1Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China.
2Hunan Provincial Tumor Hospital, Changsha, China.
3Tangdu Hospital of Forth Military Medical University, Xi'an, China.
4Xijing Hospital of Forth Military Medical University, Xi'an, China.
5The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
6The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
7Anhui Provincial Hospital, Hefei, China.
8Xiangya Hospital of Central South University, Changsha, China.
9Xinqiao Hospital of Third Military Medical University, Chongqing, China.
10Xinjiang Tumor Hospital, Wulumuqi, China.
11Henan Cancer Hospital, Zhengzhou, China.
12The People's Hospital of Guangxi Zhuang Zu Autonomous Region, Nanning, China.
OBJECTIVES: The objective of this study was to evaluate the efficacy of combined therapy using Sorafenib and radiofrequency ablation (RFA) with curative intent for all detectable lesions in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0-B1 hepatocellular carcinoma (HCC).
METHODS: One hundred and twenty-eight patients with HCC from 12 centers were enrolled in this retrospective study; 64 patients who received Sorafenib plus RFA (Sorafenib-RFA) were compared with a control group treated with RFA alone. The two patient groups were selected with a predefined criterion and matched in terms of their clinical and tumor characteristics at baseline. The primary end point of the study was the incidence of post-RFA HCC recurrence. Secondary end points were overall survival (OS) and treatment toxicity.
RESULTS: During a median follow-up of 134.1 weeks, 49 patients died and 79 survived. The 1-, 2-, and 3-year cumulative incidences of post-RFA recurrence were 40.5%, 62.9%, and 74.5%, respectively, in the Sorafenib-RFA group, and 62.8%, 85.4%, and 92.7%, respectively, in the RFA group. The 1-, 2-, 3-, and 4-year OS rates were 85.6%, 64.0%, 58.7%, and 50.3%, respectively, in the Sorafenib-RFA group, and 80.7%, 47.2%, 30.9%, and 30.9%, respectively, in the RFA group. Thus, the Sorafenib-RFA group exhibited better survival than the RFA alone group.
CONCLUSIONS: Combined therapy with Sorafenib-RFA was associated with a lower incidence of post-RFA recurrence and better OS than RFA alone in patients with BCLC Stage 0-B1 HCC. Although these findings suggest that Sorafenib and RFA is safe and effective for the treatment of early HCC, prospective and randomized controlled trials are needed to validate them.