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接受免疫检查点阻断治疗的转移性肾细胞癌患者临床结局的种族差异

Racial Differences in Clinical Outcomes for Metastatic Renal Cell Carcinoma Patients Treated With Immune-Checkpoint Blockade.

作者信息

Olsen T Anders, Martini Dylan J, Goyal Subir, Liu Yuan, Evans Sean T, Magod Benjamin, Brown Jacqueline T, Yantorni Lauren, Russler Greta Anne, Caulfield Sarah, Goldman Jamie M, Harris Wayne B, Kucuk Omer, Carthon Bradley C, Master Viraj A, Nazha Bassel, Bilen Mehmet Asim

机构信息

Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA, United States.

Winship Cancer Institute of Emory University, Atlanta, GA, United States.

出版信息

Front Oncol. 2021 Jun 16;11:701345. doi: 10.3389/fonc.2021.701345. eCollection 2021.

Abstract

BACKGROUND

Immune-checkpoint-inhibitors (ICIs) have become the cornerstone of metastatic renal-cell-carcinoma (mRCC) therapy. However, data are limited regarding clinical outcomes by race. In this study, we compared the real-world outcomes between African American (AA) and Caucasian mRCC patients treated with ICIs.

METHODS

We performed a retrospective study of 198 patients with mRCC who received ICI at the Emory Winship Cancer Institute from 2015-2020. Clinical outcomes were measured by overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) defined as a complete or partial response maintained for at least 6 months per response evaluation criteria in solid tumors version 1.1. Univariate and multivariable analyses were carried out for OS and PFS by Cox proportional-hazard model and ORR by logistical-regression model. Descriptive statistics compared rates of immune-related adverse events (irAEs) and non-clear-cell-RCC (nccRCC) histology were assessed using Chi-square test.

RESULTS

Our cohort was comprised of 38 AA and 160 Caucasian patients. Most were diagnosed with clear-cell-RCC (ccRCC) (78%) and more than half received (57%) PD-1/PD-L1 monotherapy. Most patients were intermediate or poor-risk groups (83%). Comparing to Caucasians, our AA cohort contained more females and nccRCC cases. Kaplan-Meier method showed AAs had no statistically different median OS (17 25 months, p=0.368) and PFS (3.1 4.4 months, p=0.068) relative to Caucasian patients. On multivariable analysis, AA patients had significantly shorter PFS (HR=1.52, 95% CI: 1.01-2.3, p=0.045), similar ORR (OR=1.04, 95% CI: 0.42-2.57, p=0.936) and comparable OS (HR=1.09, 95% CI: 0.61-1.95, p=0.778) relative to Caucasians.

CONCLUSIONS

Our real-world analysis of ICI-treated mRCC patients showed that AAs experienced shorter PFS but similar OS relative to Caucasians. This similarity in survival outcomes is reassuring for the use of ICI amongst real-world patient populations, however, the difference in treatment response is poorly represented in early outcomes data from clinical trials. Thus, the literature requires larger prospective studies to validate these findings.

摘要

背景

免疫检查点抑制剂(ICIs)已成为转移性肾细胞癌(mRCC)治疗的基石。然而,关于种族对临床结局影响的数据有限。在本研究中,我们比较了接受ICIs治疗的非裔美国(AA)和白种人mRCC患者的实际临床结局。

方法

我们对198例2015年至2020年在埃默里温希普癌症研究所接受ICI治疗的mRCC患者进行了一项回顾性研究。临床结局通过总生存期(OS)、无进展生存期(PFS)和总缓解率(ORR)来衡量,ORR定义为根据实体瘤疗效评价标准1.1版,每次缓解评估标准中维持至少6个月的完全或部分缓解。通过Cox比例风险模型对OS和PFS进行单变量和多变量分析,通过逻辑回归模型对ORR进行分析。使用卡方检验评估免疫相关不良事件(irAEs)和非透明细胞肾细胞癌(nccRCC)组织学发生率的描述性统计。

结果

我们的队列包括38例AA患者和160例白种人患者。大多数患者被诊断为透明细胞肾细胞癌(ccRCC)(78%),超过一半的患者接受(57%)PD-1/PD-L1单药治疗。大多数患者为中危或低危组(83%)。与白种人相比,我们的AA队列中女性和nccRCC病例更多。Kaplan-Meier方法显示,AA患者与白种人患者相比,中位OS(17对25个月,p = 0.368)和PFS(3.1对4.4个月,p = 0.068)无统计学差异。多变量分析显示,与白种人相比,AA患者的PFS显著缩短(HR = 1.52,95%CI:1.01 - 2.3,p = 0.045),ORR相似(OR = 1.04,95%CI:0.42 - 2.57,p = 0.936),OS相当(HR = 1.09,95%CI:0.61 - 1.95,p = 0.778)。

结论

我们对接受ICI治疗的mRCC患者的实际分析表明,与白种人相比,AA患者的PFS较短,但OS相似。生存结局的这种相似性对于在实际患者群体中使用ICI来说是令人放心的,然而,治疗反应的差异在临床试验的早期结局数据中表现不佳。因此,文献需要更大规模的前瞻性研究来验证这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ac5/8242950/7b603b7104af/fonc-11-701345-g001.jpg

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