Service d’oncologie, hôpital Pitié-Salpêtrière, 47 boulevard de l’Hôpital, 75013 Paris, France, Service de pneumologie et réanimation respiratoire, hôpital Pitié Salpêtrière, Paris, France, Clinique Hartmann, Neuilly sur Seine, France, Aventis Pharma, Antony Cedex, France
In this phase II study, the feasibility and efficacy of sequential chemotherapy were tested with agents shown to be active as monotherapy. Patients with chemotherapy-naïve, locally advanced or metastatic non-small cell lung cancer were selected for the study. Treatment involved four cycles of docetaxel (100 mg/m
2 on day 1, every 3 weeks) (sequence A), followed by four cycles of cisplatin–vindesine (cisplatin 120 mg/m
2 on day 1 and vindesine 3 mg/m
2 on days 1, 8, 15, and 22, every 4 weeks) (sequence B). Responding patients received 3 cycles of docetaxel 100 mg/m
2 (day 1, every 3 weeks) as consolidation (sequence C). Thirty-two patients entered the study with thirty being evaluable for efficacy. Four patients showed a partial response and one patient a complete response, resulting in an objective response rate of 16.7 %. The median survival time (intent-to-treat) was 11 months (95 %CI = 8.0–15.4 months) with an estimated 1-year survival rate of 47%. The median time to progression was 17.6 weeks in the evaluable population. Main grade 4 toxicity was neutropenia (21.8 % and 68.2 % of patients in sequence A and B, respectively) while grade 3 peripheral neuropathy was documented in five patients during sequence B. There were no treatment-related deaths. Sequential chemotherapy may show promise for the treatment of advanced non-small cell lung cancer. Given the feasibility of this pilot study, sequential chemotherapy concept should be investigated with newer cisplatin-based regimens using this approach in larger prospective studies.