Comparison of selective intra-arterial to standard intravenous administration in percutaneous Electrochemotherapy (pECT) for liver tumours

Abstract

Background. Electrochemotherapy (ECT) is a local nonsurgical effective tumor treat-ment in the hand of the clinician for the treatment of patients with liver tumors or metas-tases. The study aimed to test the technical feasibility and safety of intra-arterial (i.a.) bleomycin administration compared to the established intravenous (i.v.) administration in percutaneous Electrochemotherapy (pECT). Furthermore, the non-inferiority hypothe-sis was tested between the 2 modalities in terms of local short-term response and pro-gression-free survival.
Patients and methods. / Materials and methods. Forty-four patients have been re-cruited and treated by pECT for hepatocellular carcinoma, cholangiocarcinoma and liver metastatic lesions from cancers of different origin: 18 were treated with standard i.v., 26 with bleomycin i.a. administration.
Results. The 2 groups were similar for anagraphic and anamnestic data, as well as for most relevant disease specific characteristics. Technical success of the treatment was obtained in 95% and 100% of patients in i.v. and i.a. groups respectively. Short-term local response was similar in the 2 groups with a slightly higher CR rate in the i.a. group: 61.9% CR, 23.8% PR, 4.8% SD in the i.v. group, and 80.6%, CR 12.9% PR, 3.2% PD (p=0.3454). One-year progression free survival was 60% (C.I. 33%-88%) in the i.v. group and 67% (C.I. 42%-91%) in the i.a. group (p=0.5849).
Conclusions. The results of this study confirm the safety and feasibility of super-selective i.a. bleomycin administration. Analysis of local response and progression free survival confirms the non-inferiority hypothesis of the new modality compared to standard i.v. administration in the treatment of primary and secondary liver malignancies by pECT.