经导管肝动脉化疗栓塞术联合载药微球治疗不可切除肝细胞肝癌的单中心 II 期临床试验：美国的初步经验。
Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States.
机构信息
Department of Radiology, Johns Hopkins Hospital, Baltimore, MD, USA.
出版信息
Cancer J. 2009 Nov-Dec;15(6):526-32. doi: 10.1097/PPO.0b013e3181c5214b.
PURPOSE
This prospective phase II pilot study evaluated safety and efficacy of transarterial chemoembolization (TACE) with drug-eluting beads (DEBs) loaded with doxorubicin in patients with unresectable hepatocellular carcinoma (HCC).
METHODS
Twenty patients with unresectable HCC (75% Child's A, 95% Eastern Cooperative Oncology Group performance status 0 to 1, 60% Barcelona Clinic Liver Cancer C, tumor size 6.9 cm) underwent 34 DEB-TACE sessions. Primary endpoints were tumor response, assessed by contrast-enhanced magnetic resonance imaging at 1 month after treatment, using size (response evaluation criteria in solid tumors [RECIST]), contrast-enhancement (European Association for the Study of the Liver) and apparent diffusion coefficient values, and safety assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Secondary endpoints included feasibility, progression-free survival, and overall survival.
RESULTS
DEB-TACE was successfully performed in 34 sessions and demonstrated a favorable safety profile. On initial (1 month) postprocedural magnetic resonance imaging, treated lesions had a mean decrease in size of 4% (P = 0.1129). Using RECIST, partial response was achieved in 2 patients (10%), and 18 patients (90%) had stable disease. Treated tumors demonstrated a mean decrease in contrast enhancement of 64% (P < 0.0001). By European Association for the Study of the Liver criteria, 12 patients (60%) had objective tumor response, and 8 (40%) had stable disease. No patients had progression of a treated lesion while undergoing treatment. At 6 months, the disease control rate was 95% using RECIST. Overall survival rates at 1 and 2 years were 65% and 55%, respectively; median overall survival was 26 months.
DISCUSSION
DEB-TACE is safe and effective in achieving local tumor control in patients with unresectable HCC.
目的
本前瞻性 II 期试验研究评估了载多柔比星药物洗脱微球（DEB）经动脉化疗栓塞（TACE）治疗不可切除肝细胞癌（HCC）患者的安全性和疗效。
方法
20 例不可切除 HCC 患者（75% Child's A，95%东部肿瘤协作组体能状态 0-1，60%巴塞罗那临床肝癌 C，肿瘤大小 6.9cm）接受了 34 次 DEB-TACE 治疗。主要终点是治疗 1 个月后使用增强磁共振成像（根据实体瘤反应评估标准 [RECIST]）评估的肿瘤反应、增强程度（欧洲肝病研究协会）和表观扩散系数值，安全性通过美国国立癌症研究所不良事件通用术语标准（NCI CTCAE）进行评估。次要终点包括可行性、无进展生存期和总生存期。
结果
34 次 DEB-TACE 治疗均成功完成，具有良好的安全性。初次（1 个月）治疗后磁共振成像显示，治疗病灶平均缩小 4%（P=0.1129）。根据 RECIST，2 例（10%）患者获得部分缓解，18 例（90%）患者疾病稳定。治疗后的肿瘤平均增强程度下降 64%（P<0.0001）。根据欧洲肝病研究协会标准，12 例（60%）患者肿瘤有客观反应，8 例（40%）患者疾病稳定。在治疗过程中，没有患者出现治疗病灶进展。6 个月时，根据 RECIST，疾病控制率为 95%。1 年和 2 年的总生存率分别为 65%和 55%，中位总生存期为 26 个月。
讨论
DEB-TACE 治疗不可切除 HCC 患者可安全有效地实现局部肿瘤控制。
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