title: Erlotinib in first-line therapy for non-small cell lung cancer: a prospective phase II study.
abstract: BACKGROUND
  This phase II study evaluated efficacy of first-line erlotinib therapy for chemo-naïve patients with non-small cell lung cancer (NSCLC) by their clinicopathological and/or molecular characteristics.
  
  
  METHODS
  Eligible patients received erlotinib 150 mg daily until disease progression, followed by a gemcitabine/carboplatin doublet. By clinicopathological characteristics, the patients were categorized as squamous cell carcinoma (SQCC group), ever-smoker with adenocarcinoma (ever-smoking ADCC group), or never-smoker with adenocarcinoma (never-smoking ADCC group). Epidermal Growth Factor Receptor (EGFR) mutations were prospectively assessed by a direct sequencing method and confirmed retrospectively by the Scorpion amplified refractory mutation system (ARMS).
  
  
  RESULTS
  Seventy-five patients participated in this study. The direct sequencing method detected 18 EGFR mutations while ARMS detected an additional 3 EGFR mutations and 1 second EGFR T790M mutation. The objective response rates (ORR) were 71.7% in never-smoking ADCC, 25.0% in ever-smoking ADCC, but no response in SQCC, while those of the patients with EGFR mutant and wild-type ere 85.7% and 10.0%, respectively. Even in never-smoking ADCC, the EGFR mutants responded better, with ORR of 88.9% and survived longer, with median survival time of 25.4 months, than those with wild-type EGFR with ORR of 25.0% and median survival time of 16.6 months (p<0.05). ORR for gemcitabine and carboplatin was 16.1%.
  
  
  CONCLUSIONS
  The decision to administer first-line erlotinib should be decided by molecular characteristics, if known, but can be made by clinico-pathological characteristics as second best policy.
authors.affiliation: Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, 388-1 Pungnap-2 dong, Songpa-gu, Seoul 138-736, Korea.
authors.forename: Dae Ro
authors.initials: DR
authors.lastname: Choi
authors.forename: Dae Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Chang-Min
authors.initials: CM
authors.lastname: Choi
authors.forename: Sang-We
authors.initials: SW
authors.lastname: Kim
authors.forename: Cheolwon
authors.initials: C
authors.lastname: Suh
authors.forename: Jung-Shin
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics; D011446:Prospective Studies; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors