Preoperative TACE with lenvatinib and PD-1 inhibitors in patients with CNLC stage Ib to IIIa hepatocellular carcinoma: a propensity multicenter score matched analysis.

BACKGROUND: Hepatocellular carcinima (HCC) is a common malignant tumor with poor prognosis, mainly because of high recurrence after surgery. The aim of this study was to evaluate the efficacy of neoadjuvant treatment, consisting of preoperative transarterial chemoembolization (TACE) with lenvatinib and programmed death 1(PD-1) inhibitors, in resectable HCC patients with China Liver Cancer Staging (CNLC) stage Ib to IIIa. METHODS: This retrospective multicenter study compared outcomes of patients who completed neoadjuvant treatment and surigical resection with hepatectomy alone. All Patients were 1:3 propensity score matched with each comparison. Neoadjuvant treatment included TACE with PD-1 inhibitors plus lenvatinib. RESULTS: A total of 401 patients were enrolled of whom 74 (18.5%) received neoadjuvant treatment. 62 (83.8%) of these patients had adverse events (AEs) and 2 (2.7%) patients had grade 3/4 of alanine aminotransferase (ALT) level elevated or leukocytopenia. All patients performed surgery successfully and no severe postoperative complications occurred. The objective response rate (ORR) was 55.4% and 81.1% based on RECIST 1.1 and mRECIST in neoadjuvant group. 25 (33.8%) patients had radiological complete tumor necrosis and the disease control rate (DCR) was 100%. The pathological complete response (pCR) and major pathological response (MPR) was 24 (32.4%) and 37 (50.0%), respectively. The incidence of microvascular invasion (MVI) was 28.4% in neoadjuvant treatment patients, compared with 50.9% for surgery alone patients. Neoadjuvant treatment patients had a significant better prognosis than surgery alone patients (progression-free survival p = 0.017, overall survival p = 0.017). CONCLUSIONS: Neoadjuvant TACE, lenvatinib and PD-1 inhibitors treatment is safe and beneficial to the pathological results and prognosis for patients with resectable HCC with CNLC stage Ib to IIIa.