COMPARISON OF 3 TROPISETRON-CONTAINING ANTIEMETIC REGIMENS IN THE PROPHYLAXIS OF ACUTE AND DELAYED CHEMOTHERAPY-INDUCED EMESIS AND NAUSEA

There is still controversy as to what constitutes the optimal therapy for acute and delayed chemotherapy-induced emesis and nausea. We condu cted a three-armed randomized multi-centre study in 193 chemotherapy-n aive patients receiving highly emetogenic chemotherapy inducing both a cute and delayed symptoms (cisplatin greater than or equal to 50 mg/m( 2), carboplatin greater than or equal to 300 mg/m(2), cyclophosphamide greater than or equal to 750 mg/m(2), ifosfamide greater than or equa l to 1.5 g/m(2) on day 1). Group A: 1 x 5 mg tropisetron i.v. on day 1 + 2, then 10 mg p.o. (oral dose now recommended: 5 mg); group B: trop isetron as for A + dexamethasone, 20 mg i.v., on days 1 + 2, then 4 mg i.v./p.o.; group C: tropisetron as for A + metoclopramide, 20 mg i.v. + 2 x 10 mg p.o. on day 1, then 3 x 10 mg p.o. Treatment was continue d for at least 2 days after the end of chemotherapy. Tropisetron + dex amethasone was significantly superior to tropisetron alone both for ac ute (P=0.0064) and delayed (P=0.0053) emesis, Complete control of acut e and delayed emesis (nausea) was achieved in 80% (75%) and 53% (46%) in group A, 97% (90%) and 80% (58%) in group B, and 86% (80%) and 49% (45%) in group C, Patients completely asymptomatic during the whole cy cle accounted for 26% of those in group A, 49% in group B and 28% in g roup C, The most frequent adverse events were constipation (16.6%), he adache (7.3%) and tiredness (7.3%). Once-daily tropisetron + dexametha sone over several days is well tolerated and is a simple means of achi eving further significant improvement in the efficacy of tropisetron a gainst acute and delayed symptoms.