Ramosetron Versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting
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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.
Fang B, Zhao L, Yu S, Chen F Dose Response. 2024; 22(4):15593258241293220.
PMID: 39415761 PMC: 11481085. DOI: 10.1177/15593258241293220.
Herrstedt J, Clark-Snow R, Ruhlmann C, Molassiotis A, Olver I, Rapoport B ESMO Open. 2024; 9(2):102195.
PMID: 38458657 PMC: 10937211. DOI: 10.1016/j.esmoop.2023.102195.
Herrstedt J, Celio L, Hesketh P, Zhang L, Navari R, Chan A Support Care Cancer. 2023; 32(1):47.
PMID: 38127246 PMC: 10739516. DOI: 10.1007/s00520-023-08221-4.
Kim H, Ahn E, Choi G, Kang H J Pers Med. 2023; 13(1).
PMID: 36675743 PMC: 9866437. DOI: 10.3390/jpm13010082.
Qian M, Liu Y Acta Cir Bras. 2022; 37(10):e371004.
PMID: 36542041 PMC: 9762430. DOI: 10.1590/acb371004.