KMID : 1137020180290050077
|
|
Journal of Gynecologic Oncology 2018 Volume.29 No. 5 p.77 ~ p.77
|
|
Efficacy of palonosetron plus dexamethasone in preventing chemotherapy-induced nausea and emesis in patients receiving carboplatin-based chemotherapy for gynecologic cancers: a phase II study by the West Japan Gynecologic Oncology Group (WJGOG 131)
|
|
Nishio Shin
Aihara Satomi Shimokawa Mototsugu Fujishita Akira Taniguchi Shuichi Hachisuga Toru Yanazume Shintaro Kobayashi Hiroaki Murakami Fumihiro Numa Fumitaka Kotera Kohei Okura Naofumi Toki Naoyuki Yokoyama Masatoshi Ushijima Kimio
|
|
Abstract
|
|
|
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-naive 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).
|
|
KEYWORD
|
|
Palonosetron, Carboplatin, Nausea, Vomiting, Gynecologic Neoplasm
|
|
FullTexts / Linksout information
|
|
|
|
Listed journal information
|
|
|
|