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

Springer Science and Business Media LLC - Tập 22 - Trang 2161-2166 - 2014
Shota Hamada1, Shiro Hinotsu2, Koji Kawai3, Shigeyuki Yamada4, Shintaro Narita5, Tomomi Kamba6, Hiroyuki Nishiyama3, Yoichi Arai4, Tomonori Habuchi5, Osamu Ogawa6, Koji Kawakami1
1Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
2Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan
3Department of Urology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
4Department of Urology, Tohoku University School of Medicine, Sendai, Japan
5Department of Urology, Akita University School of Medicine, Akita, Japan
6Department of Urology, Graduate School of Medicine, Kyoto University, Kyoto, Japan

Tóm tắt

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. 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. 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. 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.

Tài liệu tham khảo

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