文章：

可降解淀粉微球经动脉化疗栓塞联合或不联合碘油治疗胰腺癌肝转移：一项前瞻性随机试验

Degradable Starch Microspheres Transarterial Chemoembolization with or without Lipiodol for Liver Metastases from Pancreatic Cancer: A Prospective Randomized Trial

原文发布日期：31 October 2023

DOI: 10.3390/cancers15215239

类型: Article

开放获取: 是

英文摘要：

To evaluate and compare the outcome of patients with liver metastases from pancreatic cancer treated by transarterial chemoembolization (TACE) using two different protocols. In this prospective, randomized, single-center trial, patients were randomly assigned to receive TACE therapy either with degradable starch microspheres (DSM) alone or a combination of Lipiodol and DSM. From the initial 58 patients, 26 patients (13 DSM-TACE, 13 Lipiodol + DSM-TACE) who completed 3 TACE treatments at an interval of four weeks were considered for evaluation of tumor responses. Initial and final MRIs were used to evaluate local therapy response by RECIST 1.1; changes in diameter, volume, ADC value, and survival rate were statistically evaluated. The differences between the DSM-TACE and Lipiodol + DSM-TACE were identified for partial response (PR) as 15.4% versus 53.8%, stable disease (SD) as 69.2% versus 46.2%, progressive disease (PD) as 15.4% versus 0%, respectively (p= 0.068). Median overall survival times for DSM-TACE and Lipiodol + DSM-TACE were 20 months (95% CI, 18.1–21.9) and 23 months (95% CI, 13.8–32.2), respectively (p= 0.565). The one-year survival rates for DSM-TACE and Lipiodol + DSM-TACE were 85.4% and 60.4%, the two-year survival rates were 35.9% and 47.7%, and the three-year survival rates were 12% and 30.9%, respectively. The evaluated local therapy response by RECIST 1. was not significantly different between the two studied groups. A longer overall survival time was observed after Lipiodol + DSM-TACE therapy; however, it was not significantly different.

摘要翻译： 

评估并比较采用两种不同方案经动脉化疗栓塞术（TACE）治疗胰腺癌肝转移患者的疗效。本项前瞻性、随机、单中心试验将患者随机分配至仅使用可降解淀粉微球（DSM）或联合使用碘油与DSM的TACE治疗组。在初始58例患者中，共26例（DSM-TACE组13例，碘油+DSM-TACE组13例）完成间隔四周的三次TACE治疗，纳入肿瘤反应评估。采用RECIST 1.1标准通过治疗前后MRI评估局部治疗反应；对病灶直径、体积、ADC值变化及生存率进行统计学分析。DSM-TACE组与碘油+DSM-TACE组在部分缓解（PR）率（15.4%对53.8%）、疾病稳定（SD）率（69.2%对46.2%）、疾病进展（PD）率（15.4%对0%）方面存在差异（p=0.068）。两组中位总生存期分别为20个月（95% CI：18.1-21.9）和23个月（95% CI：13.8-32.2）（p=0.565）。DSM-TACE组与碘油+DSM-TACE组的一年生存率分别为85.4%和60.4%，两年生存率为35.9%和47.7%，三年生存率为12%和30.9%。根据RECIST 1.1标准评估的局部治疗反应在两组间无显著差异。碘油+DSM-TACE治疗组观察到更长的总生存期，但差异未达统计学显著性。

原文链接：

Degradable Starch Microspheres Transarterial Chemoembolization with or without Lipiodol for Liver Metastases from Pancreatic Cancer: A Prospective Randomized Trial