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자료유형
학술저널
저자정보
Shin Nishio (Kurume University) Satomi Aihara (2Department of Obstetrics and Gynecology Faculty) Mototsugu Shimokawa (Clinical Research Institute National Kyushu Cance) Akira Fujishita (Department of Obstetrics and Gynecology Saiseika) Shuichi Taniguchi (Department of Obstetrics and Gynecology Miyazaki) Toru Hachisuga (University of Occupational and Environmental Health Japan) Shintaro Yanazume (Department of Gynecology National Hospital Organi) Hiroaki KOBAYASHI (Tokyo University of Marine Science and Technology) Fumihiro Murakami (Department of Obstetrics and Gynecology St. Mary') Fumitaka Numa (Department of Obstetrics and Gynecology Tokuyama) Kohei Kotera (Department of Obstetrics and Gynecology Nagasaki) Naofumi Okura (Department of Obstetrics and Gynecology NHO Kokur) Naoyuki Toki (Department of Obstetrics and Gynecology Kyushu Ro) Masatoshi Yokoyama (Department of Obstetrics and Gynecology Faculty) Kimio Ushijima (Department of Obstetrics and Gynecology Kurume University School of Medicine Fukuoka Japan)
저널정보
대한부인종양학회 Journal of Gynecologic Oncology Journal of Gynecologic Oncology Vol.29 No.5
발행연도
2018.1
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1 - 13 (13page)

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Objective: Palonosetron is effective for the management of acute and delayed chemotherapy-induced nausea and vomiting (CINV). While emetogenic carboplatin-based chemotherapy is widely used to treat gynecologic cancers, few studies have evaluated the antiemetic effectiveness of palonosetron in this setting. Methods: A multicenter, single-arm, open-label phase II trial was conducted to evaluate the safety and effectiveness of palonosetron in controlling CINV in patients with gynecologic cancer. Chemotherapy-naïve patients received intravenous palonosetron (0.75 mg/body) and dexamethasone before the infusion of carboplatin-based chemotherapy on day 1. Dexamethasone was administered (orally or intravenously) on days 2–3. The incidence and severity of CINV were evaluated using the patient-completed Multinational Association of Supportive Care in Cancer Antiemesis Tool and treatment diaries. The primary endpoint was the proportion of patients experiencing complete control (CC) of vomiting, with “no rescue antiemetic medication” and “no clinically significant nausea” or “only mild nausea” in the delayed phase (24–120 hours post-chemotherapy). Secondary endpoints were the proportion of patients with a complete response (CR: “no vomiting” and “no rescue antiemetic medication”) in the acute (0–24 hours), delayed (24–120 hours), and overall (0–120 hours) phases, and CC in the acute and overall phases. Results: Efficacy was assessable in 77 of 80 patients recruited. In the acute and delayed phases, the CR rates the primary endpoint, were 71.4% and 59.7% and the CC rates, the secondary endpoint, were 97.4% and 96.1%, respectively. Conclusion: While palonosetron effectively controls acute CINV, additional antiemetic management is warranted in the delayed phase after carboplatin-based chemotherapy in gynecologic cancer patients (Trial registry at UMIN Clinical Trials Registry, UMIN000012806).

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