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KMID : 0939920200520030907
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대한암학회지
2020 Volume.52 No. 3 p.907 ~ p.916
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Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting
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Kang Jin-Hyoung
Kwon Jung-Hye
Lee Yun-Gyoo
Park Keon-Uk
An Ho-Jung
Sohn Joo-Hyuk
Seol Young-Mi
Lee Hyun-Woo
Yun Hwan-Jung
Ahn Jin-Seok
Yang Ji-Hyun
Song Hun-Ho
Koo Dong-Hoe
Kim Jin-Young
Kim Gun-Min
Kim Hwa-Jung
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Abstract
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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 QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.
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KEYWORD
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Ramosetron, Palonosetron, Aprepitant, Antiemetics, Nausea, Vomiting, Neoplasms
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