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转移性肾细胞癌一线和二线靶向治疗的最佳序贯:基于韩国国家健康保险系统的全国代表性数据分析。

Optimal sequencing of the first- and second-line target therapies in metastatic renal cell carcinoma: based on nationally representative data analysis from the Korean National Health Insurance System.

机构信息

Department of Urology, Inha University College of Medicine, Incheon, Korea.

Department of Urology, Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.

出版信息

BMC Cancer. 2023 May 30;23(1):483. doi: 10.1186/s12885-023-10991-3.

Abstract

BACKGROUND

The authors intend to compare the effects of each targeted therapy (TT) in the treatment of patients with metastatic renal cell carcinoma (mRCC) using big data based on the Korean National Health Insurance System (NHIS) and determine the optimal treatment sequence.

METHODS

Data on the medical use of patients with kidney cancer were obtained from the NHIS database from January 1, 2002, to December 31, 2020. Patient variables included age, sex, income level, place of residence, prescribing department, and duration from diagnosis to the prescription date. The primary outcome was overall survival (OS) for each drug and sequencing. We performed propensity score matching (PSM) according to age, sex, and Charlson Comorbidity Index based on the primary TTs.

RESULTS

After 1:1 PSM, the sunitinib (SUN) (n = 1,214) and pazopanib (PAZ) (n = 1,214) groups showed a well-matched distribution across the entire cohort. In the primary treatment group, PAZ had lower OS than SUN (HR, 1.167; p = 0.0015). In the secondary treatment group, axitinib (AXI) had more favorable OS than cabozantinib (CAB) (HR, 0.735; p = 0.0118), and everolimus had more adverse outcomes than CAB (HR, 1.544; p < 0.0001). In the first to second TT sequencing, SUN-AXI had the highest OS; however, there was no statistically significant difference when compared with PAZ-AXI, which was the second highest (HR, 0.876; p = 0.3312). The 5-year survival rate was calculated in the following order: SUN-AXI (51.44%), PAZ-AXI (47.12%), SUN-CAB (43.59%), and PAZ-CAB (34.28%). When the four sequencing methods were compared, only SUN-AXI versus PAZ-CAB (p = 0.003) and PAZ-AXI versus PAZ-CAB (p = 0.017) were statistically significant.

CONCLUSIONS

In a population-based RWD analysis of Korean patients with mRCC, SUN-AXI sequencing was shown to be the most effective among the first to second TT sequencing methods in treatment, with a relative survival advantage over other sequencing combinations. To further support the results of this study, risk-stratified analysis is needed.

摘要

背景

作者旨在利用基于韩国国民健康保险系统(NHIS)的大数据,比较每种靶向治疗(TT)在转移性肾细胞癌(mRCC)患者治疗中的效果,并确定最佳治疗顺序。

方法

从 NHIS 数据库中获取 2002 年 1 月 1 日至 2020 年 12 月 31 日期间患有肾癌患者的医疗使用数据。患者变量包括年龄、性别、收入水平、居住地、处方科室和从诊断到处方日期的时间。主要结局是每种药物和治疗顺序的总生存期(OS)。我们根据主要 TT 按年龄、性别和 Charlson 合并症指数进行倾向评分匹配(PSM)。

结果

经过 1:1 PSM,舒尼替尼(SUN)(n=1214)和帕唑帕尼(PAZ)(n=1214)组在整个队列中表现出良好的匹配分布。在初始治疗组中,PAZ 的 OS 低于 SUN(HR,1.167;p=0.0015)。在二线治疗组中,阿西替尼(AXI)的 OS 优于卡博替尼(CAB)(HR,0.735;p=0.0118),依维莫司的结局比 CAB 更差(HR,1.544;p<0.0001)。在第一至第二 TT 序贯治疗中,SUN-AXI 的 OS 最高;然而,与 PAZ-AXI 相比,这并没有统计学意义,PAZ-AXI 是第二高的(HR,0.876;p=0.3312)。计算了以下顺序的 5 年生存率:SUN-AXI(51.44%)、PAZ-AXI(47.12%)、SUN-CAB(43.59%)和 PAZ-CAB(34.28%)。当比较四种序贯方法时,只有 SUN-AXI 与 PAZ-CAB(p=0.003)和 PAZ-AXI 与 PAZ-CAB(p=0.017)有统计学意义。

结论

在对韩国 mRCC 患者进行基于人群的 RWD 分析中,SUN-AXI 序贯治疗在治疗中表现出最有效的作用,与其他序贯组合相比具有相对生存优势。为了进一步支持本研究的结果,需要进行风险分层分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9d4f/10228030/1d9471abe727/12885_2023_10991_Fig1_HTML.jpg

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