背景:OlympiA研究的结果导致批准PARP抑制剂(奥拉帕尼)作为生殖系BRCA1/2突变(gBRCAm)患者复发风险高的早期乳腺癌(eBC)的辅助治疗。然而,符合OlympiA研究中应用的“高风险”标准的常规实践患者比例,现在对谁来说gBRCAm测试是强制性的,仍然未知。
方法:在这项基于人群的研究中,我们使用法国专业的科特迪瓦或乳腺癌和妇科癌症登记处的独特数据,为了评估现实生活中的比例,以及2005年至2015年间接受标准治疗的EBC患者的长期预后,根据OlympiA试验标准,处于复发的“高风险”状态。
结果:我们包括3483例接受HER2阴性eBC治疗的患者(N=380,ER-,和N=3103与ER+肿瘤)。我们发现N=62(1.8%)患者存在gBRCA1/2突变。根据奥林匹亚标准,共有494名患者(14.2%)被归类为“高风险”;55%患有ER肿瘤,9.1%有ER+肿瘤,分别。尽管对“高风险”患者进行了更密集的全身治疗,与其他患者相比,这些“高风险”患者的10年总生存率要差得多:ER肿瘤为60.1%vs83.8%,ER+肿瘤为55.4%vs84.1%。我们对净生存率的估计显示出更大的差异。
结论:这项研究提供了对高风险eBC患者的患病率和预后的真实见解,在批准奥拉帕利佐剂需要仔细重组护理的情况下,以免忽视gBRCAm患者可以从奥拉帕尼辅助治疗中获益。
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.
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.
CONCLUSIONS: 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.