Randomized phase II trial of erlotinib alone or with carboplatin and paclitaxel in patients who were never or light former smokers with advanced lung adenocarcinoma: CALGB 30406 trial Journal Article


Authors: Jänne, P. A.; Wang, X.; Socinski, M. A.; Crawford, J.; Stinchcombe, T. E.; Gu, L.; Capelletti, M.; Edelman, M. J.; Villalona-Calero, M. A.; Kratzke, R.; Vokes, E. E.; Miller, V. A.
Article Title: Randomized phase II trial of erlotinib alone or with carboplatin and paclitaxel in patients who were never or light former smokers with advanced lung adenocarcinoma: CALGB 30406 trial
Abstract: Purpose: Erlotinib is clinically effective in patients with non-small-cell lung cancer (NSCLC) who have adenocarcinoma, are never or limited former smokers, or have EGFR mutant tumors. We investigated the efficacy of erlotinib alone or in combination with chemotherapy in patients with these characteristics. Patients and Methods: Patients with advanced NSCLC (adenocarcinoma) who were epidermal growth factor receptor tyrosine kinase inhibitor and chemotherapy naive never or light former smokers (smokers of > 100 cigarettes and ≤ 10 pack years and quit ≥ 1 year ago) were randomly assigned to continuous erlotinib or in combination with carboplatin and paclitaxel (ECP) for six cycles followed by erlotinib alone. The primary end point was progression-free survival (PFS). Tissue collection was mandatory. Results PFS was similar (5.0 v 6.6 months; P = .1988) in patients randomly assigned to erlotinib alone (arm A; n = 81) or to ECP (arm B; n = 100). EGFR mutation analysis was possible in 91% (164 of 181) of patients, and EGFR mutations were detected in 40% (51 of 128) of never smokers and in 42% (15 of 36) of light former smokers. In arm A, response rate (70% v 9%), PFS (14.1 v 2.6 months), and overall survival (OS; 31.3 v 18.1 month) favored EGFR-mutant patients. In arm B, response rate (73% v 30%), PFS (17.2 v 4.8 months), and OS (38.1 v 14.4 months) favored EGFR-mutant patients. Incidence of grades 3 to 4 hematologic (2% v 49%; P = .001) and nonhematologic (24% v 52%; P < .001) toxicity was greater in patients treated with ECP. Conclusion Erlotinib and erlotinib plus chemotherapy have similar efficacy in clinically selected populations of patients with advanced NSCLC. EGFR mutations identify patients most likely to benefit. © 2012 by American Society of Clinical Oncology.
Keywords: adult; controlled study; human tissue; treatment response; aged; aged, 80 and over; disease-free survival; middle aged; gene mutation; major clinical study; overall survival; fatigue; neutropenia; cigarette smoking; erlotinib; advanced cancer; cancer combination chemotherapy; diarrhea; drug efficacy; drug safety; drug withdrawal; monotherapy; paclitaxel; adenocarcinoma; gene; carboplatin; progression free survival; multiple cycle treatment; phase 2 clinical trial; sensory neuropathy; anemia; lung non small cell cancer; nausea; randomized controlled trial; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; lung neoplasms; smoking; receptor, epidermal growth factor; drug hypersensitivity; febrile neutropenia; rash; egfr gene; quinazolines; placebos
Journal Title: Journal of Clinical Oncology
Volume: 30
Issue: 17
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2012-06-10
Start Page: 2063
End Page: 2069
Language: English
DOI: 10.1200/jco.2011.40.1315
PROVIDER: scopus
PMCID: PMC3397694
PUBMED: 22547605
DOI/URL:
Notes: --- - "Cited By (since 1996): 1" - "Export Date: 1 August 2012" - "CODEN: JCOND" - "Source: Scopus"
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  1. Vincent Miller
    251 Miller