Safety and Efficacy of Transcatheter Arterial Chemoembolization Plus Radiotherapy Combined with Sorafenib in Hepatocellular Carcinoma with Macrovascular Invasion

Abstract

The safety and efficacy of transcatheter arterial chemoembolization (TACE) plus intensity-modulated radiotherapy (IMRT) combined with sorafenib in hepatocellular carcinoma (HCC) with macrovascular invasion (MVI) remains controversial. We compared the survival and safety of TACE plus IMRT with TACE plus RT and sorafenib in patients with HCC with MVI. The medical records of 63 consecutive patients with advanced-stage HCC showing MVI, who underwent IMRT plus TACE combined with (28participants; Group A) or without (35 participants; Group B) sorafenib from October 2015 to October 2018, were retrospectively reviewed to assess the overall survival (OS), progression-free survival (PFS), tumor response, and treatment-associated toxicity. The propensity score matching (PSM) method was used to comprehensively analyze the effects between Group A and Group B. The median follow-up time was 14.1 months. The overall response rate (ORR) was achieved in 46.4% of patients with complete response (CR) in 10.7% of patients at 3 months after IMRT in Group A, while the ORR and CR rate were 45.7% and 0% in Group B. The median PFS in Group A (13.6 months, 95% CI =11.2-16.1) was longer than that in Group B (9.2 months, 95%CI =7.0-11.3) (P=0.044), and it was still significant after PSM (P=0.033). However, the median OS was similar in the two groups (19.0 vs 15.2 months, P=0.094 before PSM; P=0.204 after PSM). The grade 3 hematologic toxicity was present in 10 patients (15.9%), including 4 patients in Group A and 6 patients in Group B (14.3% vs 17.1%, P=1.000). Seven of 63 patients, including 3 patients in Group A (10.7%) and 4 patients in Group B (11.4%) (P=1.000), developed grade 3 hepatic toxicity. Incidences of skin reaction, hand-foot syndrome and diarrhea, which were all 1-2 grade adverse events, were significantly higher (P=0.027, 0.014, and 0.001, respectively) in Group A (92.9%, 17.9%, and 28.6%, respectively) than that in Group B (68.6%, 0%, and 0%, respectively). No patient experienced grade 4 or 5 toxicity, and radiation-induced liver disease was also not observed. TACE plus IMRT combined with sorafenib showed a good safety profile and clinical benefit in HCC patients with MVI.