Phase II study with vinorelbine and cisplatin in advanced non-small cell lung cancer after failure of previous chemotherapy.

Background: We conducted a phase II study of vinorelbine and cisplatin chemotherapy in non-small cell lung cancer (NSCLC) patients who had failed previous chemotherapy, to assess the response and toxicity of this combination chemotherapy.
Methods: Twenty-two patients were enrolled from September 1999 to March 2001. The median age was 70 years. All patients had a performance status of 2. Vinorelbine was administered on days 1, 8 and 15, at a dose of 20 mg/m2; and cisplatin was given on day 1 at a dose of 50 mg/m2, every 4 weeks.
Results: Sixty-eight cycles of treatment were given, with a median of 3 cycles. All patients were evaluable for toxicity profile, and 21 patients were evaluable for response rate. The major toxicity was myelosuppression. Grade 3 or 4 neutropenia occurred in 40.9% of the patients, and grade 3 or 4 anemia occurred in 13.6% of the patients during treatment. Uneventful febrile neutropenia occurred in 1 patient. Other toxicities were few and mild in severity. After 2 cycles of treatment, 2 of 21 patients (9.5%) had a partial response (95% confidence interval 0%-22%). The median time of disease progression was 3.7 months, the median survival was 7.6 months, and the one-year survival was 12.3%. Median survival was 8.7 and 4.9 months in those patients receiving this treatment as second-line and > or = third-line chemotherapy, respectively.
Conclusions: Vinorelbine and cisplatin salvage chemotherapy produced a modest anti-tumor response, a mild toxicity profile, and reasonable survival in our elderly NSCLC patients with a poor performance status. This regimen deserves further study in elderly NSCLC patients who have failed previous chemotherapy.