Palonosetron in combination with 1‐day versus 3‐day dexamethasone for prevention of nausea and vomiting following paclitaxel and carboplatin in patients with gynecologic cancers: A randomized, multicenter, phase‐II trial

Aim Chemotherapy-induced nauseaand vomiting(CINV) can affect a patient's quality of life, leading to poor compliance with further treatments. Previous studies have provided minimal data about carboplatin-based regimens. Female sex is a known risk factor for CINV. The purpose of this study was to evaluate palonosetronplus single-dose dexamethasone (DEX) for preventing CINV caused by carboplatinplus paclitaxel combination therapy (TC regimen) in patients with gynecologic cancers. Material and Methods Patients were recruited for this phase-II, multicenter, randomized trial from 12 hospitals in Hokkaido, Japan. Eligible patients were women with uterine cervical, endometrial or ovarian cancer scheduled to receive conventional TC regimenor dose-dense TC regimen; 116 patients were randomly assigned to receive palonosetronin combination with 1-day DEX or 3-day DEX. Results During the overall period, complete response (CR) was observed in 67.9% (95% confidence interval, 53.7–80.1) of patients in the 3-day DEX arm, and 60.7% (95% confidence interval, 46.8–73.5) of patients in the 1-day DEX arm; CR was significantly lower in the 1-day DEX arm if motion sicknesswas already present (P = 0.0370). In the severe hyperemesis gravidarumcohort, CR in the 1-day DEX arm tended to be lower than in the 3-day DEX arm. Conclusion Combination therapy of palonosetronand 1-day DEX was effective for subjects undergoing a TC regimenfor gynecologic cancers. However, the possibility of reduced efficacy of 1-day only DEX therapy in women undergoing a TC regimencould not be refuted and requires further investigation.