Safety and pharmacokinetic evaluation of repeated intravenous administration of palonosetron 0.75?mg in patients receiving highly or moderately emetogenic chemotherapy

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• 作者：Yosuke Ikari (1)
  Kentaro Ogata (2)
  Yuta Nakashima (1)
  Eiichi Sato (1)
  Michio Masaki (1)
  Hiroo Katsuya (1)
  Toshitaka Goto (1)
  Toshihiro Tanaka (1)
  Kenji Ishitsuka (1)
  Yasushi Takamatsu (1)
  Shuuji Hara (2)
  Kazuo Tamura (1)
  
• 关键词：Palonosetron ; Multiple ; day chemotherapy ; Antiemetics ; Chemotherapy ; induced nausea and vomiting ; Pharmacokinetics
• 刊名：Supportive Care in Cancer
• 出版年：2014
• 出版时间：July 2014
• 年：2014
• 卷：22
• 期：7
• 页码：1959-1964
• 全文大小：
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  7. Giralt SA, Mangan KF, Maziarz RT, Bubalo JS, Beveridge R, Hurd DD, Mendoza FL, Rubenstein EB, DeGroot TJ, Schuster MW (2010) Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation. Ann Oncol 22(4):939-46 CrossRef
  8. Musso M, Scalone R, Bonanno V, Crescimanno A, Polizzi V, Porretto F, Bianchini C, Perrone T (2009) Palonosetron (Aloxi) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy. Support Care Cancer 17(2):205-09 CrossRef
  9. Maemondo M, Masuda N, Sekine I, Kubota K, Segawa Y, Shibuya M, Imamura F, Katakami N, Hida T, Takeo S, PALO Japanese Cooperative Study Group (2009) A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Ann Oncol 20(11):1860-866 CrossRef
  10. Segawa Y, Aogi K, Inoue K, Sano M, Sekine I, Tokuda Y, Isobe H, Ogura T, Tsuboi M, Atagi S, PALO Japanese Cooperative Study Group (2009) A phase II dose-ranging study of palonosetron in Japanese patients receiving moderately emetogenic chemotherapy, including anthracycline and cyclophosphamide-based chemotherapy. Ann Oncol 20(11):1874-880 CrossRef
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• 作者单位：Yosuke Ikari (1)
  Kentaro Ogata (2)
  Yuta Nakashima (1)
  Eiichi Sato (1)
  Michio Masaki (1)
  Hiroo Katsuya (1)
  Toshitaka Goto (1)
  Toshihiro Tanaka (1)
  Kenji Ishitsuka (1)
  Yasushi Takamatsu (1)
  Shuuji Hara (2)
  Kazuo Tamura (1)
  
  1. Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, School of Medicine, Fukuoka University, Nanakuma, Jyonan-ku, Fukuoka, Japan
  2. Faculty of Pharmaceutical Science, Fukuoka University, Fukuoka, Japan
  
• ISSN：1433-7339

文摘

Purpose The 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. Methods Twenty- six patients received palonosetron 0.75?mg intravenously before chemotherapy on days 1 and 3 plus dexamethasone (12-6?mg before chemotherapy on day 1 and 4-?mg on days 2 and 3). The primary endpoints were safety and pharmacokinetics. Pharmacokinetics were evaluated in a subset of patients (n--). Complete response and complete protection were evaluated as secondary endpoints. Results The 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 (24-92?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. Conclusions This 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.