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基于人群注册登记的研究数据:根据 OlympiA 试验纳入标准,强制性检测 gBRCA1/2 突变的“高危”早期乳腺癌的真实世界患病率、治疗和生存情况。

Real-world prevalence, treatment and survival of "high risk" early breast cancer, with mandatory testing of gBRCA1/2 mutation according to the OlympiA trial inclusion criteria: Data from a population-based registry.

机构信息

Department of Medical Oncology, Centre Georges-François Leclerc, 1 rue du Professeur Marion, 21000, Dijon, France; INSERM U1231, Université de Bourgogne, 21000, Dijon, France; Université de Bourgogne, 21000, Dijon, France.

INSERM U1231, Université de Bourgogne, 21000, Dijon, France; Breast and Gynaecologic Cancer Registry of Côte d'Or, Epidemiology and Quality of Life Research Unit, Georges-François Leclerc Comprehensive Cancer Centre-UNICANCER, 1 rue du Professeur Marion, 21000, Dijon, France.

出版信息

Breast. 2024 Dec;78:103789. doi: 10.1016/j.breast.2024.103789. Epub 2024 Aug 28.

Abstract

BACKGROUND

The results of the OlympiA study led to the approval of a PARP inhibitor (olaparib) as adjuvant treatment for early breast cancer (eBC) at high risk of relapse in patients with a germline BRCA1/2 mutation (gBRCAm). However, the proportion of patients in routine practice who meet the "high-risk" criteria applied in the OlympiA study, and for whom gBRCAm testing would now be mandatory, remains unknown.

PATIENTS AND METHODS

In this population-based study, we use unique data from the French specialized Côte d'Or Breast and Gynecological Cancer Registry, to assess the real-life proportion, and long-term prognosis of patients treated for eBC between 2005 and 2015 with standard treatment, and at "high risk" of relapse according to the OlympiA trial criteria.

RESULTS

We included 3483 patients treated for HER2-negative eBC (N = 380 with ER-, and N = 3103 with ER + tumor). We found N = 62 (1.8 %) patients with gBRCA1/2 mutations. A total of 494 patients (14.2 %) were classified as "high risk" according to the Olympia criteria; 55 % with ER-tumors, and 9.1 % with ER + tumors, respectively. Despite more intensive systemic treatments in "high risk" patients, 10-year overall survival was much worse in these "high risk" patients compared to the others: 60.1 % vs 83.8 % in ER-tumors, and 55.4 % vs 84.1 % in ER + tumors. Our estimates of net survival show an even greater difference.

CONCLUSION

This study provides real-life insights into the prevalence and prognosis of patients with high-risk eBC, in a context where the approval of adjuvant olaparib requires careful reorganization of care, so as not to overlook a patient with gBRCAm who could benefit from adjuvant olaparib.

摘要

背景

OlympiA 研究的结果导致 PARP 抑制剂(奥拉帕利)被批准用于治疗携带种系 BRCA1/2 突变(gBRCAm)的早期乳腺癌(eBC)高复发风险患者的辅助治疗。然而,在 OlympiA 研究中应用的“高危”标准下,符合条件并需要进行 gBRCAm 检测的患者比例在常规实践中仍不清楚。

患者和方法

在这项基于人群的研究中,我们利用法国科多尔乳房和妇科癌症登记处的独特数据,评估 2005 年至 2015 年间接受标准治疗且根据 OlympiA 试验标准具有高复发风险的 eBC 患者的真实比例和长期预后。

结果

我们纳入了 3483 例 HER2 阴性 eBC 患者(N=380 例 ER-,N=3103 例 ER+肿瘤)。我们发现 62 例(1.8%)患者存在 gBRCA1/2 突变。根据 OlympiA 标准,共有 494 例(14.2%)患者被归类为“高危”;其中 55%为 ER-肿瘤,9.1%为 ER+肿瘤。尽管“高危”患者接受了更强化的系统治疗,但与其他患者相比,这些“高危”患者的 10 年总生存率要差得多:ER-肿瘤为 60.1%比 83.8%,ER+肿瘤为 55.4%比 84.1%。我们的净生存估计显示出更大的差异。

结论

本研究提供了高危 eBC 患者的患病率和预后的真实情况,在奥拉帕利辅助治疗获批的背景下,需要仔细重组护理,以免忽视可能从辅助奥拉帕利治疗中获益的 gBRCAm 患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc02/11406442/feaa13c9aa9d/gr1.jpg

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