乳腺癌 (BC) 诊断的年轻年龄历来是过度治疗的理由。关于 HER2 阳性 BC 诊断时年龄的预后价值和年轻患者抗 HER2 治疗的益处的短期随访数据有限。

APHINITY (NCT01358877) 是一项针对 HER2 阳性早期 BC 患者的国际性、安慰剂对照、双盲随机 III 期试验，研究将帕妥珠单抗添加到辅助化疗加曲妥珠单抗中。评估了年龄作为连续和二分变量（40 岁或更年轻和 40 岁以上）对侵袭性无病生存 (IDFS) 的预后和预测价值。进行了亚群治疗效果模式图分析，以说明基于年龄作为连续因素的可能的治疗效果异质性。

在纳入的 4804 名患者中，768 名（16.0%）在入组时年龄在 40 岁或以下。中位随访时间为 74（四分位距 = 62-75）个月。作为二分变量（风险比 [HR] = 1.06, 95% 置信区间 [CI] = 0.84 至 1.33）或连续变量（HR = 1.00, 95% CI = 1.00 至 1.01），年轻的年龄均不能预测预后。无论激素受体状态和治疗组如何，都观察到缺乏年龄的预后影响。在年龄和帕妥珠单抗效应之间未观察到统计学上显着的相互作用（Pinteraction = 0.61）。添加帕妥珠单抗可改善年轻（HR = 0.86, 95% CI = 0.56 至 1.32）和老年（HR = 0.75, 95% CI = 0.62 至 0.92）队列患者的 IDFS。无论激素受体状态如何，都观察到了类似的结果。亚群治疗效果模式图分析证实了帕妥珠单抗在跨年龄亚群的 6 年 IDFS 中的益处。在接受现代抗癌疗法治疗的 HER2 阳性早期 BC 患者中，无论激素受体状态如何，年轻时都没有表现出预后或预测价值。

Abstract

Background: Young age at breast cancer (BC) diagnosis has historically been a rationale for overtreatment. Limited data with short follow-up exist on the prognostic value of age at diagnosis in HER2-positive BC and the benefit of anti-HER2 therapy in young patients.

Methods: APHINITY (NCT01358877) is an international, placebo-controlled, double-blind randomized phase III trial in HER2-positive early BC patients investigating the addition of pertuzumab to adjuvant chemotherapy plus trastuzumab. The prognostic and predictive value of age on invasive disease-free survival (IDFS) as continuous and dichotomous variable (aged 40 years or younger and older than 40 years) was assessed. A subpopulation treatment effect pattern plot analysis was conducted to illustrate possible treatment-effect heterogeneity based on age as a continuous factor.

Results: Of 4804 included patients, 768 (16.0%) were aged 40 years or younger at enrollment. Median follow-up was 74 (interquartile range = 62-75) months. Young age was not prognostic either as dichotomous (hazard ratio [HR] = 1.06, 95% confidence interval [CI] = 0.84 to 1.33) or continuous (HR = 1.00, 95% CI = 1.00 to 1.01) variable. Lack of prognostic effect of age was observed irrespective of hormone receptor status and treatment arm. No statistically significant interaction was observed between age and pertuzumab effect (Pinteraction = 0.61). Adding pertuzumab improved IDFS for patients in the young (HR = 0.86, 95% CI = 0.56 to 1.32) and older (HR = 0.75, 95% CI = 0.62 to 0.92) cohorts. Similar results were observed irrespective of hormone receptor status. Subpopulation treatment effect pattern plot analysis confirmed the benefit of pertuzumab in 6-year IDFS across age subpopulations.

Conclusions: In patients with HER2-positive early BC treated with modern anticancer therapies, young age did not demonstrate either prognostic or predictive value, irrespective of hormone receptor status.

原文链接：

https://academic.oup.com/jnci/search-results?page=1&q=Impact%20of%20Age%20on%20Clinical%20Outcomes%20and%20Efficacy%20of%20Adjuvant%20Dual%20Anti-HER2%20Targeted%20Therapy&fl_SiteID=5125&SearchSourceType=1&allJournals=1

百度浏览   来源 : 医微客   

版权声明：本网站所有注明来源“医微客”的文字、图片和音视频资料，版权均属于医微客所有，非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源：”医微客”。本网所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，转载仅作观点分享，版权归原作者所有。不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。 本站拥有对此声明的最终解释权。