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Randomised trial for the prevention of delayed emesis in patients receiving high-dose cisplatin.

Author(s): Matsui K, Fukuoka M, Takada M, Kusunoki Y, Yana T, Tamura K, Yoshida T, Iida K, Hirashima T, Tsukada H, Ushijima S, Miyawaki H, Masuda N

Affiliation(s): Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Japan.

Publication date & source: 1996-01, Br J Cancer., 73(2):217-21.

Publication type: Clinical Trial; Randomized Controlled Trial

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).

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