Medical Oncology Department, Institut Gustave Roussy, Villejuif, France.
BJU Int. 2012 Dec;110(11):1747-53. doi: 10.1111/j.1464-410X.2012.11518.x. Epub 2012 Oct 26.
Study Type--Prognosis (cohort series) Level of Evidence 2b. What's known on the subject? and What does the study add? In the literature, few studies have evaluated the role of tumour burden (TB) in metastatic real cell carcinoma (mRCC), even though it has been considered as important in localized tumours. In metastatic patients the role of TB is uncertain because it was analyzed in chemotherapy treated patients or using a partial evaluation of TB. This study, first reports the independent prognostic and predictive role of TB in mRCC patients treated with targeted agents in prospective clinical trials. TB is able to predict prognosis independently to localization of metastases and prognostic class defined by MSKCC criteria, moreover it is strictly related to patient's performance status.
• To investigate the possible prognostic role of baseline tumour burden (TB) in terms of progression-free survival (PFS) and overall survival (OS), in patients with metastatic renal cell carcinoma (mRCC).
• A homogenous group of patients with mRCC enrolled in second-line trials post-cytokine treatment were selected for the present analysis. • The Response Evaluation Criteria in Solid Tumors (the sum of the longest unidimensional diameter of each target lesion) were used to assess TB. • The PFS and OS rates were estimated using the Kaplan-Meier method and compared across the groups using the log-rank test. • The association between TB and PFS or OS was evaluated using a Cox proportional hazards model. Multivariable analyses were adjusted for other prognostic variables: the Memorial Sloan Kettering Cancer Centre (MSKCC) risk class and treatment.
• A total of 124 patients were included in the final analysis. Of these, 66% received sorafenib or sunitinib and 34% received placebo. The median follow-up was 80.1 month. • TB was directly related to PFS and OS and these associations remained significant after adjusting for modified MSKCC risk class and treatment,. • Each 1-cm increase in TB increased the risk of progression by 4.5% (hazard ratio [HR]: 1.05; 95% confidence interval [CI] 1.02-1.07; P < 0.001) and the risk of death by 5% (HR: 1.05; 95% CI 1.03-1.08; P < 0.001).
• TB is easy to calculate from standard computed tomography and significantly relates to OS in patients with mRCC. • We report for the first time the independent prognostic role of baseline TB in multivariate analysis. • We believe that this information could be translated into clinical practice.
探讨基线肿瘤负荷（TB）在无进展生存期（PFS）和总生存期（OS）方面的可能预后作用，以转移性肾细胞癌（mRCC）患者。
选择细胞因子治疗后二线试验入组的同质 mRCC 患者进行本分析。采用实体瘤反应评价标准（RECIST）（每个靶病灶最长一维直径之和）评估 TB。使用 Kaplan-Meier 法估计 PFS 和 OS 率，并使用对数秩检验比较各组之间的差异。采用 Cox 比例风险模型评估 TB 与 PFS 或 OS 的相关性。多变量分析调整了其他预后变量：纪念斯隆-凯特琳癌症中心（MSKCC）风险类别和治疗。
共 124 例患者纳入最终分析。其中，66%接受索拉非尼或舒尼替尼治疗，34%接受安慰剂治疗。中位随访时间为 80.1 个月。TB 与 PFS 和 OS 直接相关，调整改良 MSKCC 风险类别和治疗后，这些相关性仍然显著。TB 每增加 1cm，进展风险增加 4.5%（风险比[HR]：1.05；95%置信区间[CI]：1.02-1.07；P < 0.001），死亡风险增加 5%（HR：1.05；95%CI：1.03-1.08；P < 0.001）。
TB 易于从标准计算机断层扫描中计算，与 mRCC 患者的 OS 显著相关。我们首次报告了基线 TB 在多变量分析中的独立预后作用。我们相信这些信息可以转化为临床实践。
