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帕妥珠单抗和 ado-trastuzumab emtansine 对美国局部晚期、炎性或早期 HER2 阳性乳腺癌女性患者复发累积避免的影响。

Impact of Pertuzumab and Ado-Trastuzumab Emtansine on Cumulative Avoidance of Recurrence Among Women Treated for Locally Advanced, Inflammatory, or Early-Stage Nonmetastatic HER2-Positive Breast Cancer in the United States.

机构信息

Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.

F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland.

出版信息

Adv Ther. 2023 Sep;40(9):3857-3874. doi: 10.1007/s12325-023-02554-6. Epub 2023 Jun 26.

Abstract

INTRODUCTION

We assessed the impact of HER2-positive early breast cancer (EBC) treatment landscape changes following the introduction of pertuzumab and ado-trastuzumab emtansine (T-DM1) on cumulative population-level recurrences avoided since 2013 (first pertuzumab approval for EBC in the United States; US).

METHODS

We constructed a multi-year epidemiologic population treatment-impact model to estimate annual recurrences between 2013 and 2031. Parameters were: BC incidence; stage I-III proportion; HER2-positive disease proportion; treatment proportions for neoadjuvant-only, adjuvant-only, and neoadjuvant-adjuvant continuation; and therapeutic agent proportions within each of those settings (chemotherapy only, trastuzumab ± chemotherapy, pertuzumab with trastuzumab ± chemotherapy, or T-DM1). The primary endpoint was cumulative recurrences, estimated by incorporating extrapolated clinical trial data for each regimen of interest into the model under four scenarios.

RESULTS

Approximately 889,057 women were predicted to be diagnosed with stage I-III HER2-positive BC from 2006 to 2031 in the US and potentially indicated for HER2-targeted treatment. In steady-state equilibrium, the model estimated that real-world utilization of pertuzumab and T-DM1 will reduce the population-level number of recurrences by approximately 32%, with 7226 recurrences predicted in 2031 based on current utilization rates. In different modeled scenarios, use of neoadjuvant pertuzumab, continuation of pertuzumab in the adjuvant setting, and T-DM1 in the adjuvant setting in women with residual disease after neoadjuvant treatment were all predicted to reduce the number of recurrences.

CONCLUSION

Given the improvement of HER2-targeted treatments, alongside increases in BC disease burden, we expect that the population-level impact of HER2-targeted treatments will accelerate over the next decade. Our results suggest that utilization of HER2-targeted treatments in the US has the potential to change the epidemiology of HER2-positive EBC by preventing a substantial number of women from experiencing disease recurrence. These improvements may help to inform our understanding of the future disease and economic burden of HER2-positive BC in the US.

摘要

简介

本研究评估了曲妥珠单抗和恩美曲妥珠单抗(T-DM1)用于人表皮生长因子受体 2(HER2)阳性早期乳腺癌(EBC)治疗后,自 2013 年(美国首次批准曲妥珠单抗用于 EBC)以来对累计人群复发率的影响。

方法

我们构建了一个多年的流行病学人群治疗影响模型,以估计 2013 年至 2031 年之间的年度复发率。参数包括:乳腺癌发病率;I-III 期比例;HER2 阳性疾病比例;新辅助治疗、辅助治疗和新辅助-辅助连续治疗的比例;以及每种治疗方案中的治疗药物比例(仅化疗、曲妥珠单抗+化疗、曲妥珠单抗+化疗+帕妥珠单抗或 T-DM1)。主要终点是通过将每个感兴趣的治疗方案的临床研究数据外推到模型中,在四种情况下估算累计复发率。

结果

预计 2006 年至 2031 年期间,美国将有 889057 名妇女被诊断为 I-III 期 HER2 阳性乳腺癌,并可能需要接受 HER2 靶向治疗。在稳定状态平衡下,该模型估计曲妥珠单抗和 T-DM1 的真实世界应用将使人群水平的复发率降低约 32%,基于目前的使用率,预计 2031 年将有 7226 例复发。在不同的模拟场景中,新辅助使用曲妥珠单抗、辅助治疗中继续使用曲妥珠单抗以及新辅助治疗后残留疾病中使用 T-DM1 均被预测可降低复发率。

结论

鉴于 HER2 靶向治疗的改善,以及乳腺癌疾病负担的增加,我们预计未来十年,HER2 靶向治疗的人群影响将加速。我们的研究结果表明,在美国,HER2 靶向治疗的应用有可能通过防止大量妇女出现疾病复发,改变 HER2 阳性 EBC 的流行情况。这些改进可能有助于我们了解美国 HER2 阳性乳腺癌的未来疾病和经济负担。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d0e/10427558/3aecc0752967/12325_2023_2554_Fig1_HTML.jpg

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