Comparison of the Efficacy between Gemcitabine-Cisplatin and Capecitabine-Cisplatin Combination Chemotherapy for Advanced Biliary Tract Cancer
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Purpose Gemcitabine-cisplatin combination chemotherapy has been regarded as standard regimenfor advanced or metastatic biliary tract cancer (BTC), based on the ABC-02 trial. To date,however, no studies have compared the efficacies of gemcitabine-platinum and fluoropyrimidine-platinum combination chemotherapy, even though fluoropyrimidine has beenwidely used as a backbone agent for gastrointestinal cancer. This study compared the efficacyand toxicities of gemcitabine-cisplatin (GP) and capecitabine-cisplatin (XP) combinationchemotherapy for treatment of advanced BTC. Materials and MethodsWe examined 49 patients treated with GP and 44 patients treated with XP from October2009 to July 2012. All patients had unresectable BTC. The GP regimen comprised gemcitabine(1,000 mg/m2, intravenously [IV], days 1 and 8) and cisplatin (75 mg/m2, IV, day 1). The XP regimen comprised capecitabine (1,250 mg/m2 twice a day, peroral, days 1-14) andcisplatin (60 mg/m2, IV, day 1, every three weeks). We analyzed the response rate (RR),time to progression (TTP), overall survival (OS), and toxicity. ResultsThe RRs were 27.3% and 6.1% in the XP and GP arms, respectively. XP resulted in longerTTP (5.2 months vs. 3.6 months, p=0.016), but OS was not statistically different (10.7months vs. 8.6 months, p=0.365). Both regimens resulted in grade 3-4 hematologic toxicities,but febrile neutropenia was not noted. Grade 3-4 asthenia, stomatitis, and hand-footsyndrome occurred more frequently in the XP arm. ConclusionXP resulted in a superior TTP and RR compared to GP for treatment of advanced BTC, withcomparable toxicity. Conduct of prospective large, randomized trials to evaluate the possibilityof XP as another standard therapy is warranted.
Abstract
Purpose Gemcitabine-cisplatin combination chemotherapy has been regarded as standard regimenfor advanced or metastatic biliary tract cancer (BTC), based on the ABC-02 trial. To date,however, no studies have compared the efficacies of gemcitabine-platinum and fluoropyrimidine-platinum combination chemotherapy, even though fluoropyrimidine has beenwidely used as a backbone agent for gastrointestinal cancer. This study compared the efficacyand toxicities of gemcitabine-cisplatin (GP) and capecitabine-cisplatin (XP) combinationchemotherapy for treatment of advanced BTC. Materials and MethodsWe examined 49 patients treated with GP and 44 patients treated with XP from October2009 to July 2012. All patients had unresectable BTC. The GP regimen comprised gemcitabine(1,000 mg/m2, intravenously [IV], days 1 and 8) and cisplatin (75 mg/m2, IV, day 1). The XP regimen comprised capecitabine (1,250 mg/m2 twice a day, peroral, days 1-14) andcisplatin (60 mg/m2, IV, day 1, every three weeks). We analyzed the response rate (RR),time to progression (TTP), overall survival (OS), and toxicity. ResultsThe RRs were 27.3% and 6.1% in the XP and GP arms, respectively. XP resulted in longerTTP (5.2 months vs. 3.6 months, p=0.016), but OS was not statistically different (10.7months vs. 8.6 months, p=0.365). Both regimens resulted in grade 3-4 hematologic toxicities,but febrile neutropenia was not noted. Grade 3-4 asthenia, stomatitis, and hand-footsyndrome occurred more frequently in the XP arm. ConclusionXP resulted in a superior TTP and RR compared to GP for treatment of advanced BTC, withcomparable toxicity. Conduct of prospective large, randomized trials to evaluate the possibilityof XP as another standard therapy is warranted.
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