{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T15:18:09Z","timestamp":1784128689666,"version":"3.55.0"},"reference-count":13,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2014,12,15]],"date-time":"2014-12-15T00:00:00Z","timestamp":1418601600000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2014,12]]},"abstract":"<jats:p>Interstitial lung disease (<jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content>) occurrence and risk factors were investigated in the Japanese non\u2010small\u2010cell lung cancer, post\u2010marketing, large\u2010scale surveillance study, <jats:styled-content style=\"fixed-case\">POLARSTAR<\/jats:styled-content>. All patients with unresectable, recurrent\/advanced non\u2010small\u2010cell lung cancer who were treated with erlotinib in Japan between December 2007 and October 2009 were enrolled. Primary endpoints were patterns of <jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content> and risk factors for onset of <jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content>\u2010related death. Overall survival, progression\u2010free survival, and occurrence of adverse drug reactions were secondary endpoints. Interstitial lung disease was confirmed in 429 (4.3%) patients. Concurrent\/previous <jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content> (hazard ratio, 3.19), emphysema or chronic obstructive pulmonary disease (hazard ratio, 1.86), lung infection (hazard ratio, 1.55), smoking history (hazard ratio, 2.23), and period from initial cancer diagnosis to the start of treatment (&lt;360\u00a0days; hazard ratio, 0.58) were identified as significant risk factors for developing <jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content> by Cox multivariate analysis. Logistic regression analysis identified Eastern Cooperative Oncology Group performance status 2\u20134 (odds ratio, 2.45 [95% confidence interval, 1.41\u20134.27]; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0016), \u226450% remaining normal lung area (odds ratio, 3.12 [1.48\u20136.58]; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0029), and concomitant honeycombing with interstitial pneumonia (odds ratio, 6.67 [1.35\u201332.94]; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.02) as poor prognostic factors for <jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content> death. Median overall survival was 277\u00a0days; median progression\u2010free survival was 67\u00a0days. These data confirm the well\u2010characterized safety profile of erlotinib. Interstitial lung disease is still an adverse drug reaction of interest in this population, and these results, including <jats:styled-content style=\"fixed-case\">ILD<\/jats:styled-content> risk factors, give helpful information for treatment selection and monitoring. Erlotinib efficacy was additionally confirmed in this population. (<jats:styled-content style=\"fixed-case\">POLARSTAR<\/jats:styled-content> trial <jats:styled-content style=\"fixed-case\">ML<\/jats:styled-content>21590.)<\/jats:p>","DOI":"10.1111\/cas.12550","type":"journal-article","created":{"date-parts":[[2014,10,7]],"date-time":"2014-10-07T07:49:55Z","timestamp":1412668195000},"page":"1584-1590","source":"Crossref","is-referenced-by-count":85,"title":["Final safety and efficacy of erlotinib in the phase 4 <scp>POLARSTAR<\/scp> surveillance study of 10\u00a0708 Japanese patients with non\u2010small\u2010cell lung cancer"],"prefix":"10.1111","volume":"105","author":[{"given":"Akihiko","family":"Gemma","sequence":"first","affiliation":[{"name":"Department of Pulmonary Medicine and Oncology Nippon Medical School Graduate School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoji","family":"Kudoh","sequence":"additional","affiliation":[{"name":"Anti\u2010Tuberculosis Association Double\u2010Barred Cross Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiko","family":"Ando","sequence":"additional","affiliation":[{"name":"Center for Advanced Medicine and Clinical Research Nagoya University Graduate School of Medicine Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichiro","family":"Ohe","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiko","family":"Nakagawa","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Kinki University School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Johkoh","sequence":"additional","affiliation":[{"name":"Department of Radiology Kinki Central Hospital of Mutual Aid Association of Public School Teachers Hyogo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoya","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Department of Dermatology National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Arakawa","sequence":"additional","affiliation":[{"name":"Department of Radiology Dokkyo Medical University Hospital Tochigi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshikazu","family":"Inoue","sequence":"additional","affiliation":[{"name":"Clinical Research Center National Hospital Organization Kinki\u2010Chuo Chest Medical Center Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahito","family":"Ebina","sequence":"additional","affiliation":[{"name":"Pulmonary Center Tohoku Pharmaceutical University Hospital Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiko","family":"Kusumoto","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Radiology National Cancer Center Hospital East Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuyoshi","family":"Kuwano","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine Department of Internal Medicine Jikei University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumikazu","family":"Sakai","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Radiology Saitama Medical University International Medical Center Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Taniguchi","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine and Allergy Tosei General Hospital Aichi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuh","family":"Fukuda","sequence":"additional","affiliation":[{"name":"Division of Diagnostic Pathology Itabashi Chuo Medical Center Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiro","family":"Seki","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance Chugai Pharmaceutical Co. 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