Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
Department of Urology, Tokyo Women's Medical University Medical Center East, 2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567, Japan.
Med Oncol. 2019 Mar 16;36(4):35. doi: 10.1007/s12032-019-1261-5.
The correlation between the magnitudes of best tumor response (bTR) and patient survival in immune checkpoint inhibitor therapy for metastatic renal cell carcinoma (mRCC) remains unclear. In this article, we retrospectively investigated the prognostic association of the magnitude of bTR in nivolumab therapy for mRCC. Fifty-five patients treated with nivolumab after failure of at least one molecular-targeted therapy were evaluated. Assessment of the magnitude of bTR was based on the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. Endpoints were progression-free survival (PFS) and overall survival (OS) after the initiation of nivolumab therapy. In regard to the magnitude of bTR, complete response, partial response, stable disease, and progressive disease were observed in three (5.46%), 15 (27.3%), 19 (34.5%), and 18 (32.7%) patients, respectively. PFS and OS were significantly correlated with the magnitude of bTR (median PFS: not reached (N.R.) [95% confidence interval (CI) 16.8-N.R.] vs. 13.0 [8.38-56.0] vs. 5.95 [4.27-7.30] vs. 1.92 [0.53-3.91] months, p < 0.0001; OS: N.R. [N.R.-N.R.] vs. N.R. [21.4-N.R.] vs. 23.3 [23.3-N.R.] vs. 7.36 [1.41-N.R.] months, p < 0.0001). In addition, multivariate analyses show that the magnitude of bTR was an independent factor for PFS (p < 0.0001) and OS (p = 0.0010). In conclusion, this retrospective study shows the significant correlation between the magnitude of bTR and patient survival in nivolumab therapy for mRCC. The magnitude of bTR can be an effective surrogate marker for survival.
在免疫检查点抑制剂治疗转移性肾细胞癌（mRCC）中，最佳肿瘤反应（bTR）的幅度与患者生存之间的相关性尚不清楚。在本文中，我们回顾性研究了纳武利尤单抗治疗 mRCC 时 bTR 幅度的预后相关性。评估了 55 例至少一种分子靶向治疗失败后接受纳武利尤单抗治疗的患者。bTR 幅度的评估基于实体瘤反应评估标准（RECIST）v.1.1。终点是纳武利尤单抗治疗开始后的无进展生存期（PFS）和总生存期（OS）。根据 bTR 幅度，完全缓解、部分缓解、疾病稳定和疾病进展分别在 3 例（5.46%）、15 例（27.3%）、19 例（34.5%）和 18 例（32.7%）患者中观察到。PFS 和 OS 与 bTR 幅度显著相关（中位 PFS：未达到（N.R.）[95%置信区间（CI）16.8-N.R.] vs. 13.0 [8.38-56.0] vs. 5.95 [4.27-7.30] vs. 1.92 [0.53-3.91] 个月，p<0.0001；OS：N.R. [N.R.-N.R.] vs. N.R. [21.4-N.R.] vs. 23.3 [23.3-N.R.] vs. 7.36 [1.41-N.R.] 个月，p<0.0001）。此外，多变量分析显示 bTR 幅度是 PFS（p<0.0001）和 OS（p=0.0010）的独立因素。总之，这项回顾性研究表明，bTR 幅度与纳武利尤单抗治疗 mRCC 患者的生存之间存在显著相关性。bTR 幅度可以作为生存的有效替代标志物。
