Tropisetron (Navoban) in the prevention of chemotherapy-induced nausea and vomiting — the Nordic experience

Abstract

An open,noncomparative, Nordic multicenter study was carried out during 1991–1992 to evaluate the 5-HT₃ receptor antagonist tropisetron (Navoban) as an antiemetic agent for various types of cancer chemotherapy. A total of 630 patients were recruited from 15 centers in Sweden, Denmark, and Finland. Gynecological cancers (60%), breast cancer (15%), and lung cancer (10%) were the main diagnoses. Prior experience of chemotherapy was documented in 338 patients (54%). In 260 patients (41%), cisplatin was part of the cytostatic regimen. Carboplatin (23%), doxorubicin (27%), and epidoxorubicin (24%) were also frequently included. In all, 23 cytostatic agents were used in various combinations. The mean number of courses studied was 4.6 (range 1–19). Altogether, 394 of 619 evaluable patients (64%) were completely protected from acute nausea and vomiting during the first course of chemotherapy. Delayed nausea and vomiting were completely prevented in 45%–73% (days 2–6) in the complete series. Treatment efficacy remained stable (60%–79%) during ten consecutive courses of chemotherapy. With noncisplatin regimens, complete protection from acute nausea and vomiting was achieved in 72% compared with 52% for cisplatin regimens (P<0.0001). Patients without prior experience of chemotherapy had higher control rates of acute nausea and vomiting (72%) compared to patients treated before (57%) during the first course,but not later on. There were no differences in delayed nausea and vomiting. Sex and age were significant prognostic factors with regard to antiemetic response. Adverse events were recorded in 19%–37% of the cases during long-term follow-up. Headache (18%) and constipation (8%) were most frequent. The side effects were mild, however, and tropisetron (Navoban) was a safe drug and was well tolerated by the patients.