Mita Yoshie, Teishima Jun, Hara Takuto, Ueki Hideto, Wakita Naoto, Okamura Yasuyoshi, Suzuki Kotaro, Bando Yukari, Terakawa Tomoaki, Chiba Koji, Miyake Hideaki
Department of Surgery, Division of Urology, Kobe University, Graduate School of Medicine, Kobe, Japan.
Int J Urol. 2025 Jul;32(7):850-858. doi: 10.1111/iju.70065. Epub 2025 Apr 7.
This study assessed the prognostic value of maximal evaluable lesion size (MLS) in predicting the efficacy and outcomes of nivolumab plus ipilimumab (NIVO+IPI) therapy for metastatic renal cell carcinoma (mRCC).
We retrospectively analyzed 99 mRCC patients treated with NIVO + IPI. Patients were divided into larger-MLS (≥ 35 mm) and smaller-MLS (< 35 mm) groups based on the median MLS. Objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were compared, and predictive factors for PFS and OS were identified.
The median follow-up period was 29.5 months. In the larger-MLS group (50 patients), the number of patients who did not undergo cytoreductive nephrectomy, as well as the number of patients in whom the kidney, lymph node, and lung were identified as an organ of MLS origin, was significantly higher compared to the smaller-MLS group. ORR was 40% in the larger-MLS group and 32.7% in the smaller-MLS group (p = 0.4315). However, PFS and OS were significantly worse in the larger-MLS group (p = 0.0016 and p = 0.0002, respectively). Multivariate analysis identified Karnofsky performance status (KPS) < 80%, non-clear cell histology, and larger MLS as independent predictors of worse PFS and OS. A prognostic model integrating MLS, KPS, and histology stratified patients effectively, with ≥ 2 risk factors predicting significantly worse OS (p < 0.0001).
MLS is a key prognostic factor in mRCC patients treated with NIVO+IPI. A risk model incorporating MLS, KPS, and histology can aid in patient stratification and treatment decisions.
本研究评估了最大可评估病灶大小（MLS）对预测纳武利尤单抗联合伊匹木单抗（NIVO+IPI）治疗转移性肾细胞癌（mRCC）疗效及预后的价值。
我们回顾性分析了99例接受NIVO + IPI治疗的mRCC患者。根据MLS中位数将患者分为较大MLS（≥35mm）组和较小MLS（<35mm）组。比较客观缓解率（ORR）、无进展生存期（PFS）和总生存期（OS），并确定PFS和OS的预测因素。
中位随访期为29.5个月。与较小MLS组相比，较大MLS组（50例患者）中未接受减瘤性肾切除术的患者数量以及肾脏、淋巴结和肺被确定为MLS起源器官的患者数量显著更高。较大MLS组的ORR为40%，较小MLS组为32.7%（p = 0.4315）。然而，较大MLS组的PFS和OS显著更差（分别为p = 0.0016和p = 0.0002）。多因素分析确定卡诺夫斯基体能状态（KPS）<80%、非透明细胞组织学和较大MLS是PFS和OS较差的独立预测因素。整合MLS、KPS和组织学的预后模型有效地对患者进行了分层，≥2个危险因素预测OS显著更差（p < 0.0001）。
MLS是接受NIVO+IPI治疗的mRCC患者的关键预后因素。纳入MLS、KPS和组织学的风险模型有助于患者分层和治疗决策。
