BACKGROUND: A phase II study was conducted to assess the efficacy and tolerability of substituting capecitabine for 5-fluorouracil in combination with cisplatin in patients with advanced biliary cancer. PATIENTS AND METHODS: Patients with previously untreated metastatic or unresectable measurable biliary adenocarcinoma received oral capecitabine 1250 mg/m(2) twice daily on days 1-14, and intravenous cisplatin 60 mg/m(2) on day 1. This cycle was repeated every 21 days. RESULTS: Forty-two patients were enrolled in this study. Of these, 38 were assessable for efficacy and 41 were assessable for safety. A median of three cycles of treatment (range one to eight) were administered. One patient achieved a complete response, and eight had partial responses, giving an overall response rate of 21.4% in the intention-to-treat population (95% confidence interval 9.1% to 33.9%). The median response duration was 5.1 months. The median time to progression and median overall survival were 3.7 and 9.1 months, respectively. The most common grade 3/4 adverse events were neutropenia (20% of patients), vomiting (12%), diarrhea (7%) and stomatitis (5%). There were no treatment-related deaths. CONCLUSIONS: The combination of capecitabine and cisplatin has promising antitumor activity and is well tolerated in patients with advanced biliary cancer.
BACKGROUND: A phase II study was conducted to assess the efficacy and tolerability of substituting capecitabine for 5-fluorouracil in combination with cisplatin in patients with advanced biliary cancer. PATIENTS AND METHODS: Patients with previously untreated metastatic or unresectable measurable biliary adenocarcinoma received oral capecitabine 1250 mg/m(2) twice daily on days 1-14, and intravenous cisplatin 60 mg/m(2) on day 1. This cycle was repeated every 21 days. RESULTS: Forty-two patients were enrolled in this study. Of these, 38 were assessable for efficacy and 41 were assessable for safety. A median of three cycles of treatment (range one to eight) were administered. One patient achieved a complete response, and eight had partial responses, giving an overall response rate of 21.4% in the intention-to-treat population (95% confidence interval 9.1% to 33.9%). The median response duration was 5.1 months. The median time to progression and median overall survival were 3.7 and 9.1 months, respectively. The most common grade 3/4 adverse events were neutropenia (20% of patients), vomiting (12%), diarrhea (7%) and stomatitis (5%). There were no treatment-related deaths. CONCLUSIONS: The combination of capecitabine and cisplatin has promising antitumor activity and is well tolerated in patients with advanced biliary cancer.
Authors: Al B Benson; Thomas A Abrams; Edgar Ben-Josef; P Mark Bloomston; Jean F Botha; Bryan M Clary; Anne Covey; Steven A Curley; Michael I D'Angelica; Rene Davila; William D Ensminger; John F Gibbs; Daniel Laheru; Mokenge P Malafa; Jorge Marrero; Steven G Meranze; Sean J Mulvihill; James O Park; James A Posey; Jasgit Sachdev; Riad Salem; Elin R Sigurdson; Constantinos Sofocleous; Jean-Nicolas Vauthey; Alan P Venook; Laura Williams Goff; Yun Yen; Andrew X Zhu Journal: J Natl Compr Canc Netw Date: 2009-04 Impact factor: 11.908
Authors: Susanna V Ulahannan; Osama E Rahma; Austin G Duffy; Oxana V Makarova-Rusher; Metin Kurtoglu; David J Liewehr; Seth M Steinberg; Tim F Greten Journal: Hepat Oncol Date: 2015-01-01
Authors: Jennifer Yang; Matthew R Farren; Daniel Ahn; Tanios Bekaii-Saab; Gregory B Lesinski Journal: Expert Opin Ther Targets Date: 2017-03-17 Impact factor: 6.902