Iizuka Yusuke, Hiraoka Masahiro, Kokubo Masaki, Sakamoto Takashi, Karasawa Katsuyuki, Murofushi Keiko, Nakamura Mitsuhiro, Matsuo Yukinori, Morita Satoshi, Inokuchi Haruo, Mizowaki Takashi
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Japan.
Department of Radiation Oncology, Japanese Red Cross Society Wakayama Medical Center, Japan.
Clin Transl Radiat Oncol. 2023 Feb 10;39:100591. doi: 10.1016/j.ctro.2023.100591. eCollection 2023 Mar.
This prospective multicenter phase II study aimed to evaluate the safety and efficacy of dynamic tumor tracking (DTT) stereotactic body radiotherapy (SBRT) with real-time monitoring of liver tumors using a gimbal-mounted system.
Patients with < 4 primary or metastatic liver tumors with diameters ≤ 50 mm and expected to have a respiratory motion of ≥ 10 mm were eligible. The prescribed dose was 40 Gy in five fractions. The primary endpoint was local control (LC) at 2 years. The secondary endpoints were overall survival (OS), progression-free survival (PFS), treatment-related toxicity, and tracking accuracy.
Between September 2015 and March 2019, 48 patients (48 lesions) with a median age of 74 years were enrolled from four institutions. Of these, 39 were diagnosed with hepatocellular carcinoma and nine with metastatic liver cancer. The median tumor diameter was 17.5 mm. DTT-SBRT was successfully performed in all patients; the median treatment time was 28 min/fraction. The median follow-up period was 36.5 months. The 2-year LC, OS, and PFS rates were 98.0 %, 88.8 %, and 55.1 %, respectively. Disease progression was observed in 33 (68.8 %) patients. One patient (0.2 %) had local recurrence, 31 (64.6 %) developed new hepatic lesions outside the irradiation field, and nine (18.8 %) had distant metastases (including overlap). Grade 3 late adverse events were observed in seven patients (14.5 %). No grade 4 or 5 treatment-related toxicity was observed. The median tracking accuracy was 2.9 mm.
Employing DTT-SBRT to treat liver tumors results in excellent LC with acceptable adverse-event incidence.
这项前瞻性多中心II期研究旨在评估使用万向架安装系统对肝脏肿瘤进行实时监测的动态肿瘤追踪（DTT）立体定向体部放疗（SBRT）的安全性和有效性。
符合条件的患者为原发性或转移性肝脏肿瘤≤4个、直径≤50mm且预计呼吸运动≥10mm者。处方剂量为40Gy，分5次给予。主要终点为2年时的局部控制（LC）。次要终点为总生存期（OS）、无进展生存期（PFS）、治疗相关毒性和追踪准确性。
2015年9月至2019年3月，从4家机构纳入了48例患者（48个病灶），中位年龄74岁。其中，39例诊断为肝细胞癌，9例为转移性肝癌。中位肿瘤直径为17.5mm。所有患者均成功进行了DTT-SBRT；中位治疗时间为每次28分钟。中位随访期为36.5个月。2年时的LC、OS和PFS率分别为98.0%、88.8%和55.1%。33例（68.8%）患者出现疾病进展。1例患者（0.2%）出现局部复发，31例（64.6%）在照射野外出现新的肝脏病灶，9例（18.8%）出现远处转移（包括重叠）。7例患者（14.5%）出现3级晚期不良事件。未观察到4级或5级治疗相关毒性。中位追踪准确性为2.9mm。
采用DTT-SBRT治疗肝脏肿瘤可获得良好的局部控制，不良事件发生率可接受。
