{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T18:11:37Z","timestamp":1770833497148,"version":"3.50.1"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2004,11,22]],"date-time":"2004-11-22T00:00:00Z","timestamp":1101081600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2005,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Gemcitabine has broad activity in a variety of solid tumors including biliary tract carcinomas. The authors evaluated 6\u2010month survival, response, and toxicity associated with a combination of gemcitabine, 5\u2010fluorouracil (5\u2010FU), and leucovorin (LV) in patients with unresectable or metastatic biliary tract or gallbladder adenocarcinoma (ACA).<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>A 4\u2010week course included 1000 mg\/m<jats:sup>2<\/jats:sup> gemcitabine by intravenous infusion over 30 minutes on Days 1, 8, and 15, 25 mg\/m<jats:sup>2<\/jats:sup> LV by intravenous push, and 600 mg\/m<jats:sup>2<\/jats:sup> 5\u2010FU by intravenous push after LV.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Forty\u2010two patients were enrolled in 6 months, 35 of whom had metastatic disease. Patients with biliary tract ACA included 24 with hepatic disease (19 patients had intrahepatic disease and 5 patients had extrahepatic disease) and 4 with disease in the ampulla of Vater. All patients were evaluable and received a median of 4 courses of treatment (range, 1\u201321 courses). Commonly occurring severe toxicity (NCI CTC Grade 3 or worse) included: dyspnea (four patients), nausea (four patients), fatigue (seven patients), thrombocytopenia (six patients), emesis (four patients), and diarrhea (four patients). Five partial responses (9.5%) occurred, 3 of which were sustained for \u2265 8 weeks. No treatment\u2010related deaths occurred. Thirty\u2010two patients had disease progression and 38 died after a median follow\u2010up of 20 months (range, 1.4\u201324 months). The median time to disease progression was 4.6 months (95% confidence interval [95% CI], 2.4\u20136.6%). The median survival period was 9.7 months (95% CI, 7\u201312%).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>This combination regimen was manageable in patients with advanced biliary tract and gallbladder ACA. Of 42 patients, 24 (57%) survived \u2265 6 months, satisfying the primary end point of the trial. The length of survival suggested that gemcitabine, 5\u2010FU, and LV had benefit equivalent to gemcitabine alone. Cancer 2005. \u00a9 2004 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.20753","type":"journal-article","created":{"date-parts":[[2004,11,22]],"date-time":"2004-11-22T12:19:03Z","timestamp":1101125943000},"page":"111-118","source":"Crossref","is-referenced-by-count":101,"title":["Gemcitabine, 5\u2010fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma"],"prefix":"10.1002","volume":"103","author":[{"given":"Steven R.","family":"Alberts","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hani","family":"Al\u2010Khatib","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle R.","family":"Mahoney","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lawerence","family":"Burgart","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter 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