A phase II trial of hypofractionated high-dose proton beam therapy for unresectable liver metastases

医学 临床终点 转移 质子疗法 内科学 存活率 放射治疗 胃肠病学 原发性肿瘤 束流扫描 临床研究阶段 癌症 肿瘤科 放射科 核医学 毒性 随机对照试验
作者
Kangpyo Kim,Jeong Il Yu,Hee Chul Park,Gyu Sang Yoo,Do Hoon Lim,Jae Myoung Noh,Woo Kyoung Jeong
出处
期刊:Radiotherapy and Oncology [Elsevier]
卷期号:176: 9-16 被引量:7
标识
DOI:10.1016/j.radonc.2022.09.003
摘要

Background and purpose Proton beam therapy (PBT) is an effective treatment option for primary malignant liver disease. However, evidence regarding liver metastasis is insufficient. We aimed to investigate the efficacy and safety of hypofractionated high-dose PBT in the treatment of metastatic liver disease. Materials and methods From January 2019 to January 2021, patients with unresectable liver metastases were enrolled. For PBT, the dose schemes of 60 Gy relative biological effectiveness (GyRBE) in 5 fractions (fx) (biologically effective dose [BED] 132 GyE) or 70 GyRBE in 10 fx (BED 119 GyE) were used. Either a passive scattered beam or pencil beam scanning (PBS)-based intensity-modulated proton therapy (IMPT) was performed with proper respiratory management. The primary endpoint of the study was 6-month freedom from local progression (FFLP) rate; and the Kaplan–Meier method was used to calculate the FFLP and survival rates. Results Of the 49 liver metastases in 46 patients, the colorectum accounted for 60% of the primary cancer sites, followed by the gastrointestinal organs and pancreas/biliary tract. Forty patients presented only 1 liver metastasis, while the other 6 patients had 2 to 4 metastases. The Six-month FFLP rate was 95.2%. The 1-year FFLP rate in patients with <3 cm liver metastasis was 87.4%, while that was 74.1% in patients with > 3 cm group (p = 0.087). With regard to systemic treatment, the 1-year FFLP rate after PBT was better (94.1%) than that without systemic treatment (75.8%; p = 0.051). Regarding PBT-related toxicity, one patient developed a grade 2 gastric ulcer, while none of the patients developed grade ≥3 toxicities. Conclusions Hypofractionated PBT with a BED > 100 GyRBE for liver metastasis is safe and effective, given the high rate of 6-month FFLP without grade ≥3 treatment-related toxicities. However, further improvements are required for larger tumors and/or those without prior systemic therapy.
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