title: Phase II randomized trial of erlotinib or vinorelbine in chemonaive, advanced, non-small cell lung cancer patients aged 70 years or older.
abstract: BACKGROUND
  The primary objective of this study was to compare the response rates of elderly, chemonaive patients with advanced non-small cell lung cancer (NSCLC) treated with daily oral erlotinib versus oral vinorelbine.
  
  
  METHODS
  Chemonaive Taiwanese patients aged 70 years or older who had advanced NSCLC were randomized to receive either oral erlotinib 150 mg (E) daily or oral vinorelbine 60 mg/m (V) on days 1 and 8 every 3 weeks.
  
  
  RESULTS
  From February 2007 to July 2008, 116 patients were enrolled and 113 were included in the intent-to-treat population: 57 patients in the E group and 56 patients in the V group. Objective response rates were 22.8% (13 of 57) in E and 8.9% (5 of 56) in V (p = 0.0388). Median progression-free survival (PFS) was 4.57 months in E and 2.53 months in V (p = 0.0287), with an 80.6% increase in median PFS for E compared with V. Median survival time was 11.67 months in E and 9.3 months in V (p = 0.6975). Toxicities were generally mild in both groups. Median PFS was longest for epidermal growth factor receptor gene (EGFR)-mutated patients in the E group, followed by EGFR-mutated patients in V, EGFR wild type in E, and EGFR wild type in V (p = 0.0034). Overall survival was longer for EGFR-mutated patients than for EGFR wild-type patients (p < 0.0001).
  
  
  CONCLUSIONS
  Erlotinib is highly effective compared with oral vinorelbine in elderly, chemonaive, Taiwanese patients with NSCLC. EGFR-mutated patients had better survival than those with EGFR wild-type disease, regardless of the treatment received.
authors.affiliation: Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan. ymchen@vghtpe.gov.tw
authors.forename: Yuh-Min
authors.initials: YM
authors.lastname: Chen
authors.forename: Chun-Ming
authors.initials: CM
authors.lastname: Tsai
authors.forename: Wen-Chien
authors.initials: WC
authors.lastname: Fan
authors.forename: Jen-Fu
authors.initials: JF
authors.lastname: Shih
authors.forename: Shih-Hao
authors.initials: SH
authors.lastname: Liu
authors.forename: Chieh-Hung
authors.initials: CH
authors.lastname: Wu
authors.forename: Teh-Ying
authors.initials: TY
authors.lastname: Chou
authors.forename: Yu-Chin
authors.initials: YC
authors.lastname: Lee
authors.forename: Reury-Perng
authors.initials: RP
authors.lastname: Perng
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Whang-Peng
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069347:Erlotinib Hydrochloride; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D009367:Neoplasm Staging; D011788:Quality of Life; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D011799:Quinazolines; D014747:Vinblastine; D000069347:Erlotinib Hydrochloride; D000077235:Vinorelbine