Impact on disease-free survival of adjuvant erlotinib or gefitinib in patients with resected lung adenocarcinomas that harbor EGFR mutations Journal Article


Authors: Janjigian, Y. Y.; Park, B. J.; Zakowski, M. F.; Ladanyi, M.; Pao, W.; D'Angelo, S. P.; Kris, M. G.; Shen, R.; Zheng, J.; Azzoli, C. G.
Article Title: Impact on disease-free survival of adjuvant erlotinib or gefitinib in patients with resected lung adenocarcinomas that harbor EGFR mutations
Abstract: Background: Patients with stage IV lung adenocarcinoma and epidermal growth factor receptor (EGFR) mutation derive clinical benefit from treatment with EGFR tyrosine kinase inhibitors (TKIs). Whether treatment with TKI improves outcomes in patients with resected lung adenocarcinoma and EGFR mutation is unknown. Methods: Data were analyzed from a surgical database of patients with resected lung adenocarcinoma harboring EGFR exon 19 or 21 mutations. In a multivariate analysis, we evaluated the impact of treatment with adjuvant TKI. Results: The cohort consists of 167 patients with completely resected stages I to III lung adenocarcinoma. Ninety-three patients (56%) had exon 19 del, 74 patients (44%) had exon 21 mutations, and 56 patients (33%) received perioperative TKI. In a multivariate analysis controlling for sex, stage, type of surgery, and adjuvant platinum chemotherapy, the 2-year disease-free survival (DFS) was 89% for patients treated with adjuvant TKI compared with 72% in control group (hazard ratio = 0.53; 95% confidence interval: 0.28-1.03; p = 0.06). The 2-year overall survival was 96% with adjuvant EGFR TKI and 90% in the group that did not receive TKI (hazard ratio: 0.62; 95% confidence interval: 0.26-1.51; p = 0.296). Conclusions: Compared with patients who did not receive adjuvant TKI, we observed a trend toward improvement in DFS among individuals with resected stages I to III lung adenocarcinomas harboring mutations in EGFR exon 19 or 21 who received these agents as adjuvant therapy. Based on these data, 320 patients are needed for a randomized trial to prospectively validate this DFS benefit. Copyright © 2011 The International Association for the Study of Lung Cancer.
Keywords: controlled study; human tissue; aged; cancer surgery; human cell; major clinical study; exon; mutation; erlotinib; adjuvant therapy; disease free survival; cancer staging; lung resection; cohort analysis; data base; lung adenocarcinoma; adjuvant chemotherapy; clinical evaluation; gefitinib; data analysis; platinum; multivariate analysis; perioperative period; epidermal growth factor receptor kinase inhibitor; egfr mutation; lung adenocarinoma
Journal Title: Journal of Thoracic Oncology
Volume: 6
Issue: 3
ISSN: 1556-0864
Publisher: Elsevier Inc.  
Date Published: 2011-03-01
Start Page: 569
End Page: 575
Language: English
DOI: 10.1097/JTO.0b013e318202bffe
PROVIDER: scopus
PUBMED: 21150674
PMCID: PMC3778680
DOI/URL:
Notes: --- - "Export Date: 23 June 2011" - "Source: Scopus"
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MSK Authors
  1. Junting Zheng
    133 Zheng
  2. Christopher G Azzoli
    105 Azzoli
  3. Ronglai Shen
    129 Shen
  4. Yelena Yuriy Janjigian
    148 Janjigian
  5. Marc Ladanyi
    879 Ladanyi
  6. Maureen F Zakowski
    280 Zakowski
  7. Bernard J Park
    156 Park
  8. Mark Kris
    612 Kris