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Japanese Journal of Clinical Oncology Advance Access originally published online on April 24, 2009
Japanese Journal of Clinical Oncology 2009 39(7):443-448; doi:10.1093/jjco/hyp036
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© The Author (2009). Published by Oxford University Press. All rights reserved

Randomized Controlled Study Comparing Two Doses of Intravenous Granisetron (1 and 3 mg) for Acute Chemotherapy-induced Nausea and Vomiting in Cancer Patients: A Non-inferiority Trial

Masahito Yonemura1, Noriyuki Katsumata2, Hironobu Hashimoto1, Shoko Satake1, Masayuki Kaneko3, Yuka Kobayashi1, Atsuo Takashima2, Yasuhisa Kato1, Masahiro Takeuchi3, Yasuhiro Fujiwara2, Hiroshi Yamamoto1 and Taisuke Hojo1

1 Department of Pharmacy, National Cancer Center Hospital
2 Breast and Medical Oncology Division, National Cancer Center Hospital
3 Division of Biostatistics, School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan

For reprints and all correspondence: Masahito Yonemura, Department of Pharmacy, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: myonemur{at}ncc.go.jp

Received December 21, 2008; accepted March 18, 2009

Objective: The aim of this study was to assess the non-inferiority of 1 mg to 3 mg granisetron (GRN) injection for the treatment of acute chemotherapy-induced nausea and vomiting (CINV) and to evaluate the tolerability of GRN given at 1 mg in Japanese cancer patients.

Methods: Patients with cancer receiving highly emetogenic chemotherapy were enrolled in this single-blind randomized controlled study. Patients were randomly assigned to receive GRN at a single dose of 1 or 3 mg. The primary endpoint was the rate of complete protection from emetic events (no vomiting, no retching and no need for rescue medication) during the first 24 h following the initiation of chemotherapy.

Results: There were 89 patients in the 1 mg group and 90 patients in the 3 mg group. Complete protection was achieved in 70 patients (78.7%) in the 1 mg group and 73 (81.1%) patients in the 3 mg group. The one-sided test did not reveal non-inferiority of either dose of GRN to the other at a 5% significance level.

Conclusions: Our data failed to show the non-inferiority of 1 mg of GRN to 3 mg of GRN administered as a single dose. However, the rate of complete protection from nausea and vomiting was similar in the two groups. Given the recommended dosage in the guidelines and the economic need for reduction of medical care expenses in Japan, prophylactic administration of GRN at 1 mg may be an appropriate, alternative treatment for acute CINV in cancer patients.

Key Words: granisetron • serotonin antagonist • antiemetic • vomiting • non-inferiority trial


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