Background:This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule(S-1)for patients with advanced biliary tract carcinoma(BTC).Meth...Background:This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule(S-1)for patients with advanced biliary tract carcinoma(BTC).Methods:Patients were treated with nab-paclitaxel at a dose of 125 mg/m2 on day 1 and 8,and S-1,80 to 120 mg/day on days 1-14 of a 21-day cycle.Treatments were repeated until disease progression or unacceptable toxicity occurred.The primary endpoint was objective response rate(ORR).The secondary endpoints were median progression-free survival(PFS),overall survival(OS),and adverse events(AEs).Results:The number of patients enrolled were 54,and 51 patients were evaluated for efficacy.A total of 14 patients achieved partial response(PR)with an ORR of 27.5%.The ORR varied by sites,with 53.8%(7/13)for gallbladder carcinoma,18.4%(7/38)for cholangiocarcinoma.The most common grade 3 or 4 toxicities were neutropenia and stomatitis.The median PFS and OS were 6.0 and 13.2 months,respectively.Conclusions:The combination of nab-paclitaxel with S-1 showed explicit antitumor activities and favorable safety profile in advanced BTC and could serve as a potential non-platinum and-gemcitabine-based regimen.展开更多
文摘Background:This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule(S-1)for patients with advanced biliary tract carcinoma(BTC).Methods:Patients were treated with nab-paclitaxel at a dose of 125 mg/m2 on day 1 and 8,and S-1,80 to 120 mg/day on days 1-14 of a 21-day cycle.Treatments were repeated until disease progression or unacceptable toxicity occurred.The primary endpoint was objective response rate(ORR).The secondary endpoints were median progression-free survival(PFS),overall survival(OS),and adverse events(AEs).Results:The number of patients enrolled were 54,and 51 patients were evaluated for efficacy.A total of 14 patients achieved partial response(PR)with an ORR of 27.5%.The ORR varied by sites,with 53.8%(7/13)for gallbladder carcinoma,18.4%(7/38)for cholangiocarcinoma.The most common grade 3 or 4 toxicities were neutropenia and stomatitis.The median PFS and OS were 6.0 and 13.2 months,respectively.Conclusions:The combination of nab-paclitaxel with S-1 showed explicit antitumor activities and favorable safety profile in advanced BTC and could serve as a potential non-platinum and-gemcitabine-based regimen.
