{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T16:15:52Z","timestamp":1772813752941,"version":"3.50.1"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2019,12,11]],"date-time":"2019-12-11T00:00:00Z","timestamp":1576022400000},"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":[[2020,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Trial Information<\/jats:title><jats:p>Click here to access other published clinical trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Lessons Learned<\/jats:title><jats:p>Trifluridine\/tipiracil (FTD\/TPI) shows promising antitumor activity in heavily pretreated patients with advanced biliary tract carcinoma, including patients with 5-fluorouracil refractory tumors. FTD\/TPI has an acceptable safety profile and should be studied further in patients with advanced biliary tract carcinoma after progression on standard first-line therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Patients with advanced biliary tract carcinoma (BTC) refractory to first-line therapy lack an established second-line option. Trifluridine\/tipiracil (FTD\/TPI) has activity in both fluoropyrimidine-sensitive and -resistant tumors, which led us to conduct a single arm phase II trial to evaluate the safety and efficacy of FTD\/TPI for patients previously treated for advanced BTC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with advanced BTC previously treated with at least one line of chemotherapy were enrolled and treated with FTD\/TPI until disease progression or unacceptable toxicity. The primary endpoint target was to have at least 6 patients who were progression free and alive at 16\u2009weeks among 25 evaluable patients. Secondary endpoints included overall survival (OS), overall response rate (ORR), progression-free survival (PFS), and toxicity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 27 evaluable patients, 59.3% received at least three prior lines of therapy, and 81.5% had previous exposure to fluoropyrimidine. Eight (32%, 95% confidence interval [CI], 14.9%\u201353.5%) patients were progression free at 16\u2009weeks in the primary analysis population (n =\u200925), which met the predefined efficacy criteria. Median PFS and OS were 3.8 (95% CI, 2\u20135.8 months) and 6.1 (95% CI, 4.4\u201311.4 months) months, respectively. No objective responses were seen. There were no unexpected safety signals noted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>FTD\/TPI demonstrated promising antitumor activity, with acceptable toxicity, in heavily pretreated patients with advanced BTC.<\/jats:p><\/jats:sec>","DOI":"10.1634\/theoncologist.2019-0874","type":"journal-article","created":{"date-parts":[[2019,12,11]],"date-time":"2019-12-11T19:07:40Z","timestamp":1576091260000},"page":"380-e763","source":"Crossref","is-referenced-by-count":11,"title":["Phase II Trial of Trifluridine\/Tipiracil in Patients with Advanced, Refractory Biliary Tract Carcinoma"],"prefix":"10.1093","volume":"25","author":[{"given":"Sakti","family":"Chakrabarti","sequence":"first","affiliation":[{"name":"Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tyler J.","family":"Zemla","sequence":"additional","affiliation":[{"name":"Department\u2009of Biostatistics, Mayo Clinic, 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