年龄不影响HER2阳性乳腺癌患者的生存

一项大型随机乳腺癌研究的回顾性分析显示，年龄≤40岁对人类表皮生长因子受体2(HER2)阳性乳腺癌女性患者的生存无显著影响(J. Clin. Oncol. 2013;31:2692-8)。


Ann Partridge医生

这项回顾性分析由波士顿Dana-Farber癌症研究所的Ann H. Partridge医生及其同事进行，数据来自赫赛汀辅助治疗(HERA)研究，后者是一项开放标记Ⅲ期随机试验，在辅助化疗后接受曲妥珠单抗治疗1年的HER2阳性乳腺癌患者中观察到无病生存率显著改善(N. Engl. J. Med. 2005;353:1659-72 )。

研究入组时，共722例女性患者(21%)的年龄≤40岁。在1,698例随机接受观察的女性中，年龄≤40岁的女性的无病生存率(HR 1.18；95%CI：0.90~1.54)和总生存率(HR 1.01；95%CI：0.60~1.69)与40岁以上女性无显著差异。

在1,703例随机接受曲妥珠单抗治疗的女性中也观察到相同结果。年龄≤40岁的女性的无病生存率(HR 1.11；95%CI：0.81~1.51)和总生存率(HR 1.18；95%CI：0.66~2.09)与40岁以上女性无差异。在无病生存(P=0.89)和总生存(P=0.55)方面均未观察到年龄组与治疗效应之间有显著统计学交互作用。

研究者表示，上述结果表明，随着乳腺癌的分子学研究日益深入，并且随着曲妥珠单抗等药物被开发用于靶向分子亚型，年龄在预后方面的重要性将趋于降低。该研究的局限性在于随访时间较短。未来研究应探讨年龄是否是迟发性复发的预测因素，并在其他肿瘤亚型中评估年龄的影响。

Partridge医生是曲妥珠单抗生产商基因泰克公司的顾问。另有1名研究者是罗氏(基因泰克母公司)的员工，并持有其股份。其他6名研究者中除1名外均与这两家公司存在联系。

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By: M. ALEXANDER OTTO, Internal Medicine News Digital Network

Being less than 40 years old does not significantly impact survival in women with HER2-positive breast cancer, according to a retrospective analysis of a large, randomized breast cancer study.

"Our finding that age is neither a clear prognostic factor for early recurrence nor a predictive factor for benefit of trastuzumab in women with HER2-positive breast cancer may have important implications for care and future research. Most prior research suggesting that age is an independent prognostic factor has not taken HER2 status into account," noted Dr. Ann H. Partridge and her colleagues.

Younger women are more likely to present with aggressive breast tumors and advanced disease; young age at diagnosis is an independent risk factor for recurrence and death. Few studies have been conducted to evaluate if the finding remains the same among women with HER2-positive (human epidermal growth factor receptor 2–positive) tumors, according to Dr. Partridge, an oncologist at the Dana-Farber Cancer Institute in Boston, and her colleagues.
 
They performed a retrospective analysis of data from the HERA [Herceptin Adjuvant] study, an open-label, phase III randomized trial that found significantly improved disease-free survival in HER2-positive breast cancer patients who received a year of trastuzumab following adjuvant chemotherapy (N. Engl. J. Med. 2005;353:1659-72).

Among 1,698 women randomly assigned to observation in the trial, there was no significant difference in disease-free survival (HR 1.18; 95% CI, 0.90-1.54) or overall survival (HR 1.01; 95% CI, 0.60-1.69) in women aged 40 years or younger, compared with women over age 40 years (J. Clin. Oncol. 2013;31:2692-8).

This was also true among the 1,703 women randomly assigned to trastuzumab. Disease-free survival (HR 1.11; 95% CI, 0.81-1.51) and overall survival (HR 1.18; 95% CI, 0.66-2.09) were comparable in younger women, compared with those over 40 years of age. Interaction between age group and treatment effect was not statistically significant for either parameter (DFS P = 0.89; OS P = 0.55).

Overall, 722 women (21%) were 40 years of age or younger at study entry.

"Our findings suggest that as breast cancer continues to be better characterized molecularly, and therapies such as trastuzumab are developed to target molecular subtypes, the importance of age with regard to prognosis will continue to diminish, if not disappear," they wrote.

The short follow-up was a limitation of the study. "Future research should investigate whether age is a predictor of later recurrence and evaluate the impact of age within groups with other tumor subtypes," they noted.

Dr. Partridge is a consultant for Genentech, maker of trastuzumab. Another author is an employee of, and holds stock in, Roche, the parent company of Genentech. All but one of the six other investigators have ties to the two companies