舒尼替尼治疗转移性肾细胞癌患者：国际转移性肾细胞癌数据库联盟风险组的临床结局。
Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group.
机构信息
Cleveland Clinic, Taussig Cancer Institute, Cleveland, OH.
Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX.
出版信息
Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.
BACKGROUND
Sunitinib malate, a targeted tyrosine kinase inhibitor, is standard of care for metastatic renal cell carcinoma (mRCC) and serves as the active comparator in several ongoing mRCC clinical trials. In this analysis we report benchmarks for clinical outcomes on the basis of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups for patients treated with sunitinib for mRCC in a first-line setting.
MATERIALS AND METHODS
A retrospective analysis was performed on data from sunitinib-treated patients (n = 375) in the pivotal phase III trial of sunitinib versus interferon-α as first-line treatment for mRCC. Objective response rates (ORRs) were determined from independently reviewed radiologic assessments. The Kaplan-Meier method was used to estimate median progression-free survival (PFS) and median overall survival (OS) according to patient risk group.
RESULTS
Median PFS (95% confidence interval [CI]) was 14.1 (13.4-17.1), 10.7 (10.5-12.5), 2.4 (1.1-4.7), and 10.6 (8.1-10.9) months in sunitinib-treated patients in the IMDC favorable (n = 134), intermediate (n = 205), poor (n = 34), and intermediate + poor (n = 239) risk groups, respectively. Median OS (95% CI) was 23.0 (19.8-27.8), 5.1 (4.3-9.9), and 20.3 (16.8-23.0) months in sunitinib-treated patients in IMDC intermediate, poor, and intermediate + poor risk groups, respectively, and was not reached in the favorable risk group (>50% of patients were alive at data cutoff). ORRs (95% CI) was 53.0% (44.2%-61.7%), 33.7% (27.2%-40.6%), 11.8% (3.3%-27.5%), and 30.5% (24.8%-36.8%) in sunitinib-treated patients in IMDC favorable, intermediate, poor, and intermediate + poor risk groups, respectively.
CONCLUSION
Results of this retrospective analysis show differences in patient outcomes for PFS, OS, and ORR on the basis of IMDC prognostic risk group assignment for patients with mRCC.
背景
苹果酸舒尼替尼是一种靶向酪氨酸激酶抑制剂，是转移性肾细胞癌（mRCC）的标准治疗方法，也是几种正在进行的 mRCC 临床试验中的活性对照药物。在这项分析中，我们根据国际转移性肾细胞癌数据库联盟（IMDC）风险组报告了转移性肾细胞癌患者一线使用舒尼替尼治疗的临床结果基准。
材料和方法
对舒尼替尼治疗的转移性肾细胞癌患者（n=375）的回顾性分析，该患者为一线治疗转移性肾细胞癌的舒尼替尼与干扰素-α的关键性 III 期试验数据。客观缓解率（ORR）根据独立审查的影像学评估确定。根据患者风险组，Kaplan-Meier 法用于估计无进展生存期（PFS）和总生存期（OS）的中位数。
结果
在 IMDC 预后良好（n=134）、中危（n=205）、高危（n=34）和中危+高危（n=239）风险组中，接受舒尼替尼治疗的患者的中位 PFS（95%置信区间[CI]）分别为 14.1（13.4-17.1）、10.7（10.5-12.5）、2.4（1.1-4.7）和 10.6（8.1-10.9）个月。在 IMDC 中危、高危和中危+高危风险组中，接受舒尼替尼治疗的患者的中位 OS（95%CI）分别为 23.0（19.8-27.8）、5.1（4.3-9.9）和 20.3（16.8-23.0）个月，而在预后良好的风险组中，中位 OS 无达到（数据截止时>50%的患者存活）（>50%的患者存活）。接受舒尼替尼治疗的患者的 ORR（95%CI）分别为 53.0%（44.2%-61.7%）、33.7%（27.2%-40.6%）、11.8%（3.3%-27.5%）和 30.5%（24.8%-36.8%）。
结论
这项回顾性分析的结果表明，根据 IMDC 预后风险组对 mRCC 患者进行分组，患者的 PFS、OS 和 ORR 存在差异。
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