Division of Hematology and Medical Oncology, The Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY 10029, USA.
Cancer. 2013 Aug 15;119(16):3012-9. doi: 10.1002/cncr.28146. Epub 2013 May 29.
The current study was conducted to develop a pretreatment prognostic model for patients with unresectable and/or metastatic urothelial cancer who were treated with first-line, cisplatin-based chemotherapy.
Individual data were pooled from 399 patients who were enrolled on 8 phase 2 and 3 trials evaluating cisplatin-based, first-line chemotherapy in patients with metastatic urothelial carcinoma. Variables selected for inclusion in the model were combined in a Cox proportional hazards model to produce a points-based nomogram with which to predict the median, 1-year, 2-year, and 5-year survival. The nomogram was validated externally using data from a randomized trial of the combination of methotrexate, vinblastine, doxorubicin plus cisplatin versus docetaxel plus cisplatin.
The median survival of the development cohort was 13.8 months (95% confidence interval, 12.1 months-16.0 months); 68.2% of the patients had died at the time of last follow-up. On multivariable analysis, the number of visceral metastatic sites, Eastern Cooperative Oncology Group performance status, and leukocyte count were each found to be associated with overall survival (P < .05), whereas the site of the primary tumor and the presence of lymph node metastases were not. All 5 variables were included in the nomogram. When subjected to internal validation, the nomogram achieved a bootstrap-corrected concordance index of 0.626. When applied to the external validation cohort, the nomogram achieved a concordance index of 0.634. Calibration plots suggested that the nomogram was well calibrated for all predictions.
Based on routinely measured pretreatment variables, a nomogram was constructed that predicts survival in patients with unresectable and/or metastatic urothelial cancer who are treated with cisplatin-based chemotherapy. This model may be useful in patient counseling and clinical trial design.
本研究旨在为接受一线含顺铂化疗治疗的不可切除和/或转移性尿路上皮癌患者建立预处理预后模型。
从 8 项评估转移性尿路上皮癌患者接受含顺铂的一线化疗的 2 期和 3 期试验中，汇总了 399 名患者的个体数据。选择纳入模型的变量，将其组合在 Cox 比例风险模型中，以生成一个基于点的列线图，用于预测中位、1 年、2 年和 5 年生存率。使用顺铂联合甲氨蝶呤、长春碱、阿霉素与多西紫杉醇联合顺铂的随机试验数据对列线图进行外部验证。
开发队列的中位生存时间为 13.8 个月（95%置信区间，12.1 个月-16.0 个月）；截至最后一次随访时，68.2%的患者已死亡。多变量分析显示，内脏转移部位数量、东部合作肿瘤学组表现状态和白细胞计数与总生存相关（P<0.05），而原发肿瘤部位和淋巴结转移的存在则与总生存无关。所有 5 个变量均纳入列线图。经内部验证，该列线图的 Bootstrap 校正一致性指数为 0.626。应用于外部验证队列时，该列线图的一致性指数为 0.634。校准图表明，该列线图对所有预测均具有良好的校准度。
基于常规测量的预处理变量，构建了一个预测接受顺铂化疗治疗的不可切除和/或转移性尿路上皮癌患者生存的列线图。该模型可能对患者咨询和临床试验设计有用。
