title: Gefitinib as front-line treatment in Chinese patients with advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  This phase II single arm, open label study was designed to evaluate the efficacy and toxicity of oral gefitinib (250mg) daily in previously untreated patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Eligible patients had stage IIIB or IV NSCLC with adequate organ functions, and were chemonaïve. All eligible patients were treated with oral administration of 250mg of gefitinib until intolerable toxicity, disease progression or death occurred. Responses were assessed after every 8 weeks of therapy.
  
  
  RESULTS
  For a total of 53 patients, the objective response rate (ORR) was 32.1% and overall disease control rate (DCR) was 52.8%. Median overall and progression-free survivals (PFS) were 9.4 (95% CI, 8.8-13.3) and 3.2 months (95% CI, 1.1-5.2) months, and 1-year survival rate was 41.5%. Patients with adenocarcinoma (n=35) had a higher response rate. Adenocarcinoma, female gender (n=24), and response to gefitinib were predictive factors for better survival. The most commonly seen adverse events (AEs) were skin toxicity (54.7%), diarrhea (43.4%) and nail change (16.9%). Most AEs were mild to moderate and considered manageable. Drug-related interstitial pneumonia was clinically diagnosed in four cases (7.5%).
  
  
  CONCLUSIONS
  Oral gefitinib, as compared to conventional chemotherapy, has comparable effect but less toxicity as a first-line treatment in Chinese patients who have advanced NSCLC, especially in those with adenocarcinoma histology. A further phase III prospective study comparing gefitinib to standard chemotherapy to define the efficacy of gefitinib is appropriate in advanced NSCLC patients.
authors.affiliation: Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Wei-Chun
authors.initials: WC
authors.lastname: Lin
authors.forename: Chao-Hua
authors.initials: CH
authors.lastname: Chiu
authors.forename: Jia-Ling
authors.initials: JL
authors.lastname: Liou
authors.forename: Yuh-Min
authors.initials: YM
authors.lastname: Chen
authors.forename: Reury-Perng
authors.initials: RP
authors.lastname: Perng
authors.forename: Chun-Ming
authors.initials: CM
authors.lastname: Tsai
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D009367:Neoplasm Staging; D011379:Prognosis; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib