{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T16:32:55Z","timestamp":1793118775706,"version":"4.5.0"},"reference-count":41,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,12,18]],"date-time":"2018-12-18T00:00:00Z","timestamp":1545091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000801","name":"Bayer HealthCare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000801","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["P30CA047904"],"award-info":[{"award-number":["P30CA047904"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2019,3,15]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Biliary tract cancers are rare, aggressive neoplasms. Most patients present with advanced\/unresectable or metastatic disease at diagnosis, and no second\u2010line regimen has demonstrated clinical benefit. This was a phase 2 study evaluating the efficacy and safety of regorafenib in patients who had advanced\/unresectable or metastatic disease after receiving standard therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this single arm\u2010study, patients with advanced\/unresectable or metastatic biliary tract cancer who failed at least 1 line of systemic chemotherapy received regorafenib once daily on a schedule of 21\u2010days on\/7\u2010days off in a 28\u2010day cycle. Patients initially received a standard 160\u00a0mg dose. After toxicity assessments in the first 3 patients, the dose was reduced to 120 mg for subsequent patients, as preplanned. The primary endpoint was progression\u2010free survival (PFS). Secondary objectives included overall survival (OS), the objective response rate, and the disease control rate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty\u2010three patients received at least 1 dose of regorafenib, and 34 patients who received at least 1 cycle of treatment were evaluable for tumor response. The median PFS was 15.6 weeks (90% confidence interval, 12.9\u201024.7 weeks), and the median OS was 31.8 weeks (90% confidence interval, 13.3\u201074.3 weeks), with survival rates 40% at 12 months and 32% at 18 months. A partial response was achieved in 5 patients (11%), and 19 had stable disease (44%), for a disease control rate of 56%. The toxicity profile was as expected, with grade 3 and 4 adverse events reported in 40% of patients. The most common toxicities were hypophosphatemia (40%), hyperbilirubinemia (26%), hypertension (23%), and hand\u2010foot skin reaction (7%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The current results suggest promising efficacy of regorafenib in patients with chemotherapy\u2010refractory, advanced\/metastatic biliary tract cancer, warranting further studies to confirm its clinical efficacy. There is a clear unmet need for effective therapies in patients who have advanced and metastatic biliary tract cancer.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncr.31872","type":"journal-article","created":{"date-parts":[[2018,12,18]],"date-time":"2018-12-18T10:54:29Z","timestamp":1545130469000},"page":"902-909","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":116,"title":["A phase 2 trial of regorafenib as a single agent in patients with chemotherapy\u2010refractory, advanced, and metastatic biliary tract adenocarcinoma"],"prefix":"10.1002","volume":"125","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6549-9605","authenticated-orcid":false,"given":"Weijing","family":"Sun","sequence":"first","affiliation":[{"name":"University of Kansas School of Medicine Westwood Kansas"},{"name":"University of Kansas Cancer Center Westwood 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