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
目的探索安罗替尼(anlotinib)靶向治疗联合化疗治疗晚期乳腺癌的疗效与安全性。方法回顾性分析我中心2018年7月-2019年2月10例接受安罗替尼联合化疗的晚期乳腺癌患者的疗效和不良反应。结果随访10个月,部分缓解1例,疾病稳定3例,疾病进展...目的探索安罗替尼(anlotinib)靶向治疗联合化疗治疗晚期乳腺癌的疗效与安全性。方法回顾性分析我中心2018年7月-2019年2月10例接受安罗替尼联合化疗的晚期乳腺癌患者的疗效和不良反应。结果随访10个月,部分缓解1例,疾病稳定3例,疾病进展6例。中位治疗失败时间(median time to treatment failure,mTTF)为1.9个月(95%CI:1.3~2.6),中位总生存期(median overall survival,mOS)为5.4个月(95%CI:2.0~8.8)。客观缓解率(objective response rate,ORR)为10.0%,疾病控制率(disease control rate,DCR)为40.0%。常见不良反应为高血压、手足综合征、乏力、厌食、恶心、谷丙转氨酶升高、谷草转氨酶升高、高三酰甘油血症、疼痛,对症处理及安罗替尼减量或停药后不良反应均可缓解。3/4级不良反应发生率30%,表现为乏力、白细胞减少症、中性粒细胞减少症。未出现药物相关死亡。结论安罗替尼联合化疗在晚期乳腺癌治疗中显示出一定的疗效,不良反应可控。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.
文摘目的探索安罗替尼(anlotinib)靶向治疗联合化疗治疗晚期乳腺癌的疗效与安全性。方法回顾性分析我中心2018年7月-2019年2月10例接受安罗替尼联合化疗的晚期乳腺癌患者的疗效和不良反应。结果随访10个月,部分缓解1例,疾病稳定3例,疾病进展6例。中位治疗失败时间(median time to treatment failure,mTTF)为1.9个月(95%CI:1.3~2.6),中位总生存期(median overall survival,mOS)为5.4个月(95%CI:2.0~8.8)。客观缓解率(objective response rate,ORR)为10.0%,疾病控制率(disease control rate,DCR)为40.0%。常见不良反应为高血压、手足综合征、乏力、厌食、恶心、谷丙转氨酶升高、谷草转氨酶升高、高三酰甘油血症、疼痛,对症处理及安罗替尼减量或停药后不良反应均可缓解。3/4级不良反应发生率30%,表现为乏力、白细胞减少症、中性粒细胞减少症。未出现药物相关死亡。结论安罗替尼联合化疗在晚期乳腺癌治疗中显示出一定的疗效,不良反应可控。
