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In this study, the authors assessed the activity and safety of this combination regimen in patients with advanced BTA.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS:<\/jats:title><jats:p>PEFG (cisplatin 40 mg\/m<jats:sup>2<\/jats:sup> and epirubicin 40 mg\/m<jats:sup>2<\/jats:sup> on Day 1; gemcitabine 600 mg\/m<jats:sup>2<\/jats:sup> on Days 1 and 8; and 5\u2010fluorouracil [FU] 200 mg\/m<jats:sup>2<\/jats:sup> daily as a continuous infusion) was administered to chemotherapy\u2010naive patients who had a cytologic or histologic diagnosis of locally advanced or metastatic BTA, aged \u226475 years, and a performance status (PS) &gt;60 either until they had evidence progressive disease or for a maximum of 6 months. Tumor size was assessed every 2 months during treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS:<\/jats:title><jats:p>Between May 1999 and December 2005, 37 patients (62% metastatic) who had a median age of 62 years and a median PS of 90 received the PEFG regimen at the authors' institution. Primary tumor sites were the intrahepatic bile duct in 10 patients (27%), the extrahepatic bile duct in 8 patients (22%), the gallbladder in 12 patients (32%), and the ampulla of Vater in 7 patients (19%). A partial response was observed in 16 patients (43%), and stable disease was observed in 12 patients (32%). The median overall survival (OS) was 12.1 months, and the 1\u2010year OS rate was 52%. The median progression\u2010free survival (PFS) was 7.9 months, and the 6\u2010month PFS rate was 67%. The main grade 3\/4 toxicity was neutropenia in 18% of cycles followed by thrombocytopenia in 9% of cycles, nausea\/vomiting in 5% of cycles, and febrile neutropenia, fatigue, anemia, and stomatitis in 2% of cycles.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS:<\/jats:title><jats:p>The current results demonstrated that PEFG was an active regimen with a manageable toxicity profile for patients with advanced BTA. Cancer 2010. \u00a9 2010 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.24970","type":"journal-article","created":{"date-parts":[[2010,2,24]],"date-time":"2010-02-24T14:40:03Z","timestamp":1267022403000},"page":"2208-2214","source":"Crossref","is-referenced-by-count":32,"title":["The cisplatin, epirubicin, 5\u2010fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma"],"prefix":"10.1002","volume":"116","author":[{"given":"Stefano","family":"Cereda","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paolo","family":"Passoni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michele","family":"Reni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria 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