Buus Richard, Sestak Ivana, Kronenwett Ralf, Denkert Carsten, Dubsky Peter, Krappmann Kristin, Scheer Marsel, Petry Christoph, Cuzick Jack, Dowsett Mitch
Affiliations of authors: The Breast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK (RB, MD); Academic Department of Biochemistry, Royal Marsden Hospital, London, UK (RB, MD); Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK (IS, JC); Sividon Diagnostics GmbH, Cologne, Germany (RK, KK, MS, CP); Institute of Pathology, Charité University Hospital and German Cancer Consortium (DKTK), Berlin, Germany (CD); Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria (PD).
J Natl Cancer Inst. 2016 Jul 10;108(11). doi: 10.1093/jnci/djw149. Print 2016 Nov.
Estimating distant recurrence (DR) risk among women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative early breast cancer helps decisions on using adjuvant chemotherapy. The 21-gene Oncotype DX recurrence score (RS) is widely used for this. EndoPredict (EPclin) is an alternative test combining prognostic information from an eight-gene signature (EP score) with tumor size and nodal status. We compared the prognostic information provided by RS and EPclin for 10-year DR risk.
We used likelihood ratio χ² and Kaplan-Meier survival analyses to compare prognostic information provided by EP, EPclin, RS, and the clinical treatment score (CTS) of clinicopathologic parameters in 928 patients with ER+ disease treated with five years' anastrozole or tamoxifen. Comparisons were made for early (0-5 years) and late (5-10 years) DR according to nodal status. All statistical tests were two-sided.
In the overall population, EP and EPclin provided substantially more prognostic information than RS (LRχ(2): EP = 49.3; LRχ(2): EPclin = 139.3; LRχ(2): RS = 29.1), with greater differences in late DR and in node-positive patients. EP and EPclin remained statistically significantly prognostic when adjusted for RS (ΔLRχ(2): EP+RS vs RS = 20.2; ΔLRχ(2): EPclin+RS vs RS = 113.8). Using predefined cut-offs, EPclin and RS identified 58.8% and 61.7% patients as low risk, with hazard ratios for non-low vs low risk of 5.99 (95% confidence interval [CI] = 3.94 to 9.11) and 2.73 (95% CI = 1.91 to 3.89), respectively.
EP and EPclin were highly prognostic for DR in endocrine-treated patients with ER+, HER2-negative disease. EPclin provided more prognostic information than RS. This was partly but not entirely because of EPclin integrating molecular data with nodal status and tumor size.
评估雌激素受体阳性(ER+)、人表皮生长因子受体2(HER2)阴性早期乳腺癌女性的远处复发(DR)风险有助于辅助化疗决策。21基因Oncotype DX复发评分(RS)广泛用于此。EndoPredict(EPclin)是一种将来自八基因特征(EP评分)的预后信息与肿瘤大小和淋巴结状态相结合的替代检测方法。我们比较了RS和EPclin提供的10年DR风险的预后信息。
我们使用似然比χ²和Kaplan-Meier生存分析,比较928例接受五年阿那曲唑或他莫昔芬治疗的ER+疾病患者中,EP、EPclin、RS以及临床病理参数的临床治疗评分(CTS)所提供的预后信息。根据淋巴结状态对早期(0至5年)和晚期(5至10年)DR进行比较。所有统计检验均为双侧检验。
在总体人群中,EP和EPclin提供的预后信息比RS多得多(似然比χ²:EP = 49.3;似然比χ²:EPclin = 139.3;似然比χ²:RS = 29.1),在晚期DR和淋巴结阳性患者中差异更大。在根据RS进行校正后,EP和EPclin的预后仍具有统计学意义(似然比χ²差值:EP + RS与RS比较 = 20.2;似然比χ²差值:EPclin + RS与RS比较 = 113.8)。使用预定义的临界值,EPclin和RS分别将58.8%和61.7%的患者确定为低风险,非低风险与低风险的风险比分别为5.99(95%置信区间[CI] = 3.94至9.11)和2.73(95%CI = 1.91至3.89)。
EP和EPclin对接受内分泌治疗的ER+、HER2阴性疾病患者的DR具有高度预后价值。EPclin提供的预后信息比RS更多。部分但并非完全是因为EPclin将分子数据与淋巴结状态和肿瘤大小相结合。