Annals of Oncology 13:742-747, 2002
© 2002 European Society for Medical Oncology
Original Paper |
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
1Groupe Français de Pneumo-Cancérologie, Hôpital de la Croix-Rousse, Lyon; 2Laboratoires Aventis, Paris; 3Department of Biostatistics, Université Lyon, Lyon, France
Received 16 July 2001; revised 13 November 2001; accepted 5 December 2001.
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 II 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/m2 on days (D) 1 and 43 alternating with cisplatin 100 mg/m2 on D22 and vinorelbine 30 mg/m2 on D22, D29 and D36. Those randomized to the control group (B) received cisplatin 80 mg/m2 on D1, D22 and D43 and vinorelbine 30 mg/m2 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 B (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 10% to 40%) 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 B, 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.
Key words: chemotherapy, metastatic disease, non-small-cell lung cancer
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