{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T00:17:15Z","timestamp":1785025035235,"version":"3.55.0"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2022,9,23]],"date-time":"2022-09-23T00:00:00Z","timestamp":1663891200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2022,9,23]],"date-time":"2022-09-23T00:00:00Z","timestamp":1663891200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"funder":[{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"publisher","award":["22H04281"],"award-info":[{"award-number":["22H04281"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"publisher","award":["20K07150"],"award-info":[{"award-number":["20K07150"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Invest New Drugs"],"published-print":{"date-parts":[[2022,12]]},"DOI":"10.1007\/s10637-022-01304-9","type":"journal-article","created":{"date-parts":[[2022,9,23]],"date-time":"2022-09-23T08:03:30Z","timestamp":1663920210000},"page":"1254-1262","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Effects of CYP3A4\/5 and ABC transporter polymorphisms on osimertinib plasma concentrations in Japanese patients with non-small cell lung cancer"],"prefix":"10.1007","volume":"40","author":[{"given":"Hayato","family":"Yokota","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sho","family":"Sakamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuji","family":"Okuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natsuki","family":"Fukuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariko","family":"Asano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahide","family":"Takeda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsutoshi","family":"Nakayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masatomo","family":"Miura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,9,23]]},"reference":[{"key":"1304_CR1","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1056\/NEJMoa1913662","volume":"382","author":"SS Ramalingam","year":"2020","unstructured":"Ramalingam SS, Vansteenkiste J, Planchard D et al (2020) Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med 382:41\u201350. https:\/\/doi.org\/10.1056\/NEJMoa1913662","journal-title":"N Engl J Med"},{"key":"1304_CR2","doi-asserted-by":"publisher","first-page":"629","DOI":"10.1056\/NEJMoa1612674","volume":"376","author":"TS Mok","year":"2017","unstructured":"Mok TS, Wu YL, Ahn MJ et al (2017) Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. N Engl J Med 376:629\u2013640. https:\/\/doi.org\/10.1056\/NEJMoa1612674","journal-title":"N Engl J Med"},{"key":"1304_CR3","doi-asserted-by":"publisher","first-page":"1216","DOI":"10.1111\/bcp.13223","volume":"83","author":"K Brown","year":"2017","unstructured":"Brown K, Comisar C, Witjes H et al (2017) Population pharmacokinetics and exposure-response of osimertinib in patients with non-small cell lung cancer. Br J Clin Pharmacol 83:1216\u20131226. https:\/\/doi.org\/10.1111\/bcp.13223","journal-title":"Br J Clin Pharmacol"},{"key":"1304_CR4","doi-asserted-by":"publisher","first-page":"1201","DOI":"10.1124\/dmd.115.069203","volume":"44","author":"PA Dickinson","year":"2016","unstructured":"Dickinson PA, Cantarini MV, Collier J et al (2016) Metabolic disposition of osimertinib in rats, dogs, and humans: insights into a drug designed to bind covalently to a cysteine residue of epidermal growth factor receptor. Drug Metab Dispos 44:1201\u20131212. https:\/\/doi.org\/10.1124\/dmd.115.069203","journal-title":"Drug Metab Dispos"},{"key":"1304_CR5","doi-asserted-by":"publisher","first-page":"2138","DOI":"10.1158\/1078-0432.CCR-17-3555","volume":"24","author":"AK MacLeod","year":"2018","unstructured":"MacLeod AK, Lin D, Huang JT, McLaughlin LA, Henderson CJ, Wolf CR (2018) Identification of novel pathways of osimertinib disposition and potential implications