FROM JAMA ONCOLOGY
Use of transarterial chemoembolization (TACE) plus external beam radiotherapy may improve outcomes in patients with hepatocellular carcinoma (HCC) showing macroscopic vascular invasion, according to results of a recent randomized study.
The TACE plus radiotherapy approach was well tolerated and improved progression-free survival compared with sorafenib treatment, investigators wrote. The report was published in JAMA Oncology .
“The results of this study represent a significant advance in addressing an urgent unmet need in treating patients with advanced HCC,” noted Sang Min Yoon, MD, PhD, of the department of radiation oncology, University of Ulsan College of Medicine, Seoul, Republic of Korea, and coauthors.
Patients with HCC that shows macroscopic vascular invasion are a particularly poor prognosis subset, according to Dr. Yoon and coauthors.
“Sorafenib is the sole treatment option for these patients, with unsatisfactory response and survival benefit,” they wrote.
Building on observational studies suggesting TACE plus external beam therapy may be a promising approach, Dr. Yoon and colleagues initiated a randomized, open-label clinical trial including 90 patients with liver-confined HCC and macroscopic vascular invasion.
Patients were randomized to sorafenib either 400 mg twice daily or TACE every 6 weeks plus radiotherapy starting within 3 weeks of the first TACE, according to the study description.
The primary endpoint, 12-week progression-free survival, was 86.7% for patients receiving TACE plus radiotherapy, versus 34.3% for patients receiving sorafenib (P less than .001).
The TACE plus radiotherapy group also had a significantly longer overall survival (55.0 vs. 43.0 weeks; P = .04), as well as a significantly higher radiologic response rate and significantly longer median time to progression, the authors reported.
Five patients (11.1%) in the TACE plus radiotherapy group were able to undergo curative surgical resection due to downstaging.
The risk of TACE-induced liver failure is a concern based on results of previous studies in patients with HCC and macroscopic vascular invasion, but in this study, there were no discontinuations due to adverse events in the TACE-radiation group, the authors noted.
“Our study may not be large enough to accurately establish the incidence of adverse events,” they wrote. “However, considering the dismal prognosis, the superior efficacy of TACE plus RT vs. sorafenib may justify its use for these patients.”
Dr. Yoon reported no disclosures related to the study. One coauthor reported research funding and advisory board membership with Bayer Healthcare and Gilead Sciences.
SOURCE: Yoon SM et al. 2018 Mar 15 JAMA Oncol. doi: 10.1001/jamaoncol.2017.5847 .
