Optimal Dose Period for Indisetron Tablets for Preventing Chemotherapy-Induced Nausea and Vomiting with Modified FOLFOX6: A Randomized Pilot Study

Background: Indisetron is a serotonin (5-hydroxytryptamine type 3) receptor antagonist that also antagonizes 5-hydroxytryptamine type 4 receptors. We designed a pilot study in order to explore the optimal dosing period for indisetron during modified FOLFOX6 (mFOLFOX6). Patients and Methods: Forty-two chemotherapy-naive patients with advanced colorectal cancer scheduled to receive mFOLFOX6 were randomly assigned to either a 1or 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 interReceived: 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 D ow nl oa de d by : 54 .7 0. 40 .1 1 12 /2 5/ 20 17 1 :3 6: 07 P M