for the outcome of lung cancer therapy. Clin Cancer Res 24:2138\u20132147. https:\/\/doi.org\/10.1158\/1078-0432.CCR-17-3555","journal-title":"Clin Cancer Res"},{"key":"1304_CR6","doi-asserted-by":"publisher","first-page":"5130","DOI":"10.1158\/1078-0432.CCR-16-0399","volume":"22","author":"P Ballard","year":"2016","unstructured":"Ballard P, Yates JW, Yang Z et al (2016) Preclinical comparison of osimertinib with other EGFR-TKIs in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. Clin Cancer Res 22:5130\u20135140. https:\/\/doi.org\/10.1158\/1078-0432.CCR-16-0399","journal-title":"Clin Cancer Res"},{"key":"1304_CR7","doi-asserted-by":"publisher","first-page":"321","DOI":"10.1002\/psp4.12289","volume":"7","author":"V Pilla Reddy","year":"2018","unstructured":"Pilla Reddy V, Walker M, Sharma P, Ballard P, Vishwanathan K (2018) Development, verification, and prediction of osimertinib drug-drug interactions using PBPK modeling approach to inform drug label. CPT Pharmacometrics Syst Pharmacol 7:321\u2013330. https:\/\/doi.org\/10.1002\/psp4.12289","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"1304_CR8","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.794931","volume":"13","author":"N Gao","year":"2022","unstructured":"Gao N, Zhang X, Hu X et al (2022) The influence of CYP3A4 genetic polymorphism and proton pump inhibitors on osimertinib metabolism. Front Pharmacol 13:794931. https:\/\/doi.org\/10.3389\/fphar.2022.794931","journal-title":"Front Pharmacol"},{"key":"1304_CR9","doi-asserted-by":"publisher","first-page":"100","DOI":"10.1002\/humu.9210","volume":"23","author":"H Fukushima-Uesaka","year":"2004","unstructured":"Fukushima-Uesaka H, Saito Y, Watanabe H et al (2004) Haplotypes of CYP3A4 and their close linkage with CYP3A5 haplotypes in a Japanese population. Hum Mutat 23:100\u2013108. https:\/\/doi.org\/10.1002\/humu.9210","journal-title":"Hum Mutat"},{"key":"1304_CR10","doi-asserted-by":"publisher","first-page":"977","DOI":"10.2217\/pgs.11.33","volume":"12","author":"M Miura","year":"2011","unstructured":"Miura M, Satoh S, Kagaya H et al (2011) Impact of the CYP3A4*1G polymorphism and its combination with CYP3A5 genotypes on tacrolimus pharmacokinetics in renal transplant patients. Pharmacogenomics 12:977\u2013984. https:\/\/doi.org\/10.2217\/pgs.11.33","journal-title":"Pharmacogenomics"},{"key":"1304_CR11","doi-asserted-by":"publisher","first-page":"274","DOI":"10.1016\/j.cllc.2014.12.004","volume":"16","author":"H Kobayashi","year":"2015","unstructured":"Kobayashi H, Sato K, Niioka T, Miura H, Ito H, Miura M (2015) Relationship among gefitinib exposure, polymorphisms of its metabolizing enzymes and transporters, and side effects in Japanese patients with non-small-cell lung cancer. Clin Lung Cancer 16:274\u2013281. https:\/\/doi.org\/10.1016\/j.cllc.2014.12.004","journal-title":"Clin Lung Cancer"},{"key":"1304_CR12","doi-asserted-by":"publisher","first-page":"325","DOI":"10.2133\/dmpk.dmpk-11-rg-128","volume":"27","author":"Y Akiyama","year":"2012","unstructured":"Akiyama Y, Fujita K, Ishida H et al (2012) Association of ABCC2 genotype with efficacy of first-line FOLFIRI in Japanese patients with advanced colorectal cancer. Drug Metab Pharmacokinet 27:325\u2013335. https:\/\/doi.org\/10.2133\/dmpk.dmpk-11-rg-128","journal-title":"Drug Metab Pharmacokinet"},{"key":"1304_CR13","doi-asserted-by":"publisher","first-page":"731","DOI":"10.1038\/jhg.2010.98","volume":"55","author":"N Takahashi","year":"2010","unstructured":"Takahashi N, Miura M, Scott SA et al (2010) Influence of CYP3A5 and drug transporter polymorphisms on imatinib trough concentration and clinical response among patients with chronic phase chronic myeloid leukemia. J Hum Genet 55:731\u2013737. https:\/\/doi.org\/10.1038\/jhg.2010.98","journal-title":"J Hum