Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02115, USA.
J Clin Oncol. 2013 Jul 20;31(21):2692-8. doi: 10.1200/JCO.2012.44.1956. Epub 2013 Jun 10.
Previous research has suggested that young age at diagnosis is an independent risk factor for breast cancer recurrence and death. No prior studies have adequately controlled for human epidermal growth factor receptor 2 (HER2) status or anti-HER2 treatment. We sought to evaluate whether age was a prognostic or predictive factor in the HERA trial.
We used 2-year median follow-up data and dichotomized age at 40 years to evaluate its prognostic effect on outcomes for women assigned to trastuzumab for 1 year or observation.
Of the 1,703 women randomly assigned to 1 year of trastuzumab and 1,698 to observation, 722 (21%) were age ≤ 40 years at study entry. In separate Cox models, controlling for relevant prognostic and predictive factors, disease-free (DFS) and overall survival (OS) hazard ratios (HRs) were consistent for women age ≤ 40 versus > 40 years, regardless of treatment assignment (observation group: DFS HR age ≤ 40 v > 40 years, 1.18; 95% CI, 0.90 to 1.54; OS HR age ≤ 40 v > 40 years, 1.01; 95% CI, 0.60 to 1.69; trastuzumab group: DFS HR age ≤ 40 v > 40 years, 1.11; 95% CI, 0.81 to 1.51; OS HR age ≤ 40 v > 40 years, 1.18; 95% CI, 0.66 to 2.09). Interaction between age group and treatment effect was not statistically significant (DFS P = .89; OS P = .55).
In a retrospective analysis of a large randomized controlled trial of women with early-stage HER2-positive breast cancer, age was not strongly associated with risk of early recurrence or prediction of benefit from trastuzumab therapy. Future research should investigate whether age is a predictor of later recurrence and evaluate the impact of age within groups with other tumor subtypes.
既往研究提示,诊断时年龄较轻是乳腺癌复发和死亡的独立危险因素。既往研究并未充分控制人表皮生长因子受体 2(HER2)状态或抗 HER2 治疗。本研究旨在评估年龄在 HERA 试验中的预后或预测因素。
我们利用中位随访 2 年的数据,将年龄以 40 岁为界进行二分类,以评估其对接受曲妥珠单抗治疗 1 年或观察的患者结局的预后影响。
在 1703 例随机分配至曲妥珠单抗治疗 1 年和观察的患者中,722 例(21%)入组时年龄≤40 岁。在单独的 Cox 模型中,控制相关预后和预测因素后,疾病无进展生存(DFS)和总生存(OS)的风险比(HR)在年龄≤40 岁与>40 岁的患者中一致,与治疗分配无关(观察组:DFS HR 年龄≤40 岁与>40 岁,1.18;95%CI,0.90 至 1.54;OS HR 年龄≤40 岁与>40 岁,1.01;95%CI,0.60 至 1.69;曲妥珠单抗组:DFS HR 年龄≤40 岁与>40 岁,1.11;95%CI,0.81 至 1.51;OS HR 年龄≤40 岁与>40 岁,1.18;95%CI,0.66 至 2.09)。年龄组与治疗效果之间的交互作用无统计学意义(DFS P=0.89;OS P=0.55)。
在一项针对早期 HER2 阳性乳腺癌女性的大型随机对照试验的回顾性分析中,年龄与早期复发风险无明显关联,也不能预测曲妥珠单抗治疗的获益。未来的研究应探讨年龄是否为晚期复发的预测因素,并评估年龄在其他肿瘤亚型亚组中的影响。