Division of Diagnostic Oncology, Netherlands Cancer Institute, Plesmanlaan, Amsterdam, The Netherlands.
Breast Cancer Res Treat. 2010 Apr;120(3):655-61. doi: 10.1007/s10549-010-0814-2. Epub 2010 Mar 5.
Multigene assays have been developed and validated to determine the prognosis of breast cancer. In this study, we assessed the additional predictive value of the 70-gene MammaPrint signature for chemotherapy (CT) benefit in addition to endocrine therapy (ET) from pooled study series. For 541 patients who received either ET (n = 315) or ET + CT (n = 226), breast cancer-specific survival (BCSS) and distant disease-free survival (DDFS) at 5 years were assessed separately for the 70-gene high and low risk groups. The 70-gene signature classified 252 patients (47%) as low risk and 289 (53%) as high risk. Within the 70-gene low risk group, BCSS was 97% for the ET group and 99% for the ET + CT group at 5 years with a non-significant univariate hazard ratio (HR) of 0.58 (95% CI 0.07-4.98; P = 0.62). In the 70-gene high risk group, BCSS was 81% (ET group) and 94% (ET + CT group) at 5 years with a significant HR of 0.21 (95% CI 0.07-0.59; P < 0.01). DDFS was 93% (ET) versus 99% (ET + CT), respectively, in the 70-gene low risk group, HR 0.26 (95% CI 0.03-2.02; P = 0.20). In the high risk group DDFS was 76 versus 88%, HR of 0.35 (95% CI 0.17-0.71; P < 0.01). Results were similar in multivariate analysis, showing significant survival benefit by adding CT in the 70-gene high risk group. A significant and clinically meaningful benefit was observed by adding chemotherapy to endocrine treatment in 70-gene high risk patients. This benefit was not significant in low risk patients, who were at such low risk for recurrence and cancer-related death, that adding CT does not appear to be clinically meaningful.
多基因检测已被开发和验证，用于确定乳腺癌的预后。在这项研究中，我们评估了 70 基因 MammaPrint 签名在附加化疗（CT）益处方面的预测价值，以补充内分泌治疗（ET）的效果。对于接受 ET（n = 315）或 ET + CT（n = 226）的 541 例患者，分别评估 70 基因高风险和低风险组的乳腺癌特异性生存（BCSS）和远处无病生存（DDFS）。70 基因签名将 252 例患者（47%）分类为低风险，289 例（53%）为高风险。在 70 基因低风险组中，ET 组的 BCSS 在 5 年内为 97%，ET + CT 组为 99%，单变量风险比（HR）无显著性（0.58，95%CI 0.07-4.98；P = 0.62）。在 70 基因高风险组中，ET 组的 BCSS 在 5 年内为 81%，ET + CT 组为 94%，HR 显著（0.21，95%CI 0.07-0.59；P < 0.01）。在 70 基因低风险组中，DDFS 分别为 93%（ET）和 99%（ET + CT），HR 0.26（95%CI 0.03-2.02；P = 0.20）。在高风险组中，DDFS 为 76%和 88%，HR 为 0.35（95%CI 0.17-0.71；P < 0.01）。多变量分析结果相似，显示在 70 基因高风险组中添加 CT 有显著的生存获益。在 70 基因高风险患者中，在内分泌治疗中添加化疗可观察到显著且有临床意义的获益。在低风险患者中，这种获益并不显著，这些患者复发和癌症相关死亡的风险如此之低，以至于添加 CT 似乎没有临床意义。
