A phase 2 multicenter study of stereotactic body radiotherapy for hepatocellular carcinoma: Safety and efficacy.

Autor:	Jang, Won Il, Bae, Sun Hyun, Kim, Mi‐Sook, Han, Chul Ju, Park, Su Cheol, Kim, Sang Bum, Cho, Eung‐Ho, Choi, Chul Won, Kim, Kyung Su, Hwang, Sangyoun, Kim, Jin Ho, Chang, A Ram, Park, Younghee, Kim, Eun Seog, Kim, Woo Chul, Jo, Sunmi, Park, Hae Jin, Kim, Mi-Sook, Cho, Eung-Ho
Předmět:	STEREOTACTIC radiotherapy HEPATOCELLULAR carcinoma HEPATOTOXICOLOGY HEPATITIS B PROGRESSION-free survival RESEARCH LIVER tumors CLINICAL trials RESEARCH methodology CANCER relapse EVALUATION research MEDICAL cooperation COMPARATIVE studies RESEARCH funding RADIATION injuries RADIOSURGERY LONGITUDINAL method
Zdroj:	Cancer (0008543X); Jan2020, Vol. 126 Issue 2, p363-372, 10p
Abstrakt:	Background: Although several prospective studies have reported the efficacy of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma (HCC), treatment-related toxicity varies and has not been determined. Therefore, the authors evaluated the safety and efficacy of SBRT for patients with HCC in a hepatitis B virus-endemic area.Methods: This multicenter phase 2 trial enrolled patients with unresectable HCC. Patients received SBRT with 45 to 60 Gy in 3 fractions. To evaluate gastroduodenal toxicity, esophagogastroduodenoscopy (EGD) was performed before and 2 months after SBRT. The primary endpoint was treatment-related severe toxicity at 1 year after SBRT. The secondary endpoints were the 2-year local control, progression-free survival, and overall survival rates.Results: In total, 74 patients were enrolled between January 2012 and April 2015, and 65 eligible patients were analyzed. One patient experienced radiation-induced liver disease with acute grade ≥3 toxicity 1 month after SBRT. In addition, 1 patient had a grade 3 esophageal ulcer with stenosis 5 months after SBRT. The actuarial rate of treatment-related severe toxicity at 1 year was 3%. The pre-SBRT and post-SBRT EGD findings were not significantly different among the 57 evaluable patients who underwent EGD. The 2-year and 3-year local control rates were 97% and 95%, respectively. The progression-free and overall survival rates were 48% and 84% at 2 years, respectively, and 36% and 76% at 3 years, respectively.Conclusions: With a median follow-up of 41 months, this prospective multicenter study demonstrated that SBRT for patients with HCC is well tolerated and is an effective treatment modality. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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