Prognostic nomogram for sunitinib in patients with metastatic renal cell carcinoma
Prognostic nomogram for sunitinib in patients with metastatic renal cell carcinoma
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DOI：
10.1002/cncr.23776
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发表时间：
2008-10-01
期刊：
影响因子：
6.2
通讯作者：
Kaftan, Michael W.
中科院分区：
文献类型：
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作者：
Motzer, Robert J.;Bukowski, Ronald M.;Kaftan, Michael W.
背景在一项随机、3期试验中，舒尼替尼作为转移性透明细胞肾细胞癌（RCC）患者的一线治疗显示出优于α-干扰素的上级疗效。根据该试验的结果数据，作者开发了一个列线图，用于预测接受舒尼替尼治疗的患者12个月无进展生存的概率。在III期试验中接受舒尼替尼治疗的375例患者是当前分析的受试者。诺模图治疗前预测变量包括校正的血清钙水平、转移部位数量、血红蛋白水平、既往肾切除术、肺和肝转移的存在、血小板增多、东部肿瘤协作组体力状态、从诊断到治疗的时间以及血清碱性磷酸酶和乳酸脱氢酶水平。研究者评估的无进展生存期是预测的结局终点。诺模图的内部验证包括用一致性指数量化歧视和评估校准。接受舒尼替尼治疗的375例患者中有174例（46%）达到了客观缓解，中位无进展生存期为10.8个月（95%置信区间，10.6-12.6个月）。根据治疗前确定的11个参数，基于考克斯回归模型构建了预测舒尼替尼治疗患者12个月无进展生存概率的列线图。一致性指数为0.633。根据治疗前的临床特征建立列线图，预测舒尼替尼治疗转移性透明细胞肾细胞癌获得12个月无进展生存的可能性。作者得出结论，需要对诺模图进行独立验证，并进行额外研究以确定肿瘤特异性预后因素。
BACKGROUND. in a randomized, phase 3 trial, sunitinib demonstrated superior efficacy over interferon-alfa as first-line therapy in patients with metastatic clear-cell renal cell carcinoma (RCC). On the basis Of outcome data from that trial, the authors developed a nomogram for predicting the probability of 12-month progression-free survival for patients who received sunitinib therapy.METHODS. Three-hundred seventy-five patients who received sunitinib in the phase 3 trial were the Subject of the Current analysis. Nomogram pretreatment predictor variables included corrected serum calcium levels, the number of metastatic sites, hemoglobin levels, prior nephrectomy, the presence Of lung and liver metastases, thrombocytosis, Eastern Cooperative Oncology Group performance status, time from diagnosis to treatment, and serum levels of alkaline phosphatase and lactate dehydrogenase. Investigator-assessed progression-free survival was the predicted outcome endpoint. Internal validation of the nomogram consisted of quantification of the discrimination with the concordance index and assessment of calibration.RESULTS. One-hundred seventy-four of 375 patients (46%) who received sunitinib achieved an objective response, and the median progression-free survival was 10.8 months (95% confidence interval, 10.6-12.6 months). A nomogram for predicting the probability of 12-month progression-free survival for patients who received sunitinib therapy was constructed on the basis of a Cox regression model from 11 parameters that were determined before treatment. The concordance index was 0.633.CONCLUSIONS. A nomogram was developed from pretreatment clinical features to predict the probability of achieving 12-month progression-free survival with sunitinib therapy for metastatic clear-cell RCC. The authors concluded that independent validation of the nomogram and additional studies to identify tumor specific prognostic factors are warranted.