Background:This study was conducted to evaluate the efficacy and safety of docetaxel/S-1(TS)compared with docetaxel/capecitabine(TX)as a first-line treatment for advanced breast cancer.Methods:Patients with advanced m...Background:This study was conducted to evaluate the efficacy and safety of docetaxel/S-1(TS)compared with docetaxel/capecitabine(TX)as a first-line treatment for advanced breast cancer.Methods:Patients with advanced metastatic breast cancer were randomly divided into the TS group(n=54)and the TX group(n=57)for first-line chemotherapy from August 2015 to April 2019(ClinicalTrials.org registration no.NCT02947061).Following the completion of combination therapy,patients without progression received S-1 or capecitabine maintenance treatment.The primary end point was progression-free survival(PFS).Results:Among 111 enrolled patients,the median PFS did not differ significantly between the TS group and the TX group(TS vs.TX,9.0 vs.7.4 months,P=0.365,95%confidence interval[CI]:0.50-1.11,hazard ratio[HR]:0.75).There was also no statistically significant difference in median overall survival(OS)between the two groups(TS vs.TX,40.2 vs.41.3 months,P=0.976).In addition,visceral metastasis and metastasis sites,such as the liver or lung,did not lead to a significant effect on PFS and OS.The two regimens showed no significant difference in adverse events,except hand-foot syndrome,which predominated in the TX group(38.6%vs.7.4%,P=0.001),and diarrhea(24.1%vs.3.6%,P=0.003)and elevation of aspartate aminotransferase(AST)/alanine aminotransferase(ALT)levels(14.8%vs.3.5%,P=0.049),which were more frequent in the TS group.Conclusions:The TS and TX regimens demonstrated similar efficacy and safety for the first-line treatment of advanced breast cancer.The TS regimen had fewer cases of severe hand-foot syndrome than the TX regimen,representing an effective alternative option to the TX regimen.Further studies are warranted to define the efficacy and safety of this strategy in real-world settings.展开更多
文摘Background:This study was conducted to evaluate the efficacy and safety of docetaxel/S-1(TS)compared with docetaxel/capecitabine(TX)as a first-line treatment for advanced breast cancer.Methods:Patients with advanced metastatic breast cancer were randomly divided into the TS group(n=54)and the TX group(n=57)for first-line chemotherapy from August 2015 to April 2019(ClinicalTrials.org registration no.NCT02947061).Following the completion of combination therapy,patients without progression received S-1 or capecitabine maintenance treatment.The primary end point was progression-free survival(PFS).Results:Among 111 enrolled patients,the median PFS did not differ significantly between the TS group and the TX group(TS vs.TX,9.0 vs.7.4 months,P=0.365,95%confidence interval[CI]:0.50-1.11,hazard ratio[HR]:0.75).There was also no statistically significant difference in median overall survival(OS)between the two groups(TS vs.TX,40.2 vs.41.3 months,P=0.976).In addition,visceral metastasis and metastasis sites,such as the liver or lung,did not lead to a significant effect on PFS and OS.The two regimens showed no significant difference in adverse events,except hand-foot syndrome,which predominated in the TX group(38.6%vs.7.4%,P=0.001),and diarrhea(24.1%vs.3.6%,P=0.003)and elevation of aspartate aminotransferase(AST)/alanine aminotransferase(ALT)levels(14.8%vs.3.5%,P=0.049),which were more frequent in the TS group.Conclusions:The TS and TX regimens demonstrated similar efficacy and safety for the first-line treatment of advanced breast cancer.The TS regimen had fewer cases of severe hand-foot syndrome than the TX regimen,representing an effective alternative option to the TX regimen.Further studies are warranted to define the efficacy and safety of this strategy in real-world settings.
