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

Journal: Chemotherapy 2013;58(6):439-44

PMID: 23364217

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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.

Address: Department of Internal Medicine, Wakkanai City Hospital, Wakkanai, Hokkaido 097-8555, Japan. [email protected]

DOI: 10.1159/000345920