A Prospective Phase 2 Multicenter Study for
the Efficacy of Radiation Therapy Following
Incomplete Transarterial Chemoembolization
in Unresectable Hepatocellular Carcinoma
- Alternative Author(s)
- Kim, Jin Hee
- Publication Year
- Purpose: The purpose of this study was to investigate the efficacy and toxicity of
radiation therapy (RT) following incomplete transarterial chemoembolization (TACE)
in unresectable hepatocellular carcinoma (HCC).
Methods and Materials: The study was designed as a prospective phase 2 multicenter
trial. Patients with unresectable HCC, who had viable tumor after TACE of no more
than 3 courses, were eligible. Three-dimensional conformal RT (3D-CRT) was added
for HCC treatment with incomplete uptake of iodized oil, and the interval from TACE
to RT was 4 to 6 weeks. The primary endpoint of this study was the tumor response
after RT following incomplete TACE in unresectable HCC. Secondary endpoints were
patterns of failure, progression-free survival (PFS), time to tumor progression (TTP),
overall survival (OS) rates at 2 years, and treatment-associated toxicity. Survival was
calculated from the start of RT.Results: Between August 2008 and December 2010, 31 patients were enrolled. RT
was delivered at a median dose of 54 Gy (range, 46-59.4 Gy) at 1.8 to 2 Gy per fraction.
A best objective in-field response rate was achieved in 83.9% of patients, with
complete response (CR) in 22.6% of patients and partial response in 61.3% of patients
within 12 weeks post-RT. A best objective overall response rate was achieved in 64.5%
of patients with CR in 19.4% of patients and PR in 45.1% of patients. The 2-year
in-field PFS, PFS, TTP, and OS rates were 45.2%, 29.0%, 36.6%, and 61.3%, respectively.
The Barcelona Clinic liver cancer stage was a significant independent prognostic
factor for PFS (PZ.023). Classic radiation-induced liver disease was not
observed. There were no treatment-related deaths or hepatic failure.
Conclusions: Early 3D-CRT following incomplete TACE is a safe and practical treatment
option for patients with unresectable HCC. 2014 Elsevier Inc.
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