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Multicenter prospective study of stereotactic body radiotherapy for previously untreated solitary primary hepatocellular carcinoma: The STRSPH study
Author(s) -
Kimura Tomoki,
Takeda Atsuya,
Sanuki Naoko,
Ariyoshi Keisuke,
Yamaguchi Takuhiro,
Imagumbai Toshiyuki,
Katoh Norio,
Eriguchi Takahisa,
Oku Yohei,
Ozawa Shuichi,
Tsurugai Yuichiro,
Kokubo Masaki,
Shimizu Shinichi,
Ishikura Satoshi
Publication year - 2021
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.13595
Subject(s) - medicine , hepatocellular carcinoma , clinical endpoint , radiofrequency ablation , adverse effect , incidence (geometry) , confidence interval , radiosurgery , prospective cohort study , oncology , radiation therapy , radiology , ablation , clinical trial , physics , optics
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 the following: (1) primary solitary HCC; (2) no prior treatment for HCC; (3) Child–Turcotte–Pugh score of seven or less; and (4) unsuitability for or refusal of surgery and radiofrequency ablation (RFA). The prescribed dose of SBRT was 40 Gy in five fractions. The primary endpoint was 3‐year overall survival (OS); the secondary endpoints included local progression‐free survival (LPFS), local control (LC), and adverse events. The accrual target was 60 patients, expecting a 3‐year OS of 70% with a 50% threshold. Results Between 2014 and 2018, 36 patients were enrolled; enrollment was closed early because of slow accrual. The median tumor size was 2.3 cm. The median follow‐up at the time of evaluation was 20.8 months. The 3‐year OS was 78% (95% confidence interval [CI]: 53%–90%). The 3‐year LPFS and LC proportion were 73% (95% CI: 48%–87%) and 90% (95% CI: 65%–97%), respectively. Grade 3 or higher SBRT‐related toxicities were observed in four patients (11%), and grade five toxicities were not observed. Conclusions This study showed acceptably low incidence of SBRT‐related toxicities. LC and OS after SBRT were comparable for previously untreated solitary HCC for patients unfit for resection and RFA. Although a definitive conclusion cannot be drawn by this study, the promising results indicate that SBRT may be an alternative option in the management of early HCC.