TRIBUTE: A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer

Roy S. Herbst, Diane Prager, Robert Hermann, Lou Fehrenbacher, Bruce E. Johnson, Alan Sandler, Mark G. Kris, Hai T. Tran, Pam Klein, Xin Li, David Ramies, David H. Johnson, Vincent A. Miller

Research output: Contribution to journalArticle

1309 Citations (Scopus)

Abstract

Purpose: Erlotinib is a potent reversible HER1/epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with single-agent activity in patients with non-small-cell lung cancer (NSCLC). Erlotinib was combined with chemotherapy to determine if it could improve the outcome of patients with NSCLC. Patients and Methods: TRIBUTE randomly assigned patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC to erlotinib 150 mg/d or placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib. Random assignment was stratified by stage, weight loss in the previous 6 months, measurable disease, and treatment center. The primary end point was overall survival (OS). Secondary end points included time to progression (TTP), objective response (OR), and duration of response. Results: There were 1,059 assessable patients (526 erlotinib; 533 placebo). Median survival for patients treated with erlotinib was 10.6 v 10.5 months for placebo (hazard ratio, 0.99; 95% CI, 0.86 to 1.16; P = .95). There was no difference in OR or median TTP. Patients who reported never smoking (72 erlotinib; 44 placebo) experienced improved OS in the erlotinib arm (22.5 v 10.1 months for placebo), though no other prespecified factors showed an advantage in OS with erlotinib. Erlotinib and placebo arms were equivalent in adverse events (except rash and diarrhea). Conclusion: Erlotinib with concurrent carboplatin and paclitaxel did not confer a survival advantage over carboplatin and paclitaxel alone in patients with previously untreated advanced NSCLC. Never smokers treated with erlotinib and chemotherapy seemed to experience an improvement in survival and will undergo further investigation in future randomized trials.

Original languageEnglish (US)
Pages (from-to)5892-5899
Number of pages8
JournalJournal of Clinical Oncology
Volume23
Issue number25
DOIs
StatePublished - 2005

Fingerprint

Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Drug Therapy
Placebos
Survival
Erlotinib Hydrochloride
Exanthema
Epidermal Growth Factor Receptor
Protein-Tyrosine Kinases
Weight Loss
Diarrhea
Smoking
Maintenance

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

TRIBUTE : A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. / Herbst, Roy S.; Prager, Diane; Hermann, Robert; Fehrenbacher, Lou; Johnson, Bruce E.; Sandler, Alan; Kris, Mark G.; Tran, Hai T.; Klein, Pam; Li, Xin; Ramies, David; Johnson, David H.; Miller, Vincent A.

In: Journal of Clinical Oncology, Vol. 23, No. 25, 2005, p. 5892-5899.

Research output: Contribution to journalArticle

Herbst, RS, Prager, D, Hermann, R, Fehrenbacher, L, Johnson, BE, Sandler, A, Kris, MG, Tran, HT, Klein, P, Li, X, Ramies, D, Johnson, DH & Miller, VA 2005, 'TRIBUTE: A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer', Journal of Clinical Oncology, vol. 23, no. 25, pp. 5892-5899. https://doi.org/10.1200/JCO.2005.02.840
Herbst, Roy S. ; Prager, Diane ; Hermann, Robert ; Fehrenbacher, Lou ; Johnson, Bruce E. ; Sandler, Alan ; Kris, Mark G. ; Tran, Hai T. ; Klein, Pam ; Li, Xin ; Ramies, David ; Johnson, David H. ; Miller, Vincent A. / TRIBUTE : A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 25. pp. 5892-5899.
@article{186acbb5ecd74ffbb7dc939caded3242,
title = "TRIBUTE: A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer",
abstract = "Purpose: Erlotinib is a potent reversible HER1/epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with single-agent activity in patients with non-small-cell lung cancer (NSCLC). Erlotinib was combined with chemotherapy to determine if it could improve the outcome of patients with NSCLC. Patients and Methods: TRIBUTE randomly assigned patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC to erlotinib 150 mg/d or placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib. Random assignment was stratified by stage, weight loss in the previous 6 months, measurable disease, and treatment center. The primary end point was overall survival (OS). Secondary end points included time to progression (TTP), objective response (OR), and duration of response. Results: There were 1,059 assessable patients (526 erlotinib; 533 placebo). Median survival for patients treated with erlotinib was 10.6 v 10.5 months for placebo (hazard ratio, 0.99; 95{\%} CI, 0.86 to 1.16; P = .95). There was no difference in OR or median TTP. Patients who reported never smoking (72 erlotinib; 44 placebo) experienced improved OS in the erlotinib arm (22.5 v 10.1 months for placebo), though no other prespecified factors showed an advantage in OS with erlotinib. Erlotinib and placebo arms were equivalent in adverse events (except rash and diarrhea). Conclusion: Erlotinib with concurrent carboplatin and paclitaxel did not confer a survival advantage over carboplatin and paclitaxel alone in patients with previously untreated advanced NSCLC. Never smokers treated with erlotinib and chemotherapy seemed to experience an improvement in survival and will undergo further investigation in future randomized trials.",
author = "Herbst, {Roy S.} and Diane Prager and Robert Hermann and Lou Fehrenbacher and Johnson, {Bruce E.} and Alan Sandler and Kris, {Mark G.} and Tran, {Hai T.} and Pam Klein and Xin Li and David Ramies and Johnson, {David H.} and Miller, {Vincent A.}",
year = "2005",
doi = "10.1200/JCO.2005.02.840",
language = "English (US)",
volume = "23",
pages = "5892--5899",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "25",

