Efficacy, Safety of Stereotactic Body Radiotherapy for Patients With HCC

Currently, there is a lack of research on the efficacy and safety of stereotactic body radiotherapy (SBRT) prior to liver transplant for patients with hepatocellular carcinoma (HCC).

A study from Victor Ho-Fun Lee, MD, and colleagues published in JAMA Network Open sought to determine the potential of SBRT prior to receiving a deceased donor liver transplant (DDLT) for patients with previously untreated unresectable HCC.

The phase 2, nonrandomized trial investigated the data of 32 patients who underwent dual-tracer positron emission tomography (PET) with computed tomography and magnetic resonance imaging combined with gadoxetate. Patients then received 35 to 50 Gy of SBRT in 5 fractions, followed by an identical imaging process while waiting for a DDLT.

The primary end points were progression-free survival (PFS) and objective response rate (ORR) determined by the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST), modified RECIST (mRECIST), and PET Response Criteria in Solid Tumors (PERCIST). Secondary end points included local control rate, overall survival (OS), and safety.

Following a 74.6-month median follow-up period, the median PFS was 17.6 months (95% CI, 6.6-28.6), and the median OS was 60.5 months (95% CI, 29.7-91.2). At 5 years, the median PFS was 39.9% (95% CI, 19.9-59.9), while the median OS was 51.3% (95% CI, 31.7-70.9).

Regarding number of patients, the ORR was 71.9% (95% CI, 63.7-79.0) following mRECIST, compared with 78.1% (95% CI, 73.2-86.7) following PERCIST and 62.5% (95% CI, 54.2-68.7) following RECIST. For lesions, the ORRs were 83.9% (95% CI, 74.7-90.6), 87.5% (95% CI, 81.3-98.6), and 75.0% (95% CI, 61.6-80.8), respectively.

Through multivariable analysis, investigators found that pretreatment metabolic tumor volume and complete metabolic response by PERCIST are related to PFS.

“This phase 2, nonrandomized, controlled trial demonstrated promising survival and safety outcomes of SBRT before DDLT for unresectable HCC,” the researchers wrote. “Future randomized, clinical trials are warranted.”