Abstract
Background: Proton beam has an excellent depth dose distribution due to its unique physical properties, and thus proton beam therapy (PBT) has been tried and showed promising outcomes in hepatocellular carcinoma (HCC). The purpose of this phase II study is to evaluate the efficacy of hypofractionated PBT in HCC.Methods: The eligibility criteria for this study were as follows: patients with HCC lesion(s) who were failed after, were difficult to treat with, or refused to other local treatments; tumor size and number of ≤7 and ≤2 cm, respectively, and HCC lesion(s) of ≥2 cm from gastrointestinal organs; Child–Pugh score of ≤7; Eastern Cooperative Oncology Group performance status ≤1; and age ≥18 years. The prescribed dose of PBT was 70 Gy equivalent in 10 fractions. The primary endpoint was 3-year local progression-free survival (LPFS) rate.Results: Forty-five patients were prospectively enrolled, and there were 35 men and 10 women with a median age of 63 years (range, 46–78 years). Thirty-seven patients had recurrent and/or residual disease, and eight patients had treatment-naive disease. All patients received the planned treatments without treatment interruption, and grade ≥3 acute toxicity did not occur. The median follow-up duration was 35.1 months (range, 11.2–56.3 months) and local progression occurred in two patients (8.7%). The 3-year rates of LPFS and overall survival (OS) were 95.2% (95% confidence interval [CI], 89.1%−100%) and 86.4% (95% CI, 72.9–99.9%), respectively.Conclusion: Hypofractionated PBT showed promising LPFS and OS, and further studies are warranted to compare PBT with other local modalities.
Highlights
Hepatocellular carcinoma (HCC) patients mostly have an underlying chronic liver disease resulting from hepatitis B (HBV) and C virus infection, alcoholic liver disease, nonalcoholic fatty liver disease, and so on
Most (n = 37, 82.2%) patients, except eight patients (17.8%) who were treatment-naive due to difficultto-treat lesions or refused to undergo other local treatments, had recurrent and/or residual tumor(s) in the proton beam therapy (PBT) site, and the number of lesions treated with PBT was one and two in 42 and three patients, respectively
With increasing tumor size [2 cm (n = 28), 2.1–4 cm (n = 14), and >4 cm (n = 3)], the median times to complete response (CR) increased [4.6 months, 6.4 months, and 5.1 months, respectively], but these differences were not significant (p = 0.675)
Summary
Hepatocellular carcinoma (HCC) patients mostly have an underlying chronic liver disease resulting from hepatitis B (HBV) and C virus infection, alcoholic liver disease, nonalcoholic fatty liver disease, and so on. Hypofractionated RT can potentially improve the therapeutic ratio compared with conventional fractionated RT by reducing the cancer cell proliferation within the tolerances of surrounding noncancerous tissues and shortening the overall treatment time Based on this rationale, this single-institutional, single-arm, prospective study was conducted to evaluate the efficacy of hypofractionated PBT for HCC patients. Proton beam has an excellent depth dose distribution due to its unique physical properties, and proton beam therapy (PBT) has been tried and showed promising outcomes in hepatocellular carcinoma (HCC).
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