Abstract
Purpose
This study aimed to determine the antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT) receiving 5-day cisplatin-based combination chemotherapy.
Methods
An open-label, single-arm, multicenter study was performed in patients with TGCT who were scheduled to receive 5-day cisplatin-based combination chemotherapy. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2 to 5, and dexamethasone 9.9 mg on day 1 and 6.6 mg on days 2 to 8. The primary endpoint was complete response (CR) rate, which was defined as no vomiting and no rescue medication, in the overall period (0 to 216 h) in the first chemotherapy course. Incidence and severity of nausea were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and a subjective rating scale completed by patients.
Results
Thirty patients were included in the analysis. CR was achieved in 90.0 % of the patients in the first chemotherapy course, and high CR rates were also observed in the second and third courses (82.1 and 78.3 %, respectively). The incidence of nausea peaked on days 4 to 6 in about 50 % of the patients. The reported adverse drug reactions were hiccups (13.3 %), anorexia (3.3 %), and stomach pain (3.3 %). None of these were unexpected and none were grade 3 or 4.
Conclusions
The combination antiemetic therapy examined in this study was highly effective and well-tolerated in patients with TGCT receiving 5-day cisplatin-based combination chemotherapy.
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Conflict of interest
Shota Hamada was an employee of MSD K.K., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ, USA, when the study was conducted. Hiroyuki Nishiyama received honoraria, grants, or other funding from Taiho Pharmaceutical Co., Ltd. and received grants or other funding from Ono Pharmaceutical Co., Ltd. Tomonori Habuchi, Osamu Ogawa, and Koji Kawakami received grants and other funding from Taiho Pharmaceutical Co., Ltd. The other authors declare that they have no conflicts of interest.
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Hamada, S., Hinotsu, S., Kawai, K. et al. Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy. Support Care Cancer 22, 2161–2166 (2014). https://doi.org/10.1007/s00520-014-2182-7
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DOI: https://doi.org/10.1007/s00520-014-2182-7