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

Authors: Rocha Lima, C. M. S.; Rizvi, N. A.; Zhang, C.; Herndon, J. E.; Crawford, J.; Govindan, R.; King, G. W.; Green, M. R.
Article Title: Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC
Abstract: 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. © 2004 European Society for Medical Oncology.
Keywords: adult; cancer survival; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; major clinical study; clinical trial; drug activity; drug tolerability; fatigue; neutropenia; diarrhea; dose response; drug safety; drug withdrawal; gemcitabine; combined modality therapy; cancer staging; neoplasm staging; controlled clinical trial; infection; phase 2 clinical trial; anemia; leukopenia; lung non small cell cancer; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; dehydration; camptothecin; cancer mortality; docetaxel; irinotecan; febrile neutropenia; hypokalemia; hyponatremia; depression; multicenter study; thromboembolism; nausea and vomiting; taxoids; motor dysfunction; erythrocyte transfusion; deoxycytidine; sodium; non-small cell lung cancer; hematologic disease; potassium; thrombocyte transfusion; humans; human; male; female; priority journal; article; calgb 39809
Journal Title: Annals of Oncology
Volume: 15
Issue: 3
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2004-03-01
Start Page: 410
End Page: 418
Language: English
DOI: 10.1093/annonc/mdh104
PROVIDER: scopus
PUBMED: 14998842
Notes: Ann. Oncol. -- Cited By (since 1996):18 -- Export Date: 16 June 2014 -- CODEN: ANONE -- Source: Scopus
Citation Impact
MSK Authors
  1. Naiyer A Rizvi
    166 Rizvi