PDF(Pubmed)
Abstract：
UNASSIGNED: Clinical outcomes of anti-programmed death‑(ligand) 1 (anti-PD-[L]1) therapy in patients with locally advanced or metastatic urothelial carcinoma (mUC) and fibroblast growth factor receptor alterations (FGFRa+) remain unclear; recent studies have reported either comparable or poorer outcomes versus patients without FGFR alterations (FGFRa-).
UNASSIGNED: To analyze the outcomes of patients with mUC and any FGFRa (mutations or fusions) who received anti-PD-(L)1 therapy.
UNASSIGNED: In this noninterventional, retrospective, multicenter study, clinical practice data were collected from FGFRa+/- patients who received prior immunotherapy between May 2018 and July 2019.
UNASSIGNED: Investigator‑determined overall response rate (ORR), disease control rate (DCR), and overall survival (OS) were assessed in multivariate and unadjusted analyses.
UNASSIGNED: Ninety-four patients (66% men; median age, 63 yr) with mUC and known FGFR status were included; 38 (40%) were FGFRa+ and 56 (60%) were FGFRa-. In FGFRa+ versus FGFRa- patients who received any line of anti-PD-(L)1 therapy (n = 92), ORR, DCR, and OS were 16% versus 26%, 29% versus 52% (relative risk: 1.14 [95% confidence interval {CI}, 0.92-1.40]; p = 0.3), and 8.57 versus 13.2 mo (hazard ratio [HR]: 1.33 [95% CI, 0.77-2.30]; p = 0.3), respectively. A multivariate analysis provided some evidence supporting shorter OS in FGFRa+ versus FGFRa- (any line of anti-PD-L[1] therapy; HR: 1.81 [95% CI, 0.99-3.31]; p = 0.054). Limitations include this study\'s retrospective nature and a potential selection bias from small sample size.
UNASSIGNED: Some evidence of lower response rates and shortened OS following anti-PD-(L)1 therapy was observed in FGFRa+ patients. The phase 3 THOR study (NCT03390504) will prospectively compare FGFRa+ patients with advanced mUC treated with erdafitinib versus pembrolizumab.
UNASSIGNED: Patients with metastatic urothelial carcinoma and prespecified fibroblast growth factor receptor alterations (FGFRa) potentially have worse clinical outcomes when treated with anti-PD-(L)1 therapy than those without FGFRa.
UNASSIGNED: To analyze the outcomes of patients with mUC and any FGFRa (mutations or fusions) who received anti-PD-(L)1 therapy.
UNASSIGNED: In this noninterventional, retrospective, multicenter study, clinical practice data were collected from FGFRa+/- patients who received prior immunotherapy between May 2018 and July 2019.
UNASSIGNED: Investigator‑determined overall response rate (ORR), disease control rate (DCR), and overall survival (OS) were assessed in multivariate and unadjusted analyses.
UNASSIGNED: Ninety-four patients (66% men; median age, 63 yr) with mUC and known FGFR status were included; 38 (40%) were FGFRa+ and 56 (60%) were FGFRa-. In FGFRa+ versus FGFRa- patients who received any line of anti-PD-(L)1 therapy (n = 92), ORR, DCR, and OS were 16% versus 26%, 29% versus 52% (relative risk: 1.14 [95% confidence interval {CI}, 0.92-1.40]; p = 0.3), and 8.57 versus 13.2 mo (hazard ratio [HR]: 1.33 [95% CI, 0.77-2.30]; p = 0.3), respectively. A multivariate analysis provided some evidence supporting shorter OS in FGFRa+ versus FGFRa- (any line of anti-PD-L[1] therapy; HR: 1.81 [95% CI, 0.99-3.31]; p = 0.054). Limitations include this study\'s retrospective nature and a potential selection bias from small sample size.
UNASSIGNED: Some evidence of lower response rates and shortened OS following anti-PD-(L)1 therapy was observed in FGFRa+ patients. The phase 3 THOR study (NCT03390504) will prospectively compare FGFRa+ patients with advanced mUC treated with erdafitinib versus pembrolizumab.
