Phase II study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases: high incidence of biliary injury.
Phase II study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases: high incidence of biliary injury.
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DOI：
10.1007/s00270-012-0424-y
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发表时间：
2013-04
影响因子：
2.9
通讯作者：
Geschwind, J. F.
中科院分区：
文献类型：
--
作者：
Bhagat, Nikhil;Reyes, Diane K.;Lin, Mingde;Kamel, Ihab;Pawlik, Timothy M.;Frangakis, Constantine;Geschwind, J. F.
作为II期试验的一部分，在13例神经内分泌肿瘤（NET）肝转移患者中评价使用多柔比星洗脱珠（DEB）进行经动脉化疗栓塞（TACE）的中期分析的安全性。获得机构审查委员会批准和知情同意。13例患者完成了初步安全性分析。他们的平均年龄为65岁，东部肿瘤协作组状态为0/1，肿瘤负荷范围为4- 75%，平均靶向肿瘤大小为5.9 cm。允许在6个月内进行最多4次DEB-TACE治疗（100-300 μm微珠装载≤100 mg阿霉素）。治疗后1个月，使用对比度增强[欧洲肝脏研究协会（EASL）和实体瘤大小缓解评价标准（RECIST）]标准，通过磁共振成像评估肿瘤缓解。安全性由国家癌症研究所通用术语标准评估。所有13例患者均成功进行了DEB-TACE。在1个月随访时，肿瘤大小平均减小12%（p <0.0003），肿瘤增强平均减小56%（p <0.0001）。根据EASL标准，靶病变客观缓解率为78%。3 - 4级毒性为疲乏（23%）、丙氨酸氨基转移酶升高（15%）、高血糖（15%）和腹痛（8%）。7例患者发生胆汁瘤（54%）;所有这些患者均存在多发性小（<4 cm）病变。随后，4例患者接受经皮引流，3例因脓肿形成，1例因肿块效应相关症状。虽然胆汁瘤和肝脓肿是TACE后的已知风险，但我们研究人群的高发生率是意外的，并迫使试验中断。虽然这发生在一小群患者中，但由于这些发现，我们改变了我们的技术和患者选择，从而允许恢复试验。
To evaluate safety in an interim analysis of transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) in 13 patients with hepatic metastases from neuroendocrine tumors (NETs) as part of a phase II trial. Institutional Review Board approval and informed consent were obtained. Thirteen patients completed preliminary safety analysis. Their mean age was 65 years, Eastern Cooperative Oncology Group status was 0/1, tumor burden range was 4–75 %, and mean targeted tumor size was 5.9 cm. Up to four DEB-TACE sessions (100–300 μm beads loaded with ≤100 mg doxorubicin) within 6 months were allowed. Tumor response was assessed by magnetic resonance imaging 1 month after treatment using contrast-enhancement [European Association for the Study of the Liver (EASL) and size Response Evaluation Criteria in Solid Tumors (RECIST)] criteria. Safety was assessed by National Cancer Institute Common Terminology Criteria. DEB-TACE was successfully performed in all 13 patients. At 1 month follow-up, there was a mean 12 % decrease in tumor size (p <0.0003) and a 56 % decrease in tumor enhancement (p <0.0001). By EASL criteria, the targeted lesion objective response rate was 78 %. Grade 3 to 4 toxicities were fatigue (23 %), increased alanine amino transferase (15 %), hyperglycemia (15 %), and abdominal pain (8 %). Seven patients developed bilomas (54 %); all of these patients had multiple small (<4 cm) lesions. Subsequently, four underwent percutaneous drainage, three for abscess formation and one for symptoms related to mass effect. Although biloma and liver abscess are known risks after TACE, the high incidence in our study population was unexpected and forced interruption of the trial. Although this occurred in a small group of patients, we have changed our technique and patient selection as a result of these findings, thus allowing resumption of the trial.
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影响因子：
29.4
作者：
Davila, JA;Morgan, RO;El-Serag, HB
通讯作者：
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影响因子：
6.2
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DOI：
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影响因子：
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影响因子：
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作者：
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