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

Publication ,  Journal Article
Rocha Lima, CM; Rizvi, NA; Zhang, C; Herndon, JE; Crawford, J; Govindan, R; King, GW; Green, MR; Cancer Leukemia Group B,
Published in: Ann Oncol
March 2004

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.

Duke Scholars

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Published In

Ann Oncol

DOI

ISSN

0923-7534

Publication Date

March 2004

Volume

15

Issue

3

Start / End Page

410 / 418

Location

England

Related Subject Headings

  • Treatment Outcome
  • Taxoids
  • Survival Rate
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lung Neoplasms
  • Irinotecan
  • Humans
 

Citation

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ICMJE
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Rocha Lima, C. M., Rizvi, N. A., Zhang, C., Herndon, J. E., Crawford, J., Govindan, R., … Cancer Leukemia Group B, . (2004). Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol, 15(3), 410–418. https://doi.org/10.1093/annonc/mdh104
Rocha Lima, C. M., N. A. Rizvi, C. Zhang, J. E. Herndon, J. Crawford, R. Govindan, G. W. King, M. R. Green, and M. R. Cancer Leukemia Group B. “Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC.Ann Oncol 15, no. 3 (March 2004): 410–18. https://doi.org/10.1093/annonc/mdh104.
Rocha Lima CM, Rizvi NA, Zhang C, Herndon JE, Crawford J, Govindan R, et al. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol. 2004 Mar;15(3):410–8.
Rocha Lima, C. M., et al. “Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC.Ann Oncol, vol. 15, no. 3, Mar. 2004, pp. 410–18. Pubmed, doi:10.1093/annonc/mdh104.
Rocha Lima CM, Rizvi NA, Zhang C, Herndon JE, Crawford J, Govindan R, King GW, Green MR, Cancer Leukemia Group B. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol. 2004 Mar;15(3):410–418.
Journal cover image

Published In

Ann Oncol

DOI

ISSN

0923-7534

Publication Date

March 2004

Volume

15

Issue

3

Start / End Page

410 / 418

Location

England

Related Subject Headings

  • Treatment Outcome
  • Taxoids
  • Survival Rate
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lung Neoplasms
  • Irinotecan
  • Humans