Department of Medical Oncology, Waterford Regional Hospital, Waterford, Ireland.
Department of Medical Oncology/Hematology, Division of Medical Oncology/Hematology, Sunnybrook Health Sciences Centre, Toronto, Canada.
Ann Oncol. 2011 Nov;22(11):2387-2393. doi: 10.1093/annonc/mdq786. Epub 2011 Mar 15.
Recent retrospective studies have suggested that patients with T1a,bN0M0 human epidermal growth factor receptor 2 (HER2)-positive breast cancer are at a higher risk for recurrence and might benefit from adjuvant trastuzumab. The absolute benefits associated with treating this subgroup are uncertain.
We reviewed recent studies examining the prognostic value of HER2 in patients with node-negative T1a,b HER2-positive breast cancer. We calculated the number needed to treat (NNT) using baseline risk estimates for untreated T1a,bN0M0 breast cancer and the number needed to harm (NNH) using the incidence of cardiac events in each of the adjuvant trastuzumab clinical trials.
Several studies were identified, each with limitations inherent to retrospective database analyses: small cohort sizes, lack of systematic HER2 testing in older specimens, variations in the use of adjuvant therapy and definitions of study end points, and lack of information relating to comorbidities. The 5-year disease-free survival in the pre-trastuzumab era ranged from 77% to 95%. Comparisons between small HER2 -positive and small HER2 -negative cancers showed numerically worse outcome for the HER2-positive cohort in some but not all studies. In many instances, the NNH was larger (26-250) than the NNT (13-35); however, in a subset of patients, the NNH was lower (6) than the NNT (13-35).
Better prediction tools to estimate more precisely the risk for death due to comorbid illness versus breast cancer are needed. In some patients, the risks of therapy could outweigh the benefits. Treatment selection for T1a,bN0 HER2-positive cancers remains in the transition area between evidence- and subjective judgment-based medicine.
最近的回顾性研究表明，T1a,bN0M0 人表皮生长因子受体 2（HER2）阳性乳腺癌患者复发风险较高，可能从辅助曲妥珠单抗治疗中获益。但治疗该亚组的绝对获益尚不确定。
我们复习了近期研究，以评估 HER2 在淋巴结阴性 T1a,b HER2 阳性乳腺癌患者中的预后价值。我们根据未经治疗的 T1a,bN0M0 乳腺癌的基线风险估计计算了需要治疗的人数（NNT），并根据每个辅助曲妥珠单抗临床试验中心脏事件的发生率计算了需要治疗的人数（NNH）。
确定了几项研究，但每个研究都存在回顾性数据库分析固有的局限性：队列规模小，缺乏对老年标本的系统性 HER2 检测，辅助治疗和研究终点定义的使用存在差异，以及与合并症相关的信息缺失。在曲妥珠单抗治疗前时代，5 年无病生存率从 77%到 95%不等。在一些但不是所有研究中，小 HER2 阳性和小 HER2 阴性癌症之间的比较显示，HER2 阳性组的结果略差。在许多情况下，NNH 较大（26-250）而 NNT 较小（13-35）；然而，在一部分患者中，NNH 较低（6）而 NNT 较大（13-35）。
需要更好的预测工具来更准确地估计因合并症而非乳腺癌而死亡的风险。在某些患者中，治疗的风险可能超过获益。T1a,bN0 HER2 阳性癌症的治疗选择仍处于证据和基于主观判断的医学之间的过渡区。
