Docetaxel and irinotecan as first-line chemotherapy in patients with advanced non-small-cell lung cancer: a pilot study.

Aims: The aim of this study is to evaluate the activity and toxicity of the combination docetaxel and irinotecan as first-line therapy for advanced non-small-cell lung cancer (NSCLC).
Materials & Methods: Twenty-two chemotherapy-naive patients with stage IIIB with pleural effusion or stage IV NSCLC received irinotecan 50 mg/m2 on days 1, 8, and 15, and docetaxel 50 mg/m2 on day 2, every 28 days until disease progression.
Results: Median follow-up was 10 months (range: 2-28 months). The overall response rate was 36.4% (8/22 patients; 95% confidence interval: 16.8-56.0), with no complete responses. Median time to disease progression was 5 months (range: 1-24 months) and median overall survival was 10 months (range: 2-28). Grade 3-4 diarrhea was observed in 2 patients (9.1%). Grade 3-4 neutropenia occurred in 2 patients (9.1%): 1 episode of febrile neutropenia in one patient, and 1 death due to neutropenic sepsis in another patient. One patient received transfusion for grade 4 anemia.
Conclusions: Irinotecan showed a moderate response rate and overall survival of clinical interest. Diarrhea was the main toxicity. This regimen may be suitable for patients unable to tolerate cisplatin-based therapy, for elderly and/or for patients with poor performance status, and should be investigated in a larger trial.