Stereotactic Ablative Radiation for Systemic Therapy-naïve Oligometastatic Kidney Cancer.
Stereotactic Ablative Radiation for Systemic Therapy-naïve Oligometastatic Kidney Cancer.
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DOI：
10.1016/j.euo.2022.06.008
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发表时间：
2022-12
影响因子：
8.2
通讯作者：
Brugarolas, James
中科院分区：
文献类型：
--
作者：
Hannan, Raquibul;Christensen, Michael;Christie, Alana;Garant, Aurelie;Pedrosa, Ivan;Robles, Liliana;Mannala, Samantha;Wang, Chiachien;Hammers, Hans;Arafat, Waddah;Courtney, Kevin;Bowman, Isaac A.;Sher, David;Ahn, Chul;Cole, Suzanne;Choy, Hak;Timmerman, Robert;Brugarolas, James
关键词：
缺乏系统治疗初治的寡转移性肾细胞癌（RCC）的循证指南。这项前瞻性II期单组试验评估了立体定向消融放疗（SAbR）在系统治疗初治的寡转移性RCC患者中提供纵向疾病控制同时保持生活质量的潜力。有≤3处颅外转移的RCC患者符合条件。SAbR纵向给予所有前期和后续转移（如适用）。该研究的主要目的是使>60%的患者（使用Clopper和Pearson方法）免于全身治疗>1年。次要终点包括无进展生存期（PFS），定义为从第一次SAbR到不适合SAbR的进展（在SAbR治疗部位的局部失败;不适合SAbR的新转移; >3个新转移;或脑转移）的时间;患者报告的生活质量（QOL）度量;局部控制（LC）率;毒性;癌症特异性生存期（CSS）;和总生存期（OS）。23例患者在33个初始和总共57个研究中心接受了SAbR。中位随访时间为21.7个月（四分位距16.3-30.3）。超过预先规定的60%基准，1年时无全身治疗率为91.3%（95%CI：69.5，97.8）。1年PFS为82.6%（95%CI：60.1，93.1）。QOL基本未受影响。LC为100%。没有3/4级毒性，但在SAbR后3个月，在随后的检查点抑制剂治疗中，由于免疫相关性结肠炎而导致1例死亡，其中SAbR的作用不能排除。1年CSS和OS均为95.7%（95%CI：72.9，99.4）。少转移性RCC的SAbR与有意义的纵向疾病控制相关，同时保持生活质量。这些数据支持进一步评价SAbR用于系统治疗初治的寡转移性RCC。序贯立体定向放射治疗可以安全有效地控制转移性肾癌，在一年以上的有限扩散，而不影响患者的生活质量。这项II期试验提供了前瞻性证据，表明在选定的（和预定义的）全身治疗初治患者人群中，当疾病保持寡转移时，对寡转移性RCC的所有部位进行序贯SAbR，可在>90%的患者中控制疾病，同时维持健康相关的生活质量。
Evidence-based guidelines for the management of systemic therapy naïve oligometastatic renal cell carcinoma (RCC) are lacking. This prospective phase II single-arm trial evaluated the potential of stereotactic ablative radiotherapy (SAbR) to provide longitudinal disease control while preserving quality of life in patients with systemic therapy naïve oligometastatic RCC. RCC patients with ≤3 extracranial metastases were eligible. SAbR was administered longitudinally to all upfront and, as applicable, subsequent metastases. The study was powered to achieve a primary objective of freedom from systemic therapy >1 year in >60% of patients (using Clopper and Pearson methodology). Secondary endpoints included progression-free survival (PFS), defined as time from first SAbR to progression not amenable to SAbR (local failure at SAbR-treated sites; new metastases not amenable to SAbR; >3 new metastases; or brain metastases); patient-reported quality of life (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. Median follow-up was 21.7 months (interquartile range 16.3–30.3). Exceeding the pre-specified 60% benchmark, freedom from systemic therapy at one-year was 91.3% (95%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 three months after SAbR while on subsequent checkpoint inhibitor therapy where a SAbR contribution could not be excluded. One-year CSS and OS were both 95.7% (95%CI: 72.9, 99.4). SAbR for oligometastatic RCC was associated with meaningful longitudinal disease control while preserving quality of life. 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. This phase II trial provides prospective evidence that sequential SAbR to all sites of oligometastatic RCC while the disease remains oligometastatic in a selected (and predefined) systemic therapy naïve patient population offers disease control in >90% of patients while maintaining health-related quality of life.
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影响因子：
45.3
作者：
RABINOVITCH, RA;ZELEFSKY, MJ;FUKS, Z
通讯作者：
FUKS, Z
影响因子：
51.1
作者：
Ko, Jenny J.;Xie, Wanling;Heng, Daniel Y. C.
通讯作者：
Heng, Daniel Y. C.
影响因子：
51.1
作者：
Tang, Chad;Msaouel, Pavlos;Tannir, Nizar M.
通讯作者：
Tannir, Nizar M.
影响因子：
158.5
作者：
Motzer, Robert J.;Hutson, Thomas E.;Choueiri, Toni K.
通讯作者：
Choueiri, Toni K.
影响因子：
45.3
作者：
Kavolius, JP;Mastorakos, DP;Brady, MS
通讯作者：
Brady, MS