title: Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE).
abstract: BACKGROUND
  This study was designed to analyze the efficacy of gefitinib as a second-line therapy, according to the clinical characteristics in Korean patients with non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  In this Phase IV observational study, we recruited patients, previously failed first-line chemotherapy, who had locally advanced or metastatic NSCLC, and who were found to be either epidermal growth factor receptor (EGFR) mutation-positive or satisfied 2 or more of the 3 characteristics: adenocarcinoma, female, and non-smoker. These patients were administered with gefitinib 250 mg/day, orally. The primary endpoints were to evaluate the objective response rate (ORR) and to determine the relationship of ORRs, depending on each patient's characteristics of modified intent-to-treat population.
  
  
  RESULTS
  A total of 138 patients participated in this study. One subject achieved complete response, and 42 subjects achieved partial response (ORR, 31.2%). The subgroup analysis demonstrated that the ORR was significantly higher in patients with EGFR mutation-positive, compared to that of EGFR mutation-negative (45.8% vs. 14.0%, p=0.0004). In a secondary efficacy variable, the median progression-free survival (PFS) was 5.7 months (95% confidence interval, 3.9~8.4 months) and the 6-month PFS and overall survival were 49.6% and 87.9%, respectively. The most common reported adverse events were rash (34.4%), diarrhea (26.6%), pruritus (17.5%), and cough (15.6%).
  
  
  CONCLUSIONS
  Gefitinib was observed in anti-tumor activity with favorable tolerability profile as a second-line therapy in these selected patients. When looking at EGFR mutation status, EGFR mutation-positive showed strong association with gefitinib by greater response and prolonged PFS, compared with that of EGFR mutation-negative.
authors: Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea.
authors: Kwan-Ho
authors: KH
authors: Lee
authors: Kye-Young
authors: KY
authors: Lee
authors: Young-June
authors: YJ
authors: Jeon
authors: Maan-Hong
authors: MH
authors: Jung
authors: Choonhee
authors: C
authors: Son
authors: Min-Ki
authors: MK
authors: Lee
authors: Jeong-Seon
authors: JS
authors: Ryu
authors: Sei-Hoon
authors: SH
authors: Yang
authors: Jae-Cheol
authors: JC
authors: Lee
authors: Young-Chul
authors: YC
authors: Kim
authors: Sun-Young
authors: SY
authors: Kim
keywords: Carcinoma, Non-Small-Cell Lung; Disease-Free Survival; Gefitinib; Mutation; Receptor, Epidermal Growth Factor