{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T22:11:02Z","timestamp":1777500662875,"version":"3.51.4"},"reference-count":12,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2021,6,21]],"date-time":"2021-06-21T00:00:00Z","timestamp":1624233600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Lessons Learned<\/jats:title>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>OX-IRIS is a new combination therapy of oxaliplatin, irinotecan, and S-1 for unresectable pancreatic ductal adenocarcinoma (PDAC), which may be beneficial because S-1 is administered orally and continuous infusion of 5-fluorouracil (5-FU) is not needed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients who had not received prior therapy for unresectable PDAC were enrolled. Adenocarcinoma or adenosquamous histology was required. Oxaliplatin and irinotecan were administered on days 1 and 15; S-1 was administered orally twice a day on days 1\u201314, followed by 14 days of rest (one cycle). Primary endpoints were dose-limiting toxicity (DLT) and maximum tolerated dose (MTD). Secondary endpoints were safety, overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In level 0 (oxaliplatin, 85 mg\/m2; irinotecan, 100 mg\/m2; S-1, 80 mg\/m2), two of five patients experienced DLT. In level \u22121 (oxaliplatin, 65 mg\/m2; irinotecan, 100 mg\/m2; S-1, 80 mg\/m2), DLT could not be evaluated in two of eight patients because one cycle was not completed; one of the remaining six patients experienced DLT. Anemia, thrombocytopenia, fatigue, nausea, anorexia, diarrhea, and peripheral sensory neuropathy were seen frequently in levels 0 and \u22121. ORR was 30% in levels 0 and \u22121. Median progression-free survival and median overall survival were 4.1 months (95% confidence interval [CI], 0.0\u20138.9 months) and 13.7 months (95% CI, 4.8\u201322.6 months), respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>MTD of OX-IRIS therapy was estimated to be level 0, and the recommended dose (RD) for future trial was level \u22121.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1002\/onco.13838","type":"journal-article","created":{"date-parts":[[2021,5,29]],"date-time":"2021-05-29T02:21:09Z","timestamp":1622254869000},"page":"e1675-e1682","source":"Crossref","is-referenced-by-count":8,"title":["A Phase I Trial of Oxaliplatin, Irinotecan, and S-1 Combination Therapy (OX-IRIS) as Chemotherapy for Unresectable Pancreatic Cancer (HGCSG 1403)"],"prefix":"10.1093","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7706-0015","authenticated-orcid":false,"given":"Yasuyuki","family":"Kawamoto","sequence":"first","affiliation":[{"name":"Division of Cancer Center, Hokkaido University Hospital, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Nakatsumi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, National Hospital Organization Hokkaido Medical Center, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9577-1884","authenticated-orcid":false,"given":"Kazuaki","family":"Harada","sequence":"additional","affiliation":[{"name":"Division of Deparment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuhito","family":"Muranaka","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Wakkanai City Hospital, Wakkanai, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Ishiguro","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Teine Keijinkai Hospital, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshimitsu","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideyuki","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Genomic Unit, Keio Cancer Center, Keio University School of Medicine, Tokyo, 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