A Phase II Study to Evaluate the Efficacy of Ramosetron, Aprepitant, and Dexamethasone in Preventing Cisplatin-Induced Nausea and Vomiting in Chemotherapy-Naive Cancer Patients.
- Author:
Geundoo JANG
1
;
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
Author Information
1. Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Aprepitant;
Dexamethasone;
Ramosetron;
Chemotherapy-induced nausea and vomiting
- MeSH:
Benzimidazoles;
Cisplatin;
Dexamethasone;
Humans;
Male;
Morpholines;
Nausea;
Prospective Studies;
Serotonin;
Steroids;
Vomiting
- From:Cancer Research and Treatment
2013;45(3):172-177
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: Combination therapy with aprepitant, serotonin receptor antagonist, and steroids improves the complete response rate of both acute and delayed chemotherapy-induced 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-naive 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.
