PREVENTION OF ACUTE EMESIS IN CANCER-PATIENTS FOLLOWING HIGH-DOSE CISPLATIN WITH THE COMBINATION OF ORAL DOLASETRON AND DEXAMETHASONE

Purpose: Dolasetron is a 5-HT3 antagonist antiemetic with active oral and intravenous formulations. The effects of this class are enhanced w hen combined with dexamethasone. This study tested the ability of the combination of oral dolasetron 200 mg and oral dexamethasone 20 mg to prevent acute emesis in cancer patients receiving initial cisplatin at doses greater than or equal to 70 mg/m(2). Additionally, patients wer e randomly assigned to receive a second dosage of the regimen 16 hours later to improve control of acute symptoms. Patients and Methods: A t otal of 75 patients were entered, with 38 randomized to the two-dose r egimen, Thirty-five percent were women and 77% had lung cancer. Result s: Overall, the regimen prevented acute vomiting in 76% (95% confidenc e interval, 65% to 85%), including 74% of 35 patients who received cis platin at doses greater than or equal to 100 mg/m(2). There was no obs erved difference in emesis prevention between the one-dose (76%) and t wo-dose (76%) regimens (95% confidence interval for the difference, -2 0% to 19%). The median rime to the onset of emesis was 19 hours for th e one-dose regimen and 17 hours for the two-dose regimen in those pati ents with emesis. Headache occurred in 11% who received one dose and 1 6% who received two doses. Conclusion: The combination of oral dolaset ron 200 mg and dexamethasone 20 mg given only once prevented acute eme sis in 76% of patients who received cisplatin greater than or equal to 70 mg/m(2). Administration of a second dose of the regimen did not im prove the observed prevention rate or delay the time to emesis. This o ne-dose oral regimen has comparable or better effectiveness than repor ted results of intravenous combination regimens in preventing cisplati n-induced vomiting and merits further study and use. (C) 1997 by Ameri can Society of Clinical Oncology.