Neoadjuvant SABR for Renal Cell Carcinoma Inferior Vena Cava Tumor Thrombus-Safety Lead-in Results of a Phase 2 Trial.
Neoadjuvant SABR for Renal Cell Carcinoma Inferior Vena Cava Tumor Thrombus-Safety Lead-in Results of a Phase 2 Trial.
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DOI：
10.1016/j.ijrobp.2021.01.054
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发表时间：
2021-07-15
期刊：
影响因子：
--
通讯作者：
Hannan R
中科院分区：
文献类型：
--
作者：
Margulis V;Freifeld Y;Pop LM;Manna S;Kapur P;Pedrosa I;Christie A;Mohamad O;Mannala S;Singla N;Wait M;Bagrodia A;Woldu SL;Gahan J;Brugarolas J;Timmerman R;Hannan R
目的：评价新辅助立体定向放射治疗(Neo-SABR)联合根治性肾切除加血栓切除术(RN-IVCT)的可行性、安全性、肿瘤学转归和免疫效果。这些结果来自单臂1期和2期试验的安全引入部分。对肾癌(肾细胞癌)和下腔静脉癌栓(TT)患者行Neo-SABR(40Gy5次)至IVC-TT，然后行开放式RN-IVCT。RN-IVCT后90天内无4-5级不良事件(AEs)是主要终点。探索性研究包括SABR引起的病理和免疫学改变。最终分析包括6名患者。未见4~5级不良反应。术后90天内共发生AE81例：1级占73%(59/81)，2级占23%(19/81)，3级占4%(3/81)。中位随访24个月，所有患者均存活。一名患者发展为新发转移疾病。在诊断时发生转移的3例患者中，1例完全缓解，1例部分缓解，未同时使用系统治疗。Neo-SABR导致IVC-TT中Ki-67表达降低，PD-L1表达增加。在非进展性疾病患者中观察到炎性细胞因子和自身抗体滴度反映较好的宿主免疫状态。Neo-SABR和RN-IVCT用于肾癌IVC-TT是可行和安全的。良好的宿主免疫环境与SABR的异常反应和肾癌的无复发生存相关，尽管与SABR的直接因果关系尚未建立。
To evaluate the feasibility, safety, oncologic outcomes, and immune effect of neoadjuvant stereotactic radiation (Neo-SAbR) followed by radical nephrectomy and thrombectomy (RN-IVCT). These are results from the safety lead-in portion of a single-arm phase 1 and 2 trial. Patients with kidney cancer (renal cell carcinoma [RCC]) and inferior vena cava (IVC) tumor thrombus (TT) underwent Neo-SAbR (40 Gy in 5 fractions) to the IVC-TT followed by open RN-IVCT. Absence of grade 4 to 5 adverse events (AEs) within 90 days of RN-IVCT was the primary endpoint. Exploratory studies included pathologic and immunologic alterations attributable to SAbR. Six patients were included in the final analysis. No grade 4 to 5 AEs were observed. A total of 81 AEs were reported within 90 days of surgery: 73% (59/81) were grade 1, 23% (19/81) were grade 2, and 4% (3/81) were grade 3. After a median follow-up of 24 months, all patients are alive. One patient developed de novo metastatic disease. Of 3 patients with metastasis at diagnosis, 1 had a complete and another had a partial abscopal response without the concurrent use of systemic therapy. Neo-SABR led to decreased Ki-67 and increased PD-L1 expression in the IVC-TT. Inflammatory cytokines and autoantibody titers reflecting better host immune status were observed in patients with nonprogressive disease. Neo-SAbR followed by RN-IVCT for RCC IVC-TT is feasible and safe. Favorable host immune environment correlated with abscopal response to SABR and RCC relapse-free survival, though direct causal relation to SABR has yet to be established.
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影响因子：
23.4
作者：
Abel, E. Jason;Thompson, R. Houston;Wood, Christopher G.
通讯作者：
Wood, Christopher G.
由 17 种循环细胞因子组成的预后分类器是转移性结直肠癌患者总生存期的新预测因子
影响因子：
6.4
作者：
Chen, Zhi-Yuan;He, Wen-Zhuo;Qian, Chao-Nan
通讯作者：
Qian, Chao-Nan
影响因子：
82.9
作者：
Formenti SC;Rudqvist NP;Golden E;Cooper B;Wennerberg E;Lhuillier C;Vanpouille-Box C;Friedman K;Ferrari de Andrade L;Wucherpfennig KW;Heguy A;Imai N;Gnjatic S;Emerson RO;Zhou XK;Zhang T;Chachoua A;Demaria S
通讯作者：
Demaria S
影响因子：
158.5
作者：
Ravaud, A.;Motzer, R. J.;Patard, J. -J.
通讯作者：
Patard, J. -J.
影响因子：
6.6
作者：
Haddad, Ahmed Q.;Wood, Christopher G.;Leibovich, Bradley C.
通讯作者：
Leibovich, Bradley C.