{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:36:15Z","timestamp":1793331375828,"version":"4.5.0"},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T00:00:00Z","timestamp":1676332800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["20ck0106464h0003"],"award-info":[{"award-number":["20ck0106464h0003"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The safety of osimertinib is limited in patients with severe or moderate renal impairment, or low body weight. This study aimed to investigate the safety, pharmacokinetics (PK) and recommended dose (RD) of osimertinib in patients with epidermal growth factor receptor (EGFR)\u2010mutated non\u2013small cell lung cancer (NSCLC) with impaired renal function and low body weight. Thirty\u2010one eligible patients were enrolled and allocated into four cohorts: A, normal renal function (estimated glomerular filtration rate [eGFR]\u2009\u2265\u200950\u2009mL\/min\/1.73\u2009m<jats:sup>2<\/jats:sup>) and normal body weight (\u226545\u2009kg); B, moderate renal impairment (eGFR\u00a0=\u00a030\u201050\u2009mL\/min\/1.73\u2009m<jats:sup>2<\/jats:sup>); C, low body weight (&lt;45\u2009kg); and D, severe renal impairment (eGFR &lt;30\u2009mL\/min\/1.73\u2009m<jats:sup>2<\/jats:sup> or undergoing dialysis). PK parameters and safety were evaluated with a starting dose of 80\u2009mg osimertinib administered orally once daily in cohorts A, B, and C and 40\u2009mg once daily in cohort D. The PK parameters in cohorts A, B, and C were found to be similar. No dose\u2010limiting toxicity was observed, and the RD was determined to be 80\u2009mg once daily in patients with moderate renal function and low body weight. Four serious adverse events, acneiform rash, diarrhea, QTc prolongation, and interstitial lung disease, were noted. Although the PK parameters of osimertinib were similar across all cohorts, toxicity occurred more frequently in patients with impaired renal function and low body weight. Clinicians should prescribe osimertinib with caution in NSCLC patients with impaired renal function and low body weight.<\/jats:p>","DOI":"10.1111\/cas.15736","type":"journal-article","created":{"date-parts":[[2023,1,27]],"date-time":"2023-01-27T07:29:03Z","timestamp":1674804543000},"page":"2087-2097","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Pharmacokinetic and dose\u2010finding study of osimertinib in patients with impaired renal function and low body weight"],"prefix":"10.1111","volume":"114","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6981-0800","authenticated-orcid":false,"given":"Yutaka","family":"Fujiwara","sequence":"first","affiliation":[{"name":"Department of Thoracic Oncology Aichi Cancer Center  Nagoya Japan"},{"name":"Department of Respiratory Medicine Mitsui Memorial Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reiko","family":"Makihara","sequence":"additional","affiliation":[{"name":"Department of Pharmacy National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9653-8424","authenticated-orcid":false,"given":"Tetsunari","family":"Hase","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Graduate School of Medicine Nagoya University  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2337-629X","authenticated-orcid":false,"given":"Naozumi","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Graduate School of Medicine Nagoya University  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoyuki","family":"Naito","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Mitsui Memorial Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukari","family":"Tsubata","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology and Respiratory Medicine, Department of Internal Medicine Shimane University Faculty of Medicine  Izumo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takae","family":"Okuno","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology and Respiratory Medicine, Department of Internal Medicine Shimane University Faculty of Medicine  Izumo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8188-2505","authenticated-orcid":false,"given":"Toshiaki","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Division of Thoracic Oncology Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haruki","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Division of Thoracic Oncology Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Shinno","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7641-9065","authenticated-orcid":false,"given":"Yoshitaka","family":"Zenke","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital East  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takaya","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital East  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukio","family":"Hosomi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology and Respiratory Medicine Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kageaki","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology and Respiratory Medicine Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Kitazono","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medical Oncology, Cancer Institute Hospital Japanese Foundation for Cancer Research  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi","family":"Sakiyama","sequence":"additional","affiliation":[{"name":"Department of Pharmacy National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinori","family":"Makino","sequence":"additional","affiliation":[{"name":"Department of Pharmacy National Cancer Center Hospital  Tokyo Japan"},{"name":"Departments of Pharmacy and Cancer Genome Medicine Saitama Medical University International Medical Center  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0787-2851","authenticated-orcid":false,"given":"Noboru","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital  Tokyo Japan"},{"name":"Department of Experimental Therapeutics National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,2,14]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-16-1337"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.76.7293"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cllc.2018.02.002"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2018.01.002"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1612674"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1713137"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyy179"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1411817"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-14-0337"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-016-2992-z"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13223"},{"key":"e_1_2_10_13_1","unstructured":"OuSI SalgiaR ClarkJ et al.Comparison of crizotinib (PF\u201002341066) pharmacokinetics between Asian and non\u2010Asian patients with advanced malignancies. 4th Asia Pacific Lung Cancer Conference. Seoul South Korea.2010."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.12983"},{"key":"e_1_2_10_15_1","unstructured":"U.S. Department of Health and Human Services FaDA Center for Drug Evaluation and Research (CDER).Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function\u2013Study Design Data Analysis and Impact on Dosing. Revesion 2 edn.2020."},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2008.12.034"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2014.04.010"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-145-4-200608150-00004"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-150-9-200905050-00006"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2102953"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hys235"},{"key":"e_1_2_10_22_1","first-page":"2020","volume-title":"The National Health and Nutrition Survey in Japan","author":"Ministry of Health Law","year":"2019"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-016-0490-z"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.3109\/00498254.2014.941964"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.613"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bcp.2014.10.010"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-017-0090-8"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms21041279"}],"container-title":["Cancer Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15736","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cas.15736","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15736","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,23]],"date-time":"2024-07-23T20:35:53Z","timestamp":1721766953000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cas.15736"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,14]]},"references-count":27,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2023,5]]}},"alternative-id":["10.1111\/cas.15736"],"URL":"https:\/\/doi.org\/10.1111\/cas.15736","archive":["Portico"],"relation":{},"ISSN":["1347-9032","1349-7006"],"issn-type":[{"value":"1347-9032","type":"print"},{"value":"1349-7006","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,14]]},"assertion":[{"value":"2022-10-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-01-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-02-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}