Martini Dylan J, Olsen T Anders, Goyal Subir, Liu Yuan, Evans Sean T, Hitron Emilie Elise, Russler Greta Anne, Yantorni Lauren, Caulfield Sarah, Brown Jacqueline T, Goldman Jamie M, Nazha Bassel, Carthon Bradley C, Harris Wayne B, Kucuk Omer, Master Viraj A, Bilen Mehmet Asim
Winship Cancer Institute of Emory University, Atlanta, GA, USA.
Department of Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
J Immunother Precis Oncol. 2022 Jun 14;5(3):52-57. doi: 10.36401/JIPO-22-2. eCollection 2022 Aug.
There are three combination immune checkpoint inhibitor (ICI)-based regimens in the first-line setting for metastatic renal cell carcinoma (mRCC). Currently, there is limited real-world data for clinical outcomes and toxicity in mRCC patients treated with first-line ICI-based regimens.
We performed a retrospective review of 49 mRCC patients treated with ICI-based combination regimens in the standard of care setting at the Winship Cancer Institute of Emory University from 2015-2020. We collected baseline data from the electronic medical record including demographic information and disease characteristics. Immune-related adverse events (irAEs) were collected from clinic notes and laboratory values. The primary clinical outcomes measured were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
The median age was 65 years, and most patients (80%) were males. The majority were White (86%) and had clear cell RCC (83%). Most patients had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 (43%) or 1 (45%). Approximately one-half (49%) had at least three sites of distant metastatic disease. Most patients (88%) received nivolumab and ipilimumab. More than one-half (53%) of patients experienced an irAE, with 13 (27%) patients having treatment delayed and 18% discontinuing treatment for toxicity. The median OS was not reached, and the median PFS was 8.0 months per a Kaplan-Meier estimation. More than half of patients (53%) had a PFS > 6 months, and 22% had PFS > 1 year. The ORR was 33% for the entire cohort, and 7% of patients had a complete response.
We presented real-world efficacy and toxicity data for front-line ICI combination treatment regimens. The ORR and median PFS were lower in our cohort of patients compared to the available data in the clinical trial setting. This was likely because of more advanced disease in this study. Future studies should provide additional data that will allow comparisons between different ICI combination regimens for untreated mRCC.
在转移性肾细胞癌（mRCC）的一线治疗中，有三种基于免疫检查点抑制剂（ICI）的联合治疗方案。目前，关于接受一线基于ICI方案治疗的mRCC患者的临床结局和毒性的真实世界数据有限。
我们对2015年至2020年在埃默里大学温希普癌症研究所接受基于ICI联合方案治疗的49例mRCC患者进行了回顾性研究。我们从电子病历中收集基线数据，包括人口统计学信息和疾病特征。免疫相关不良事件（irAE）从临床记录和实验室值中收集。测量的主要临床结局为总生存期（OS）、无进展生存期（PFS）和客观缓解率（ORR）。
中位年龄为65岁，大多数患者（80%）为男性。大多数为白人（86%），患有透明细胞肾细胞癌（83%）。大多数患者东部肿瘤协作组（ECOG）体能状态评分为0（43%）或1（45%）。约一半（49%）患者有至少三个远处转移病灶部位。大多数患者（88%）接受纳武利尤单抗和伊匹木单抗治疗。超过一半（53%）的患者发生irAE，13例（27%）患者治疗延迟，18%的患者因毒性而停止治疗。中位OS未达到，根据Kaplan-Meier估计，中位PFS为8.0个月。超过一半的患者（53%）PFS>6个月，22%的患者PFS>1年。整个队列的ORR为33%，7%的患者完全缓解。
我们展示了一线ICI联合治疗方案的真实世界疗效和毒性数据。与临床试验环境中的可用数据相比，我们队列中的患者ORR和中位PFS较低。这可能是因为本研究中的疾病更晚期。未来的研究应提供更多数据，以便能够对未经治疗的mRCC的不同ICI联合方案进行比较。
