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Annals of Oncology 15:410-418, 2004
© 2004 European Society for Medical Oncology

Original Paper

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

Received 24 July 2003; revised 27 October 2003; accepted 19 December 2003

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 IIIB or IV NSCLC were randomized to receive gemcitabine 1000 mg/m2 on days 1 and 8, plus either irinotecan 100 mg/m2 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-naïve advanced NSCLC. The survival data with the combination gemcitabine–docetaxel are promising. Gemcitabine–docetaxel combination therapy 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.

C. M. Rocha Lima1,*, N. A. Rizvi2, C. Zhang3, J. E. Herndon, 2nd3, J. Crawford4, R. Govindan6, G. W. King6 and M. R. Green7

1 University of Miami and Sylvester Cancer Center, Miami, FL; 2 Memorial Sloan-Kettering Cancer Center, New York, NY; 3 CALGB Statistical Center, Durham, NC; 4 Duke University Medical Center, Durham, NC; 5 Washington University School of Medicine, St Louis, MO; 6 Cancer Centers of the Carolinas, Greenville, SC; 7 Medical University of South Carolina, Charleston, SC, USA

Key words: CALGB 39809, docetaxel, gemcitabine, irinotecan, non-small cell lung cancer


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