From the Service de Radiologie de l'Hôpital Jean Verdier, Hôpitaux universitaires Paris-Seine-Saint-Denis, Assistance publique Hôpitaux de Paris, Avenue du 14 juillet, 93140 Bondy, France (O. Sutter, J.C., R.O., N.Z., F.B., N.S., O. Seror); Unité mixte de Recherche 1162, Génomique fonctionnelle des Tumeurs solides, Institut National de la Santé et de la Recherche médicale, Paris, France (J.C.N., P.N., N.G.C., O. Seror); Unité de Formation et de Recherche Santé Médecine et Biologie humaine, Université Paris 13, Communauté d'Universités et Etablissements Sorbonne Paris Cité, Paris, France (O. Sutter, J.C.N., P.N., N.G.C., N.S., O. Seror); Service d'Hépatologie de l'Hôpital Jean Verdier, Hôpitaux Universitaires Paris-Seine-Saint-Denis, Assistance publique Hôpitaux de Paris, Bondy, France (G.N., J.C.N., P.N., N.G.C., V.B.); and Département d'Information Médical de l'Hôpital Avicenne, Hôpitaux Universitaires Paris-Seine-Saint-Denis, Assistance publique Hôpitaux de Paris, Bobigny, France (A.D.).
Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28.
Purpose To assess the safety and efficacy of irreversible electroporation (IRE) in the treatment of patients with inoperable hepatocellular carcinoma (HCC) who are ineligible for thermal ablative techniques. Materials and Methods This retrospective study was approved by an ethics review board, and the requirement to obtain informed written consent was waived. From March 2012 to June 2015, 58 patients (median age, 65.4 years; range 41.6-90 years) with cirrhosis received IRE for the treatment of 75 HCC tumors. The median tumor diameter was 24 mm (range, 6-90 mm). IRE was selected because of tumor location (48 patients) or the patient's poor general condition (10 patients). Treatment response was assessed with magnetic resonance (MR) imaging 1 month after treatment and every 3 months thereafter. Overall local tumor progression-free survival (PFS) per nodule (including initial treatment failures) was assessed by using the Kaplan-Meier method. The marginal Cox proportional hazards model was used to assess the factors associated with overall local tumor PFS. Complications were recorded and graded according to the Clavien-Dindo classification. Results Of 75 tumors, 58 (77.3%), 67 (89.3%), and 69 (92%) were completely ablated after one, two, and three IRE procedures, respectively. After a median follow-up of 9 months (range, 3 days to 31 months), the 6- and 12-month overall local tumor PFS rates for the 75 treated nodules were 87% (95% confidence interval [CI]: 77%, 93%) and 70% (95% CI: 56%, 81%), respectively. A preablative serum α-fetoprotein level higher than 200 ng/mL (hazard ratio: 9.94 [95% CI: 2.82, 35.06], P = .0004) was the only factor linked with overall local tumor PFS. Complications occurred in 11 of the 58 patients (19%) and were classified as grade I in three patients, grade II in five patients, grade IV in two patients, and grade V in one patient. The three (5.2%) complications classified as grade III or higher were liver failures occurring in patients with Child-Pugh class B disease; one led to death. Conclusion IRE offers safe, complete ablation of HCC tumors in patients with contraindications to other commonly used ablative techniques. RSNA, 2017 Online supplemental material is available for this article.
目的 评估不可逆电穿孔（IRE）在治疗不适合热消融技术的失代偿期肝硬化不可切除肝细胞癌（HCC）患者中的安全性和疗效。
材料与方法 本回顾性研究经伦理审查委员会批准，豁免了获得知情书面同意的要求。2012 年 3 月至 2015 年 6 月，58 例（中位年龄 65.4 岁；范围 41.6-90 岁）肝硬化患者因肿瘤位置（48 例）或患者一般状况不佳（10 例）接受 IRE 治疗 75 个 HCC 肿瘤。中位肿瘤直径为 24 mm（范围 6-90 mm）。选择 IRE 治疗是因为肿瘤位置（48 例）或患者一般状况不佳（10 例）。治疗后 1 个月和此后每 3 个月采用磁共振（MR）成像评估治疗反应。采用 Kaplan-Meier 法评估每个结节（包括初始治疗失败）的总局部肿瘤无进展生存期（PFS）。采用边际 Cox 比例风险模型评估与总局部肿瘤 PFS 相关的因素。根据 Clavien-Dindo 分类记录和分级并发症。
结果 75 个肿瘤中，分别有 58（77.3%）、67（89.3%）和 69（92%）个肿瘤在 1、2 和 3 次 IRE 治疗后完全消融。中位随访 9 个月（范围 3 天至 31 个月）后，75 个治疗结节的 6 个月和 12 个月总局部肿瘤 PFS 率分别为 87%（95%置信区间：77%，93%）和 70%（95%置信区间：56%，81%）。治疗前血清甲胎蛋白（AFP）水平高于 200 ng/mL（风险比：9.94 [95%置信区间：2.82，35.06]，P =.0004）是与总局部肿瘤 PFS 相关的唯一因素。58 例患者中发生 11 例（19%）并发症，3 例为 1 级，5 例为 2 级，2 例为 4 级，1 例为 5 级。3 例（5.2%）分类为 3 级或更高级别的并发症为伴有 Child-Pugh 分级 B 级疾病的患者发生肝衰竭，其中 1 例导致死亡。
结论 IRE 为不适合其他常用消融技术的患者提供了 HCC 肿瘤安全、完全消融的治疗选择。
RSNA，2017 在线补充材料可从本文获得。
