EFFICACY AND TOLERABILITY OF TROPISETRON AND DEXAMETHASONE IN THE CONTROL OF NAUSEA AND VOMITING INDUCED BY CISPLATIN

A multicentre study was performed at four oncology centres in Sweden, in 160 chemotherapy-naive women, primarily with ovarian or endometrial carcinomas. Abdominal surgery preceded chemotherapy in 146 (91%) women, and another 39 (24%) women had a history of radiotherapy. The chemotherapy regimens contained cisplatin (50-100 mg/m2), in combination with a variety of other agents. In Course 1, all patients received tropisetron (5 mg i.v. Day 1; 5 mg p.o. Days 2-6) and 84% of patients achieved total or partial control of vomiting; 95% of patients achieved total or partial control of nausea during the first 24 hours. Vomiting was least successfully controlled on Day 2 (73% total or partial control) and Days 2-4 for the control of nausea (81, 83, 88% total or partial control, respectively). Patients with partial response in Course 1 (39% of patients) were randomized to addition of dexamethasone or placebo in Course 2. In Course 2, tropisetron plus dexamethasone (Group B2) prevented acute vomiting in 75% of patients, compared with 40% of patients receiving tropisetron plus placebo (Group B1). Over the entire 6 days, there was no vomiting at all in 54% and 20% of B2 and B1 patients, respectively. In Course 2, acute nausea was prevented in 75% of patients (receiving B1) and in 37% of patients (receiving B2). For nausea, over the complete 6 days, the figures were 64% and 3% (p < 0.001). This indicated that patients with incomplete control of emesis in Course 1 benefited from the addition of dexamethasone, provided that it was added for each of the 6 days studied. Tropisetron was well tolerated, both as monotherapy and in combination with dexamethasone. The most frequently reported side effects were headache, constipation and fatigue. The frequency of headache and constipation were lower in the B2 group than in the B1 group.