The addition of transcatheter arterial chemoembolization to radiofrequency ablation extended survival in patients with hepatocellular carcinoma, according to results of a prospective randomized study.
HCC is the sixth most common cancer worldwide and the third most frequent cause of cancer death. Resection benefits approximately 30% of patients, according to background information in the study.
The combination of transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) is appealing because it could potentially diminish tumor size while preserving maximum liver function, according to Zhen-Wei Peng, MD, of the State Key Laboratory of Oncology in China.
Peng and researchers compared RFA with or without TACE in patients with HCC less than 7 cm in diameter.
The study included 189 patients aged 18 to 75 years. Researchers randomly assigned patients to receive TACE-RFA (n=94) or RFA alone (n=95). The investigators stratified patients using tumor size and the number of tumors.
OS served as the primary endpoint, and RFS was a secondary endpoint.
Patients assigned to TACE-RFA experienced higher rates of 1-year OS (92.6% vs. 85.3%), 3-year OS (66.6% vs. 59%) and 4-year OS (61.8% vs. 45%; HR=0.525; 95% CI, 0.335-0.822) than patients assigned to RFA alone. Patients who received the combination treatment also achieved longer RFS (HR=0.575; 95% CI, 0.374-0.897).
At median follow-up (36 months), 33 patients (35.1%) in the TACE group and 52 patients (54.7%) in the RFA group experienced recurrence (P=.116).
Thirty-four patients in the TACE-RFA group and 48 patients in the RFA group died. However, researchers reported no treatment-related deaths.
Results of multivariate Cox regression analysis showed the significant prognostic indicators of OS included treatment allocation (P=.006), tumor size (P=.018) and tumor number (P<.001). Prognostic indicators for RFS included treatment allocation (P=.02) and tumor number (P=.003).
“The future standard of care for HCC treatable with RFA should shift toward combination treatment,” Peng and colleagues wrote. “The study also provides evidence that altering the tumor microenvironment and supporting vasculature may help improve the efficacy of locoregional therapy in HCC.”
Future studies should investigate the potential benefits of targeted agents in combination with TACE-RFA, the researchers said.
In an accompanying editorial, Andrew X. Zhu, MD, PhD, associate professor in the department of medicine at Harvard Medical School, and Riad Salem, MD, professor of radiology, medicine and surgery at the Robert H. Lurie Comprehensive Cancer Center at Northwestern University, wrote that despite the positive results associated with TACE-RFA, HCC management remains complex.
“Although the [study] provides further data regarding the added value of TACE in addition to RFA, it does not clarify the current landscape of locoregional therapy of HCC, nor does it inform the future direction of therapeutic interventions for intermediate-stage HCC,” Zhu and Salem wrote. “For those patients with early-stage disease, either surgery or RFA is currently the first treatment choice, and sorafenib (Nexavar, Bayer-Onyx) has become the standard of care for advanced HCC.”
Disclosure: Zhu and Salem are consultants with and have received research funding from Bayer-Onyx, Bristol-Myers Squibb, Daiichi Sankyo, ImClone-Lilly, Nordion, Novartis and Sanofi-Aventis.