Genet"},{"key":"1304_CR14","doi-asserted-by":"publisher","first-page":"767","DOI":"10.1007\/s00280-016-2992-z","volume":"77","author":"D Planchard","year":"2016","unstructured":"Planchard D, Brown KH, Kim DW et al (2016) Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies. Cancer Chemother Pharmacol 77:767\u2013776. https:\/\/doi.org\/10.1007\/s00280-016-2992-z","journal-title":"Cancer Chemother Pharmacol"},{"key":"1304_CR15","doi-asserted-by":"publisher","first-page":"24","DOI":"10.1097\/FTD.0b013e31829dabbc","volume":"36","author":"M Miura","year":"2014","unstructured":"Miura M, Sato K, Miura H et al (2014) A limited sampling strategy for estimation of the area under the plasma concentration-time curve of gefitinib. Ther Drug Monit 36:24\u201329. https:\/\/doi.org\/10.1097\/FTD.0b013e31829dabbc","journal-title":"Ther Drug Monit"},{"key":"1304_CR16","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1016\/j.lungcan.2017.07.007","volume":"112","author":"T Tamura","year":"2017","unstructured":"Tamura T, Takagi Y, Okubo H et al (2017) Plasma concentration of osimertinib in a non-small cell lung cancer patient with chronic renal failure undergoing hemodialysis. Lung Cancer 112:225\u2013226. https:\/\/doi.org\/10.1016\/j.lungcan.2017.07.007","journal-title":"Lung Cancer"},{"key":"1304_CR17","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1002\/jso.20774","volume":"96","author":"L Wu","year":"2007","unstructured":"Wu L, Xu X, Shen J et al (2007) MDR1 gene polymorphisms and risk of recurrence in patients with hepatocellular carcinoma after liver transplantation. J Surg Oncol 96:62\u201368. https:\/\/doi.org\/10.1002\/jso.20774","journal-title":"J Surg Oncol"},{"key":"1304_CR18","doi-asserted-by":"publisher","first-page":"206","DOI":"10.1007\/BF02981939","volume":"73","author":"H Tanaka","year":"2001","unstructured":"Tanaka H, Imamura N, Oguma N et al (2001) Acute myelogenous leukemia with PIG-A gene mutation evolved from aplastic anemia-paroxysmal nocturnal hemoglobinuria syndrome. Int J Hematol 73:206\u2013212. https:\/\/doi.org\/10.1007\/BF02981939","journal-title":"Int J Hematol"},{"key":"1304_CR19","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1067\/mcp.2001.114164","volume":"69","author":"I Cascorbi","year":"2001","unstructured":"Cascorbi I, Gerloff T, Johne A et al (2001) Frequency of single nucleotide polymorphisms in the P-glycoprotein drug transporter MDR1 gene in white subjects. Clin Pharmacol Ther 69:169\u2013174. https:\/\/doi.org\/10.1067\/mcp.2001.114164","journal-title":"Clin Pharmacol Ther"},{"key":"1304_CR20","doi-asserted-by":"publisher","first-page":"94","DOI":"10.1124\/dmd.104.001628","volume":"33","author":"D Kobayashi","year":"2005","unstructured":"Kobayashi D, Ieiri I, Hirota T et al (2005) Functional assessment of ABCG2 (BCRP) gene polymorphisms to protein expression in human placenta. Drug Metab Dispos 33:94\u2013101. https:\/\/doi.org\/10.1124\/dmd.104.001628","journal-title":"Drug Metab Dispos"},{"key":"1304_CR21","doi-asserted-by":"publisher","first-page":"1074","DOI":"10.1097\/01.tp.0000235533.29300.e7","volume":"82","author":"M Naesens","year":"2006","unstructured":"Naesens M, Kuypers DR, Verbeke K, Vanrenterghem Y (2006) Multidrug resistance protein 2 genetic polymorphisms influence mycophenolic acid exposure in renal allograft recipients. Transplantation 82:1074\u20131084. https:\/\/doi.org\/10.1097\/01.tp.0000235533.29300.e7","journal-title":"Transplantation"},{"key":"1304_CR22","doi-asserted-by":"publisher","first-page":"1156","DOI":"10.1111\/bcp.13534","volume":"84","author":"K Vishwanathan","year":"2018","unstructured":"Vishwanathan K, Dickinson PA, So K, Thomas K et al (2018) The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib. Br J Clin Pharmacol 84:1156\u20131169. https:\/\/doi.org\/10.1111\/bcp.13534","journal-title":"Br J Clin Pharmacol"},{"key":"1304_CR23","unstructured":"TAGRISSO\u00ae (Osimertinib) (2022) Drug interview form (package insert). AstraZeneca K.K., Osaka, Japan.