Huppert Peter, Wenzel Thorsten, Wietholtz Hubertus
Department of Diagnostic and Interventional Radiology, Klinikum Darmstadt GmbH, Grafenstrasse 9, 64283, Darmstadt, Germany,
Cardiovasc Intervent Radiol. 2014 Feb;37(1):154-64. doi: 10.1007/s00270-013-0632-0. Epub 2013 May 14.
This prospective study evaluated the effectiveness and safety of TACE using irinotecan loaded superabsorbent polymer (SAP) microspheres for treatment of colorectal cancer liver metastases (CCLM) in a salvage setting of patients.
A total of 71 TACE procedures were performed in 29 patients with liver only or liver-dominant CCLM. In all patients, systemic chemotherapy before TACE had failed. Two hundred milligrams of irinotecan were loaded into 50-100 mg of SAP microspheres (HepaSphere™ Microspheres) considering tumor size and vascularization. TACE was performed selectively with respect to tumor distribution. Response was evaluated following RECIST and EASL criteria, respectively. Median follow-up after last TACE was 8 (range 1-54) months. All patients had died at time of analysis.
All TACE procedures were performed successfully; 35-400 mg (mean 168.3 mg) of irinotecan loaded in 13-100 mg (mean 48.3 mg) SAP microspheres were injected during individual sessions. No major complications occurred. Three, 6, and 12 months after first TACE complete and partial response was present in 72, 32 %, 0 of patients by EASL criteria and stable disease was seen in 86, 48, and 8 % with no complete and no partial response by RECIST criteria. Median overall survival after first TACE was 8 months, and median time to progression was 5 months. Median overall survival was longer in patients with limited (<25 %) compared with extensive (>50 %) intrahepatic disease (21 vs. 5 months, p < 0.005).
TACE using irinotecan loaded SAP microspheres is safe and effective in terms of tumor necrosis. Survival benefit in a salvage setting seems to be limited in patients with advanced intrahepatic tumor load.
本前瞻性研究评估了使用载有伊立替康的超吸收性聚合物（SAP）微球的经动脉化疗栓塞术（TACE）在挽救性治疗患者的结直肠癌肝转移（CCLM）中的有效性和安全性。
对29例仅肝转移或肝主导型CCLM患者共进行了71次TACE手术。所有患者在TACE前的全身化疗均失败。根据肿瘤大小和血管化情况，将200毫克伊立替康负载到50 - 100毫克的SAP微球（HepaSphere™微球）中。根据肿瘤分布选择性地进行TACE。分别按照RECIST和EASL标准评估反应。最后一次TACE后的中位随访时间为8（范围1 - 54）个月。在分析时所有患者均已死亡。
所有TACE手术均成功完成；在各个疗程中，将13 - 100毫克（平均48.3毫克）SAP微球中负载的35 - 400毫克（平均168.3毫克）伊立替康进行了注射。未发生重大并发症。首次TACE后3、6和12个月，根据EASL标准，完全缓解和部分缓解的患者分别为72%、32%、0%，根据RECIST标准，疾病稳定的患者分别为86%、48%、8%，无完全缓解和部分缓解。首次TACE后的中位总生存期为8个月，中位疾病进展时间为5个月。与广泛（>50%）肝内疾病患者相比，肝内疾病局限（<25%）患者的中位总生存期更长（21个月对5个月，p < 0.005）。
使用载有伊立替康的SAP微球的TACE在肿瘤坏死方面是安全有效的。在挽救性治疗中，对于肝内肿瘤负荷晚期的患者，生存获益似乎有限。
