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首页> 外文期刊>Anticancer Research: International Journal of Cancer Research and Treatment >Trans-arterial chemoembolization of metastatic colorectal carcinoma to the liver adopting DC Bead(R), drug-eluting bead loaded with irinotecan: results of a phase II clinical study.
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Trans-arterial chemoembolization of metastatic colorectal carcinoma to the liver adopting DC Bead(R), drug-eluting bead loaded with irinotecan: results of a phase II clinical study.

机译：采用装载伊立替康的药物洗脱微珠DC Bead（R），将转移性结直肠癌经动脉化学栓塞至肝脏：II期临床研究的结果。

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Trans-arterial chemoembolization (TACE) is a promising locoregional therapy for the treatment of primary hepatic tumors and liver metastases. The aim of the study was to define the activity and outcome of using DC Bead, drug-eluting bead, a spherical embolic device capable of being loaded with irinotecan. PATIENTS AND METHODS: We conducted a double institutional, single arm, phase II clinical study to evaluate TACE adopting this device in 82 patients presenting with metastatic colorectal carcinoma to the liver after failing chemotherapy. The primary endpoints were tumor shrinkage, safety, feasibility, compliance, and overall survival. RECIST criteria were used to assess responses. Quality of life (QoL) was addressed using Edmonton SAS improvement scale. RESULTS: Out of 103 patients considered, 82 were enrolled and underwent a total of 185 treatments of TACE. The median number of TACE was 2.2 (1-4). A post-embolization syndrome was frequently observed. Adverse observed effects were: right upper quadrant pain (40%), fever (80%), nausea (27%) and increased transaminases (70%). The median follow-up was 29 months. Within one month after treatment, each patient received a computed tomograpic scan. It showed reduction of metastatic contrast enhancement in all patients. Responses were 78% at 3 months. After the first treatment, 75 out 82 patients declared an improvement of their well being lasting more than 18 weeks. The median duration of response was 6 (range 3-10) months; the median follow up was 29 (range 7-48) months. The median survival was 25 (range 6-34) months, with progression free survival at 8 (range 4-16) months. CONCLUSION: We suggest that TACE adopting DC Bead(R), drug-eluting bead loaded with irinotecan could be proposed as palliative therapy for unresectable and chemotherapy resistant liver metastases from CRC.
机译：跨动脉化学栓塞术（TACE）是用于治疗原发性肝肿瘤和肝转移的有希望的局部疗法。该研究的目的是确定使用DC Bead（药物洗脱珠子）的活性和结果，DC Bead是一种能够装载伊立替康的球形栓塞装置。患者和方法：我们进行了一项双机构，单臂，II期临床研究，以评估82例化疗失败后肝转移性结直肠癌患者采用TACE的情况。主要终点是肿瘤缩小，安全性，可行性，依从性和总生存期。 RECIST标准用于评估反应。生活质量（QoL）使用Edmonton SAS改善量表进行评估。结果：在所考虑的103例患者中，有82例被纳入研究，总共接受了185种TACE治疗。 TACE的中位数为2.2（1-4）。经常观察到栓塞后综合征。观察到的不良影响是：右上腹痛（40％），发烧（80％），恶心（27％）和转氨酶升高（70％）。中位随访时间为29个月。治疗后一个月内，每位患者均接受了计算机断层扫描。它显示了所有患者转移对比增强的降低。 3个月时的反应为78％。首次治疗后，82例患者中有75例的健康状况持续了18周以上。中位反应持续时间为6（3-10）个月;中位随访时间为29（7-48）个月。中位生存期为25（6-34）个月，而无进展生存期为8（4-16）个月。结论：我们建议采用DC Bead（R），载有伊立替康的药物洗脱微珠的TACE可作为姑息疗法用于CRC不可切除和化疗耐药的肝转移。

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