title: Postmarketing surveillance study of erlotinib in Japanese patients with non-small-cell lung cancer (NSCLC): an interim analysis of 3488 patients (POLARSTAR).
abstract: BACKGROUND
  Interstitial lung disease (ILD) is an adverse drug reaction (ADR) of concern in Japanese patients with non-small-cell lung cancer (NSCLC) receiving erlotinib. To investigate erlotinib safety and efficacy in Japanese patients, a large-scale surveillance study was implemented.
  
  
  METHODS
  All patients with recurrent/advanced NSCLC receiving erlotinib in Japan were enrolled (December 2007-October 2009). During the 12-month observation period, adverse-event data were collected; any adverse event where erlotinib could not be excluded as a causative factor was termed an ADR. An independent review committee assessed ILD-like events. Overall survival and progression-free survival were also assessed. Interim data were analyzed for patients registered before June 30, 2008.
  
  
  RESULTS
  In total, 10,708 patients were enrolled, 3743 by June 30, 2008, with data available for 3488 patients. Overall ADR incidence was 81.8% (mostly grade 1/2); skin disorders (68.5%) including rash (63.0%) were most common. However, 81.8% of patients who experienced rash recovered or improved. ILD-like events, diagnosed by local physicians, were reported in 189 patients. The independent review committee confirmed ILD (all grades) in 158 patients (4.5% of interim population) with a mortality rate of 1.6% (55 patients). Significant ILD risk factors included concomitant or previous ILD, smoking history, concomitant or previous lung infection, and Eastern Cooperative Oncology Group performance status 2 to 4. Median overall survival and progression-free survival were 260 and 64 days, respectively.
  
  
  CONCLUSIONS
  These interim data support the clinical benefits of erlotinib in Japanese NSCLC patients with no new safety signals. The risk/benefit balance for erlotinib in recurrent/advanced NSCLC remains favorable.
authors.affiliation: Department of Medical Oncology, Kinki University School of Medicine, Osaka, Japan. nakagawa@med.kindai.ac.jp
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Shoji
authors.initials: S
authors.lastname: Kudoh
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ohe
authors.forename: Takeshi
authors.initials: T
authors.lastname: Johkoh
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.forename: Naoya
authors.initials: N
authors.lastname: Yamazaki
authors.forename: Akihiro
authors.initials: A
authors.lastname: Seki
authors.forename: Shinya
authors.initials: S
authors.lastname: Takemoto
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000401:mortality; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000378:metabolism; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D017563:Lung Diseases, Interstitial / Q000453:epidemiology* / Q000209:etiology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D009367:Neoplasm Staging; D011358:Product Surveillance, Postmarketing; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D012307:Risk Factors; D012907:Smoking / Q000009:adverse effects; D015996:Survival Rate; D055815:Young Adult
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors