Tolerability and efficacy of Rolapitant for prevention of Chemotherapy induced nausea and vomiting: A systematic review and meta-analysis of active-controlled trials.


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Hussien Ahmed1,Ali Mohamed Hammad2,Mohamed Zidan3,Mohamed Salem4,Ahmed Negida5
1Faculty of Medicine Zagazig University,2Faculty of Medicine, Cairo University, Cairo, Egypt.,35Faculty of Medicine, Tanta University, Egypt.,4Faculty of Medicine, Al Azhar University, Cairo, Egypt,5School of Medicine, Liverpool University, UK

Abstract

Background

Chemotherapy-induced nausea and vomiting (CINV) is a common side-effect of many antineoplastic regimens. Many studies evaluated the safety and efficacy of neurokinin-1 receptor antagonist Rolapitant, in combination with a serotonin (5-HT3) receptor antagonist and dexamethasone for the prevention of CINV. The aim of this study is to synthesize the evidence for safety and efficacy of Rolapitant in combination with other antiemetic for prevention of chemotherapy-induced nausea and vomiting.

Method

A computer literature search of PubMed, SCOPUS, EPSCO, Embase, and Cochrane CENTRAL has been conducted using relevant keywords. Studies were screened for eligibility and data were extracted. The efficacy endpoints (complete response (CR), no emesis, no significant nausea) were pooled as risk ratio (RR) in a fixed effect model meta-analysis using Mantel–Haenzel method. Statistical analysis was performed by Review Manager Version 5.3 for windows.

Results

Five randomized controlled trials (n=2984) were pooled in the final analysis. Rolapitant 180 mg in combination with a 5-HT3 receptor antagonist and dexamethasone was statistically superior to active control in term of CR in the acute phase (RR 1.06, 95% CI [1.03, 1.1); CR in the delayed phase (RR 1.19, 95% CI [1.13, 1.25]). Rates of no emesis were significantly higher with Rolapitant 180 mg group versus active control group in the acute and delayed phases (RR 1.07, 95% CI [1.04, 1.1], RR 1.17, 95% CI [1.12, 1.25]), retrospectively. Moreover, Rates of complete protection were significantly higher with Rolapitant 180 mg group than active control group in the overall, acute, and delayed phases (RR 1.18, 95% CI [1.11, 1.26], RR 1.05, 95% CI [1.01, 1.07], RR 1.17, 95% CI [1.1, 1.24]), retrospectively. The incidence of adverse events was similar in Rolapitant and control groups.

Conclusion

Rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well tolerated and shows superiority over active control for the prevention of CINV.