Somma Francesco, D'Angelo Roberto, Serra Nicola, Gatta Gianluca, Grassi Roberto, Fiore Francesco
Department of Medicine and Surgery "Magrassi and Lanzara", Section of Radiology, Second University of Naples (SUN), Napoli, Italy.
Department of Interventional Radiology, National Cancer Institute of Naples "Fondazione Pascale", Napoli, Italy.
PLoS One. 2015 Jun 25;10(6):e0129573. doi: 10.1371/journal.pone.0129573. eCollection 2015.
To evaluate safety and efficacy of Trans-Arterial Ethanol-Lipiodol Embolization (TAELE) compared with conventional Trans-Arterial Chemo-Embolization (cTACE) in the treatment of small intermediate-HCC (BCLC-Stage B).
A random sample of 87 patients (37.93% male; 62.07% female; age range, 36-86 years) with documented small intermediate-HCC and treated with TAELE (mixture 1:1 of Ethanol and Lipiodol) or cTACE (mixture of 50mg-Epirubicin and 5cc-Lipiodol) were retrospectively studied in an institutional review board approved protocol. The two procedures were compared with χ2-test, χ2-test with Yates correction, McNemar's exact test, ANOVA test and log-rank test.
TAELE and cTACE therapies were performed in 45 and 42 patients, respectively. Thirty days after the procedure, a Multi-Detector Computed Tomography (MDCT) showed no significant difference in the number of patients with partial and complete response between the two groups (p-value = 0.958), according to mRECIST. Contrary, significant differences were found in tumor-devascularization, lesion-reduction and post-embolization syndrome occurrence (p-value = 0.0004, p-value = 0.0003 and p-value = 0.009, respectively). Similar survival was observed during 36-month follow-up (p-value = 0.884).
Compared to cTACE, TAELE showed a better toxicity profile with similar 36-month survival and similar one-month anti-tumor effects, which makes it better tolerated by patients, especially in case of more than one treatment.
评估经动脉乙醇-碘油栓塞术（TAELE）与传统经动脉化疗栓塞术（cTACE）治疗小的中期肝细胞癌（BCLC分期B期）的安全性和疗效。
在一项经机构审查委员会批准的方案中，对87例记录有小的中期肝细胞癌且接受TAELE（乙醇与碘油1:1混合）或cTACE（50mg表柔比星与5cc碘油混合）治疗的患者（男性占37.93%；女性占62.07%；年龄范围36 - 86岁）进行回顾性研究。采用卡方检验、校正Yates卡方检验、McNemar精确检验、方差分析和对数秩检验对这两种治疗方法进行比较。
分别对45例和42例患者实施了TAELE和cTACE治疗。根据改良RECIST标准，术后30天，多排螺旋计算机断层扫描（MDCT）显示两组间部分缓解和完全缓解患者数量无显著差异（p值 = 0.958）。相反，在肿瘤去血管化、病灶缩小和栓塞后综合征发生方面发现了显著差异（p值分别为0.0004、0.0003和0.009）。在36个月的随访期间观察到相似的生存率（p值 = 0.884）。
与cTACE相比，TAELE显示出更好的毒性特征，36个月生存率相似且1个月抗肿瘤效果相似，这使得患者对其耐受性更好，尤其是在进行多次治疗的情况下。
