Optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with modified FOLFOX6: a randomized pilot study

  • Chemotherapy. 2012;58(6):439-44. doi: 10.1159/000345920.
Hiroshi Nakatsumi  1 ,  Yoshito Komatsu ,  Satoshi Yuki ,  Susumu Sogabe ,  Miki Tateyama ,  Shuichi Muto ,  Mineo Kudo ,  Kanji Kato ,  Takuto Miyagishima ,  Minoru Uebayashi ,  Takashi Meguro ,  Koji Oba ,  Masahiro Asaka
Affiliations
  • 1. Department of Internal Medicine, Wakkanai City Hospital, Wakkanai, Hokkaido 097-8555, Japan. [email protected]
PMID: 23364217 DOI: 10.1159/000345920
Abstract

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 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 interval (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 preventing nausea and vomiting induced by mFOLFOX6.

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