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寡进展性转移性肾细胞癌立体定向消融放疗的 II 期临床试验。

Phase II Trial of Stereotactic Ablative Radiation for Oligoprogressive Metastatic Kidney Cancer.

机构信息

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.

出版信息

Eur Urol Oncol. 2022 Apr;5(2):216-224. doi: 10.1016/j.euo.2021.12.001. Epub 2022 Jan 2.

DOI:10.1016/j.euo.2021.12.001
PMID:34986993
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9090939/
Abstract

BACKGROUND

Patients with metastatic renal cell carcinoma (mRCC) treated with systemic therapy sometimes progress at limited sites.The best treatment approach for patients with oligoprogression remains unclear.

OBJECTIVE

To determine the ability of stereotactic ablative radiation (SAbR) to extend ongoing systemic therapy in mRCC patients with oligoprogression.

DESIGN, SETTING, AND PARTICIPANTS: A single-arm phase II clinical trial was conducted at a university medical center and county hospital, including 20 patients with mRCC on first- to fourth-line systemic therapy with three or fewer sites of progression (including new sites) involving ≤30% of all sites.

INTERVENTION

SAbR to oligoprogressing metastases at outset and longitudinally, while radiated sites remain controlled and overall disease oligoprogressive.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary objective was to extend ongoing systemic therapy by >6 mo in >40% of patients. Secondary endpoints included overall survival, toxicity, and patient-reported quality of life.

RESULTS AND LIMITATIONS

Twenty patients were enrolled. Upfront and sequential SAbR was administered to a total of 37 sites. The local control rate was 100%. At a median follow-up of 10.4 mo (interquartile range: 5.8-16.4), SAbR extended the duration of the ongoing systemic therapy by >6 mo in 14 patients (70%, 95% confidence interval [CI]: 49.9-90.1). The median time from SAbR to the onset of new systemic therapy or death was 11.1 mo (95% CI: 4.5-19.3). The median duration of SAbR-aided systemic therapy was 24.4 mo (95% CI: 15.3-42.2). Median overall survival was not reached. One patient developed grade 3 gastrointestinal toxicity possibly related to treatment. There was no significant decline in quality of life. Limitations include nonrandomized design and a small patient cohort.

CONCLUSIONS

SAbR extended the duration of the ongoing systemic therapy for patients with oligoprogressive mRCC without undermining quality of life. These data support the evaluation of SAbR for oligoprogressive mRCC in a prospective randomized clinical trial.

PATIENT SUMMARY

Patients with metastatic kidney cancer on systemic therapy but progressing at limited sites may benefit from focused radiation to progressive sites. Focused radiation was safe and effective, and extended the duration of the ongoing systemic therapy.

摘要

背景

接受系统治疗的转移性肾细胞癌(mRCC)患者有时会在有限的部位进展。寡进展患者的最佳治疗方法仍不清楚。

目的

确定立体定向消融放疗(SAbR)在 mRCC 寡进展患者中延长正在进行的系统治疗的能力。

设计、地点和参与者:一项单臂二期临床试验在一所大学医学中心和县级医院进行,包括 20 名接受一线至四线系统治疗的 mRCC 患者,这些患者的进展部位为 3 个或更少(包括新部位),进展累及所有部位的比例≤30%。

干预

在寡进展转移部位开始时和纵向进行 SAbR,同时辐射部位保持控制,且总体疾病仍为寡进展。

测量和统计分析结果

主要目标是使>40%的患者正在进行的系统治疗延长>6 个月。次要终点包括总生存、毒性和患者报告的生活质量。

结果和局限性

共纳入 20 名患者。总共对 37 个部位进行了 upfront 和序贯 SAbR。局部控制率为 100%。在中位随访 10.4 个月(四分位间距:5.8-16.4)时,SAbR 将 14 名患者(70%,95%置信区间[CI]:49.9-90.1)正在进行的系统治疗延长了>6 个月。从 SAbR 到新的系统治疗开始或死亡的中位时间为 11.1 个月(95%CI:4.5-19.3)。SAbR 辅助系统治疗的中位持续时间为 24.4 个月(95%CI:15.3-42.2)。中位总生存未达到。1 名患者发生可能与治疗相关的 3 级胃肠道毒性。生活质量无显著下降。局限性包括非随机设计和患者队列小。

结论

SAbR 延长了寡进展 mRCC 患者正在进行的系统治疗的持续时间,而不会降低生活质量。这些数据支持在前瞻性随机临床试验中评估 SAbR 治疗寡进展 mRCC。

患者总结

正在接受系统治疗但仅有限部位进展的转移性肾癌患者可能受益于对进展部位进行集中放疗。集中放疗安全有效,可延长正在进行的系统治疗的持续时间。

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