Cited by 1,490Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

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

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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.·2005·Journal of Clinical Oncology

DOI 10.1200/jco.2005.02.840

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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.

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Authors: Herbst, R. S., Prager, D., Hermann, R., Fehrenbacher, L., Johnson, B. E., Sandler, A., Kris, M. G., Tran, H. T., Klein, P., Li, X., Ramies, D., Johnson, D. H., & Miller, V. A.
Affiliations: Memorial Sloan Kettering Cancer Center (US)
ORCID: Herbst, Roy S.
Johnson, Bruce E.
Sandler, Alan
Kris, Mark G.
Tran, Hai T.
Li, Xin
Ramies, David
Johnson, David H.
Miller, Vincent A.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2005-09-01
Volume: 23
Issue: 25
Pages: 5892-5899
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2005.02.840
OpenAlex: W2162724777
Cited by: 1,490
References: 25
Citations by year: 2026: 9 · 2025: 4 · 2024: 7 · 2023: 11 · 2022: 19 · 2021: 24 · 2020: 29 · 2019: 22 · 2018: 32 · 2017: 48 · 2016: 56 · 2015: 83 · 2014: 79 · 2013: 122 · 2012: 96
FWCI: 123.05
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords: erlotinib, carboplatin, paclitaxel, non-small cell lung cancer, EGFR tyrosine kinase inhibitors, combination chemotherapy, never smokers, overall survival, time to progression, objective response, maintenance therapy
MeSH terms: Erlotinib Hydrochloride, Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Placebos, Quinazolines, Survival Analysis, Carboplatin, Paclitaxel, Disease Progression, Protein Kinase Inhibitors, ErbB Receptors

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

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