APHINITY试验中他汀类药物使用与早期her2阳性乳腺癌患者生存结局的关系

IF 3 3区 医学 Q2 ONCOLOGY
Breast Cancer Research and Treatment Pub Date : 2025-07-01 Epub Date: 2025-04-28 DOI:10.1007/s10549-025-07699-2
Christian Maurer, Elisa Agostinetto, Lieveke Ameye, Matteo Lambertini, Samuel Martel, Noam Ponde, Mariana Brandão, Francesca Poggio, Arlindo Ferreira, Rachel Schiff, Carmine De Angelis, Richard D Gelber, Susan Dent, Christoph Thomssen, Martine Piccart, Evandro de Azambuja
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引用次数: 0

摘要

目的:有证据表明他汀类药物可能改善乳腺癌患者的预后。他汀类药物在早期her2阳性乳腺癌患者中的作用尚不清楚。因此,我们在III期APHINITY试验(辅助帕妥珠单抗/曲妥珠单抗)中探讨了他汀类药物使用与早期her2阳性乳腺癌患者生存结局之间的关系。方法:纳入所有患者(意向治疗人群,n = 4804)(中位随访时间为6.2年)。主要目的是研究他汀类药物使用与侵袭性无病生存期(IDFS)、远端无复发间期(DRFI)和总生存期(OS)的关系。基线时接受他汀类药物治疗或随机分组后1年内开始使用他汀类药物的患者被认为是他汀类药物使用者。使用Kaplan-Meier法估计生存曲线。我们使用Cox比例风险模型进行多变量分析。结果:总体而言,423例(8.8%)患者被归类为他汀类药物使用者。她们年龄较大,绝经后的情况较多,体重指数较高,患糖尿病、高血压、冠心病和高脂血症的情况较多,肿瘤较小,接受保乳手术的情况较多,使用含蒽环类药物治疗的情况较少。总体而言,发生了508例IDFS事件(他汀类药物使用者12.8%,非他汀类药物使用者10.4%)和272例死亡(分别为8.5%和5.4%)。在多变量分析中,他汀类药物的使用与IDFS无关(HR, 1.11;95% ci, 0.80-1.52), drfi (hr, 1.21;95% CI, 0.81-1.81)和OS (HR, 1.16;95% ci, 0.78-1.73)。结论:在APHINITY中,他汀类药物的使用与生存结果的改善无关。由于分析的探索性和相关的局限性,必须谨慎解释这些结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Association of statin use on survival outcomes of patients with early-stage HER2-positive breast cancer in the APHINITY trial.

Purpose: There is evidence that statins might improve the outcome of patients with breast cancer. The role of statins in patients with early HER2-positive breast cancer is unknown. Therefore, we explored the association between statin use and survival outcomes in early HER2-positive breast cancer patients in the phase III APHINITY trial (adjuvant pertuzumab/trastuzumab).

Methods: All patients (intent-to-treat population, n = 4804) were included (6.2 years median follow-up database). The primary objective was to investigate the association of statin use on invasive disease-free survival (IDFS), distant relapse-free interval (DRFI), and overall survival (OS). Patients who received statins at baseline, or started statins within 1 year from randomization were considered statin users. Survival curves were estimated using the Kaplan-Meier method. We used a Cox proportional hazards model for multivariate analysis.

Results: Overall, 423 (8.8%) patients were classified as statin users. They were older, more often postmenopausal, had a higher body mass index, more often diabetes, hypertension, coronary heart disease and hyperlipidemia, had smaller sized tumors, were treated more often with breast conserving surgery, and less often with anthracycline-containing regimens. Overall, 508 IDFS events (12.8% among statin users and 10.4% among non-statin users) and 272 deaths (8.5% and 5.4%, respectively) occurred. In multivariate analysis, statin use was not associated with IDFS (HR, 1.11; 95% CI, 0.80-1.52), DRFI (HR, 1.21; 95% CI, 0.81-1.81) nor OS (HR, 1.16; 95% CI, 0.78-1.73).

Conclusion: In APHINITY, statin use was not associated with improved survival outcomes. These results must be interpreted with caution due to the exploratory nature of the analysis and the associated limitations.

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来源期刊
CiteScore
6.80
自引率
2.60%
发文量
342
审稿时长
1 months
期刊介绍: Breast Cancer Research and Treatment provides the surgeon, radiotherapist, medical oncologist, endocrinologist, epidemiologist, immunologist or cell biologist investigating problems in breast cancer a single forum for communication. The journal creates a "market place" for breast cancer topics which cuts across all the usual lines of disciplines, providing a site for presenting pertinent investigations, and for discussing critical questions relevant to the entire field. It seeks to develop a new focus and new perspectives for all those concerned with breast cancer.
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