TY - JOUR T1 - Incidence of interstitial lung disease (ILD) and risk factors for developing ILD: A final analysis of a large-scale erlotinib Japanese surveillance study in non-small-cell lung cancer (NSCLC) JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P5124 AU - Hiroyuki Taniguchi AU - Shoji Kudoh AU - Masahiko Ando AU - Yuichiro Ohe AU - Kazuhiko Nakagawa AU - Hiroaki Arakawa AU - Masahito Ebina AU - Yoshikazu Inoue AU - Akihiko Gemma AU - Masahiko Kusumoto AU - Kazuyoshi Kuwano AU - Fumikazu Sakai AU - Takeshi Johkoh AU - Yuh Fukuda AU - Yoshio Kiyohara AU - Naoya Yamazaki AU - Akihiro Seki AU - Masahiro Fukuoka Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P5124.abstract N2 - Background: Erlotinib (E) is approved in Japan for advanced NSCLC after failure of ≥1 chemotherapy regimen. ILD is an adverse drug reaction (ADR) of particular concern in Japanese pts with NSCLC receiving drugs targeting the epidermal growth factor receptor, such as E. A large-scale surveillance study was implemented to investigate the safety and efficacy of E in Japanese pts, focusing on the incidence of ILD and risk factors for developing ILD.Methods: Enrolment: Dec 2007–Oct 2009; observation period: 12 months. All ILD-like events were assessed by an independent ILD committee. Overall survival (OS), progression-free survival (PFS) and other ADRs/adverse events were also assessed.Results: A total of 10,708 pts were enrolled by data cut-off, 12 Oct 2009. Data were available for 9,909 pts. ADRs were reported in 79% of pts, the most common were skin disorders (67%) including rash (61%). 491 pts had ILD-like events, 62 events were deemed non-ILD by the independent ILD committee. ILD was confirmed in 429 pts (4.3%), with a mortality rate of 1.5%. The majority of ILD cases were reported within 4 weeks of receiving E. Concurrent/previous ILD (hazard ratio [HR] =3.2), emphysema/COPD (HR=1.9) or lung infection (HR=1.6), smoking status (HR=2.2) and ECOG performance status 2–4 (HR=1.4) were identified as risk factors for ILD by multivariate analysis. Median OS was 277 days, median PFS was 67 days.Conclusions: Final data from this large-scale erlotinib surveillance study in Japanese pts with advanced NSCLC show that ILD is the most special interest and provide further risk factors on ILD. ER -