The Safety and Efficacy of Transarterial Chemoembolization with Bleomycin for Hepatocellular Carcinoma Unresponsive to Doxorubicin:A Prospective Single-center Study

Abstract Purpose To investigate the safety and efficacy of transarterial chemoembolization (TACE) with bleomycin for hepatocellular carcinoma (HCC) unresponsive to doxorubicin.Methods We did a randomized controlled trial in HCC patients resistant to TACE with doxorubicin to assess the survival benefits of the experimental group (TACE with bleomycin) compared with the control group (TACE with doxorubicin). 170 patients were allocated randomly between December 2015 and December 2017 and 80 patients of each group were accomplished and analyzed finally. The modified response evaluation criteria in solid tumors (mRECIST) was used to evaluated the tumor response every 4-6 weeks. The primary endpoint was median progression-free survival (mPFS) and median overall survival (mOS). Safety was assessed by post-procedure complications.Results The study was stopped in October 2018. Objective response rate (ORR) of the experimental group was 27.5% (22/80) , mPFS and mOS was 5.8 and 8.1 months. ORR of the control group was 7.5% (6/80) , mPFS and mOS was 2.9 and 4.0 months. The ORR were significantly different between two grous ( χ²= 0.348, P＜0.05). The differences of mPFS and mOS between the two groups were statistically significant (χ² = 2.865, P＜0.05 and χ² = 0.926, P＜0.05, respectively). There were no significant difference in post-procedure complications (P＞0.05) and no major complications occurred.Conclusion It is suggested that TACE with bleomycin is a safe and effective method for HCC and bleomycin can be a second-line chemotherapeutic agent for the HCC patients unresponsive to TACE with doxorubicin.