Erlotinib in Previously Treated Non–Small-Cell Lung Cancer

Shepherd, Frances A.; Rodrigues Pereira, José; Ciuleanu, Tudor; Tan, Eng Huat; Hirsh, Vera; Thongprasert, Sumitra; Campos, Daniel; Maoleekoonpiroj, Savitree; Smylie, Michael; Martins, Renato; van Kooten, Maximiliano; Dediu, Mircea; Findlay, Brian; Tu, Dongsheng; Johnston, Dianne; Bezjak, Andrea; Clark, Gary; Santabárbara, Pedro; Seymour, Lesley

doi:10.1056/nejmoa050753

Cited by 5,419Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Erlotinib in Previously Treated Non–Small-Cell Lung Cancer

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Shepherd, Frances A., Rodrigues Pereira, José, Ciuleanu, Tudor, Tan, Eng Huat, Hirsh, Vera, Thongprasert, Sumitra, Campos, Daniel, Maoleekoonpiroj, Savitree +11 more·2005·New England Journal of Medicine

DOI 10.1056/nejmoa050753

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Abstract

BACKGROUND: We conducted a randomized, placebo-controlled, double-blind trial to determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival in non-small-cell lung cancer after the failure of first-line or second-line chemotherapy. METHODS: Patients with stage IIIB or IV non-small-cell lung cancer, with performance status from 0 to 3, were eligible if they had received one or two prior chemotherapy regimens. The patients were stratified according to center, performance status, response to prior chemotherapy, number of prior regimens, and prior platinum-based therapy and were randomly assigned in a 2:1 ratio to receive oral erlotinib, at a dose of 150 mg daily, or placebo. RESULTS: The median age of the 731 patients who underwent randomization was 61.4 years; 49 percent had received two prior chemotherapy regimens, and 93 percent had received platinum-based chemotherapy. The response rate was 8.9 percent in the erlotinib group and less than 1 percent in the placebo group (P<0.001); the median duration of the response was 7.9 months and 3.7 months, respectively. Progression-free survival was 2.2 months and 1.8 months, respectively (hazard ratio, 0.61, adjusted for stratification categories; P<0.001). Overall survival was 6.7 months and 4.7 months, respectively (hazard ratio, 0.70; P<0.001), in favor of erlotinib. Five percent of patients discontinued erlotinib because of toxic effects. CONCLUSIONS: Erlotinib can prolong survival in patients with non-small-cell lung cancer after first-line or second-line chemotherapy.

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The clinical development of EGFR inhibitors in NSCLC started before the discovery of EGFR mutations, with initial studies of Gefitinib and Erlotinib conducted in unselected patients in both pretreated and treatment-naïve settings in combination with standard chemotherapy.
“The clinical development of EGFR inhibitors in NSCLC started before the discovery of EGFR mutations, therefore initial studies with Gefitinib and Erlotinib were conducted in unselected patients in both pretreated [52–54] and in treatment-naïve patients in combination with standard chemotherapy [55–58].”
From A decade of EGFR inhibition in EGFR-mutated non small cell lung cancer (NSCLC): Old successes and future perspectives (2015) · cites this paper as [52]
Erlotinib improved OS in second- or third-line treatment of all NSCLC histological subtypes in patients not eligible for further chemotherapy, including those with PS 3.
“Erlotinib improved OS in second line or in third line in all NSCLC histological subtype patients not eligible for further chemotherapy, including patients with PS 3 [88].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [88]

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Authors: Shepherd, F. A., Rodrigues Pereira, J., Ciuleanu, T., Tan, E. H., Hirsh, V., Thongprasert, S., Campos, D., Maoleekoonpiroj, S., Smylie, M., Martins, R., van Kooten, M., Dediu, M., Findlay, B., Tu, D., Johnston, D., Bezjak, A., Clark, G., Santabárbara, P., & Seymour, L.
Affiliations: University Health Network (CA)
Institute of Oncology Prof. Dr. Ion Chiricuta (RO)
National Cancer Centre Singapore (SG)
McGill University (CA)
Chiang Mai University (TH)
Phramongkutklao Hospital (TH)
Cross Cancer Institute (CA)
Instituto Nacional de Câncer - INCA (BR)
Institutul Oncologic Bucuresti (RO)
Hotel Dieu Shaver Health and Rehabilitation Centre (CA)
Canadian Cancer Trials Group (CA)
ORCID: Shepherd, Frances A.
Ciuleanu, Tudor
Smylie, Michael
Martins, Renato
Dediu, Mircea
Tu, Dongsheng
Bezjak, Andrea
Clark, Gary
Seymour, Lesley
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2005-07-14
Volume: 353
Issue: 2
Pages: 123-132
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa050753
OpenAlex: W2138297714
Cited by: 5,419
References: 2
Citations by year: 2026: 34 · 2025: 41 · 2024: 63 · 2023: 81 · 2022: 129 · 2021: 110 · 2020: 125 · 2019: 139 · 2018: 186 · 2017: 230 · 2016: 240 · 2015: 349 · 2014: 344 · 2013: 447 · 2012: 418
FWCI: 309.60
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute
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, non-small cell lung cancer, EGFR inhibitors, second-line chemotherapy, previously treated patients, progression-free survival, overall survival, platinum-based chemotherapy, oral tyrosine kinase inhibitor
MeSH terms: Erlotinib Hydrochloride, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Double-Blind Method, Female, Humans, Lung Neoplasms, Male, Middle Aged, Quality of Life, Quinazolines, Survival Analysis, Protein Kinase Inhibitors, ErbB Receptors

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Erlotinib in Previously Treated Non–Small-Cell Lung Cancer

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