Department of Urology, Center for Prostate Cancer, Research Institute and Hospital of National Cancer Center, Goyang, Korea.
Biostatistics Collaboration Team, Research Core Center, Research Institute and Hospital of National Cancer Center, Goyang, Korea.
Investig Clin Urol. 2020 Mar;61(2):146-157. doi: 10.4111/icu.2020.61.2.146. Epub 2020 Feb 13.
This study aimed to compare progression-free survival (PFS), overall survival (OS), and cancer-specific survival (CSS) in Heng intermediate-risk patients with metastatic renal cell carcinoma (mRCC) treated with first-line immunotherapy (IT) or targeted therapy (TT).
From 2000 to 2017, a total of 186 intermediate-risk mRCC patients treated with first-line IT (n=64, 34.4%) or TT (n=122, 65.6%) were retrospectively evaluated for PFS, OS, and CSS using the Kaplan-Meier method with log-rank test and Cox proportional hazards models for their risk factors with a p-value for significance of <0.05.
During a median 5.08-month of systemic treatment and 92.22 months of follow-up, the median PFS, OS, and CSS were 5.16, 18.44, and 19.04 months, respectively. The comparison of baseline characteristics between the two groups showed a significantly higher rate of T3-4 stages, a lower rate of high nuclear grades, shorter follow-up, longer treatment durations, lesser rates of cytoreductive nephrectomy, a lower objective response rate, and no cases of complete response in the TT group compared with the IT group (p<0.05). The survival comparisons between the two groups showed that PFS was significantly different, whereas OS and CSS were not significantly different. The multivariate analyses showed that synchronous metastatic type(hazard ratio [HR], 2.285), IT (HR, 1.746), and treatment-free interval <1 year (HR, 1.926) were significant factors for PFS, whereas none of the risk factors were significant for OS or CSS.
TT significantly prolonged PFS compared with IT, whereas long-term survival was not significantly different in intermediate-risk mRCC patients.
本研究旨在比较 Heng 中危转移性肾细胞癌（mRCC）患者一线免疫治疗（IT）或靶向治疗（TT）的无进展生存期（PFS）、总生存期（OS）和癌症特异性生存期（CSS）。
回顾性分析 2000 年至 2017 年期间共 186 例接受一线 IT（n=64，34.4%）或 TT（n=122，65.6%）治疗的中危 mRCC 患者的 PFS、OS 和 CSS，采用 Kaplan-Meier 法和对数秩检验比较两组患者的生存情况，采用 Cox 比例风险模型分析影响患者预后的因素，以 p 值<0.05 为差异有统计学意义。
在中位 5.08 个月的系统治疗和 92.22 个月的随访期间，中位 PFS、OS 和 CSS 分别为 5.16、18.44 和 19.04 个月。两组患者的基线特征比较显示，TT 组 T3-4 期比例较高，高核分级比例较低，随访时间较短，治疗时间较长，肾细胞减瘤术比例较低，客观缓解率较低，完全缓解率为 0；而 IT 组与 TT 组比较，差异有统计学意义（p<0.05）。两组患者的生存比较显示，PFS 差异有统计学意义，而 OS 和 CSS 差异无统计学意义。多因素分析显示，同步转移型（HR，2.285）、IT（HR，1.746）和治疗无进展时间<1 年（HR，1.926）是 PFS 的显著影响因素，而 OS 和 CSS 的任何危险因素均无统计学意义。
TT 与 IT 相比显著延长了 PFS，而中危 mRCC 患者的长期生存无显著差异。
