KEY TAKEAWAYS
- The phase 2 & 3 trials aimed to investigate the efficacy of preoperative therapy TAСE + atezolizumab + bevacizumab in pts with HCC.
- The primary endpoints were pCR, PR, QoL, and safety.
- TAСE+immunotherapy improved ORR and presented minimal toxicity profiles.
Research of the combination of immunotherapy and transarterial chemoembolization (TACE) has become relevant: sintilimab+TACE, lenvatinib+pembrolizumab+TACE, durvalumab+bevacizumab+tremelimumab+TACE, lenvatinib+pembrolizumab+TACE.
Locoregional treatment in combination therapy improves the number of complete and partial responses (pathomorphological complete response (pCR) + partial response (PR)), overall, and disease-free survival rates (OS and DFS) with controlled toxicity.
Kate A. Nasonova and the team were determined to investigate the efficacy of preoperative therapy TAСE + atezolizumab + bevacizumab in patients (pts) with hepatocellular carcinoma (HCC) as neoadjuvant treatment before liver resection or OTP.
Researchers conducted the randomized, comparative research in parallel groups that included pts aged 18 to 69 with HCC T1-3N0M0, stages I-III, BCLC A-B, and Child-Pugh A to B7. The study comprised of 3 groups: group A comprised- pts waiting for transplantation who received combined bridge therapy (TACE + immunotherapy); in group – potentially resectable pts were included who received neoadjuvant therapy (TACE + immunotherapy); and group C included the control group, which received only TACE.
The primary endpoints were pCR + PR, quality of life (QoL), and safety as per CTCAE. Secondary endpoints were overall survival (OS) and DFS according to mRECIST criteria.
Results indicated that 21 pts received treatment, with a median follow-up of 12 months. The BCLC stages were: A in 9 pts (41%) and B in 13 pts (59%). Nineteen pts (86%) had liver cirrhosis, with 19 (90%) classified as Child-Pugh A and 2 (10%) as Child-Pugh B.
In terms of QoL and safety, 6 pts (28.6%) experienced thrombocytopenia, and there were no cases of gastrointestinal toxicity. Hepatic toxicity (ALT/AST) occurred in 6 pts (28.6%), renal toxicity in 6 (28.6%), and cardiotoxicity in 4 (19.1%). Neurological complications were observed in 1 patient (4.8%), proteinuria in 1 (4.8%), hypothyroidism in 2 (9.5%), itching in 4 (19.1%), and pulmonitis in 3 (14.3%). Infections and infestations were noted in 3 pts (14.3%), upper GI bleeding in 2 (9.5%), gastrointestinal mucosa erosion in 1 (4.8%), colitis in 6 (28.6%), adrenal insufficiency in 7 (33.3%), and anemia in 7 (33.3%).
Surgical treatment was given to 11 pts, with 7 (32%) undergoing liver resection and 4 (18%) undergoing transplantation. pCR by target node was achieved in 8 pts (72%), and PR by primary focus was observed in 3 pts (28%).
The study concluded that TAСE+immunotherapy improves ORR along with manageable toxicity profile.
The trials were sponsored by Zhejiang University, Merck Sharp & Dohme LLC and National Cancer Institute (NCI).
Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3
Clinical Trials: https://www.clinicaltrials.gov/study/NCT04174781, https://www.clinicaltrials.gov/study/NCT04246177,
https://www.clinicaltrials.gov/study/NCT03937830
Nasonova K A, Zagidullina A A, Breder V V, et al. (2024). “Efficacy of the combination of transarterial chemoembolization (TACE) and immunotherapy of atezolizumab + bevacizumab in patients before liver resection and transplantation (OTP) with hepatocellular carcinoma (HCC).” Presented at ESMO-GC, (Abstract 170P)
