A double-blind, crossover, randomized comparison of granisetron and ramosetron for the prevention of acute and delayed cisplatin-induced emesis in patients with gastrointestinal cancer: is patient preference a better primary endpoint?
BACKGROUND
Serotonin receptor antagonists are recommended by the American Society of Clinical Oncology for the prevention of acute and delayed chemotherapy-induced emesis. However, the most effective agent in this class of antiemetic drugs for preventing emesis has not been clearly defined. We therefore performed a double-blind, crossover, randomized, controlled trial comparing the efficacy of granisetron and ramosetron, using patient preference as the primary endpoint.


METHODS
Thirty patients receiving two courses of combined chemotherapy (including > or =60 mg/m(2) cisplatin) for gastric or esophageal cancer were randomly assigned to the granisetron-ramosetron group (treatment phase 1: granisetron, 3 mg; treatment phase 2: ramosetron, 0.3 mg) or the ramosetron-granisetron group (treatment phase 1: ramosetron, 0.3 mg; treatment phase 2: granisetron, 3 mg). All patients received methylprednisolone sodium, 250 mg i.v., during each treatment phase.


RESULTS
The efficacy of granisetron and ramosetron was similar in terms of the suppression of emesis and appetite status. However, the majority of patients (19/30, 63.3%) expressed a preference for granisetron, as compared with 9 patients (30.0%) who preferred ramosetron; 2 patients (6.7%) had no preference (chi(2) test: p = 0.008; Fisher's exact test: p = 0.015).


CONCLUSIONS
(1) A significant proportion of patients prefer granisetron over ramosetron for the prevention of chemotherapy-induced emesis. (2) Granisetron and ramosetron possess similar effectiveness for the suppression of emesis. (3) The variable of 'patient preference' should be accepted as a primary endpoint of antiemetic drug efficacy.
Koizumi
Wasaburo
W
Department of Gastroenterology, East Hospital, Kitasato University, Sagamihara, Kanagawa, Japan. Koizumi@med.kisato-u.ac.jp
Tanabe
Satoshi
S
Nagaba
Shizuka
S
Higuchi
Katsuhiko
K
Nakayama
Norisuke
N
Saigenji
Katsunori
K
Nonaka
Miwa
M
Yago
Kazuo
K
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000494:pharmacology* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000494:pharmacology* / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects* / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D023381:Endpoint Determination; D004938:Esophageal Neoplasms / Q000188:drug therapy; D005260:Female; D017829:Granisetron / Q000494:pharmacology* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control*
D000932:Antiemetics; D000970:Antineoplastic Agents; D001562:Benzimidazoles; D002945:Cisplatin; D017829:Granisetron; C071315:ramosetron