Stage Migration and Increasing Proportion of Favorable-Prognosis Metastatic Renal Cell Carcinoma Patients Implications for Clinical Trial Design and Interpretation
Stage Migration and Increasing Proportion of Favorable-Prognosis Metastatic Renal Cell Carcinoma Patients Implications for Clinical Trial Design and Interpretation
复制标题
DOI：
10.1002/cncr.24713
复制
发表时间：
2010-01-15
期刊：
影响因子：
6.2
通讯作者：
Motzer, Robert J.
中科院分区：
文献类型：
--
作者：
Patil, Sujata;Ishill, Nicole;Motzer, Robert J.
背景：纪念斯隆-凯特琳癌症中心的风险模型根据5个预处理特征将转移性肾细胞癌（RCC）患者分为有利、中等和低风险。每个风险组的纪念斯隆-凯特琳癌症中心患者的数量按治疗年份进行检查，以分析阶段迁移。方法：回顾性分析1975年至2007年在纪念斯隆-凯特琳癌症中心接受一线治疗临床试验的789例转移性肾细胞癌患者的危险组分布。治疗起始日期在1975年至2007年间分为6组（1975-1980年、1981-1985年、1986-1990年、1991-1995年、1996-2001年和2001-2007年）。结果：一线转移性RCC临床试验患者的中位年龄为59岁（范围20-82岁）。大多数患者接受细胞因子治疗（55%），37%接受化疗/其他治疗，8%接受血管内皮生长因子靶向治疗。总生存率随着连续队列年组的增加而增加（P < 0.001）。1973 - 1980年队列的中位生存期为0.43年（95%可信区间[CI]， 0.27-0.68）， 2001-2007年队列的中位生存期为1.5年（95% CI, 1.15-2.11）。纪念斯隆-凯特琳癌症中心的风险组分布在1975年至2007年间发生了变化（P < 0.0001）。低风险组的比例变小了（从1970 -1980年的44%到2001-2007年的13%），而良好风险组的比例增加了（从1975-1980年的0%到2001-2007年的49%）。中等风险组保持稳定在50%。在调整治疗类型后，这种变化仍然是显著的（P < 0.0001）。结论：临床试验中转移性RCC患者的风险组分布从1975年到2007年发生了变化。这些变化对数据分析、转移性RCC趋势的解释和药物开发具有直接影响。癌症2010;116:347-54。(C) 2070美国癌症协会。
BACKGROUND: The Memorial Sloan-Kettering Cancer Center risk model classifies patients with metastatic renal cell carcinoma (RCC) by 5 pretreatment features as favorable, intermediate, and poor risk. The number of Memorial Sloan-Kettering Cancer Center patients in each risk group was examined by year of treatment to analyze stage migration. METHODS: The distribution of risk groups was examined retrospectively in 789 Memorial Sloan-Kettering Cancer Center patients with metastatic RCC treated in a first-line therapy clinical trial from 1975 to 2007. Date of treatment onset was divided into 6 cohorts between 1975 and 2007 (1975-1980, 1981-1985, 1986-1990, 1991-1995, 1996-2001, and 2001-2007). RESULTS: The median age of the first-line metastatic RCC clinical trial patients was 59 years (range, 20-82 years). Most patients received cytokine therapy (55%), 37% received chemotherapy/other, and 8% received vascular endothelial growth factor-targeted therapies. Overall survival increased with each consecutive cohort year group (P < .001). Median survival was 0.43 years (95% confidence interval [CI], 0.27-0.68) in the 19731980 cohort and 1.5 years in the 2001-2007 cohort (95% CI, 1.15-2.11). Memorial Sloan-Kettering Cancer Center risk-group distribution shifted between 1975 and 2007 (P < .0001). The poor-risk group proportion became smaller (from 44% in 197S-1980 to 13% in 2001-2007), whereas the favorable-risk group increased (from 0% in 1975-1980 to 49% in 2001-2007). The intermediate-risk group remained stable at 50%. After adjusting for type of therapy, the shifts continue to be significant (P < .0001). CONCLUSIONS: The risk-group distribution for metastatic RCC patients in clinical trials shifted from 1975 to 2007. These shifts have direct implications for data analysis, interpretation of metastatic RCC trends, and drug development. Cancer 2010;116:347-54. (C) 2070 American Cancer Society.