Phase II randomized multicenter study evaluating a treatment regimen alternating docetaxel and cisplatin-vinorelbine with a cisplatin-vinorelbine control group in patients with stage IV non-small-cell lung cancer: GFPC 97.01 study.

Background: The potential absence of cross-resistance between cisplatin and docetaxel in non-small-cell lung cancer (NSCLC) suggests that alternating regimens of cisplatin-based chemotherapy and docetaxel might increase the activity of chemotherapy in stage IV NSCLC. Patients and methods: Randomized, multicenter, non-comparative phase 11 study in patients with stage IV NSCLC (Eastern Cooperative Oncology Group performance status of 0-2). Patients randomized to alternating treatment group (A) received docetaxel 100 mg/m(2) on days (D) 1 and 43 alternating with cisplatin 100 mg/m(2) on D22 and vinorelbinc 30 mg/m(2) on D22, D29 and D36. Those randomized to the control group (13) received cisplatin 80 mg/m(2) on D1, D22 and D43 and vinorelbine 30 mg/m(2) once a week from D1 to D57. Treatment was continued for a further 6 weeks in the event of objective response or stabilization. Results: seventy patients were enrolled (group A: 38, group B: 32). More premature treatment discontinuations due to toxicity were observed in group A (,median number of cycles: 3) than in group 8 (median number of cycles: 5). The intention-to-treat objective response rate was 10.8% [95% confidence interval (CI) 0.8% to 20.8%] in group A compared with 25% (95% CI 107( to 4017() in group B, the median time to treatment failure being 10.2 weeks and 17.3 weeks, respectively. The median survival and 1-year survival were 29.1 weeks and 39% in group A compared with 41.6 weeks and 42% in group B. Febrile neutropenia occurred in 5.9 and 4.9% of the cycles in group A and group R, respectively. Non-hematological toxicity was moderate in the two groups. Conclusions: The addition of docetaxel alternating with cisplatin-vinorelbine did not enhance the activity of this combination. The development of sequential regimens might be a more promising way of exploiting the absence of cross-resistance between these two drugs.