The safety and efficacy of transarterial chemoembolisation with bleomycin for hepatocellular carcinoma unresponsive to doxorubicin: a prospective single-centre study. Issue 11 (November 2021) - Fu, J.
Abstract : AIM: To investigate the safety and efficacy of transarterial chemoembolisation (TACE) with bleomycin for hepatocellular carcinoma (HCC) unresponsive to doxorubicin. MATERIALS AND METHODS: A randomised controlled trial was undertaken of 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). One hundred and seventy patients were allocated randomly between December 2015 and December 2017, and 80 patients of each group were analysed. The modified response evaluation criteria in solid tumours (mRECIST) was used to evaluated the tumour 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 completed 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 months. The ORR were significantly different between two groups (χ 2 = 0.348, p< 0.05). The differences of mPFS and mOS between the two groups were statistically significant (χ 2 = 2.865, p< 0.05 and χ 2 = 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. Highlights: TACE with bleomycin is an effective method for HCC unresponsive to doxorubicin. TACE with bleomycin is a safe method for HCC without severe complications. TACE with bleomycin can be a second-line method for HCC unresponsive doxorubicin.