Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Eur Urol Oncol. 2022 Dec;5(6):695-703. doi: 10.1016/j.euo.2022.06.008. Epub 2022 Aug 16.
Evidence-based guidelines for the management of systemic therapy-naïve oligometastatic renal cell carcinoma (RCC) are lacking.
To evaluate the potential of stereotactic ablative radiotherapy (SAbR) to provide longitudinal disease control while preserving quality of life (QOL) in patients with systemic therapy-naïve oligometastatic RCC.
DESIGN, SETTING, AND PARTICIPANTS: RCC patients with three or fewer extracranial metastases were eligible. SAbR was administered longitudinally to all upfront and, as applicable, subsequent metastases.
This prospective phase II single-arm trial was powered to achieve a primary objective of freedom from systemic therapy for >1 yr in >60% of patients (using the Clopper and Pearson methodology). Secondary endpoints included progression-free survival (PFS), defined as the time from first SAbR to progression not amenable to SAbR (local failure at SAbR-treated sites, new metastases not amenable to SAbR, more than three new metastases, or brain metastases); patient-reported QOL metrics; local control (LC) rates; toxicity; cancer-specific survival (CSS); and overall survival (OS).
Twenty-three patients received SAbR to 33 initial and 57 total sites. The median follow-up was 21.7 mo (interquartile range 16.3-30.3). Exceeding the prespecified 60% benchmark, freedom from systemic therapy at 1 yr was 91.3% (95% confidence interval [CI]: 69.5, 97.8). One-year PFS was 82.6% (95% CI: 60.1, 93.1). QOL was largely unaffected. LC was 100%. There were no grade 3/4 toxicities, but there was one death due to immune-related colitis 3 mo after SAbR while on subsequent checkpoint inhibitor therapy, where a SAbR contribution could not be excluded. One-year OS was 95.7% (95% CI: 72.9, 99.4); one-year CSS was 100%.
SAbR for oligometastatic RCC was associated with meaningful longitudinal disease control while preserving QOL. These data support further evaluation of SAbR for systemic therapy-naïve oligometastatic RCC.
Sequential stereotactic radiation therapy can safely and effectively control metastatic kidney cancer with limited spread for over a year without compromising patients' quality of life.
目前缺乏针对系统治疗初治寡转移肾细胞癌（RCC）的循证指南。
评估立体定向消融放疗（SAbR）在保留生活质量（QOL）的同时，为系统治疗初治寡转移 RCC 患者提供纵向疾病控制的潜力。
设计、地点和参与者：纳入了有三个或更少颅外转移的 RCC 患者。SAbR 对所有初始转移灶和适当时的后续转移灶进行纵向治疗。
这项前瞻性 II 期单臂试验旨在实现主要目标，即>60%的患者（采用 Clopper 和 Pearson 方法）免于系统治疗 1 年以上。次要终点包括无进展生存期（PFS），定义为从首次 SAbR 到无法进行 SAbR 治疗的进展时间（SAbR 治疗部位的局部失败、无法进行 SAbR 治疗的新转移灶、超过三个新转移灶或脑转移灶）；患者报告的 QOL 指标；局部控制（LC）率；毒性；癌症特异性生存（CSS）；以及总生存（OS）。
23 例患者接受 SAbR 治疗 33 个初始和 57 个转移灶。中位随访时间为 21.7 个月（四分位距 16.3-30.3）。超过了预设的 60%基准，1 年无系统治疗的比例为 91.3%（95%置信区间[CI]：69.5，97.8）。1 年 PFS 为 82.6%（95%CI：60.1，93.1）。QOL 基本不受影响。LC 率为 100%。无 3/4 级毒性，但有 1 例死亡，归因于 SAbR 后 3 个月发生免疫相关性结肠炎，而 SAbR 与随后的检查点抑制剂治疗相关，无法排除 SAbR 的作用。1 年 OS 为 95.7%（95%CI：72.9，99.4）；1 年 CSS 为 100%。
SAbR 治疗寡转移 RCC 可显著延长疾病控制时间，同时保留 QOL。这些数据支持进一步评估 SAbR 治疗系统治疗初治寡转移 RCC。
序贯立体定向放疗可以安全有效地控制局限性扩散的转移性肾癌超过 1 年，同时不影响患者的生活质量。
