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Progression-free survival of first-line treatment with molecular-targeted therapy may be a meaningful intermediate endpoint for overall survival in patients with metastatic renal cell carcinoma

机译:一线治疗与分子靶向治疗的无进展生存率可能是转移性肾细胞癌患者总体生存率的有意义的中间终点

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摘要

The aim of the present study was to investigate the association between clinical parameters and the overall survival (OS) of Japanese patients with metastatic renal cell carcinoma (mRCC). The medical records of 59 consecutive mRCC patients receiving molecular-targeted therapy were retrospectively assessed. Kaplan-Meier and log-rank analyses were used to evaluate the progression-free survival (PFS) and OS, and a multivariate Cox proportional hazard model was used to analyze the clinical parameters for their prognostic relevance. The median OS for all patients was 23.7 months [95% confidence interval (CI): 17.9–30 months], and the median OS stratified by the Memorial Sloan Kettering Cancer Center risk classification was 28.5, 20.9 and 8.1 months for the favorable-, intermediate- and poor-risk groups, respectively (P=0.137; degree of freedom: 2). Univariate analyses identified prior nephrectomy, number of metastatic sites, anemia, best response to first-line treatment and PFS with first-line treatment as prognostic variables. Multivariate analyses identified number of metastatic sites [2: hazard ratio (HR)=3.351, 95% CI: 1.460–8.201, P=0.004; ≥3: HR=6.397, 95% CI: 1.939–20.209, P=0.003], time from diagnosis to therapy (≥1 year: HR=0.334, 95% CI: 0.137–0.755, P=0.008), PFS with first-line treatment (≥5.1 months: HR=0.353, 95% CI: 0.156–0.766, P=0.008) and number of lines of molecular-targeted agents (≥3: HR=0.248, 95% CI: 0.091–0.664, P=0.006) as independent prognostic factors. The results indicated that the PFS of first-line treatment may be a meaningful intermediate endpoint for OS in patients with mRCC who received treatment with molecular-targeted therapy.
机译:本研究的目的是研究日本转移性肾细胞癌(mRCC)患者的临床参数与总生存期(OS)之间的关系。回顾性评估了59例接受分子靶向治疗的连续mRCC患者的病历。使用Kaplan-Meier和log-rank分析评估无进展生存期(PFS)和OS,并使用多变量Cox比例风险模型分析临床参数的预后相关性。所有患者的OS的中位数为23.7个月[95%置信区间(CI):17.9–30个月],而通过纪念斯隆·凯特琳癌症中心风险分类的分层,OS的中位OS为28.5、20.9和8.1个月,中风险组和低风险组(P = 0.137;自由度:2)。单因素分析确定了先前的肾切除术,转移部位的数量,贫血,对一线治疗的最佳反应和一线治疗的PFS作为预后变量。多变量分析确定了转移部位的数量[2:危险比(HR)= 3.351,95%CI:1.460-8.201,P = 0.004; ≥3:HR = 6.397,95%CI:1.939–20.209,P = 0.003],从诊断到治疗的时间(≥1年:HR = 0.334,95%CI:0.137–0.755,P = 0.008),PFS优先线治疗(≥5.1个月:HR = 0.353,95%CI:0.156–0.766,P = 0.008)和分子靶向药物的线数(≥3:HR = 0.248,95%CI:0.091–0.664,P = 0.006)作为独立的预后因素。结果表明,一线治疗的PFS可能是接受分子靶向治疗的mRCC患者OS有意义的中间终点。

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