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

Research output: Contribution to journalArticle

22 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)410-418
Number of pages9
JournalAnnals of Oncology
Volume15
Issue number3
DOIs
StatePublished - Mar 1 2004

Fingerprint

irinotecan
docetaxel
gemcitabine
Non-Small Cell Lung Carcinoma
Confidence Intervals
Platinum
Drug Therapy
Survival
Survival Rate

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Rocha Lima, C. M. S., Rizvi, N. A., Zhang, C., Herndon, II. E., Crawford, J., Govindan, R., ... Green, M. R. (2004). Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Annals of Oncology, 15(3), 410-418. https://doi.org/10.1093/annonc/mdh104

Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. / Rocha Lima, C. M S; Rizvi, N. A.; Zhang, C.; Herndon, II E.; Crawford, J.; Govindan, R.; King, G. W.; Green, M. R.

In: Annals of Oncology, Vol. 15, No. 3, 01.03.2004, p. 410-418.

Research output: Contribution to journalArticle

Rocha Lima, CMS, Rizvi, NA, Zhang, C, Herndon, IIE, Crawford, J, Govindan, R, King, GW & Green, MR 2004, 'Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC', Annals of Oncology, vol. 15, no. 3, pp. 410-418. https://doi.org/10.1093/annonc/mdh104
Rocha Lima CMS, Rizvi NA, Zhang C, Herndon IIE, Crawford J, Govindan R et al. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Annals of Oncology. 2004 Mar 1;15(3):410-418. https://doi.org/10.1093/annonc/mdh104
Rocha Lima, C. M S ; Rizvi, N. A. ; Zhang, C. ; Herndon, II E. ; Crawford, J. ; Govindan, R. ; King, G. W. ; Green, M. R. / Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. In: Annals of Oncology. 2004 ; Vol. 15, No. 3. pp. 410-418.
@article{d0d4ac1b8c26471a8256256a01896454,
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-na{\"i}ve 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-na{\"a}ve 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.",
keywords = "CALGB 39809, Docetaxel, Gemcitabine, Irinotecan, Non-small cell lung cancer",
author = "{Rocha Lima}, {C. M S} and Rizvi, {N. A.} and C. Zhang and Herndon, {II E.} and J. Crawford and R. Govindan and King, {G. W.} and Green, {M. R.}",
year = "2004",
month = "3",
day = "1",
doi = "10.1093/annonc/mdh104",
language = "English",
volume = "15",
pages = "410--418",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "3",

}

TY - JOUR

T1 - Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC

AU - Rocha Lima, C. M S

AU - Rizvi, N. A.

AU - Zhang, C.

AU - Herndon, II E.

AU - Crawford, J.

AU - Govindan, R.

AU - King, G. W.

AU - Green, M. R.

PY - 2004/3/1

Y1 - 2004/3/1

N2 - 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.

AB - 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.

KW - CALGB 39809

KW - Docetaxel

KW - Gemcitabine

KW - Irinotecan

KW - Non-small cell lung cancer

UR - http://www.scopus.com/inward/record.url?scp=1842555352&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=1842555352&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdh104

DO - 10.1093/annonc/mdh104

M3 - Article

C2 - 14998842

AN - SCOPUS:1842555352

VL - 15

SP - 410

EP - 418

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 3

ER -