China: Study on Hepatocellular Carcinoma Treatment

A recent study showed a longer recurrence-free survival and overall survival with the combination of sorafenib and transarterial chemoembolization as postoperative adjuvant therapy among patients with hepatocellular carcinoma with portal vein tumor thrombus (PVTT).

"The randomized clinical trial comprising 158 patients showed that both the median recurrence-free survival and median overall survival were significantly longer with transarterial chemoembolization plus sorafenib versus sorafenib alone," the researchers reported in JAMA Surgery.

The transarterial chemoembolization with the sorafenib group did not show additional toxicity versus the sorafenib monotherapy group.

Previous studies have shown that surgical resection might be beneficial in certain patients with hepatocellular carcinoma with portal vein tumor thrombus, and postoperative adjuvant therapy may lower the incidence of tumor recurrence. Zhenwei Peng, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, and colleagues aimed to compare the safety and efficacy of sorafenib plus transarterial chemoembolization versus sorafenib alone as postoperative adjuvant therapy for patients with hepatocellular carcinoma with PVTT.

For this purpose, the researchers conducted a phase 3, multicenter, randomized clinical trial in five hospitals in China. One hundred and fifty-eight patients were enrolled and randomized from October 2019 to March 2022, with a median follow-up of 28.4 months. PVTT grading was done by the Cheng classification.

The trial included eligible patients with hepatocellular carcinoma with Cheng grade I to III PVTT (i.e., involving segmental or sectoral branches, right- or left-side branch, or main trunk of the portal vein).

Patients were randomly assigned in a 1:1 ratio to receive transarterial chemoembolization with sorafenib or sorafenib alone as postoperative adjuvant therapy. Of 158 included patients, the median age was 54 years and 88.6% were male.

Findings

• The median recurrence-free survival was significantly longer in the transarterial chemoembolization with sorafenib group (16.8 versus 12.6 months; hazard ratio [HR], 0.57).
• The median overall survival was also significantly longer with transarterial chemoembolization with sorafenib than with sorafenib alone (30.4 versus 22.5 months; HR, 0.57).
• The most common grade 3/4 adverse event was hand-foot syndrome (23 of 79 patients in the transarterial chemoembolization with sorafenib group [29.1%] vs 24 of 79 patients in the sorafenib alone group [30.4%]).
• There were no treatment-related deaths in either group.
• The transarterial chemoembolization with the sorafenib group did not show additional toxicity compared with the sorafenib monotherapy group.

In conclusion, the study showed longer recurrence-free survival and overall survival with the combination of sorafenib and transarterial chemoembolization as postoperative adjuvant therapy versus sorafenib alone in patients with hepatocellular carcinoma with portal vein tumor thrombus. The combination treatment was also well tolerated.

Reference

Peng Z, Fan W, Liu Z, et al. Adjuvant Transarterial Chemoembolization With Sorafenib for Portal Vein Tumor Thrombus: A Randomized Clinical Trial. JAMA Surg. Published online April 03, 2024. doi:10.1001/jamasurg.2024.0506