Randomised trial for the prevention of delayed emesis in patients receiving high-dose cisplatin.
Despite recent advances in control of acute emesis following cisplatin-based chemotherapy regimens, delayed emesis remains a significant cause of treatment-related morbidity and factors associated with delayed emesis have not yet been evaluated. A prospective randomised trial was conducted to compare the efficacy and toxicity of granisetron, dexamethasone plus prochlorperazine with granisetron alone in controlling cisplatin-induced delayed emesis and to identify the important factors that influence its occurrence and severity. Seventy cisplatin-naive patients with inoperable solid tumors participated in the trial. Patients who received 80 mg m-2 or 100 mg m-2 of cisplatin were randomly assigned to receive either granisetron 40 micrograms kg-1 intravenously (i.v.) on day 1, dexamethasone 20 mg i.v. on days 2 and 3 and prochlorperazine 5 mg orally thrice daily on days 1-5 or granisetron 40 micrograms kg-1 i.v. on day 1 alone. There was no difference in their acute antiemetic efficacy. A combination regimen was more effective than granisetron alone in preventing delayed symptoms, with superior rates of complete plus major responses of 77% vs 51% (P = 0.0460). Treatment arm was the only determinant factor for the occurrence of delayed emesis (P = 0.0101).
Matsui
K
K
Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Japan.
Fukuoka
M
M
Takada
M
M
Kusunoki
Y
Y
Yana
T
T
Tamura
K
K
Yoshida
T
T
Iida
K
K
Hirashima
T
T
Tsukada
H
H
Ushijima
S
S
Miyawaki
H
H
Masuda
N
N
D006916:5-Hydroxytryptophan / Q000037:antagonists & inhibitors; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000556:secondary; D018288:Carcinoma, Small Cell / Q000188:drug therapy / Q000556:secondary; D016009:Chi-Square Distribution; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D003110:Colonic Neoplasms / Q000188:drug therapy; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D017829:Granisetron / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007275:Injections, Intravenous; D016015:Logistic Models; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011346:Prochlorperazine / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control*
D006916:5-Hydroxytryptophan; D000932:Antiemetics; D000970:Antineoplastic Agents; D002945:Cisplatin; D003907:Dexamethasone; D004338:Drug Combinations; D017829:Granisetron; D011346:Prochlorperazine