A Validated Model for Identifying Patients Unlikely to Benefit From the 21-Gene Recurrence Score Assay.
A Validated Model for Identifying Patients Unlikely to Benefit From the 21-Gene Recurrence Score Assay.
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DOI：
10.1016/j.clbc.2015.04.006
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发表时间：
2015-12
影响因子：
3.1
通讯作者：
Tafra L
中科院分区：
文献类型：
--
作者：
Gage MM;Rosman M;Mylander WC;Giblin E;Kim HS;Cope L;Umbricht C;Wolff AC;Tafra L
预测早期乳腺癌的复发风险和化疗获益具有挑战性。经常使用 Oncotype DX 基因检测。使用 221 名患者的数据库开发了一个简单的 2 规则模型，并在 319 名患者的独立组上进行了验证。该模型对不太可能从测试中受益的患者进行分类，从而显着避免了成本。预测早期乳腺癌的复发风险和化疗益处可能具有挑战性，Oncotype DX (ODX) 通常用于获得洞察力。然而，目前尚不清楚 ODX 是否能在所有情况下受益。为了阐明 ODX 的有用性，我们试图使用现成的病理标记物开发一个模型，以帮助临床医生做出决定。使用 221 名激素受体阳性、HER2 阴性浸润性乳腺癌患者的临床病理数据创建了一个模型。然后该模型在第二个机构的 319 名患者身上进行了验证。该模型有 2 个简单规则：低级别和阳性孕激素受体肿瘤 (LG+PR) 为低风险，高级别或低雌激素受体 (ER) (ER < 20%) 肿瘤 (HG/LER) 为高风险。 TAILORx（试验分配个体化治疗方案（Rx））试验阈值复发评分（RS）≤10（当化疗几乎没有益处时）和RS≥26（当化疗可能有益时）用于判断模型性能。令人印象深刻的是，RS ≤ 10 的 HG/LER 患者的错误分类分别为 0% 和 2%，RS ≥ 26 的 LG+PR 患者的错误分类分别为 0% 和 2.6%。在验证集中，28%（232 人中的 66 人）的不确定组（HG/LER 和 LG + PR 组中都没有）的 RS ≤ 10 或 RS ≥ 26；该群体可能在临床上受益于 ODX。基于现成的病理数据开发并验证了一个简单的 2 规则模型，该模型将患者分为高复发风险和低复发风险。识别不太可能从 ODX 检测中受益的患者可能会导致显着的成本避免。
Predicting recurrence risk and chemotherapy benefit in early-stage breast cancer is challenging. The Oncotype DX gene assay is often used. Using a database of 221 patients a simple 2-rule model was developed and validated on an independent group of 319 patients. The model categorizes patients unlikely to benefit from the test thus achieving significant avoidance of cost. Predicting recurrence risk and chemotherapy benefit in early-stage breast cancer can be challenging, and Oncotype DX (ODX) is often used to gain insight. However, it is still unclear whether ODX can benefit in all cases. To clarify ODX’s usefulness we sought to develop a model using readily available pathologic markers to help clinicians make that determination. Clinical pathologic data from 221 hormone receptor-positive, HER2-negative invasive breast cancer patients was used to create a model. The model was then validated on a second institution’s set of 319 patients. The model has 2 simple rules: low grade and positive progesterone receptor tumors (LG+PR) are low risk, and high grade or low estrogen receptor (ER) (ER < 20%) tumors (HG/LER) are high risk. The TAILORx (Trial Assigning Individualized Options for Treatment (Rx)) trial thresholds of Recurrence Score (RS) ≤ 10, when chemotherapy is of little benefit, and RS ≥ 26 when chemotherapy might be beneficial were used to judge model performance. Impressively, the misclassifications of an HG/LER patient who has an RS ≤ 10 were 0% and 2%, and for LG+PR patients who had an RS ≥ 26 were 0% and 2.6%. In the validation set, 28% (66 of 232) of the indeterminate group (neither in the HG/LER nor the LG + PR groups) had an RS ≤ 10 or an RS ≥ 26; this group might clinically benefit from ODX. A simple 2-rule model based on readily available pathologic data was developed and validated, which categorized patients into high and low risk for recurrence. Identification of patients who are unlikely to benefit from ODX testing could result in significant cost avoidance.