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International Journal of Clinical Oncology

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01-06-2016 | Original Article

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 paclitaxel and carboplatin

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

Published in: International Journal of Clinical Oncology | Issue 3/2016

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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Title: 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 paclitaxel and carboplatin
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
Publication date: 01-06-2016
Publisher: Springer Japan
Published in: International Journal of Clinical Oncology / Issue 3/2016
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-015-0928-y

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