Fax +41 61 306 12 34 E-Mail karger@karger.com www.karger.com Clinical Study Chemotherapy 2012;58:439–444 DOI: 10.1159/000345920 Optimal Dose Period for Indisetron Tablets for Preventing Chemotherapy-Induced Nausea and Vomiting with Modified FOLFOX6: A Randomized Pilot Study Hiroshi Nakatsumi   a, b Yoshito Komatsu   d Satoshi Yuki   b Susumu Sogabe   h Miki Tateyama   i Shuichi Muto   j Mineo Kudo   g Kanji Kato   k Takuto Miyagishima   h Minoru Uebayashi   l Takashi Meguro   e Koji Oba   f Masahiro Asaka   c   a  Department of Internal Medicine, Wakkanai City Hospital, Wakkanai, Departments of b  Gastroenterology, and c  Cancer Preventive Medicine, Hokkaido University Graduate School of Medicine, d  Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, e  Department of Internal Medicine, Hokkaido Gastroenterology Hospital, f  Translational Research and Clinical Trial Center, Hokkaido University Hospital, Hokkaido University, and g  Department of Gastroenterological Medicine, Sapporo Hokuyo Hospital, Sapporo, h  Department of Internal Medicine, Kushiro Rosai Hospital, Kushiro, i  Department of Internal Medicine, Tomakomai Nissho Hospital, and j  Department of Gastroenterological Medicine, Tomakomai City Hospital, Tomakomai, k  Department of Internal Medicine, Iwamizawa Municipal General Hospital, Iwamizawa, and l  Department of Gastroenterological Medicine, Japanese Red Cross Kitami Hospital, Kitami, Japan val (CI) 63.7–97.0] with the 3-day regimen and 81.0% (95% CI 58.1–94.6) with the 1-day regimen. Proportions of patients with complete protection from nausea were 47.6% in each arm (95% CI 25.7–70.2). No rescue therapy rates were 66.7% (95% CI 43.0–85.4) versus 57.1% (95% CI 34.0–78.2). No severe adverse events were observed in either arm. Conclusion: Both 1- and 3-day indisetron regimens were feasible for pre- venting nausea and vomiting induced by mFOLFOX6. Copyright © 2012 S. Karger AG, Basel Introduction Chemotherapy-induced nausea and vomiting (CINV) is one of the most feared adverse events and can reduce the physical and mental status of patients, which may re- sult in deteriorated quality of life or withdrawal from fur- Key Words Indisetron hydrochloride · Chemotherapy-induced nausea and vomiting · FOLFOX · Colorectal cancer Abstract Background: Indisetron is a serotonin (5-hydroxytrypta- mine type 3) receptor antagonist that also antagonizes 5-hy- droxytryptamine type 4 receptors. We designed a pilot study in order to explore the optimal dosing period for indisetron during modified FOLFOX6 (mFOLFOX6). Patients and Meth- ods: Forty-two chemotherapy-naive patients with advanced colorectal cancer scheduled to receive mFOLFOX6 were ran- domly assigned to either a 1- or 3-day indisetron regimen arm. The primary endpoint was complete protection from vomiting. Results: Proportions of patients with complete protection from vomiting were 85.7% [95% confidence inter- Received: July 13, 2012 Accepted after revision: November 18, 2012 Published online: January 29, 2013 Hiroshi Nakatsumi, MD, PhD Department of Internal Medicine Wakkanai City Hospital 4-11-6, Chuo, Wakkanai, Hokkaido 097-8555 (Japan) E-Mail tsumi1979  @  gmail.com © 2012 S. Karger AG, Basel 0009–3157/12/0586–0439$38.00/0 Accessible online at: www.karger.com/che