{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T05:53:45Z","timestamp":1760162025976,"version":"3.37.3"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,10,20]],"date-time":"2021-10-20T00:00:00Z","timestamp":1634688000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP18ck0106306","H26\u2013047","H22\u2013019"],"award-info":[{"award-number":["JP18ck0106306","H26\u2013047","H22\u2013019"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008746","name":"National Cancer Center","doi-asserted-by":"publisher","award":["2020-J-3","29-A-3","26-A-4","23-A-19"],"award-info":[{"award-number":["2020-J-3","29-A-3","26-A-4","23-A-19"]}],"id":[{"id":"10.13039\/100008746","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,1,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Although cisplatin and 5-chloro-2,4-dihydropyrimidine (dihydropyrimidine dehydrogenase inhibitor contained in S-1) are excreted into the urine, it remains unknown how creatinine clearance (CrCl) affects the safety and efficacy of cisplatin plus S-1 and docetaxel plus cisplatin plus S-1 in patients with advanced gastric cancer.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Among the 741 participants in JCOG1013 comparing cisplatin plus S-1 with docetaxel plus cisplatin plus S-1, 723 with serum creatinine levels \u22641.2\u00a0mg\/dL were categorized into A1 (CrCl \u2265\u00a080\u00a0mL\/min), A2 (60\u00a0\u2264\u00a0CrCl &amp;lt;80) and A3 (CrCl &amp;lt;\u00a060) in the cisplatin plus S-1 arm and similarly B1, B2 and B3 in the docetaxel plus cisplatin plus S-1 arm. The initial dose modification by CrCl was pre-specified in the docetaxel plus cisplatin plus S-1 arm but not in the cisplatin plus S-1 arm.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The numbers of patients categorized as A1\/A2\/A3 and B1\/B2\/B3 were 169\/136\/57 and 170\/138\/53, respectively. In the cisplatin plus S-1 arm, a lower CrCl was associated with higher incidences of grade 4 leukopenia (P\u00a0=\u00a00.006), neutropenia (P\u00a0=\u00a00.002), and grade 3\/4 anorexia (P\u00a0=\u00a00.004) and febrile neutropenia (P\u00a0=\u00a00.049), whereas there was no association in the docetaxel plus cisplatin plus S-1 arm. No significant differences were observed according to CrCl in the overall survival [median: 15.4\/15.5\/15.4\u00a0months in A1\/A2\/A3 (P\u00a0=\u00a00.886) and 15.3\/13.7\/13.7\u00a0months in B1\/B2\/B3 (P\u00a0=\u00a00.719)], progression-free survival [median: 7.1\/6.8\/6.2\u00a0months in A1\/A2\/A3 (P\u00a0=\u00a00.884) and 7.5\/7.2\/7.8\u00a0months in B1\/B2\/B3 (P\u00a0=\u00a00.851)] and response rates [58.9\/57.8\/46.9% in A1\/A2\/A3 (P\u00a0=\u00a00.311) and 62.0\/61.5\/51.5% in B1\/B2\/B3 (P\u00a0=\u00a00.362)].<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Renal impairment was associated with severe adverse events in cisplatin plus S-1 therapy but not with the efficacy in cisplatin plus S-1 and docetaxel plus cisplatin plus S-1 therapy.<\/jats:p>\n               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