Robertson Susan J, Ibrahim Mohammed F K, Stober Carol, Hilton John, Kos Zuzana, Mazzarello Sasha, Ramsay Tim, Fergusson Dean, Vandermeer Lisa, Mallick Ranjeeta, Arnaout Angel, Dent Susan F, Segal Roanne, Sehdev Sandeep, Gertler Stan, Hutton Brian, Clemons Mark
Eastern Ontario Regional Laboratory Association and Department of Pathology and Laboratory Medicine, The University of Ottawa, Ottawa, Canada.
Division of Medical Oncology, Department of Medicine, The Ottawa Hospital Cancer Centre and The University of Ottawa, Ottawa, Canada.
J Eval Clin Pract. 2019 Apr;25(2):196-204. doi: 10.1111/jep.13094. Epub 2019 Jan 23.
The three Magee Equations provide an estimate of the Oncotype DX recurrence score using commonly available clinicopathologic information (tumour size, grade, oestrogen receptor, progesterone receptor, HER2, and Ki67). We assessed whether integration of Magee Equations into routine clinical practice affected the frequency of Oncotype DX requests.
Patients with newly diagnosed, node negative, hormone receptor positive, and HER2 negative invasive breast cancer were randomized to undergo a Magee calculation or not. At the first clinic assessment, the oncologist was provided with all routinely available clinicopathologic information (including Ki67) either with or without the results of Magee Equations. Primary outcome was frequency of Oncotype DX ordering. Secondary outcomes included frequency of chemotherapy use, time to commencement of radiotherapy, or systemic therapy. Physician comfort with systemic therapy choices and the use of Ki67 and Magee Equations was also assessed.
Data from 175 randomized patients was available, 84 patients (48%) with and 91 (52%) without calculated Magee Equations. Oncotype DX was ordered in 10 (12.05%) and 13 (14.44%) (RR 0.83, 0.39-1.80; P = 0.64) in the Magee and no Magee groups, respectively. There were no statistically or clinically significant differences between the randomized groups for any of the secondary outcomes. Availability of both Ki67 and Magee Equations was associated with increased physician comfort around systemic treatment decisions.
In a practice where Ki67 is routinely available, addition of Magee Equations into routine clinic practice was not associated with a reduction in Oncotype DX use. Availability of both Ki67 and Magee Equations did however increase physician comfort with systemic therapy decisions.
三个马吉方程利用常见的临床病理信息(肿瘤大小、分级、雌激素受体、孕激素受体、人表皮生长因子受体2和Ki67)对Oncotype DX复发评分进行估计。我们评估了将马吉方程纳入常规临床实践是否会影响Oncotype DX检测申请的频率。
将新诊断的、腋窝淋巴结阴性、激素受体阳性且人表皮生长因子受体2阴性的浸润性乳腺癌患者随机分组,一组进行马吉计算,另一组不进行。在首次临床评估时,为肿瘤学家提供所有常规可得的临床病理信息(包括Ki67),同时提供或不提供马吉方程的结果。主要结局是Oncotype DX检测的频率。次要结局包括化疗使用频率、放疗或全身治疗开始时间。还评估了医生对全身治疗选择以及Ki67和马吉方程使用的满意度。
有175例随机分组患者的数据,84例(48%)进行了马吉方程计算,91例(52%)未进行。马吉组和无马吉组中分别有10例(12.05%)和13例(14.44%)进行了Oncotype DX检测(相对危险度0.83,0.39 - 1.80;P = 0.64)。随机分组的两组在任何次要结局方面均无统计学或临床显著差异。Ki67和马吉方程的可得性与医生在全身治疗决策方面更高的满意度相关。
在常规可得Ki67的临床实践中,将马吉方程纳入常规临床实践与Oncotype DX检测的减少无关。然而,Ki67和马吉方程的可得性确实提高了医生在全身治疗决策方面的满意度。