title: Phase II study of erlotinib as third-line monotherapy in patients with advanced non-small-cell lung cancer without epidermal growth factor receptor mutations.
abstract: OBJECTIVE
  There are few standard therapeutic options beyond second-line treatment. We aimed to evaluate the efficacy and safety of erlotinib monotherapy as third-line chemotherapy in patients with advanced non-small-cell lung cancer without epidermal growth factor receptor mutations.
  
  
  METHODS
  In this phase II trial, patients who did not have epidermal growth factor receptor mutations and who had previously received two cytotoxic chemotherapy regimens containing platinum were treated with erlotinib (150 mg, per os) until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Twenty patients were eligible for the assessment of efficacy and safety. Three cases showed a partial response, and eight cases showed stable disease with an overall response rate of 15.0% (95% confidence interval: 5.2-36.0%) and a disease control rate of 55.0% (95% confidence interval: 34.2-74.2%). Median progression-free survival and overall survival time were 2.1 and 6.7 months, respectively. Although dose reduction was required in one patient because of skin toxicity, grade 3/4 toxicity or pulmonary disease was not observed.
  
  
  CONCLUSIONS
  Erlotinib as third-line therapy showed an acceptable response rate, survival time and toxicity. It could be a potential third-line therapy for patients without epidermal growth factor receptor mutations.
authors.affiliation: Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu 431-3192, Japan. inui@hama-med.ac.jp
authors.forename: Shun
authors.initials: S
authors.lastname: Matsuura
authors.forename: Naoki
authors.initials: N
authors.lastname: Inui
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ozawa
authors.forename: Yutaro
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Mikio
authors.initials: M
authors.lastname: Toyoshima
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Yasuda
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamada
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Shirai
authors.forename: Hideki
authors.initials: H
authors.lastname: Suganuma
authors.forename: Koji
authors.initials: K
authors.lastname: Yokomura
authors.forename: Takafumi
authors.initials: T
authors.lastname: Suda
authors.forename: Kingo
authors.initials: K
authors.lastname: Chida
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D001932:Brain Neoplasms / Q000556:secondary*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology / Q000556:secondary*; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D003875:Drug Eruptions / Q000209:etiology; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors