title: High efficacy of first-line gefitinib in non-Asian patients with EGFR-mutated lung adenocarcinoma.
abstract: BACKGROUND
  Several Asian studies demonstrated feasibility of front-line administration of gefitinib for the treatment of non-small cell lung carcinomas (NSCLCs) harboring intragenic epidermal growth factor receptor (EGFR) mutations. The experience of the use of this EGFR tyrosine kinase inhibitor (TKI) in non-Asian subjects remains limited.
  
  
  METHODS
  The study included lung adenocarcinoma (AC) patients treated at the N.N. Petrov Institute of Oncology (Russia).
  
  
  RESULTS
  DNA analysis of 192 consecutive AC revealed 38 (20%) TKI-sensitizing mutations. Presence of the exon 19 deletion (del19) or L858R was strongly correlated with nonsmoking status (smokers: 8/98 (8%); non-smokers: 30/94 (32%); p = 0.00004). The efficacy of first-line gefitinib therapy was evaluated in 25 patients with EGFR-mutated advanced AC. Twelve (48%) cases demonstrated tumor response (1 (4%) complete response, 11 (44%) partial responses; 10/17 (59%) patients with del19 mutation vs. 2/8 (25%) cases with L858R substitution, p = 0.11). The remaining 13 (52%) patients experienced disease stabilization. Median progression-free survival was 8.0 months. Grade 3 toxicity was the maximal adverse event, being observed only in 4 (16%) cases.
  
  
  CONCLUSIONS
  Gefitinib may be considered as an upfront treatment option for EGFR-mutated NSCLC.
authors.affiliation: N.N. Petrov Institute of Oncology, St.-Petersburg, Russia.
authors.forename: Vladimir M
authors.initials: VM
authors.lastname: Moiseyenko
authors.forename: Svetlana A
authors.initials: SA
authors.lastname: Procenko
authors.forename: Evgeny V
authors.initials: EV
authors.lastname: Levchenko
authors.forename: Alexey S
authors.initials: AS
authors.lastname: Barchuk
authors.forename: Fedor V
authors.initials: FV
authors.lastname: Moiseyenko
authors.forename: Aglaya G
authors.initials: AG
authors.lastname: Iyevleva
authors.forename: Nathalia V
authors.initials: NV
authors.lastname: Mitiushkina
authors.forename: Alexandr V
authors.initials: AV
authors.lastname: Togo
authors.forename: Igor I
authors.initials: II
authors.lastname: Semionov
authors.forename: Alexandr O
authors.initials: AO
authors.lastname: Ivantsov
authors.forename: Dmitry E
authors.initials: DE
authors.lastname: Matsko
authors.forename: Evgeny N
authors.initials: EN
authors.lastname: Imyanitov
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002872:Chromosome Deletion; D004252:DNA Mutational Analysis; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics*; D005091:Exons / Q000235:genetics; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012426:Russia; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; C512478:EGFR protein, human; D066246:ErbB Receptors; D011505:Protein-Tyrosine Kinases; D000077156:Gefitinib