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tcr:callispheres®载药微球经动脉化疗栓塞治疗继发性肝癌患者的疗效和安全性:ctilc研究的初步结果-ag捕鱼平台

文字: 2019-12-17    浏览次数:468    

background

this study aimed to assess the treatment response, short-term overall survival (os) and safety profiles of drug-eluting beads transarterial chemoembolization (deb-tace) in patients with secondary liver cancer. 

背景

本研究旨在评估载药微球经动脉化疗栓塞(deb-tace)对继发性肝癌患者的治疗反应、短期总生存(os)及安全性。

 

methods

fifty-five patients with secondary liver cancer underwent deb-tace were enrolled in this prospective cohort study. treatment response was assessed by modified response evaluation criteria in solid tumors (mrecist). os was calculated from the time of deb-tace operation until the date of death. 

方法

共有55例接受deb-tace治疗的继发性肝癌患者纳入本项前瞻性队列研究。采用改良的实体瘤反应评估标准(mrecist)评估治疗反应。os从开始deb-tace时计算,至死亡为止。

 

results

the complete response (cr) and objective response rate (orr) at 1-3 months post deb-tace were 12.7% and 67.3 %. mean os was 383 d (95% ci: 360-406), and 6-month os rate was 93.4%±3.7%.subgroup analysis revealed previous conventional tace (ctace) treatment was correlated with worse orr (p=0.028), and it was a risk factor for orr achievement (p=0.021). as for liver function, the percentages of abnormal tp (p=0.031), tbil (p=0.022), alt (p=0.002) and ast (p=0.035) were increased at 1 week post deb-tace compared to baseline, while these four indexes returned to baseline (all p>0.05) at 1-3 months post deb-tace. as to safety profiles, 41 (66.1%), 28 (45.2%), 17 (27.4%), 8 (12.9%) and 6 (9.7%) cases had pain, vomiting, fever, nausea and other adverse events (aes) respectively during deb-tace operation, while 26 (41.9%), 9 (14.5%), 8 (12.9%), 4 (6.5%), 1 (1.6%) and 2 (3.2%) cases had pain, fever, vomiting, nausea, bone marrow toxicity and other aes respectively at 1 month after deb-tace operation. 

结果

deb-tace术后1-3个月的完全缓解率(cr)和客观缓解率(orr)分别为12.7%67.3%。平均os383 d (95% ci: 360 406)6个月os93.4%±3.7%。亚组分析显示,既往常规tace (ctace)治疗与orr较差相关(p=0.028),是影响orr的危险因素之一(p=0.021)。在肝功能方面,与基线相比,deb-tace术后1tp异常(p=0.031)tbil异常(p=0.022)alt异常(p=0.002)ast异常(p=0.035)的百分比均升高,而在deb-tace术后1-3个月,这4项指标均恢复到基线水平(p值均>0.05)。安全性方面,在进行deb-tace治疗期间,疼痛、呕吐、发烧、恶心和其他不良事件(aes)分别为41 (66.1%)28 (45.2%)17(27.4%)8(12.9%)6(9.7%),而deb-tace术后1个月,疼痛、发烧、呕吐、恶心、骨髓毒性和其他aes分别为26(41.9%)9(14.5%)8(12.9%)4(6.5%)1(1.6%)2(3.2%)

 

conclusions

deb-tace was efficient and well tolerated in treating patients with secondary liver cancer.

结论

deb-tace治疗继发性肝癌有效性高,且耐受性良好。