Prospective phase II study of SBRT in hepatocellular carcinoma patients with partial response or unsuitable for TACE

Background and Purpose: Management of hepatocellular carcinoma (HCC) is challenging due to tumor aggressiveness and associated cirrhosis. There is paucity of effective local options after failure of trans arterial chemoembolization (TACE). Our objective was to test in the setting of a phase II prospective study, the efficacy and safety of Stereotactic Body Radiation Therapy (SBRT) in patients with partial response or unsuitable for TACE. Methods: Patients with HCC and up to five liver-only lesions received SBRT 30 to 50 Gy in 5 fractions. Primary endpoint was local progression-free survival. Secondary endpoints were liver progression-free survival, distant progression-free survival, overall survival and toxicity. This study is registered at clinical trials.gov NCT02221778. Results: From Nov 2014 through Jun 2018, 19 patients received SBRT with a median dose of 40Gy (range 30 – 50 Gy). All patients were Child Pugh A. Median age was 67 years old (range 42-84y). Underlying liver disease was hepatitis C in 42% of patients, hepatitis B in 26% and alcohol-related in 26%. 84% received previous TACE, with a median of two TACEs (range 0-5). Patients had a median of two lesions (range 1-4), with median size of 4 cm (1.5- 10 cm). 32% had tumor vascular thrombosis; median pretreatment AFP was 142.5 ng/ml (range 4.2 – 5,494 ng/ml). 1y local progression-free survival was 80% (95% CI, 50% to 93%). 1y liver progression-free survival, distant progression-free survival and overall survival were, respectively, 52%, 82% and 84%. No patient had clinical grade 3 or 4 toxicities. Laboratory toxicities up to grade 3 occurred in three patients (16%). Complete radiological response was seen in 53% of patients, 42% had partial response. Median time for best response was 3.4 months (range 2.4-12.6 months). Conclusion:SBRT is an effective, safe and noninvasive option in HCC patients with partial response or unsuitable for TACE. (author)