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- Title
A Phase II Study to Evaluate the Efficacy of Ramosetron, Aprepitant, and Dexamethasone in Preventing Cisplatin-Induced Nausea and Vomiting in Chemotherapy-Naïve Cancer Patients.
- Authors
Geundoo Jang; Hun Ho Song; Keon Uk Park; Hyeong Su Kim; Dae Ro Choi; Jung Hye Kwon; Ho Young Kim; Boram Han; Jung Han Kim; Joo Young Jung; Hyo Jung Kim; Dae Young Zang
- Abstract
Purpose: Combination therapy with aprepitant, serotonin receptor antagonist, and steroids improves the complete response rate of both acute and delayed chemotherapyinduced nausea and vomiting (CINV). However, it is not known whether ramosetron is suitable for administration in combination with aprepitant. Therefore, we conducted a multicenter, open-label, prospective, phase II study in order to assess the efficacy and tolerability of combination therapy with ramosetron, aprepitant, and dexamethasone (RAD) for prevention of cisplatin-based CINV in chemotherapy-naïve patients with solid cancers. Materials and Methods: Forty-one patients with various solid cancers (31 male and 10 female; median age, 59 years) who received treatment with highly emetogenic chemotherapy (median cisplatin dose, 70 mg/m²; range 50 to 75 mg/m²) were enrolled in this study. Oral aprepitant (125 mg on day 1; 80 mg on days 2 and 3), intravenous ramosetron (0.6 mg on day 1), and oral dexamethasone (12 mg on day 1; 8 mg on days 2-4) were administered for prevention of CINV. Results: The complete response (no emesisand retching and no rescue medication) rate was 94.9% in the acute period (24 hours post-chemotherapy), 92.3% in the delayed period (24-120 hours post-chemotherapy), and 92.3% in the overall period (0-120 hours). The absolute complete response (complete response plus no nausea) rate was 74.4% in the acute period, 51.3% in the delayed period, and 46.2% in the overall period. There were no grade 3 or 4 toxicities related to these antiemetic combinations. Conclusion: RAD regimen is a safe and effective antiemetic treatment for prevention of CINV in patients receiving highly emetogenic chemotherapy.
- Subjects
ANTICIPATORY nausea &; vomiting; CISPLATIN; DEXAMETHASONE; SEROTONIN antagonists; ANTIEMETICS; COMBINATION drug therapy; PREVENTION; PHYSIOLOGY; THERAPEUTICS
- Publication
Cancer Research & Treatment, 2013, Vol 45, Issue 3, p172
- ISSN
1598-2998
- Publication type
Article
- DOI
10.4143/crt.2013.45.3.172