title: High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy.
abstract: OBJECTIVE
  Erlotinib is the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) which has demonstrated a survival benefit in non-small-cell lung cancer (NSCLC) patients. An open label phase II study was conducted in Taiwanese patients with NSCLC to evaluate its efficacy.
  
  
  METHODS
  Patients with proven stage IIIB/IV NSCLC who had received at least one line of standard chemotherapy or radiotherapy were enrolled into this study. All patients were given oral erlotinib, 150mg/day till disease progression.
  
  
  RESULTS
  From May 2005 to July 2006, 300 patients were entered from 14 hospitals in Taiwan. This analysis was based on 299 patients who received at least one dose of erlotinib. The best response rates were a 29% partial response and 44% stable disease in 273 patients who had response data available. Non-smoking (p=0.033), adenocarcinoma/BAC (p=0.0027), female (p=0.0013), aged less than 65 years (p=0.0115), stage IV (p=0.0492), patients with skin rash (p=0.0216), and a higher grade of skin rash (p=0.003) were significantly correlated with response to treatment. Skin rash was a common adverse event (any grade: 84%, Gr 3-4: 16%). The median time to disease progression was 5.6 months. Cox regression model for progression free survival showed patients most at risk of early progression were males of low performance status having squamous cell carcinoma.
  
  
  CONCLUSIONS
  This was the largest multicenter prospective clinical study of NSCLC in Taiwan. The results demonstrated the excellent response rates, time-to-progression and overall survival of erlotinib in a large population of Taiwanese NSCLC patients who had been previously treated with chemotherapy or radiotherapy.
authors.affiliation: Chest Department, Taipei Veterans General Hospital, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Reury-Perng
authors.initials: RP
authors.lastname: Perng
authors.forename: Chih-Hsin
authors.initials: CH
authors.lastname: Yang
authors.forename: Yuh-Min
authors.initials: YM
authors.lastname: Chen
authors.forename: Gee-Chen
authors.initials: GC
authors.lastname: Chang
authors.forename: Meng-Chih
authors.initials: MC
authors.lastname: Lin
authors.forename: Ruey-Kuen
authors.initials: RK
authors.lastname: Hsieh
authors.forename: Nei-Min
authors.initials: NM
authors.lastname: Chu
authors.forename: Ruay-Sheng
authors.initials: RS
authors.lastname: Lai
authors.forename: Wu-Chou
authors.initials: WC
authors.lastname: Su
authors.forename: Chao-Jung
authors.initials: CJ
authors.lastname: Tsao
authors.forename: Te-Chun
authors.initials: TC
authors.lastname: Hsia
authors.forename: Hao-Cheng
authors.initials: HC
authors.lastname: Chen
authors.forename: Chih-Hung
authors.initials: CH
authors.lastname: Chen
authors.forename: Ming-Shyan
authors.initials: MS
authors.lastname: Huang
authors.forename: Jui-Long
authors.initials: JL
authors.lastname: Wang
authors.forename: Ming-Lin
authors.initials: ML
authors.lastname: Ho
authors.forename: Chih-Yuan
authors.initials: CY
authors.lastname: Chung
authors.forename: Chong-Jen
authors.initials: CJ
authors.lastname: Yu
authors.forename: Wen-Cheng
authors.initials: WC
authors.lastname: Chang
authors.forename: Han-Pin
authors.initials: HP
authors.lastname: Kuo
authors.forename: Chih-Teng
authors.initials: CT
authors.lastname: Yu
authors.forename: Zhong-Zhe
authors.initials: ZZ
authors.lastname: Lin
authors.forename: Woei-Yau
authors.initials: WY
authors.lastname: Kao
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000069347:Erlotinib Hydrochloride; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011799:Quinazolines / Q000627:therapeutic use*; D016879:Salvage Therapy; D012737:Sex Factors; D012907:Smoking; D013624:Taiwan
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride