早期结肠癌中性别预测和预后的价值：来自 ACCENT 数据库的 33345 例患者的汇总分析。
The predictive and prognostic value of sex in early-stage colon cancer: a pooled analysis of 33,345 patients from the ACCENT database.
机构信息
Division of Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada.
出版信息
Clin Colorectal Cancer. 2013 Sep;12(3):179-87. doi: 10.1016/j.clcc.2013.04.004. Epub 2013 Jun 27.
PURPOSE
To compare long-term outcomes between men and women in a large cohort of clinical trial participants with early-stage colon cancer, specifically by examining whether the prognostic effect of sex varies based on age, stage of disease, and type of adjuvant therapy received.
METHODS
A pooled analysis of individual patient data from 33,345 patients with colon cancer enrolled in 24 phase III studies of various adjuvant systemic therapies was conducted. Chemotherapy consisted of (1) fluorouracil (5-FU), (2) 5-FU variations, (3) 5-FU plus oxaliplatin, (4) 5-FU plus irinotecan, or (5) oral fluoropyrimidine-based regimens. The primary endpoint was disease-free survival; secondary endpoints included overall survival and time to recurrence. Stratified Cox models were used to assess the effect of sex on outcomes. Multivariate models were used to assess adjusted effects and to explore the interaction among sex and other factors.
RESULTS
A total of 18,244 (55%) men and 15,101 (45%) women were included. In the entire cohort, the median age was 61 years; 91% (24,868) were white; 31% (10,347) and 69% (22,964) had stage I/II and III disease, respectively. Overall, men had inferior prognoses when compared with women for time to recurrence (hazard ratio [HR] 1.05 [95% CI, 1.01-1.09]) and other endpoints after adjusting for age, stage, and treatment. Sex was not a predictive factor of treatment efficacy (P for interaction between sex and treatment when adjusting for age and stage were .40, .67, and .77 for disease-free survival, overall survival, and time to recurrence, respectively). In exploratory analyses, worse outcomes in men were more prominent in the older patients when adjusting for stage and treatment (HR 1.08 in age ≤ 65 years vs. HR 1.18 in age > 65 years; interaction P = .016 for disease-free survival). The stage of disease and type of adjuvant regimen did not modify the prognostic value of sex.
CONCLUSIONS
Sex is a modest independent prognostic marker for patients with early-stage colon cancer, particularly in older patients.
目的
通过考察性别对预后的影响是否取决于年龄、疾病分期和接受的辅助治疗类型，比较早期结肠癌临床试验中男性和女性患者的长期结局。
方法
对 24 项不同辅助全身治疗的 III 期研究中纳入的 33345 例结肠癌患者的个体患者数据进行了汇总分析。化疗包括（1）氟尿嘧啶（5-FU）、（2）5-FU 类药物、（3）5-FU 加奥沙利铂、（4）5-FU 加伊立替康、或（5）口服氟嘧啶类药物。主要终点为无病生存；次要终点包括总生存和复发时间。采用分层 Cox 模型评估性别对结局的影响。多变量模型用于评估调整后的效应，并探索性别与其他因素之间的交互作用。
结果
共纳入 18244 例（55%）男性和 15101 例（45%）女性。在整个队列中，中位年龄为 61 岁；91%（24868 例）为白人；31%（10347 例）和 69%（22964 例）为 I/II 期和 III 期疾病。总体而言，在调整年龄、分期和治疗后，男性与女性相比，复发时间（风险比 [HR] 1.05[95%CI，1.01-1.09]）和其他终点的预后更差。性别不是治疗效果的预测因素（调整年龄和分期时，性别与治疗之间的交互作用 P 值分别为.40、.67 和.77，用于无病生存、总生存和复发时间）。在探索性分析中，调整分期和治疗后，年龄较大的患者中男性的结局更差（年龄≤65 岁的 HR 为 1.08，年龄>65 岁的 HR 为 1.18；交互作用 P=.016，用于无病生存）。疾病分期和辅助治疗方案并未改变性别对预后的预测价值。
结论
性别是早期结肠癌患者的适度独立预后标志物，尤其是在老年患者中。
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