Cancer Res Treat.  2020 Jul;52(3):907-916. 10.4143/crt.2019.713.

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

• Kang JH
• Kwon JH
• Lee YG
• Park KU
• An HJ
• Sohn J
• Seol YM
• Lee H
• Yun HJ
• Ahn JS
• Yang JH
• Song H
• Koo DH
• Kim JY
• Kim GM
• Kim HJ

• KMID: 2504469
• DOI: http://doi.org/10.4143/crt.2019.713

Abstract

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 gender, 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 QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.

Keyword

Ramosetron; Palonosetron; Aprepitant; Antiemetics; Nausea; Vomiting; Neoplasms

Figure

• 

  Fig. 1. Complete response rate (A), complete protection rate (B), and total control rate (C) in intention-to-treat population (n=279) on a daily basis. (A) The risk difference between the two arms was 2.2% (95% confidence interval [CI], –7.1% to 11.4%). (B) The risk difference between the two arms was –2.3% (95% CI, –13.9% to 9.4%). (C) The risk difference between the two arms was 3.8% (95% CI, –7.9% to 15.5%) using the generalized estimating equation model. HEC, highly-emetogenic chemotherapy; mITT, modified intention to treatment.

• 

  Fig. 2. Complete response rate (A), complete protection rate (B), and total control rate (C) in intention-to-treat population (n=279) on a daily basis. There was no statistical significance by individual date. (A) The risk difference between the two arms was 2.2% (95% confidence interval [CI], –7.1 to 11.4). (B) The risk difference between the two arms was –2.3% (95% CI, –13.9 to 9.4). (C) The risk difference between the two arms was 3.8% (95% CI, –7.9 to 15.5) using the generalized estimating equation model. RAD, ramosetron, aprepitant, and dexamethasone; PAD, palonosetron, aprepitant, and dexamethasone.

Reference

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