| ORIGINAL ARTICLE |
|
| Year : 2013 | Volume
: 50
| Issue : 4 | Page : 285-291 |
A Phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis
A Maru1, VP Gangadharan2, CJ Desai3, RK Mohapatra4, AD Carides5
1 Medical Oncology, SEAROC Cancer Center, S.K. Soni Hospital Premise, Jaipur, India
2 Lakeshore Hospital and Research Centre Ltd, Kerala, India
3 Hemato-Oncology Clinic, Ahemdabad Pvt. Ltd, Vedanta Institute of Medical Sciences, Ahmedabad, Gujarat, India
4 Apollo, Speciality Hospital, Chennai, Tamil nadu, India
5 Merck Research Laboratories, Merck Sharp and Dohme Corp, Whitehouse Station, NJ, USA
Correspondence Address:
A Maru
Medical Oncology, SEAROC Cancer Center, S.K. Soni Hospital Premise, Jaipur
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0019-509X.123580
Clinical trial registration NCT00619359
Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients. Aims: This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population. A subgroup analysis was performed from data collected in a phase 3 study of intravenous (IV) fosaprepitant or oral aprepitant, plus the 5-HT 3 antagonist ondansetron and the corticosteroid dexamethasone, in cisplatin-naοve patients with solid malignancies. Materials and Methods: Patients scheduled to receive cisplatin (≥70 mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine (150 mg) on day 1 or a 3-day dosing regimen of oral aprepitant (day 1:125 mg, days 2 and 3:80 mg) with standard doses of ondansetron and dexamethasone. Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events (AEs) and tolerability. Statistical Analysis Used: Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method. Results: In the Indian subpopulation (n = 372), efficacy was similar for patients in both the fosaprepitant or aprepitant groups; complete response in the overall, acute, and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group. Fosaprepitant was generally well-tolerated; common AEs were similar to oral aprepitant. Conclusions: IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation.
[FULL TEXT] [PDF]*
|
