Iizuka Yusuke, Inoue Minoru, Kokubo Masaki, Sakamoto Takashi, Murofushi Keiko Nemoto, Imagumbai Toshiyuki, Shimizuguchi Takuya, Hiraoka Masahiro, Mizowaki Takashi
Graduate School of Medicine, Department of Radiation Oncology and Image-Applied Therapy, Kyoto University, Kyoto, Kyoto, Japan.
Department of Radiation Oncology, Shizuoka City Shizuoka Hospital, Shizuoka, Shizuoka, Japan.
Int J Clin Oncol. 2025 Jun;30(6):1211-1217. doi: 10.1007/s10147-025-02740-2. Epub 2025 Mar 21.
Despite advancements in liver tumor treatments, a persistent need remains for minimally invasive therapies with high efficacy and long-term outcomes. In a previous multicenter phase II study, the safety and efficacy of dynamic tumor-tracking stereotactic body radiotherapy with real-time monitoring of liver tumors were evaluated using a gimbal-mounted system. Herein, we report the updated long-term results of this technique.
This observational study examined patients with a single liver tumor, respiratory movement of at least 10 mm, performance status of 0-2, and Child-Pugh score of < 9. Patients who agreed to participate in the trial underwent dynamic tumor-tracking stereotactic body radiotherapy (prescribed dose, 40 Gy in five fractions for the planning target volume [D]; 70% of the maximum dose). The primary endpoint was the 4-year overall survival rate. Secondary endpoints included 4-year local control and progression-free survival rates and the incidence of adverse events.
Between September 2015 and March 2019, 48 patients (median age, 74 years; median tumor diameter, 17.5 mm) underwent dynamic tumor-tracking stereotactic body radiotherapy. All lesions were successfully treated (hepatocellular carcinoma, 39 patients; liver metastases, 9 patients). The median observation period was 46 months, and the 4-year overall survival, local control, and progression-free survival rates were 67.4%, 97.9%, and 29.1%, respectively. Eight patients had grade 3 hepatobiliary enzyme elevation, hematologic toxicity, or hyponatremia; none had grade ≥ 4 adverse events.
These findings demonstrate the long-term safety and efficacy of dynamic tumor-tracking stereotactic body radiotherapy for liver tumors, with an excellent local control rate.
尽管肝肿瘤治疗取得了进展，但对高效且具有长期疗效的微创治疗仍有持续需求。在先前的一项多中心II期研究中，使用万向架安装系统对肝肿瘤进行实时监测的动态肿瘤追踪立体定向体部放射治疗的安全性和有效性进行了评估。在此，我们报告该技术的最新长期结果。
本观察性研究纳入了患有单个肝肿瘤、呼吸运动至少10毫米、体能状态为0 - 2且Child-Pugh评分<9的患者。同意参与试验的患者接受了动态肿瘤追踪立体定向体部放射治疗（处方剂量，计划靶体积[D]为40 Gy，分5次给予；最大剂量的70%）。主要终点是4年总生存率。次要终点包括4年局部控制率、无进展生存率以及不良事件的发生率。
2015年9月至2019年3月期间，48例患者（中位年龄74岁；中位肿瘤直径17.5毫米）接受了动态肿瘤追踪立体定向体部放射治疗。所有病灶均成功治疗（肝细胞癌39例；肝转移瘤9例）。中位观察期为46个月，4年总生存率、局部控制率和无进展生存率分别为67.4%、97.9%和29.1%。8例患者出现3级肝胆酶升高、血液学毒性或低钠血症；无≥4级不良事件发生。
这些结果表明，动态肿瘤追踪立体定向体部放射治疗对肝肿瘤具有长期安全性和有效性，局部控制率极佳。
