The addition of transarterial chemoembolization (TACE) to adjuvant sorafenib improved outcomes for patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) in a phase 2 trial.
Patients who received TACE and sorafenib had superior recurrence-free survival (RFS) and overall survival (OS) compared with patients who received sorafenib alone.
These findings were presented at the 2023 ASCO Gastrointestinal Cancers Symposium by Ming Kuang, MD, PhD, of Sun Yat-sen University in Guangzhou, China.
The phase 2 trial included 158 patients with resectable HCC and PVTT who had not received previous treatment. They were randomly assigned to receive postoperative TACE plus sorafenib (n=79) or postoperative sorafenib alone (n=79). Sorafenib was given at 400 mg twice daily in both arms. Patients in the TACE arm underwent TACE 1 day after starting sorafenib.
At baseline, the median age was 55 years in the TACE arm and 52 years in the monotherapy arm. Most patients were men (69% and 71%, respectively), most had hepatitis B HCC etiology (71% and 72%), roughly half had cirrhosis (53% and 53%), and less than half had multiple intrahepatic tumors (42% and 46%).
The addition of TACE to sorafenib significantly improved both RFS (hazard ratio [HR], 0.57; 95% CI, 0.39-0.83; P =.0024) and OS (HR, 0.57; 95% CI, 0.36-0.91; P =.0174). The median RFS was 16.8 months in the TACE arm and 12.6 months in the monotherapy arm. The median OS was 30.4 months and 22.5 months, respectively.
The safety profiles did not differ significantly between the treatment arms. The most common adverse events in both arms were hand or foot skin reactions, diarrhea, hypertension, rash, and alopecia.
“The combination of sorafenib plus TACE as postoperative adjuvant therapy in HCC patients with PVTT resulted in longer RFS and OS compared to sorafenib alone and was well tolerated,” Dr Kuang said. “Adjuvant local plus TKI [tyrosine kinase inhibitor] combination therapy may provide an effective way [to control] advanced HCC after surgery.”
Kuang M, Peng Z, Fan W, et al. Adjuvant transarterial chemoembolization with sorafenib for patients with hepatocellular carcinoma patients with portal vein tumor thrombus after surgery: A phase II multicenter, randomized, controlled trial. ASCO GI 2023. January 19-21, 2023. Abstract 493.