title: Efficacy and safety of erlotinib in elderly patients in the phase IV POLARSTAR surveillance study of Japanese patients with non-small-cell lung cancer.
abstract: OBJECTIVE
  More tolerable treatment options are needed for the large number of elderly patients with non-small-cell lung cancer (NSCLC). An analysis of the phase IV POLARSTAR surveillance study examined the safety and efficacy of erlotinib in elderly Japanese patients with previously treated NSCLC.
  
  
  METHODS
  From December 2007 to October 2009, all erlotinib-treated patients with unresectable, recurrent/advanced NSCLC in Japan were enrolled. Efficacy and safety data were stratified by age (<75 years, 75-84 years, ≥85 years). Kaplan-Meier methodology was used to estimate median progression-free survival (PFS). Safety data were collected with a focus on interstitial lung disease (ILD).
  
  
  RESULTS
  A total of 9907 patients were eligible for safety assessment (<75 years, n=7848; 75-84 years, n=1911; ≥85 years, n=148) and 9651 for efficacy assessment (<75 years, n=7701; 75-84 years, n=1815; ≥85 years, n=135). Other baseline characteristics were balanced. The incidence of ILD (all grades) was 4.2% (<75 years), 5.1% (75-84 years), and 3.4% (≥85 years). The mortality rate due to ILD was ≤1.7% in all age groups. Other toxicities (including rash) were similar between age groups. The median PFS was 65 days (95% confidence interval [CI], 62-68) for patients aged <75 years, 74 days (95% CI, 69-82) for patients aged 75-84 years, and 72 days (95% CI, 56-93) for patients aged ≥85 years.
  
  
  CONCLUSIONS
  Efficacy and tolerability of erlotinib for elderly patients was not numerically inferior to that reported in younger patients. Erlotinib could be considered for elderly patients with recurrent/advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki-shi, Okayama 710-8602, Japan. Electronic address: hirotin@kchnet.or.jp.
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.affiliation: Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka 543-0035, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Komuta
authors.affiliation: Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan.
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.affiliation: Double-Barred Cross Hospital Japan Anti-Tuberculosis Association, 3-1-24 Matsuyama, Kiyose-shi, Tokyo 204-8522, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Kudoh
authors.affiliation: Chugai Pharmaceutical Co. Ltd., 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-8324, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Seki
authors.affiliation: Izumi Municipal Hospital, 4-10-10 Fuchu-cho, Izumi-shi, Osaka 594-0071, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride
keywords: Epidermal growth factor receptor; Erlotinib; Geriatric; Interstitial lung disease; Non–small-cell lung cancer; Tyrosine-kinase inhibitor