A Phase II Trial of Docetaxel and Ifosfamide for Patients with Platinum-Resistant or Refractory Non-Small Cell Lung Cancer in a Salvage Setting

Purpose: We conducted a phase II study of docetaxel and ifosfamide chemotherapy for patients with platinumresistant or refractory non-small-cell lung cancer (NSCLC) to evaluate the response and toxicity profiles as a salvage treatment. Materials and Methods: Between July 2000 and July 2004, 40 patients who had previously received platinumbased regimen as the first-line or second-line therapy were enrolled in this study. The treatment consisted of a docetaxel 75 mg/ intravenous infusion on day 1 and intravenous ifosfamide 3 g/ with Mesna uroprotectione on day 1 through 3. This regimen was repeated every 3 weeks. Results: One hundred thirty cycles of treatment were given, with a median of 3 cycles (range: 2-6 cycles). All the patients were evaluable for the response rate and toxicity profile. The major toxicity was myelosuppression. Grade 3-4 neutropenia occurred in 30 patients (75%) during treatment. Febrile neutropenia occurred in 16 patients (40%). Five of 40 patients (12.5%) had a partial response (95% confidence interval, 3.3-21.7%). The median time to disease progression was 2.65 months (range: 2.02-3.20 months), and the median survival was 5.24 months (range: 2.99-7.49 months). Conclusion: Salvage chemotherapy with docetaxel and ifosfamide showed a low efficacy and a high proportion of severe neutropenia in patients with platinum-resistant or refractory advanced NSCLC.