Djokic Mihajlo, Cemazar Maja, Bosnjak Masa, Dezman Rok, Badovinac David, Miklavcic Damijan, Kos Bor, Stabuc Miha, Stabuc Borut, Jansa Rado, Popovic Peter, Smid Lojze M, Sersa Gregor, Trotovsek Blaz
Clinical Department of Abdominal Surgery, University Medical Centre Ljubljana, Zaloska 7, SI-1000 Ljubljana, Slovenia.
Faculty of Medicine, University of Ljubljana, Vrazov trg 2, SI-1000 Ljubljana, Slovenia.
Cancers (Basel). 2020 Dec 15;12(12):3778. doi: 10.3390/cancers12123778.
The aim of this clinical study was to investigate the effectiveness and long-term safety of electrochemotherapy as an emerging treatment for HCC in patients not suitable for other treatment options. A prospective phase II clinical study was conducted in patients with primary HCC who were not suitable for other treatment options according to the Barcelona Clinic Liver Cancer classification. A total of 24 patients with 32 tumors were treated by electrochemotherapy. The procedure was effective, feasible, and safe with some procedure-related side effects. The responses of the 32 treated nodules were: 84.4% complete response (CR), 12.5% partial response (PR), and 3.1% stable disease (SD). The treatment was equally effective for nodules located centrally and peripherally. Electrochemotherapy provided a durable response with local tumor control over 50 months of observation in 78.0% of nodules. The patient responses were: 79.2% CR and 16.6% PR. The median progression-free survival was 12 months (range 2.7-50), and the overall survival over 5 years of observation was 72.0%. This prospective phase II clinical study showed that electrochemotherapy was an effective, feasible, and safe option for treating HCC in patients not suitable for other treatment options.
本临床研究的目的是调查电化学疗法作为一种新兴治疗方法，对不适合其他治疗方案的肝癌患者的有效性和长期安全性。对根据巴塞罗那临床肝癌分类不适合其他治疗方案的原发性肝癌患者进行了一项前瞻性II期临床研究。共有24例患者的32个肿瘤接受了电化学疗法治疗。该治疗方法有效、可行且安全，但有一些与治疗相关的副作用。32个接受治疗结节的反应为：84.4%完全缓解（CR），12.5%部分缓解（PR），3.1%疾病稳定（SD）。该治疗方法对位于中央和周边的结节同样有效。在78.0%的结节中，电化学疗法在50个月的观察期内提供了持久的反应和局部肿瘤控制。患者的反应为：79.2% CR和16.6% PR。无进展生存期的中位数为12个月（范围2.7 - 50个月），5年观察期的总生存率为72.0%。这项前瞻性II期临床研究表明，电化学疗法是治疗不适合其他治疗方案的肝癌患者的一种有效、可行且安全的选择。
