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).


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.


CONCLUSIONS
Both 1- and 3-day indisetron regimens were feasible for preventing nausea and vomiting induced by mFOLFOX6.
Department of Internal Medicine, Wakkanai City Hospital, Wakkanai, Hokkaido 097-8555, Japan. tsumi1979@gmail.com
Hiroshi
H
Nakatsumi
Yoshito
Y
Komatsu
Satoshi
S
Yuki
Susumu
S
Sogabe
Miki
M
Tateyama
Shuichi
S
Muto
Mineo
M
Kudo
Kanji
K
Kato
Takuto
T
Miyagishima
Minoru
M
Uebayashi
Takashi
T
Meguro
Koji
K
Oba
Masahiro
M
Asaka
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000473:pathology; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D010865:Pilot Projects; D011720:Pyrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D058832:Serotonin 5-HT4 Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000932:Antiemetics; D001952:Bridged-Ring Compounds; D009944:Organoplatinum Compounds; D011720:Pyrazoles; D058831:Serotonin 5-HT3 Receptor Antagonists; D058832:Serotonin 5-HT4 Receptor Antagonists; C500220:indisetron hydrochloride; D002955:Leucovorin; D005472:Fluorouracil