Clinical Research Papers:
Phase I dose-escalation study of helical intensity-modulated radiotherapy-based stereotactic body radiotherapy for hepatocellular carcinoma
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Jun Won Kim1, Jinsil Seong2, Ik Jae Lee1, Joong Yeol Woo2, Kwang-Hyub Han3
1Department of Radiation Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
2Department of Radiation Oncology, Yonsei Cancer Hospital, Yonsei University College of Medicine, Seoul, Korea
3Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
Jinsil Seong, email: email@example.com
Keywords: stereotactic body radiotherapy, hepatocellular carcinoma, dose escalation, intensity-modulated radiotherapy
Received: March 20, 2016 Accepted: April 16, 2016 Published: May 18, 2016
Background: Phase I trial was conducted to determine feasibility and toxicity of helical intensity-modulated radiotherapy (IMRT)-based stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma (HCC).
Results: Eighteen patients (22 lesions) were enrolled. With no DLT at 52 Gy (13 Gy/fraction), protocol was amended for further escalation to 60 Gy (15 Gy/fraction). Radiologic complete response rate was 88.9%. Two outfield intrahepatic, 2 distant, 4 concurrent local and outfield, and 1 concurrent local, outfield and distant failures (no local failure at dose levels 3–4) occurred. The worst toxicity was grade 3 hematologic in five patients, with no gastrointestinal toxicity > grade 1. At median follow-up of 28 months for living patients, 2-year local control, progression-free (PFS), and overall survival rates were 71.3%, 49.4% and 69.3%, respectively. Multi-segmental recurrences prior to SBRT was independent prognostic factor for PFS (p = 0.033).
Materials and Methods: Eligible patients had Child-Pugh’s class A or B, unresectable HCC, ≤ 3 lesions, and cumulative tumor diameter ≤ 6 cm. Starting at 36 Gy in four fractions, dose was escalated with 2 Gy/fraction per dose-level. CTCAE v 3.0 ≥ grade 3 gastrointestinal toxicity and radiation induced liver disease defined dose-limiting toxicity (DLT).
Conclusions: Helical IMRT-based SBRT was tolerable and showed encouraging results. Confirmatory phase II trial is underway.
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