Stereotactic body radiation therapy for small (≤5 cm) hepatocellular carcinoma not amenable to curative treatment: Results of a single-arm, phase II clinical trial

Abstract

Background/Aims: Stereotactic body radiation therapy (SBRT) is used as an alternative ablative treatment in patients with hepatocellular carcinoma (HCC) not suitable for curative treatments. The purpose of this prospective study was to evaluate the long-term efficacy of SBRT for small (≤5 cm) HCCs.Methods: A phase II, single-arm clinical trial on SBRT for small HCCs was conducted at an academic tertiary care center. The planned SBRT dose was 45 Gy with a fraction size of 15-Gy over 3 consecutive days. The primary endpoint was 2-year local control rate. Radiologic responses were assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and the modified RECIST criteria.Results: Between 2013 and 2016, 50 patients (53 lesions) were enrolled, with a median follow-up period of 47.8 months (range, 2.9–70.6). Patients’ age ranged from 41 to 74 years, and 80% were male. Median tumor size was 1.3 cm (range, 0.7–3.1). The 2- and 5-year local control rates were 100% and 97.1%, respectively. The 5-year overall survival rate was 77.6%. Six months after SBRT, radiologic responses were evident in 44 lesions (83%) according to the RECIST criteria and 49 (92.4%) according to the modified RECIST criteria. None of the patients showed grade ≥3 adverse events.Conclusions: SBRT showed excellent results as an ablative treatment for patients with small HCCs while showing minimal toxicities. SBRT can be a good alternative for both curative and salvage intents in patients with HCCs that are unsuitable for curative treatments.

Stereotactic Body Radiation Therapy as a Salvage Treatment for Single Viable Hepatocellular Carcinoma at the Site of Incomplete Transarterial Chemoembolization

“…As tumor responses after SBRT could be used as a surrogate measure for LC, rapid treatment changes can be considered if the tumor response is not su cient. However, the interval from SBRT to the time point of reliable response had not been evaluated until one recent phase II study [33]. Accordingly, physicians usually decided on upfront treatment changes without waiting long enough even if there is no obvious local progression at the SBRT site.…”

In reply to Huo et al.: Treating small hepatocellular carcinoma: Stereotactic body radiation therapy versus radiofrequency ablation

“…Even though only 4% of patients were treatment-naïve, the 5-year overall survival rate was as high as 77.6% in our patients who had good baseline liver function. 5 Furthermore, SBRT showed a comparable overall survival rate to RFA in patients with small HCC whose baseline characteristics were balanced after propensity score matching in a recent retrospective comparison study. 6 Therefore, the baseline characteristics of patients should be carefully examined when comparing the oncologic outcomes among different studies using RFA or SBRT.…”

“…However, it should be noted that a higher number of prior treatment sessions was associated with worse prognosis in patients with HCC. 2,5 In previous studies, the proportion of treatment-naïve patients was usually higher in patients receiving RFA than those receiving SBRT. Whereas Shiina et al reported the long-term outcomes of RFA as an initial treatment for HCC in all of the enrolled patients, 3 only eight (2.8%) patients in our study were treated with SBRT as an initial treatment for HCC.…”

“…Unlike percutaneous ablative therapies that use needle probes, SBRT is a non-invasive ablative therapy that results in minimal toxicities, both acute and late. 2,5 Although SBRT is usually delivered in the course of 3-4 days, all procedures can be performed in the outpatient setting without the need for hospitalization. Moreover, the overall quality of life of patients does not significantly decline after receiving SBRT to the liver.…”

Image-Guided Proton Therapy for Elderly Patients with Hepatocellular Carcinoma: High Local Control and Quality of Life Preservation

“…As an alternative to HR and RFA, recent studies reported favorable outcomes for small HCC treated by stereotactic body radiotherapy (SBRT) [ 15 , 16 ]. However, few studies have reported SBRT for HCC in elderly patients, and LCSGJ did not compare SBRT with other procedures.…”