• Yosuke Ikari, Kentaro Ogata, Yuta Nakashima, Eiichi Sato, Michio Masaki, Hiroo Katsuya, Toshitaka Goto, Toshihiro Tanaka, Kenji Ishitsuka, Yasushi Takamatsu, Shuuji Hara, and Kazuo Tamura.
• Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, School of Medicine, Fukuoka University, Nanakuma, Jyonan-ku, Fukuoka, Japan, yoikari@fukuoka-u.ac.jp.
• Support Care Cancer. 2014 Jul 1; 22 (7): 1959-64.

PurposeThe aims of this study were to evaluate the safety, efficacy, and pharmacokinetics of repeated doses of palonosetron 0.75 mg on days 1 and 3 in Japanese patients who received highly or moderately emetogenic chemotherapy.MethodsTwenty- six patients received palonosetron 0.75 mg intravenously before chemotherapy on days 1 and 3 plus dexamethasone (12-16 mg before chemotherapy on day 1 and 4-8 mg on days 2 and 3). The primary endpoints were safety and pharmacokinetics. Pharmacokinetics were evaluated in a subset of patients (n=6). Complete response and complete protection were evaluated as secondary endpoints.ResultsThe accumulation ratios for C max and AUClast after the second dose on day 3 were 1.42 and 1.37, respectively. These values were consistent with the theoretical values expected from the half-life of palonosetron on day 1. Almost all of the patients had no nausea or vomiting in the acute phase (complete response (CR) rate, 96.2% [25/26]; CP rate, 92.3% [24/26]). In the delayed phase (24-192 h post-chemotherapy), the complete response and complete protection rates were 76.9% (20/26) and 61.5% (16/26), respectively. Treatment was well tolerated.ConclusionsThis is the first study to report the pharmacokinetics of multiple doses of palonosetron 0.75 mg, given on days 1 and 3, in Japanese patients. Repeated treatment with palonosetron was safe and well tolerated by patients who received highly or moderately emetogenic anticancer chemotherapy.

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