球囊阻断经导管动脉化疗栓塞术（B-TACE）与 DEB-TACE 治疗肝细胞癌（HCC）的比较：单中心回顾性病例对照研究。
Balloon occluded TACE (B-TACE) vs DEM-TACE for HCC: a single center retrospective case control study.
机构信息
Vascular and Interventional Radiology Unit, Department of Diagnostic Service, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy.
Gastroenterology Division, Department of Clinical Medicine, Sapienza University of Rome, Rome, Italy.
出版信息
BMC Gastroenterol. 2021 Feb 3;21(1):51. doi: 10.1186/s12876-021-01631-w.
BACKGROUND
To compare oncological results and safety profile of balloon micro-catheter trans-arterial chemoembolization (b-TACE) and drug-eluting-microsphere (DEM-TACE) in patients with hepatocellular-carcinoma (HCC).
METHODS
This is a case-control, retrospective, single-center study. Between January-2015/March-2019, 149 patients (131 males [87.9%]) with 226 HCC were treated, 22 patients (35 HCC; 19 [86.4%] males) with b-TACE and 127 with DEM-TACE (191 HCC, 112 [88.2%] males). Embolization protocol was standardized (sequential 100 ± 25 and 200 ± 25 μm microspheres). Results were evaluated by modified-response-evaluation-criteria-in-solid-tumor [mRECIST] at 1, 3-6 and 9-12 months and time to recurrence after complete response [TTR] at 1 years. Cox's regression weighted with tumor dimensions was performed. Adverse events (AEs) were recorded.
RESULTS
mRECIST oncological response at all time points (1, 3-6 and 9-12 months) for both treatments were similar, with the exception of Objective response rate at 9-12 months. Objective response at 1 and 3-6 months between b-TACE vs DEM-TACE [23/35 (65.7%) vs 119/191 (62.3%), 21/29 (72.4%) vs 78/136 (57.4%) (p > 0.05), respectively]. On the contrary, at 9-12 months, it was significantly higher in b-TACE subgroup than DEM-TACE (15/19 [78.9%] vs 48/89 [53.9%], p = 0.05). TTR for complete response at 1 year had a better trend for b-TACE vs DEM-TACE (278.0 days [196.0-342.0] vs 219.0 days [161.0-238.0], OR 0.68 [0.4-1.0], p = 0.10). The use of balloon micro-catheter reduced the relative risk of the event of recurrence by 0.63 [CI95% 0.38-1.04]; p = 0.07). No significant differences were found in AEs rate.
CONCLUSION
b-TACE showed a trend of better oncological response over DEM-TACE with and longer TTR with a similar adverse events rate, in patients presenting with larger tumors.
背景
比较球囊微导管经动脉化疗栓塞（b-TACE）和载药微球（DEM-TACE）在肝细胞癌（HCC）患者中的肿瘤学结果和安全性。
方法
这是一项病例对照、回顾性、单中心研究。2015 年 1 月至 2019 年 3 月，共对 149 例（男性 131 例[87.9%]）226 例 HCC 患者进行了治疗，其中 22 例（35 例 HCC；19 例[86.4%]男性）采用 b-TACE，127 例采用 DEM-TACE（191 例 HCC，112 例[88.2%]男性）。栓塞方案标准化（序贯 100±25μm 和 200±25μm 微球）。采用改良实体瘤反应评价标准（mRECIST）在 1、3-6 和 9-12 个月以及完全缓解后复发时间（TTR）进行评估。采用肿瘤尺寸加权的 Cox 回归进行分析。记录不良事件（AE）。
结果
两种治疗方法在所有时间点（1、3-6 和 9-12 个月）的 mRECIST 肿瘤学反应均相似，但 9-12 个月的客观缓解率除外。b-TACE 与 DEM-TACE 的 1 个月和 3-6 个月的客观缓解率[23/35（65.7%）与 119/191（62.3%），21/29（72.4%）与 78/136（57.4%）]相比，差异无统计学意义（p>0.05）。相反，在 9-12 个月时，b-TACE 亚组明显高于 DEM-TACE 亚组（15/19[78.9%]与 48/89[53.9%]，p=0.05）。1 年完全缓解的 TTR 显示 b-TACE 优于 DEM-TACE（278.0 天[196.0-342.0]与 219.0 天[161.0-238.0]，OR 0.68[0.4-1.0]，p=0.10）。使用球囊微导管可使复发事件的相对风险降低 0.63[95%CI 0.38-1.04]；p=0.07）。AE 发生率无显著差异。
结论
在肿瘤较大的患者中，b-TACE 显示出优于 DEM-TACE 的肿瘤学反应趋势和更长的 TTR，同时具有相似的不良事件发生率。
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