Efficacy of Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting with a Moderately Emetogenic Chemotherapy Regimen: a Multicenter, Placebo-controlled, Double-blind, Randomized Study in Patients with Gynecologic Cancer Receiving...

Overview

Journal Int J Clin Oncol

Specialty Oncology

Date 2015 Dec 15

PMID 26662632

Citations 38

Authors

Hideaki Yahata

Hiroaki Kobayashi

Kenzo Sonoda

Mototsugu Shimokawa

Tatsuhiro Ohgami

Toshiaki Saito

Shinji Ogawa

Kunihiro Sakai

Akimasa Ichinoe

Yousuke Ueoka

Yasuyuki Hasuo

Makoto Nishida

Satohiro Masuda

Kiyoko Kato

Affiliations

Soon will be listed here.

Abstract

Background: Substance P contributes to the hypersensitivity reaction (HSR) to paclitaxel in a rat model. Aprepitant acts as an inhibitor of the binding of substance P to the neurokinin-1 receptor and, consequently, may reduce the frequency of paclitaxel-induced HSR. While aprepitant has a prophylactic effect against vomiting caused by high-dose cisplatin, the benefits of aprepitant have not been clearly demonstrated in patients receiving paclitaxel and carboplatin (TC) combination chemotherapy.

Methods: We conducted a multicenter, placebo-controlled, double-blind, randomized study in Japanese patients with gynecologic cancer who received TC combination chemotherapy. Patients received aprepitant or placebo together with both a 5-HT3 receptor antagonist and dexamethasone prior to chemotherapy. The primary endpoint was the proportion of patients with HSR, and the secondary endpoints were the proportion of patients with "no vomiting", "no significant nausea", and complete response, respectively.

Results: Of the 324 randomized patients, 297 (151 in the aprepitant group; 146 in the placebo group) were evaluated. The percentage of patients with HSR (9.2 vs. 7.5 %, respectively; P = 0.339) was not significantly different between the groups. The percentage of "no vomiting" patients (78.2 vs. 54.8 %; P < 0.0001), "no significant nausea" patients (85.4 vs. 74.7 %; P = 0.014), and patients showing complete response (61.6 vs. 47.3 %, P = 0.0073) was significantly higher in the aprepitant group than in the placebo group.

Conclusion: The administration of aprepitant did not have a prophylactic effect on the HSR but was effective in reducing nausea and vomiting in gynecologic cancer patients receiving TC combination chemotherapy.

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