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Impact of age on clinical outcomes and efficacy of adjuvant dual anti-HER2 targeted therapy
Journal of the National Cancer Institute ( IF 10.3 ) Pub Date : 2022-05-03 , DOI: 10.1093/jnci/djac096
Matteo Lambertini 1, 2 , Shona Fielding 3 , Sibylle Loibl 4 , Wolfgang Janni 5 , Emma Clark 6 , Maria Alice Franzoi 7 , Debora Fumagalli 8 , Carmela Caballero 8 , Luca Arecco 1, 2 , Sharon Salomoni 1 , Noam F Ponde 9 , Francesca Poggio 10 , Hee Jeong Kim 11 , Cynthia Villarreal-Garza 12 , Olivia Pagani 13 , Shani Paluch-Shimon 14 , Alberto Ballestrero 1, 15 , Lucia Del Mastro 1, 2 , Martine Piccart 16 , Jose Bines 17 , Ann H Partridge 18 , Evandro de Azambuja 16
Affiliation  

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 (≤40 years and >40 years) was assessed. A STEPP analysis was conducted to illustrate possible treatment-effect heterogeneity based on age as a continuous factor. Results Out of 4,804 included patients, 768 (16.0%) were ≤40 years at enrollment. Median follow-up was 74 months (IQR 62–75 months). Young age was not prognostic either as dichotomous (HR 1.06; 95% CI 0.84–1.33) or continuous (HR 1.00; 95% CI 1.00–1.01) variable. Lack of prognostic effect of age was observed irrespective of hormone receptor status and treatment arm. No significant interaction was observed between age and pertuzumab effect (Pinteraction=0.605). Adding pertuzumab improved IDFS for both patients in the young (HR 0.86; 95% CI 0.56–1.32) and older (HR 0.75; 95% CI 0.62–0.92) cohorts. Similar results were observed irrespective of hormone receptor status. STEPP 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.

中文翻译:

年龄对辅助双重抗HER2靶向治疗的临床结果和疗效的影响

背景 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。方法 APHINITY (NCT01358877) 是一项国际性、安慰剂对照、双盲随机 III 期试验,研究对象为 HER2 阳性早期 BC 患者,研究将帕妥珠单抗添加到辅助化疗加曲妥珠单抗中。评估了年龄对作为连续和二分变量(≤40 岁和 > 40 岁)的侵袭性无病生存期 (IDFS) 的预后和预测价值。进行 STEPP 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。结果 在 4,804 名患者中,768 名(16. 0%) 入组时≤40 岁。中位随访时间为 74 个月(IQR 62-75 个月)。无论是二分法(HR 1.06;95% CI 0.84–1.33)还是连续变量(HR 1.00;95% CI 1.00–1.01),年轻的年龄都不能预测预后。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没有观察到显着的相互作用(Pinteraction=0.605)。添加帕妥珠单抗可改善年轻(HR 0.86;95% CI 0.56–1.32)和老年(HR 0.75;95% CI 0.62–0.92)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。STEPP 分析证实了帕妥珠单抗在跨年龄亚群的 6 年 IDFS 中的益处。结论 在接受现代抗癌疗法治疗的 HER2 阳性早期 BC 患者中,
更新日期:2022-05-03
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