\u00a0Available from: https:\/\/med.astrazeneca.co.jp\/product\/TAG.html#"},{"key":"1304_CR24","doi-asserted-by":"publisher","first-page":"1054","DOI":"10.3390\/biology10101054","volume":"10","author":"H Yokota","year":"2021","unstructured":"Yokota H, Sato K, Sakamoto S et al (2021) Relationship between plasma concentrations of afatinib and the onset of diarrhea in patients with non-small cell lung cancer. Biology (Basel) 10:1054. https:\/\/doi.org\/10.3390\/biology10101054","journal-title":"Biology (Basel)"},{"key":"1304_CR25","doi-asserted-by":"publisher","first-page":"4803","DOI":"10.1038\/s41598-020-61571-5","volume":"10","author":"J Huang","year":"2020","unstructured":"Huang J, Meng L, Yang B, Sun S, Luo Z, Chen H (2020) Safety profile of epidermal growth factor receptor tyrosine kinase inhibitors: a disproportionality analysis of FDA Adverse Event Reporting System. Sci Rep 10:4803. https:\/\/doi.org\/10.1038\/s41598-020-61571-5","journal-title":"Sci Rep"},{"key":"1304_CR26","doi-asserted-by":"publisher","first-page":"1106","DOI":"10.1080\/00498254.2017.1396379","volume":"48","author":"O Yasumuro","year":"2018","unstructured":"Yasumuro O, Uchida S, Kashiwagura Y et al (2018) Changes in gefitinib, erlotinib and osimertinib pharmacokinetics under various gastric pH levels following oral administration of omeprazole and vonoprazan in rats. Xenobiotica 48:1106\u20131112. https:\/\/doi.org\/10.1080\/00498254.2017.1396379","journal-title":"Xenobiotica"},{"key":"1304_CR27","doi-asserted-by":"publisher","first-page":"474","DOI":"10.1002\/jcph.1035","volume":"58","author":"K Vishwanathan","year":"2018","unstructured":"Vishwanathan K, Dickinson PA, Bui K, Cassier PA et al (2018) The effect of food or omeprazole on the pharmacokinetics of osimertinib in patients with non-small-cell lung cancer and in healthy volunteers. J Clin Pharmacol 58:474\u2013484. https:\/\/doi.org\/10.1002\/jcph.1035","journal-title":"J Clin Pharmacol"},{"key":"1304_CR28","unstructured":"TAKECAB\u00ae (Vonoprazan) (2022) Drug interview form (package insert). Takeda Pharmaceutical Company Limited., Tokyo, Japan.\u00a0Available from: https:\/\/www.takedamed.com\/mcm\/medicine\/download.jsp?id=162&type=INTERVIEW_FORM"}],"container-title":["Investigational New Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-022-01304-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10637-022-01304-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10637-022-01304-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,11]],"date-time":"2023-03-11T04:53:15Z","timestamp":1678510395000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10637-022-01304-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,23]]},"references-count":28,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["1304"],"URL":"https:\/\/doi.org\/10.1007\/s10637-022-01304-9","relation":{},"ISSN":["0167-6997","1573-0646"],"issn-type":[{"value":"0167-6997","type":"print"},{"value":"1573-0646","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,23]]},"assertion":[{"value":"4 August 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 September 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 September 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was conducted according to the principles of the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of Akita University School of Medicine (approval numbers: 790 and 1140).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all participants enrolled in this study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"The authors have no relevant financial or nonfinancial interests to disclose.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}