Phase II trial of i.v. vinorelbine and cisplatin in inoperable locally advanced or disseminated nonsmall-cell lung cancer: The South African experience

Purpose: This multicentre phase II trial was conducted in South Africa to e valuate the activity of a combination of vinorelbine, administered in a Mew schedule, and cisplatin, in chemonaive patients with advanced non-small-ce ll lung cancer (NSCLC). Patients and Methods: Between September 1995 and December 1996 35 patients were enrolled. All patients had at least one bidimensionally measurable les ion. Vinorelbine was administered intravenously on day 1 and day 8 at a dos e of 30 mg/m(3) and cisplatin was administered intravenously on day 1 at a dose of 100 mg/m(2). The chemotherapy cycle was repeated every three weeks. Results: Of 35 evaluable patients, 14 (40%) achieved a response tone comple te response and 13 partial responses). The median time to progression was 6 .4 months (range 12-572 days) and the median survival was 15.7 months (rang e 12-882+ days). One-year survival was 56%. Toxicity was manageable and con sisted of nausea and vomiting (grade 3 in 45% of patients) and grade 3-4 ne utropenia seen in 13 patients with three patients experiencing grade 3 infe ction. Other side-effects were mild, including constipation grade 3 in 9.1% . A total of 153 courses were administered with patients receiving a median dose intensity of 81.7% for vinorelbine, while that of cisplatin was 74.1% . Conclusion: The combination of vinorelbine and cisplatin demonstrated subst antial activity in terms of objective response and survival with manageable side-effects in patients with advanced NSCLC. These findings confirm the data from previous randomised studies. Further s tudies are ongoing in order to evaluate the efficacy of this combination in the neoadjuvant and adjuvant setting.