Multicenter prospective study of stereotactic body radiotherapy for previously untreated solitary primary hepatocellular carcinoma: The STRSPH study

• DOI: 10.1111/hepr.13595
• Publication Date: 2020-11-21T06:38:45Z
• Authors: Tomoki Kimura; Atsuya Takeda; Naoko Sanuki; Keisuke Ariyoshi; Takuhiro Yamaguchi; Toshiyuki Imagumbai; Norio Katoh; Takahisa Eriguchi; Yohei Oku; Shuichi Ozawa; Yuichiro Tsurugai; Masaki Kokubo; Shinichi Shimizu; Satoshi Ishikura
• Keywords: Clinical endpoint

Abstract Aim To prospectively evaluate the efficacy and safety of stereotactic body radiotherapy (SBRT) for patients with previously untreated solitary primary hepatocellular carcinoma (HCC). Methods The main eligibility criteria included following: (1) HCC; (2) no prior treatment (3) Child–Turcotte–Pugh score seven or less; (4) unsuitability refusal surgery radiofrequency ablation (RFA). prescribed dose SBRT was 40 Gy in five fractions. endpoint 3‐year overall survival (OS); secondary endpoints local progression‐free (LPFS), control (LC), adverse events. accrual target 60 patients, expecting a OS 70% 50% threshold. Results Between 2014 2018, 36 were enrolled; enrollment closed early because slow accrual. median tumor size 2.3 cm. follow‐up at time evaluation 20.8 months. 78% (95% confidence interval [CI]: 53%–90%). LPFS LC proportion 73% CI: 48%–87%) 90% 65%–97%), respectively. Grade 3 higher SBRT‐related toxicities observed four (11%), grade not observed. Conclusions This study showed acceptably low incidence toxicities. after comparable HCC unfit resection RFA. Although definitive conclusion cannot be drawn by this study, promising results indicate that may an alternative option management HCC.