title: Final overall survival in JO22903, a phase II, open-label study of first-line erlotinib for Japanese patients with EGFR mutation-positive non-small-cell lung cancer.
abstract: BACKGROUND
  In Japan, the clinical efficacy of erlotinib monotherapy in epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer was demonstrated in the phase II JO22903 trial, which reported a median progression-free survival of 11.8 months. Here we report final overall survival data from JO22903.
  
  
  METHODS
  JO22903 (JapicCTI-101085) was a single-arm, multicenter, phase II, open-label, non-randomized study of first-line erlotinib monotherapy in EGFR mutation-positive non-small-cell lung cancer. Eligible patients (≥20 years) with stage IIIB/IV or recurrent non-small-cell lung cancer and confirmed activating mutations of EGFR (exon 19 deletion or L858R point mutation in exon 21) received oral erlotinib 150 mg/day until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival and safety; overall survival was a secondary endpoint.
  
  
  RESULTS
  At the final analysis, 102 patients were included in the modified intent-to-treat population and 103 in the safety population. Median follow-up was 32.3 months. Median overall survival was 36.3 months (95 % confidence interval 29.4-not reached). Subgroup analyses of overall survival suggested that the presence of brain metastases was a negative prognostic factor (median overall survival 22.7 months, 95 % confidence interval 19.6-29.4). The impact on overall survival of using versus not using EGFR tyrosine kinase inhibitors in any line of treatment following disease progression was unclear (median 32.8 versus 36.3 months, respectively). No new safety issues were observed.
  
  
  CONCLUSIONS
  In this survival update, single-agent erlotinib achieved a median overall survival of more than 3 years in patients with EGFR mutation-positive non-small-cell lung cancer.
authors.affiliation: Department of Thoracic Oncology, National Cancer Centre Hospital, Chuo-ku, Tokyo, Japan. nbryamam@ncc.go.jp.
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Department of Thoracic Oncology, National Cancer Centre Hospital East, Kashiwa, Chiba, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Goto
authors.affiliation: Thoracic Oncology Centre, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
authors.affiliation: Oncology Medicine, National Hospital Organization, Yamaguchi-Ube Medical Centre, Ube, Yamaguchi, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Chikamori
authors.affiliation: Department of Thoracic Oncology, Aichi Cancer Centre Hospital, Nagoya, Aichi, Japan.
authors.forename: Toyoaki
authors.initials: T
authors.lastname: Hida
authors.affiliation: Department of Respiratory Medicine, Miyagi Cancer Centre, Natori, Miyagi, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.affiliation: Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe, Hyogo, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.affiliation: Department of Thoracic Oncology, National Hospital Organization, Shikoku Cancer Centre, Matsuyama, Ehime, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.affiliation: Department of Thoracic Oncology, National Kyushu Cancer Centre, Fukuoka, Fukuoka, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Seto
authors.affiliation: Clinical Research Planning Department, Chugai Pharmaceutical Co. Ltd, Chuo-ku, Tokyo, Japan.
authors.forename: Kosei
authors.initials: K
authors.lastname: Tajima
authors.affiliation: Thoracic Center, St Luke's International Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics*; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage / Q000627:therapeutic use*; D005091:Exons; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors
keywords: EGFR mutations; Erlotinib; First line; Japanese patients; Non-small-cell lung cancer (NSCLC); Overall survival