Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial.

Abstract

PURPOSE:

Aprepitant, an oral neurokinin-1 receptor antagonist, has demonstrated improved control of chemotherapy-induced nausea and vomiting (CINV) in previous studies. This is the first phase III study to evaluate the efficacy and tolerability of aprepitant in patients receiving highly emetogenic chemotherapy (HEC) in Asian countries.

METHODS:

This multicenter, double-blind, placebo-controlled trial assessed the prevention of CINV during the acute phase (AP), delayed phase (DP), and overall phase (OP). Patients receiving HEC were randomized to either an aprepitant group (day 1, aprepitant 125 mg; days 2-3, aprepitant 80 mg) or a standard therapy group (days 1-3, placebo). Both groups received intravenous granisetron and oral dexamethasone. The primary end point was complete response (CR; no emesis and no use of rescue therapy) during the OP.

RESULTS:

Of the 421 randomized patients, 411 (98%) were assessable for efficacy; 69.6% (142/204) and 57.0% (118/207) of patients reported CR during the OP in the aprepitant and standard therapy groups, respectively (P = 0.007). CR rates in the aprepitant group were higher during the DP (74.0% vs. 59.4%, P = 0.001) but were similar during the AP (79.4% vs. 79.3%, P = 0.942). Toxicity and adverse events were comparable in both groups.

CONCLUSIONS:

The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior CINV prevention and was well tolerated.

• Authors: Zhihuang Hu, Ying Cheng, Hongyu Zhang, Caicun Zhou, Baohui Han, Yiping Zhang, Cheng Huang, Jianhua Chang, Xiangqun Song, Jun Liang, Houjie Liang, Chunxue Bai, Shiying Yu, Jia Chen, Jie Wang, Hongming Pan, Denesh K Chitkara, Darcy A Hille, Li Zhang
• Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 22 Issue 4 Pg. 979-87 (Apr 2014) ISSN: 1433-7339 [Electronic] Germany
• PMID: 24276953 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiemetics
• Antineoplastic Agents
• Morpholines
• Aprepitant
• Cisplatin

Topics

• Antiemetics (adverse effects, therapeutic use)
• Antineoplastic Agents (adverse effects, therapeutic use)
• Aprepitant
• Asian People
• Cisplatin (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Morpholines (adverse effects, therapeutic use)
• Nausea (chemically induced, prevention & control)
• Vomiting (chemically induced, prevention & control)