Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study

被引：65

作者：

Suzuki, K. ^{[1
,2
]}

Yamanaka, T. ^{[3
]}

Hashimoto, H. ^{[4
]}

Shimada, Y. ^{[5
]}

Arata, K. ^{[1
]}

Matsui, R. ^{[6
]}

Goto, K. ^{[7
]}

Takiguchi, T. ^{[2
]}

Ohyanagi, F. ^{[8
]}

Kogure, Y. ^{[9
]}

Nogami, N. ^{[10
]}

Nakao, M. ^{[11
]}

Takeda, K. ^{[12
]}

Azuma, K. ^{[13
]}

Nagase, S. ^{[14
]}

Hayashi, T. ^{[15
]}

Fujiwara, K. ^{[16
]}

Shimada, T. ^{[17
]}

Seki, N. ^{[18
]}

Yamamoto, N. ^{[19
,20
]}

机构：

[1] Shizuoka Canc Ctr, Dept Pharm, Shizuoka, Japan

[2] Japanese Fdn Canc Res, Canc Inst Hosp, Dept Pharm, Tokyo, Japan

[3] Yokohama City Univ, Sch Med, Dept Biostat, Yokohama, Kanagawa, Japan

[4] Natl Canc Ctr, Div Pharm, Tokyo, Japan

[5] Natl Canc Ctr, Div Gastrointestinal Oncol, Tokyo, Japan

[6] Natl Canc Ctr Hosp East, Dept Pharm, Chiba, Japan

[7] Natl Canc Ctr Hosp East, Dept Thorac Oncol, Chiba, Japan

[8] Japanese Fdn Canc Res, Canc Inst Hosp, Dept Thorac Med Oncol, Tokyo, Japan

[9] NHO Shikoku Canc Ctr, Dept Pharm, Shikoku, Ehime, Japan

[10] NHO Shikoku Canc Ctr, Dept Thorac Oncol, Shikoku, Ehime, Japan

[11] Osaka City Gen Hosp, Dept Pharm, Osaka, Japan

[12] Osaka City Gen Hosp, Dept Clin Oncol, Osaka, Japan

[13] Tokyo Med Univ Hosp, Dept Pharm, Tokyo, Japan

[14] Tokyo Med Univ Hosp, Dept Thorac Surg, Tokyo, Japan

[15] NHO Kyushu Canc Ctr, Dept Pharm, Fukuoka, Japan

[16] Kindai Univ Hosp, Dept Pharm, Osaka, Japan

[17] Teikyo Univ Hosp, Dept Pharm, Tokyo, Japan

[18] Teikyo Univ Hosp, Div Med Oncol, Tokyo, Japan

[19] Shizuoka Canc Ctr, Dept Thorac Oncol, Shizuoka, Japan

[20] Wakayama Med Univ, Dept Internal Med 3, 811-1 Kimiidera, Wakayama 6418509, Japan

来源：

ANNALS OF ONCOLOGY | 2016年 / 27卷 / 08期

关键词：

chemotherapy-induced nausea and vomiting (CINV); antiemetic therapy; 5-HT3 receptor antagonist; palonosetron; NK-1 receptor antagonist; aprepitant; PLACEBO-CONTROLLED TRIAL; HIGH-DOSE CISPLATIN; ANTAGONIST APREPITANT; DEXAMETHASONE; ONDANSETRON; EMESIS;

D O I：

10.1093/annonc/mdw220

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

This paper reports the result of the first phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists, palonosetron and granisetron, in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.There has been no phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy (HEC). Patients with a malignant solid tumor who would receive HEC containing 50 mg/m(2) or more cisplatin were randomly assigned to either palonosetron (0.75 mg) arm (Arm P) or granisetron (1 mg) arm (Arm G), on day 1, both arms with dexamethasone (12 mg on day 1 and 8 mg on days 2-4) and aprepitant (125 mg on day 1 and 80 mg on days 2-3). The primary end point was complete response (CR; no vomiting/retching and no rescue medication) at the 0-120 h period and secondary end points included complete control (CC; no vomiting/retching, no rescue medication, and no more than mild nausea) and total control (TC; no vomiting/retching, no rescue medication, and no nausea). Between July 2011 and June 2012, 842 patients were enrolled. Of 827 evaluable, 272 of 414 patients (65.7%) in Arm P had a CR at the 0-120 h period when compared with 244 of 413 (59.1%) in Arm G (P = 0.0539). Both arms had the same CR rate of 91.8% at the acute (0-24 h) period, while at the delayed (24-120 h) period, Arm P had a significantly higher CR rate than Arm G (67.2% versus 59.1%; P = 0.0142). In secondary end points, Arm P had significantly higher rates than Arm G at the 0-120 h period (CC rate: 63.8% versus 55.9%, P = 0.0234; TC rate: 47.6% versus 40.7%, P = 0.0369) and delayed periods (CC rate: 65.2% versus 55.9%, P = 0.0053; TC rate: 48.6% versus 41.4%, P = 0.0369). The present study did not show the superiority of palonosetron when compared with granisetron in the triplet regimen regarding the primary end point. UMIN000004863.

引用

页码：1601 / 1606

页数：6