Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting

被引：12

作者：

Kang, Jin Hyoung ^{[1
]}

Kwon, Jung Hye ^{[2
]}

Lee, Yun-Gyoo ^{[3
]}

Park, Keon Uk ^{[4
]}

An, Ho Jung ^{[5
]}

Sohn, Joohyuk ^{[6
]}

Seol, Young Mi ^{[7
]}

Lee, Hyunwoo ^{[8
]}

Yun, Hwan-Jung ^{[9
]}

Ahn, Jin Seok ^{[10
]}

Yang, Ji Hyun ^{[1
]}

Song, Hunho ^{[2
]}

Koo, Dong-Hoe ^{[3
]}

Kim, Jin Young ^{[4
]}

Kim, Gun Min ^{[6
]}

Kim, Hwa Jung ^{[11
]}

机构：

[1] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Div Med Oncol,Dept Internal Med, Seoul, South Korea

[2] Hallym Univ, Coll Med, Kangdong Sacred Heart Hosp, Div Hematooncol,Dept Internal Med, 150 Seongan Ro, Seoul 05355, South Korea

[3] Sungkyunkwan Univ, Sch Med, Kangbuk Samsung Hosp, Div Hematol Oncol,Dept Internal Med, Seoul, South Korea

[4] Keimyung Univ, Sch Med, Dongsan Hosp, Div Hematol Oncol,Dept Internal Med, Daegu, South Korea

[5] Catholic Univ Korea, St Vincents Hosp, Coll Med, Div Med Oncol,Dept Internal Med, Seoul, South Korea

[6] Yonsei Univ, Coll Med, Dept Internal Med, Div Med Oncol, Seoul, South Korea

[7] Pusan Natl Univ, Pusan Natl Univ Hosp, Dept Internal Med, Div Hematooncol,Sch Med, Busan, South Korea

[8] Ajou Univ, Sch Med, Ajou Univ Hosp, Dept Hematol Oncol, Suwon, South Korea

[9] Chungnam Natl Univ, Sch Med, Chungnam Natl Univ Hosp, Dept Internal Med, Daejeon, South Korea

[10] Sungkyunkwan Univ, Samsung Med Ctr, Dept Med, Div Hematol & Oncol,Sch Med, Seoul, South Korea

[11] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Clin Epidemiol & Biostat, Seoul, South Korea

来源：

CANCER RESEARCH AND TREATMENT | 2020年 / 52卷 / 03期

关键词：

Ramosetron; Palonosetron; Aprepitant; Antiemetics; Nausea; Vomiting; Neoplasms; RANDOMIZED PHASE-III; 5-HT3 RECEPTOR ANTAGONIST; DOUBLE-BLIND; PREVENTION; TRIAL; NETUPITANT; EFFICACY; NEPA; MULTICENTER; CISPLATIN;

D O I：

10.4143/crt.2019.713

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)-induced nausea and vomiting. Materials and Methods Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by sex, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6. Results A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], -7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, -2.3%; 95% CI, -13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, -7.9 to 15.5), respectively. FLIE total score >= 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups. Conclusion In all aspects of efficacy, safety and quality of life, RAD is non-inferior to PAD for the control of chemotherapy-induced nausea and vomiting in cancer patients receiving HEC.

引用

页码：907 / 916

页数：10

共 22 条

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