Randomized controlled study comparing two doses of intravenous granisetron (1 and 3 mg) for acute chemotherapy-induced nausea and vomiting in cancer patients: a non-inferiority trial.
OBJECTIVE
The aim of this study was to assess the non-inferiority of 1 mg to 3 mg granisetron (GRN) injection for the treatment of acute chemotherapy-induced nausea and vomiting (CINV) and to evaluate the tolerability of GRN given at 1 mg in Japanese cancer patients.


METHODS
Patients with cancer receiving highly emetogenic chemotherapy were enrolled in this single-blind randomized controlled study. Patients were randomly assigned to receive GRN at a single dose of 1 or 3 mg. The primary endpoint was the rate of complete protection from emetic events (no vomiting, no retching and no need for rescue medication) during the first 24 h following the initiation of chemotherapy.


RESULTS
There were 89 patients in the 1 mg group and 90 patients in the 3 mg group. Complete protection was achieved in 70 patients (78.7%) in the 1 mg group and 73 (81.1%) patients in the 3 mg group. The one-sided test did not reveal non-inferiority of either dose of GRN to the other at a 5% significance level.


CONCLUSIONS
Our data failed to show the non-inferiority of 1 mg of GRN to 3 mg of GRN administered as a single dose. However, the rate of complete protection from nausea and vomiting was similar in the two groups. Given the recommended dosage in the guidelines and the economic need for reduction of medical care expenses in Japan, prophylactic administration of GRN at 1 mg may be an appropriate, alternative treatment for acute CINV in cancer patients.
Yonemura
Masahito
M
Department of Pharmacy, National Cancer Center Hospital, School of Pharmaceutical Sciences, Kitasato University Tokyo, Japan. myonemur@ncc.go.jp
Katsumata
Noriyuki
N
Hashimoto
Hironobu
H
Satake
Shoko
S
Kaneko
Masayuki
M
Kobayashi
Yuka
Y
Takashima
Atsuo
A
Kato
Yasuhisa
Y
Takeuchi
Masahiro
M
Fujiwara
Yasuhiro
Y
Yamamoto
Hiroshi
H
Hojo
Taisuke
T
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D017829:Granisetron / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009367:Neoplasm Staging; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D016037:Single-Blind Method; D015996:Survival Rate; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
D000932:Antiemetics; D017829:Granisetron