目的:评估OligoCare队列中的寡转移癌患者立体定向放疗(SBRT)后6个月的急性毒性。
方法:OligoCare是一种前瞻性,基于注册表,单臂,观察性研究旨在报告接受SBRT治疗的实体癌寡转移患者的前瞻性真实世界数据(NCT03818503)。原发肿瘤包括非小细胞肺癌(NSCLC),乳腺癌(BC),结直肠癌(CRC),前列腺癌(PC)。此分析涉及试验的次要终点,SBRT后6个月内的急性毒性。
结果:在1,597名注册患者中,对1468例患者进行了急性毒性评估。全球范围内,290人(20%)患有NSCLC原发疾病,227(16%)有BC,293(20%)患有CRC,658人(45%)拥有个人电脑。527例(35.9%)患者同时进行全身治疗。根据EORTC/ESTRO寡转移疾病(OMD)分类,828例(56%)患者有从头OMD,464(32%)重复OMD,176例(12%)诱导OMD。8例(0.5%)患者报告了急性≥3级SBRT相关不良事件,包括2例(0.1%)致命不良事件。特别是,6(0.4%)3级事件是:1个脓胸,1肺炎,1放射性肺炎,1放射性皮肤损伤,1食欲下降,1骨疼痛。其中2例发生在NSCLC患者中,2在BC患者中,CRC和PC患者各1例。两种(0.1%)5级毒性表现为:肺炎和脑出血。
结论:OligoCare是关于寡转移疾病的最大的前瞻性登记队列。6个月内急性毒性低,证实SBRT治疗寡转移酶的安全性。
OBJECTIVE: To evaluate acute toxicity at 6 months after stereotactic body radiotherapy (SBRT) in patients with oligometastatic cancer within the OligoCare cohort.
METHODS: OligoCare is a prospective, registry-based, single-arm, observational study that aims to report prospective real-world data of patients with
oligometastases from solid cancer treated with SBRT (NCT03818503). Primary tumor included non-small cell lung cancer (NSCLC), breast cancer (BC), colorectal cancer (CRC), and prostate cancer (PC). This analysis addresses a secondary endpoint of the trial, acute toxicity within 6 months after SBRT.
RESULTS: Out of 1,597registered patients, 1\'468 patients were evaluated for acute toxicity. Globally, 290 (20 %) had NSCLC primary disease, 227 (16 %) had BC, 293 (20 %) had CRC, and 658 (45 %) had PC. Concomitant systemic treatment was administered in 527 (35.9 %) patients. According to the EORTC/ESTRO oligometastatic disease (OMD) classification, 828 (56 %) patients had de novo OMD, 464 (32 %) repeat OMD, and 176 (12 %) induced OMD. Acute grade ≥ 3 SBRT related adverse events were reported in 8 (0.5 %) patients, including 2 (0.1 %) fatal AEs. In particular, 6 (0.4 %) grade 3 events were: 1 empyema, 1 pneumonia, 1 radiation pneumonitis, 1 radiation skin injury, 1 decreased appetite, and 1 bone pain. Among those 2 occurred in NSCLC patients, 2 in BC patients, and 1 in CRC and PC patients each. The two (0.1 %) grade 5 toxicity were represented by: pneumonitis and cerebral hemorrhage.
CONCLUSIONS: OligoCare is the largest prospective registry cohort on oligometastatic disease. Acute toxicity within 6 months was low, confirming the safety of SBRT in the treatment of
oligometastases.