Prognostic Factors in Patients With Advanced Transitional Cell Carcinoma of the Urothelial Tract Experiencing Treatment Failure With Platinum-Containing Regimens
Prognostic Factors in Patients With Advanced Transitional Cell Carcinoma of the Urothelial Tract Experiencing Treatment Failure With Platinum-Containing Regimens
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DOI：
10.1200/jco.2009.25.4599
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发表时间：
2010-04-10
影响因子：
45.3
通讯作者：
Rosenberg, Jonathan E.
中科院分区：
文献类型：
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作者：
Bellmunt, Joaquim;Choueiri, Toni K.;Rosenberg, Jonathan E.
目的 本研究旨在确定 III 期长春氟宁试验中包含的一线铂类方案治疗失败的尿路上皮道转移性移行细胞癌 (TCCU) 患者的治疗前总生存 (OS) 的预后因素。 患者和方法 本次分析总共纳入了 370 名铂类难治性 TCCU 患者。前瞻性记录潜在的预后因素。使用单变量分析来确定显着影响生存的临床和实验室因素。采用多变量分析确定独立预后因素，并进行bootstrap分析进行内部验证，形成预后模型。对 II 期长春氟宁研究 CA183001 进行了外部验证。结果 多变量分析和内部验证确定东部肿瘤合作组的体能状态 (PS) 大于 0、血红蛋白水平小于 10 g/dL 以及肝转移是 OS 的主要不良预后因素。外部验证证实了这些预后因素。根据零个、一个、两个或三个预后因素的存在形成四个亚组；这些组的中位 OS 时间分别为 14.2、7.3、3.8 和 1.7 个月 (P < .001)。 结论 我们确定并在内部和外部验证了三个预测 OS 的不良风险因素（PS、血红蛋白水平和肝转移），并开发了一个评分系统，将二线化疗的铂类难治性疾病患者分为四个具有不同结果的风险组。与一线治疗类似，内脏转移的存在和 PS 不良预示着预后较差。这些因素与低血红蛋白一起可用于临床试验中的预测和未来患者分层。
Purpose The present study sought to identify pretreatment [prognostic factors for overall survival (OS) in patients with metastatic transitional cell carcinoma of the urothelial tract (TCCU) who experienced treatment failure with the first-line, platinum-based regimen included in the phase III vinflunine trial.Patients and Methods In total, 370 patients with platinum-refractory TCCU were included in this analysis. Potential prognostic factors were recorded prospectively. Univariate analysis was used to identify clinical and laboratory factors that significantly impact survival. Multivariate analysis was used to identify independent prognostic factors, and bootstrap analysis was performed for internal validation, forming a prognostic model. External validation was performed on the phase II vinflunine study CA183001.Results Multivariate analysis and the internal validation identified Eastern Cooperative Oncology Group performance status (PS) more than 0, hemoglobin level less than 10 g/dL, and the presence of liver metastasis as the main adverse prognostic factors for OS. External validation confirmed these prognostic factors. Four subgroups were formed based on the presence of zero, one, two, or three prognostic factors; the median OS times for these groups were 14.2, 7.3, 3.8, and 1.7 months (P < .001), respectively.Conclusion We identified and both internally and externally validated three adverse risk factors (PS, hemoglobin level, and liver metastasis) that predict for OS and developed a scoring system that classifies patients with platinum-refractory disease on second-line chemotherapy into four risk groups with different outcome. Similar to the first-line setting, the presence of visceral metastases and poor PS predict a worse prognosis. These factors, together with low hemoglobin, can be used for prognostication and future patient stratification in clinical trials.