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

Hiroshi Nakatsumi; Yoshito Komatsu; Satoshi Yuki; Susumu Sogabe; Miki Tateyama; Shuichi Muto; Mineo Kudo; Kanji Kato; Takuto Miyagishima; Minoru Uebayashi; Takashi Meguro; Koji Oba; Masahiro Asaka

doi:10.1159/000345920

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. Epub 2013 Jan 29.

Authors

Hiroshi Nakatsumi¹, Yoshito Komatsu, Satoshi Yuki, Susumu Sogabe, Miki Tateyama, Shuichi Muto, Mineo Kudo, Kanji Kato, Takuto Miyagishima, Minoru Uebayashi, Takashi Meguro, Koji Oba, Masahiro Asaka

Affiliation

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.

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Aged, 80 and over
Antiemetics / administration & dosage
Antiemetics / therapeutic use*
Antineoplastic Combined Chemotherapy Protocols / adverse effects*
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Bridged-Ring Compounds / administration & dosage
Bridged-Ring Compounds / therapeutic use*
Colorectal Neoplasms / drug therapy
Colorectal Neoplasms / pathology
Drug Administration Schedule
Feasibility Studies
Female
Fluorouracil / adverse effects
Fluorouracil / therapeutic use
Humans
Leucovorin / adverse effects
Leucovorin / therapeutic use
Male
Middle Aged
Nausea / chemically induced
Nausea / prevention & control*
Organoplatinum Compounds / adverse effects
Organoplatinum Compounds / therapeutic use
Pilot Projects
Pyrazoles / administration & dosage
Pyrazoles / therapeutic use*
Serotonin 5-HT3 Receptor Antagonists / administration & dosage
Serotonin 5-HT3 Receptor Antagonists / therapeutic use
Serotonin 5-HT4 Receptor Antagonists / administration & dosage
Serotonin 5-HT4 Receptor Antagonists / therapeutic use
Treatment Outcome
Vomiting / chemically induced
Vomiting / prevention & control*

Substances

Antiemetics
Bridged-Ring Compounds
Organoplatinum Compounds
Pyrazoles
Serotonin 5-HT3 Receptor Antagonists
Serotonin 5-HT4 Receptor Antagonists
indisetron hydrochloride
Leucovorin
Fluorouracil

Supplementary concepts

Folfox protocol