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载有伊立替康的小尺寸颗粒经动脉栓塞治疗结直肠癌肝转移:MIRACLE III研究结果

Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study.

作者信息

Mauri Giovanni, Varano Gianluca Maria, Della Vigna Paolo, Bonomo Guido, Monfardini Lorenzo, Zampino Maria Giulia, Ravenda Paola Simona, Orsi Franco

机构信息

Department of Interventional Radiology, European Institute of Oncology, via Ripamonti 435, Milan, Italy.

Unit of Interventional Radiology, Fondazione Poliambulanza Brescia, Brescia, Italy.

出版信息

Cardiovasc Intervent Radiol. 2018 Nov;41(11):1708-1715. doi: 10.1007/s00270-018-2017-x. Epub 2018 Jun 27.

DOI:10.1007/s00270-018-2017-x
PMID:29951693
Abstract

PURPOSE

This pilot study was performed to investigate safety and local tumor control following transarterial embolization with small-size particles loaded with irinotecan (DEB-IRI) in patients with colorectal liver metastases (CRLM).

MATERIALS AND METHODS

Patients with pretreated CRLM with mono- or bilobar lesions involving less than 60% of the liver parenchyma and Eastern Cooperative Oncology Group performance status 0 or 1 underwent superselective DEB-IRI embolization with 40 µm diameter embolic microspheres.

RESULTS

Eighteen patients (11 males, 7 females, median age 61 years) underwent 80 embolization procedures (mean 4.4, range 2-12 per patient). No serious adverse events were reported within 30 days. A total of 39 treatment-related AEs occurred across all embolization procedures. No G4 or G5 treatment-related AEs occurred. Local tumor control, defined as complete response, partial response, or stable disease, was achieved in 16/18 (88.9%), 7/17 (41.2%), and 3/17 (17.6%) patients at 3, 6, and 12 months, respectively. Median liver progression-free survival was 5.9 months (range 27-409 days), and median overall survival was 13.5 months.

CONCLUSION

In this small series, DEB-IRI embolization with small beads was demonstrated a safe procedure in the treatment of patients with CRLM. The promising results in terms of liver-specific progression-free survival and overall survival reported deserve further confirmation in larger prospective trials.

LEVEL OF EVIDENCE

Level 4, case series.

摘要

目的

本前瞻性研究旨在探讨载有伊立替康的小尺寸颗粒经动脉栓塞术(DEB-IRI)治疗结直肠癌肝转移(CRLM)患者后的安全性和局部肿瘤控制情况。

材料与方法

对先前接受过治疗、单叶或双叶病变累及肝实质少于60%且东部肿瘤协作组体能状态为0或1的CRLM患者,采用直径40 µm的栓塞微球进行超选择性DEB-IRI栓塞术。

结果

18例患者(11例男性,7例女性,中位年龄61岁)接受了80次栓塞手术(平均每人4.4次,范围为2 - 12次)。30天内未报告严重不良事件。所有栓塞手术共发生39例与治疗相关的不良事件。未发生4级或5级与治疗相关的不良事件。分别在3、6和12个月时,16/18(88.9%)、7/17(41.2%)和3/17(17.6%)的患者实现了局部肿瘤控制,定义为完全缓解、部分缓解或疾病稳定。肝无进展生存期的中位数为5.9个月(范围为27 - 409天),总生存期的中位数为13.5个月。

结论

在这个小样本系列中,小珠DEB-IRI栓塞术被证明是治疗CRLM患者的一种安全方法。所报告的在肝特异性无进展生存期和总生存期方面的良好结果值得在更大规模的前瞻性试验中进一步证实。

证据水平

4级,病例系列。

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