{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T17:29:33Z","timestamp":1772818173193,"version":"3.50.1"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2005,4,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Biliary cancer has a poor prognosis, and chemotherapy has had little impact. The objectives of this trial were to determine the response rate, time to disease progression, survival, and safety profile of the combination of gemcitabine and capecitabine (GemCap) in patients with advanced biliary cancer. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Eligible patients had pathologically proven, locally advanced or metastatic adenocarcinoma arising from the intra- and extrahepatic bile ducts or gallbladder with no prior chemotherapy. Patients were treated on a 3-week cycle consisting of capecitabine at 650 mg\/m<jats:sup>2<\/jats:sup> orally twice a day for 14 days and gemcitabine at a fixed dose of 1,000 mg\/m<jats:sup>2<\/jats:sup> intravenously over 30 minutes on days 1 and 8. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Forty-five patients were enrolled between July 2001 and January 2004. Fifty-three percent of patients had cholangiocarcinoma, 47% had gallbladder cancer, and 89% had metastatic disease. The overall objective response rate was 31%, with an additional 42% of patients with stable disease, for a disease control rate of 73%. The median overall survival time was 14 months (95% CI, 7.3 months to not available), and the median progression-free survival time was 7 months (95% CI, 4.6 to 11.8 months). This chemotherapy combination was generally well tolerated. Transient neutropenia, thrombocytopenia, fatigue, and hand-foot syndrome were commonly observed but were easily managed without discontinuing further treatment. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> The significant antitumor activity combined with a mild toxicity profile seen in this study argue that GemCap chemotherapy may benefit patients with advanced biliary cancer. This regimen warrants further evaluation in a randomized study with survival and quality of life end points. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2005.51.008","type":"journal-article","created":{"date-parts":[[2005,3,30]],"date-time":"2005-03-30T23:43:15Z","timestamp":1112226195000},"page":"2332-2338","source":"Crossref","is-referenced-by-count":246,"title":["Combining Gemcitabine and Capecitabine in Patients With Advanced Biliary Cancer: A Phase II Trial"],"prefix":"10.1200","volume":"23","author":[{"given":"Jennifer J.","family":"Knox","sequence":"first","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Hedley","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amit","family":"Oza","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ron","family":"Feld","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lillian L.","family":"Siu","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Chen","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mahsan","family":"Nematollahi","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory R.","family":"Pond","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Zhang","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Malcolm J.","family":"Moore","sequence":"additional","affiliation":[{"name":"From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital\/University Health Network; and Department of Medicine, University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"R1","unstructured":"Oertli D, Herzog U, Tondelli P: Primary carcinoma of the gallbladder: Operative experience during a 16-year period. Eur J Surg 159:415,1993-420,"},{"key":"R2","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9610(84)90013-8"},{"key":"R3","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-9098(199703)64:3<242::AID-JSO12>3.0.CO;2-6"},{"key":"R4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199910283411807"},{"key":"R5","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19840915)54:6<965::AID-CNCR2820540603>3.0.CO;2-X"},{"key":"R6","doi-asserted-by":"publisher","DOI":"10.1159\/000227373"},{"key":"R7","doi-asserted-by":"publisher","DOI":"10.1097\/00000421-199406000-00008"},{"key":"R8","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.annonc.a010676"},{"key":"R9","doi-asserted-by":"publisher","DOI":"10.1023\/A:1012543223020"},{"key":"R11","unstructured":"Kubicka S, Rudolph KL, Tietze MK, et al: A phase II study of gemcitabine chemotherapy for advanced unresectable hepatobiliary carcinomas. Hepatogastroenterology 48:783,2001-789,"},{"key":"R12","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008352123009"},{"key":"R14","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6601736"},{"key":"R15","doi-asserted-by":"publisher","DOI":"10.1159\/000011961"},{"key":"R16","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2001.19.20.4089"},{"key":"R17","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6601796"},{"key":"R19","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdh096"},{"key":"R21","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdf201"},{"key":"R22","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0142(19980615)82:12<2321::AID-CNCR4>3.0.CO;2-V"},{"key":"R24","unstructured":"Patt YZ, Hassan MM, Lozano RD, et al: Phase II trial of cisplatin, interferon alpha-2b, doxorubicin, and fluorouracil for biliary tract cancer. Clin Cancer Res 7:3375,2001-3380,"},{"key":"R26","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1999.17.2.585"},{"key":"R27","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2003.04.029"},{"key":"R30","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdh172"},{"key":"R31","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/92.3.205"},{"key":"R32","doi-asserted-by":"publisher","DOI":"10.1023\/A:1016209901417"},{"key":"R33","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdh351"},{"key":"R34","doi-asserted-by":"publisher","DOI":"10.3322\/canjclin.51.1.15"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.2005.51.008","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T21:08:30Z","timestamp":1653512910000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2005.51.008"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2005,4,1]]},"references-count":26,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2005,4,1]]}},"alternative-id":["10.1200\/JCO.2005.51.008"],"URL":"https:\/\/doi.org\/10.1200\/jco.2005.51.008","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2005,4,1]]}}}