title: A prospective, phase II, open-label study (JO22903) of first-line erlotinib in Japanese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC).
abstract: BACKGROUND
  The epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor erlotinib is associated with survival benefits in patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC). This phase II, single-arm study examined the efficacy and safety of first-line erlotinib in Japanese patients with EGFR mutation-positive NSCLC.
  
  
  METHODS
  Eligible patients received erlotinib 150 mg/day until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival (PFS) and safety.
  
  
  RESULTS
  A high degree of concordance was observed between different mutation testing methodologies, suggesting feasibility of early, rapid detection of EGFR mutations. Median PFS was 11.8 months (95% confidence interval [CI]: 9.7-15.3) at data cut-off (1 June 2012) (n = 102). Exon 19 deletions seemed to be associated with longer PFS compared with L858R mutations; T790M mutations were tentatively linked with shorter PFS. The safety profile was as expected: rash (any grade; 83%) and diarrhea (any grade; 81%) were most common. Six interstitial lung disease (ILD)-like cases were reported, and 5 were confirmed as ILD-like events by the extramural committee. Two patients died of treatment-related pneumonitis (JAPIC Clinical Trials Information number: Japic CTI-101085).
  
  
  CONCLUSIONS
  Erlotinib should be considered for first-line treatment in this subset of Japanese patients, with close monitoring for ILD-like events.
authors.affiliation: Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: kgoto@east.ncc.go.jp.
authors.forename: Koichi
authors.initials: K
authors.lastname: Goto
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Kenichi
authors.initials: K
authors.lastname: Chikamori
authors.forename: Toyoaki
authors.initials: T
authors.lastname: Hida
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.forename: Takashi
authors.initials: T
authors.lastname: Seto
authors.forename: Tamaki
authors.initials: T
authors.lastname: Fukuyama
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics*; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors
keywords: EGFR testing; Epidermal growth factor receptor (EGFR) mutations; Erlotinib; First line; Japanese patients; Non-small-cell lung cancer (NSCLC); Phase II