Abstract 170P
Background
Research of the combination of immunotherapy and TACE have become relevant: sintilimab+TACE(NCT04174781), lenvatinib+pembrolizumab+TACE(NCT04246177), durvalumab+bevacizumab+tremelimumab+TACE(NCT03937830), lenvatinib+pembrolizumab+TACE(NCT04246177). Locoregional treatment in combination therapy improves the number of complete and partial pathomorphological responses (pCR+PR), overall and disease-free survival rates (OS and DFS) with controlled toxicity. To investigate the efficacy of preoperative therapy TAСE + atezolizumab + bevacizumab in patients (pts) with hepatocellular carcinoma as neoadjuvant treatment before liver resection or OTP.
Methods
Prospective, randomized, comparative in parallel groups research included pts 18 to 69 years old with HCC T1-3N0M0, I-III stage, BCLC A-B, Child-Pugh A to B7. 3 groups of pts: A-pts waiting for transplantation, who received combined bridge-therapy TACE+immunotherapy, B-pts, potential resectable, who received neoadjuvant therapy TACE+immunotherapy, C-control group of pts who received only TACE. Primary endpoints are pathomorphological responses (pCR and PR), QoL and safety by CTCAE. Secondary endpoints are OS and DFS per mRECIST.
Results
21 patients received treatment. Median follow-up is 12 months. BCLC stage: A-9(41%), B-13(59%). Liver cirrhosis: n-19(86%). Child-Pugh A-19(90%), B-2(10%). QoL and safety: thrombocytopenia 6(28.6%), gastrointestinal toxicity 0%, ALT/AST hepatic toxicity 6(28.6%), renal toxicity 6(28.6%), cardiotoxicity 4(19.1%), neurological complications 1(4.8%), proteinuria 1(4.8%), hypothyroidism 2(9.5%), itching 4 (19.1%), pulmonitis 3(14.3%), infections and infestations 3(14.3%), upper GI bleeding 2(9.5%), gastrointestinal mucosa erosion 1(4.8%), colitis 6(28.6%), adrenal insufficiency 7(33.3%), anemia 7(33.3%). Surgery performed in 11 patients, liver resection-7(32%), transplantation-4(18%). pCR by target node-8(72%), PR by primary focus-3(28%).
Conclusions
The combination of TAСE+immunotherapy is an option with an acceptable toxicity profile which allows improve ORR.
Editorial acknowledgement
Liver Transplantation Center of the Research Institute of Emergency Medicine named after N.V. Sklifosovsky.
Legal entity responsible for the study
National Medical Research Center of Oncology named after N.N. Blokhin.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.