{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T16:20:08Z","timestamp":1781713208020,"version":"3.54.5"},"reference-count":23,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,11,29]],"date-time":"2020-11-29T00:00:00Z","timestamp":1606608000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>A previous Phase I\/II study demonstrated that TAS\u2010102 (trifluridine\/tipiracil [FTD\/TPI]) plus bevacizumab (Bev) has encouraging efficacy and controllable safety for patients with previously treated metastatic colorectal cancer. Therefore, we designed for assessing the efficacy and safety of FTD\/TPI plus Bev in elderly patients with previously untreated metastatic colorectal cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This is a multicenter, single\u2010arm Phase II study included patients \u226570\u00a0years old with previously untreated, unresectable metastatic colorectal cancer. Treatment consisted of FTD\/TPI plus Bev given every 4\u00a0weeks. The primary endpoint was progression\u2010free survival (PFS), assuming a null hypothesis of a PFS of 5\u00a0months. The secondary endpoints were the overall survival (OS), overall response rate (ORR), and adverse events (AEs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between 5 January 2017 and 13 March 2018, 39 patients were enrolled from 18 institutions. The median patient age was 76.0\u00a0years (range, 70\u201388); the ECOG\u2010PS was 0 in 24 patients and 1 in 15 patients. The median PFS was 9.4\u00a0months as a primary endpoint, and the median OS was 22.4\u00a0months. The ORR was 40.5% and the disease control rate was 86.5%. Grade 3\u20134 AEs included neutropenia (71.8%), leukopenia (51.3%), anorexia (15.4%), febrile neutropenia (10.3%), and fatigue (10.3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>FTD\/TPI plus Bev is an effective and well\u2010tolerated regimen for elderly patients with previously untreated metastatic colorectal cancer. Capecitabine\/bevacizumab can be selected as a subsequent maintenance therapy without irinotecan and oxaliplatin because FTD\/TPI has no cross\u2010resistance with 5\u2010fluorouracil.<\/jats:p><jats:p>Clinical trial registration: UMIN clinical trials registry (UMIN000025241).<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.3618","type":"journal-article","created":{"date-parts":[[2020,11,29]],"date-time":"2020-11-29T13:39:25Z","timestamp":1606657165000},"page":"454-461","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Trifluridine\/tipiracil plus bevacizumab as a first\u2010line treatment for elderly patients with metastatic colorectal cancer (KSCC1602): A multicenter phase II trial"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9763-9366","authenticated-orcid":false,"given":"Eiji","family":"Oki","sequence":"first","affiliation":[{"name":"Department of Surgery and Science Graduate 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