Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC

C. M.S. Rocha Lima, N. A. Rizvi, C. Zhang, II E. Herndon, J. Crawford, R. Govindan, G. W. King, M. R. Green

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24 Scopus citations


Background: To evaluate the activity and tolerability of gemcitabine plus irinotecan or docetaxel as first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Patients and methods: Eligible patients with chemotherapy-naïve stage IIIIB or IV NSCLC were randomized to receive gemcitabine 1000 mg/m2 on days 1 and 8, plus either irinotecan 100 mg/m 2 or docetaxel 40 mg/m2 on days 1 and 8. Treatment was administered every 3 weeks. Results: Of the 80 enrolled patients with stage IIIB or IV NSCLC, 78 were evaluable for activity and safety. Overall response rates, consisting of partial responses, were 12.8% [95% confidence interval (CI) 4% to 35%] for gemcitabine-irinotecan and 23.1% (95% CI 10% to 42%) for gemcitabine-docetaxel. Median overall survival was 7.95 months (95% CI 5.2-10.2) and 12.8 months (95% CI 7.9-17.1) for gemcitabine-irinotecan and gemcitabine-docetaxel, respectively. The corresponding estimated 1-year survivals were 23% and 51%, respectively. The 2-year survival rate in arm A (gemcitabine-irinotecan) is not currently estimable. The 2-year survival rate for arm B (gemcitabine-docetaxel) is 22% (95% CI 6% to 37%). Both combinations were well tolerated; the most common hematological toxicity was neutropenia, which occurred in 26% of patients in each treatment arm. Conclusions: These results suggest that gemcitabine plus docetaxel or irinotecan is well tolerated in patients with chemotherapy-naäve advanced NSCLC. The survival data with the combination gemcitabine-docetaxel are promising. Gemcitabine-docetaxeltheraphy may be particularly useful for patients who have experienced toxicities with a platinum regimen or in patients who may be more susceptible to platinum-related toxicity.

Original languageEnglish
Pages (from-to)410-418
Number of pages9
JournalAnnals of Oncology
Issue number3
StatePublished - Mar 2004


  • CALGB 39809
  • Docetaxel
  • Gemcitabine
  • Irinotecan
  • Non-small cell lung cancer


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