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

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.

• Authors: 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 (Chemotherapy) Vol. 58 Issue 6 Pg. 439-44 ( 2012) ISSN: 1421-9794 [Electronic] Switzerland
• PMID: 23364217 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 S. Karger AG, Basel.

Chemical References

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

Topics

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