Department of Women's Oncology, Comprehensive Breast Program, H. Lee Moffitt Cancer Center, Tampa, Florida 33612, USA.
Oncologist. 2011;16(11):1520-6. doi: 10.1634/theoncologist.2011-0045. Epub 2011 Oct 20.
The Oncotype DX assay predicts likelihood of distant recurrence and improves patient selection for adjuvant chemotherapy in estrogen receptor-positive (ER-positive) early stage breast cancer. This study has two primary endpoints: to evaluate the impact of Oncotype DX recurrence scores (RS) on chemotherapy recommendations and to compare the estimated recurrence risk predicted by breast oncology specialists to RS.
One hundred fifty-four patients with ER-positive early stage breast cancer and available RS results were selected. Clinicopathologic data were provided to four surgeons, four medical oncologists, and four pathologists. Participants were asked to estimate recurrence risk category and offer their chemotherapy recommendations initially without and later with knowledge of RS results. The three most important clinicopathologic features guiding their recommendations were requested.
Ninety-five (61.7%), 45 (29.2%), and 14 (9.1%) tumors were low, intermediate, and high risk by RS, respectively. RS significantly correlated with tumor grade, mitotic activity, lymphovascular invasion, hormone receptor, and HER2/neu status. Estimated recurrence risk by participants agreed with RS in 54.2% ± 2.3% of cases. Without and with knowledge of RS, 82.3% ± 1.3% and 69.0% ± 6.9% of patients may be overtreated, respectively (p = 0.0322). Inclusion of RS data resulted in a 24.9% change in treatment recommendations. There was no significant difference in recommendations between groups of participants.
Breast oncology specialists tended to overestimate the risk of tumor recurrence compared with RS. RS provides useful information that improves patient selection for chemotherapy and changes treatment recommendations in approximately 25% of cases.
Oncotype DX 检测可预测远处复发的可能性,并改善雌激素受体阳性(ER 阳性)早期乳腺癌患者的辅助化疗选择。本研究有两个主要终点:评估 Oncotype DX 复发评分(RS)对化疗建议的影响,并比较乳腺肿瘤专家预测的复发风险与 RS 的差异。
选择了 154 例 ER 阳性早期乳腺癌且有可用 RS 结果的患者。向 4 名外科医生、4 名肿瘤内科医生和 4 名病理学家提供了临床病理数据。要求参与者在不了解 RS 结果的情况下,首先估计复发风险类别并提出化疗建议,然后再根据 RS 结果提供建议。还要求他们提供指导建议的三个最重要的临床病理特征。
RS 结果分别为低风险(95 例,61.7%)、中风险(45 例,29.2%)和高风险(14 例,9.1%)。RS 与肿瘤分级、有丝分裂活动、脉管侵犯、激素受体和 HER2/neu 状态显著相关。参与者估计的复发风险在 54.2%±2.3%的病例中与 RS 一致。不考虑和考虑 RS 时,分别有 82.3%±1.3%和 69.0%±6.9%的患者可能过度治疗(p=0.0322)。纳入 RS 数据后,治疗建议的改变率为 24.9%。各组参与者之间的建议没有显著差异。
与 RS 相比,乳腺肿瘤专家倾向于高估肿瘤复发的风险。RS 提供了有用的信息,可以改善化疗患者的选择,并在大约 25%的病例中改变治疗建议。