Department of Urology, Graduate School of Medicine, Gifu University, Gifu 5011194, Japan.
Department of Urology, Kizawa Memorial Hospital, Minokamo 5058503, Japan.
Curr Oncol. 2021 Apr 3;28(2):1402-1411. doi: 10.3390/curroncol28020133.
We conducted a multicenter, retrospective study to evaluate the efficacy and safety of combination nivolumab plus ipilimumab (NIVO+IPI) in 35 patients with advanced or metastatic renal cell carcinoma (mRCC). In this study, we focused on patients who received NIVO+IPI and were stratified into intermediate- or poor-risk disease according to the International Metastatic Renal Cell Carcinoma Database Consortium model at five institutions in Japan. The primary endpoint was overall survival (OS). Secondary endpoints were disease control rate (DCR), best overall response (BOR), objective response rate (ORR), and progression-free survival (PFS). In addition, we evaluated the role of inflammatory cell ratios, namely neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), as predictive biomarkers in patients with mRCC. The median follow-up period was 1 year, and the 1-year OS rate was 95.8%. The ORR and DCR were 34.3% and 80.0%, respectively. According to BOR, four patients (11.4%) achieved complete response. According to NLR stratification, the 1-year PFS rates were 82.6% and 23.7% when the NLR was ≤4.6 and >4.6, respectively ( = 0.04). Based on PLR stratification, the 1-year PFS rates were 81.7% and 34.3% when the PLR was ≤188.1 and >188.1, respectively ( = 0.033). Although 71.4% of the patients experienced treatment-related adverse events (TRAEs) with NIVO+IPI, only four patients discontinued NIVO+IPI due to grade 3/4 TRAEs. Patients treated with NIVO+IPI as a first-line therapy for advanced or mRCC achieved relatively better oncological outcomes. Therefore, NIVO+IPI may have potential advantages and may lead to a treatment effect compared to those receiving targeted therapies. In addition, PLR >188.1 may be a useful predictive marker for mRCC patients who received NIVO+IPI.
我们进行了一项多中心、回顾性研究，评估了纳武单抗联合伊匹单抗（NIVO+IPI）在 35 例晚期或转移性肾细胞癌（mRCC）患者中的疗效和安全性。在这项研究中，我们关注的是在日本的五家机构中，根据国际转移性肾细胞癌数据库联盟模型，被归类为中危或高危疾病的接受 NIVO+IPI 治疗的患者。主要终点是总生存期（OS）。次要终点是疾病控制率（DCR）、最佳总体反应（BOR）、客观缓解率（ORR）和无进展生存期（PFS）。此外，我们评估了炎症细胞比，即中性粒细胞与淋巴细胞比（NLR）和血小板与淋巴细胞比（PLR），作为 mRCC 患者预测生物标志物的作用。中位随访时间为 1 年，1 年 OS 率为 95.8%。ORR 和 DCR 分别为 34.3%和 80.0%。根据 BOR，有 4 名患者（11.4%）达到完全缓解。根据 NLR 分层，当 NLR ≤4.6 和 >4.6 时，1 年 PFS 率分别为 82.6%和 23.7%（=0.04）。根据 PLR 分层，当 PLR ≤188.1 和 >188.1 时，1 年 PFS 率分别为 81.7%和 34.3%（=0.033）。尽管 71.4%的患者在接受 NIVO+IPI 治疗时出现了与治疗相关的不良事件（TRAEs），但只有 4 名患者因 3/4 级 TRAEs 而停止了 NIVO+IPI 治疗。作为晚期或 mRCC 一线治疗的患者接受 NIVO+IPI 治疗后获得了相对较好的肿瘤学结果。因此，NIVO+IPI 与接受靶向治疗的患者相比，可能具有潜在优势并可能产生治疗效果。此外，PLR >188.1 可能是接受 NIVO+IPI 治疗的 mRCC 患者的有用预测标志物。
