May;28(5):2229–2238.
Journal cover image

Published In

Support Care Cancer

DOI

EISSN

1433-7339

Publication Date

May 2020

Volume

28

Issue

5

Start / End Page

2229 / 2238

Location

Germany

Related Subject Headings

  • Vomiting
  • Temozolomide
  • Quality of Life
  • Ondansetron
  • Oncology & Carcinogenesis
  • Nausea
  • Middle Aged
  • Male
  • Humans
  • Glioma