}

TY - JOUR

T1 - TRIBUTE

T2 - A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer

AU - Herbst, Roy S.

AU - Prager, Diane

AU - Hermann, Robert

AU - Fehrenbacher, Lou

AU - Johnson, Bruce E.

AU - Sandler, Alan

AU - Kris, Mark G.

AU - Tran, Hai T.

AU - Klein, Pam

AU - Li, Xin

AU - Ramies, David

AU - Johnson, David H.

AU - Miller, Vincent A.

PY - 2005

Y1 - 2005

N2 - Purpose: Erlotinib is a potent reversible HER1/epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with single-agent activity in patients with non-small-cell lung cancer (NSCLC). Erlotinib was combined with chemotherapy to determine if it could improve the outcome of patients with NSCLC. Patients and Methods: TRIBUTE randomly assigned patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC to erlotinib 150 mg/d or placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib. Random assignment was stratified by stage, weight loss in the previous 6 months, measurable disease, and treatment center. The primary end point was overall survival (OS). Secondary end points included time to progression (TTP), objective response (OR), and duration of response. Results: There were 1,059 assessable patients (526 erlotinib; 533 placebo). Median survival for patients treated with erlotinib was 10.6 v 10.5 months for placebo (hazard ratio, 0.99; 95% CI, 0.86 to 1.16; P = .95). There was no difference in OR or median TTP. Patients who reported never smoking (72 erlotinib; 44 placebo) experienced improved OS in the erlotinib arm (22.5 v 10.1 months for placebo), though no other prespecified factors showed an advantage in OS with erlotinib. Erlotinib and placebo arms were equivalent in adverse events (except rash and diarrhea). Conclusion: Erlotinib with concurrent carboplatin and paclitaxel did not confer a survival advantage over carboplatin and paclitaxel alone in patients with previously untreated advanced NSCLC. Never smokers treated with erlotinib and chemotherapy seemed to experience an improvement in survival and will undergo further investigation in future randomized trials.

AB - Purpose: Erlotinib is a potent reversible HER1/epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with single-agent activity in patients with non-small-cell lung cancer (NSCLC). Erlotinib was combined with chemotherapy to determine if it could improve the outcome of patients with NSCLC. Patients and Methods: TRIBUTE randomly assigned patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC to erlotinib 150 mg/d or placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib. Random assignment was stratified by stage, weight loss in the previous 6 months, measurable disease, and treatment center. The primary end point was overall survival (OS). Secondary end points included time to progression (TTP), objective response (OR), and duration of response. Results: There were 1,059 assessable patients (526 erlotinib; 533 placebo). Median survival for patients treated with erlotinib was 10.6 v 10.5 months for placebo (hazard ratio, 0.99; 95% CI, 0.86 to 1.16; P = .95). There was no difference in OR or median TTP. Patients who reported never smoking (72 erlotinib; 44 placebo) experienced improved OS in the erlotinib arm (22.5 v 10.1 months for placebo), though no other prespecified factors showed an advantage in OS with erlotinib. Erlotinib and placebo arms were equivalent in adverse events (except rash and diarrhea). Conclusion: Erlotinib with concurrent carboplatin and paclitaxel did not confer a survival advantage over carboplatin and paclitaxel alone in patients with previously untreated advanced NSCLC. Never smokers treated with erlotinib and chemotherapy seemed to experience an improvement in survival and will undergo further investigation in future randomized trials.

UR - http://www.scopus.com/inward/record.url?scp=24944440830&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=24944440830&partnerID=8YFLogxK

U2 - 10.1200/JCO.2005.02.840

DO - 10.1200/JCO.2005.02.840

M3 - Article

C2 - 16043829

AN - SCOPUS:24944440830

VL - 23

SP - 5892

EP - 5899

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 25

ER -