UNASSIGNED: Patients with metastatic urothelial carcinoma and prespecified fibroblast growth factor receptor alterations (FGFRa) potentially have worse clinical outcomes when treated with anti-PD-(L)1 therapy than those without FGFRa.
摘要：
UNASSIGNED：局部晚期或转移性尿路上皮癌（mUC）和成纤维细胞生长因子受体改变（FGFRa）患者的抗程序性死亡（配体）1（抗PD-[L]1）治疗的临床结果尚不清楚；最近的研究报告说，与没有FGFR改变（FGFRa-）的患者相比，预后相当或较差。
UNASSIGNED：分析接受抗PD-（L）1治疗的mUC和任何FGFRa（突变或融合）患者的结局。
未经批准：在此非介入治疗中，回顾性,多中心研究，临床实践数据收集自2018年5月至2019年7月之前接受过免疫治疗的FGFRa+/-患者.
未经评估：研究者确定的总反应率（ORR），疾病控制率（DCR），在多变量和未校正分析中评估总生存期(OS).
未经评估：94名患者（66％为男性；中位年龄，包括63年）的mUC和已知的FGFR状态；38（40％）为FGFRa+，56（60％）为FGFRa-。在接受任何抗PD-（L）1治疗的FGFRa与FGFRa患者中（n=92），ORR,DCR,OS分别为16%和26%，29%对52%(相对风险：1.14[95%置信区间{CI}，0.92-1.40]；p=0.3)，和8.57对13.2mo(危险比[HR]：1.33[95%CI，0.77-2.30]；p=0.3)，分别。多变量分析提供了一些证据支持FGFRa+与FGFRa-相比OS较短(任何抗PD-L[1]治疗方案;HR:1.81[95%CI,0.99-3.31];p=0.054)。局限性包括本研究的回顾性性质和小样本量的潜在选择偏差。
UNASSIGNED：在FGFRa+患者中观察到抗PD-(L)1治疗后反应率降低和OS缩短的一些证据。3期THOR研究（NCT03390504）将前瞻性比较接受erdafitinib与pembrolizumab治疗的FGFRa+晚期mUC患者。
UNASSIGNED：患有转移性尿路上皮癌和预先指定的成纤维细胞生长因子受体改变（FGFRa）的患者在接受抗PD-（L）1治疗时，可能比没有FGFRa的患者具有更差的临床结果。
UNASSIGNED：分析接受抗PD-（L）1治疗的mUC和任何FGFRa（突变或融合）患者的结局。
未经批准：在此非介入治疗中，回顾性,多中心研究，临床实践数据收集自2018年5月至2019年7月之前接受过免疫治疗的FGFRa+/-患者.
未经评估：研究者确定的总反应率（ORR），疾病控制率（DCR），在多变量和未校正分析中评估总生存期(OS).
未经评估：94名患者（66％为男性；中位年龄，包括63年）的mUC和已知的FGFR状态；38（40％）为FGFRa+，56（60％）为FGFRa-。在接受任何抗PD-（L）1治疗的FGFRa与FGFRa患者中（n=92），ORR,DCR,OS分别为16%和26%，29%对52%(相对风险：1.14[95%置信区间{CI}，0.92-1.40]；p=0.3)，和8.57对13.2mo(危险比[HR]：1.33[95%CI，0.77-2.30]；p=0.3)，分别。多变量分析提供了一些证据支持FGFRa+与FGFRa-相比OS较短(任何抗PD-L[1]治疗方案;HR:1.81[95%CI,0.99-3.31];p=0.054)。局限性包括本研究的回顾性性质和小样本量的潜在选择偏差。
UNASSIGNED：在FGFRa+患者中观察到抗PD-(L)1治疗后反应率降低和OS缩短的一些证据。3期THOR研究（NCT03390504）将前瞻性比较接受erdafitinib与pembrolizumab治疗的FGFRa+晚期mUC患者。
UNASSIGNED：患有转移性尿路上皮癌和预先指定的成纤维细胞生长因子受体改变（FGFRa）的患者在接受抗PD-（L）1治疗时，可能比没有FGFRa的患者具有更差的临床结果。
