title: Phase II clinical trial of chemotherapy-naive patients > or = 70 years of age treated with erlotinib for advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  This is a phase II, multicenter, open-label study of chemotherapy-naïve patients with non-small-cell lung cancer (NSCLC) and age > or = 70 years who were treated with erlotinib and evaluated to determine the median, 1-year, and 2-year survival. The secondary end points include radiographic response rate, time to progression (TTP), toxicity, and symptom improvement.
  
  
  METHODS
  Eligible patients with NSCLC were treated with erlotinib 150 mg/d until disease progression or significant toxicity. Tumor response was assessed every 8 weeks by computed tomography scan using Response Evaluation Criteria in Solid Tumors. Tumor samples were analyzed for the presence of somatic mutations in EGFR and KRAS.
  
  
  RESULTS
  Eighty eligible patients initiated erlotinib therapy between March 2003 and May 2005. There were eight partial responses (10%), and an additional 33 patients (41%) had stable disease for 2 months or longer. The median TTP was 3.5 months (95% CI, 2.0 to 5.5 months). The median survival time was 10.9 months (95% CI, 7.8 to 14.6 months). The 1- and 2- year survival rates were 46% and 19%, respectively. The most common toxicities were acneiform rash (79%) and diarrhea (69%). Four patients developed interstitial lung disease of grade 3 or higher, with one treatment-related death. EGFR mutations were detected in nine of 43 patients studied. The presence of an EGFR mutation was strongly correlated with disease control, prolonged TTP, and survival.
  
  
  CONCLUSIONS
  Erlotinib monotherapy is active and relatively well tolerated in chemotherapy-naïve elderly patients with advanced NSCLC. Erlotinib merits consideration for further investigation as a first-line therapeutic option in elderly patients.
authors.affiliation: Dana-Farber Cancer Institute, Boston, MA 02115, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Jackman
authors.forename: Beow Y
authors.initials: BY
authors.lastname: Yeap
authors.forename: Neal I
authors.initials: NI
authors.lastname: Lindeman
authors.forename: Panos
authors.initials: P
authors.lastname: Fidias
authors.forename: Michael S
authors.initials: MS
authors.lastname: Rabin
authors.forename: Jennifer
authors.initials: J
authors.lastname: Temel
authors.forename: Arthur T
authors.initials: AT
authors.lastname: Skarin
authors.forename: Matthew
authors.initials: M
authors.lastname: Meyerson
authors.forename: Alison J
authors.initials: AJ
authors.lastname: Holmes
authors.forename: Ana M
authors.initials: AM
authors.lastname: Borras
authors.forename: Boris
authors.initials: B
authors.lastname: Freidlin
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Ostler
authors.forename: Joan
authors.initials: J
authors.lastname: Lucca
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Lynch
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Johnson
authors.forename: Pasi A
authors.initials: PA
authors.lastname: Jänne
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D066246:ErbB Receptors / Q000037:antagonists & inhibitors* / Q000235:genetics; D000069347:Erlotinib Hydrochloride; D005260:Female; D011905:Genes, ras; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008297:Male; D009154:Mutation; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors