Pooled analysis of fluorouracil-based adjuvant therapy for stage II and III colon cancer:: Who benefits and by how much?
Pooled analysis of fluorouracil-based adjuvant therapy for stage II and III colon cancer:: Who benefits and by how much?
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DOI：
10.1200/jco.2004.09.059
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发表时间：
2004-05-15
影响因子：
45.3
通讯作者：
Goldberg, RM
中科院分区：
文献类型：
--
作者：
Gill, S;Loprinzi, CL;Goldberg, RM
目的尽管众所周知，基于氟尿嘧啶（FU）的辅助治疗可以提高切除高危结肠癌患者的生存率，但特定亚组和个体患者的辅助治疗获益程度尚不确定。患者和方法使用汇总数据集3，来自7项比较FU +甲酰四氢叶酸或FU +左旋咪唑与单独手术的随机试验的302例II期和III期结肠癌患者，我们基于考克斯比例风险回归模型进行了分析。治疗、年龄、性别、肿瘤位置、T分期、淋巴结状态和分级对预后和预测意义进行了检验。模型推导的估计5年无病生存期和总生存期（OS）的手术单独和手术加FU为基础的治疗计算了一系列的患者subset.ResultsNodal状态，T分期和等级是唯一的预后因素独立显着的无病生存期和OS。年龄是显着的OS。辅助治疗在所有亚组中显示出有益的治疗效果。治疗获益在不同性别、部位、年龄、T分期和分级之间一致。一个显着的阶段治疗相互作用，治疗受益阶段III患者在更大程度上比阶段II patients.ConclusionPatients高风险切除结肠癌患者从FU为基础的治疗中获益，年龄，性别，位置，T分期，淋巴结状态和等级的子集。按T分期、淋巴结状态、分级和年龄分层的生存率模型估计值可在http://www.mayoclinic.com/calcs上获得。这些信息可以提高患者和医生对辅助治疗潜在益处的理解。(C)2004年，美国临床肿瘤学会。
PurposeAlthough it is well-established that fluorouracil- (FU-) based adjuvant therapy improves survival for patients with resected high-risk colon cancer, the magnitude of adjuvant therapy benefit across specific subgroups and for individual patients has been uncertain.Patients and MethodsUsing a pooled data set of 3,302 patients with stage II and III colon cancer from seven randomized trials comparing FU + leucovorin or FU + levamisole to surgery alone, we performed an analysis based on a Cox proportional hazards regression model. Treatment, age, sex, tumor location, T stage, nodal status, and grade were tested for both prognostic and predictive significance. Model derived estimates of 5-year disease-free survival and overall survival (OS) for surgery alone and surgery plus FU-based therapy were calculated for a range of patient subsets.ResultsNodal status, T stage, and grade were the only prognostic factors independently significant for both disease-free survival and OS. Age was significant only for OS. In a multivariate analysis, adjuvant therapy showed a beneficial treatment effect across all subsets. Treatment benefits were consistent across sex, location, age, T-stage, and grade. A significant stage by treatment interaction was present, with treatment benefiting stage III patients to a greater degree than stage II patients.ConclusionPatients with high-risk resected colon cancer obtain benefit from FU-based therapy across subsets of age, sex, location, T stage, nodal status, and grade. Model estimates of survival stratified by T stage, nodal status, grade, and age are available at http://www.mayoclinic.com/calcs. This information may improve patients' and physicians' understanding of the potential benefits of adjuvant therapy. (C) 2004 by American Society of Clinical Oncology.