Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER plus ) node-negative breast cancer
Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER plus ) node-negative breast cancer
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DOI：
10.1093/annonc/mdr278
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发表时间：
2012-03-01
影响因子：
50.5
通讯作者：
Lluch, A.
中科院分区：
文献类型：
--
作者：
Albanell, J.;Gonzalez, A.;Lluch, A.
背景资料：本研究探讨了西班牙乳腺癌患者的复发评分（RS）的影响，并探讨了临床病理标志物和治疗recommendations.Patients和方法的变化的可能性之间的关联：登记连续提供符合条件的女性雌激素受体阳性，人表皮生长因子受体2阴性，淋巴结阴性乳腺癌。肿瘤学家记录的治疗建议和信心，在它之前和之后知道病人的RS.Results：治疗建议改变了32%的107例患者入组：在21%从化疗激素（CHT）激素治疗（HT）和11%从HT CHT。RS与从HT到CHT（P < 0.001）和从CHT到HT（P < 0.001）的可能性相关。肿瘤学家对治疗建议的信心增加了60%。肿瘤分级较高（P = 0.007）和高增殖指数（Ki-67）（P = 0.023）与HT向CHT转变的机会显著相关，而孕酮受体阳性状态（P = 0.002），从CHT转变为HT的概率更大。第一项前瞻性欧洲研究的结果与欧洲临床实践指南中提出的RS的已发表经验和使用一致，并提供了关于Oncotype DX和临床病理因素如何互补的证据并且可以改进患者选择。
Background: This study examined the impact of the Recurrence Score (RS) in Spanish breast cancer patients and explored the associations between clinicopathological markers and likelihood of change in treatment recommendations.Patients and methods: Enrollment was offered consecutively to eligible women with estrogen receptor-positive; human epidermal growth factor receptor 2-negative, node-negative breast cancer. Oncologists recorded treatment recommendation and confidence in it before and after knowing the patient's RS.Results: Treatment recommendation changed in 32% of 107 patients enrolled: in 21% from chemohormonal (CHT) to hormonal therapy (HT) and in 11% from HT to CHT. RS was associated with the likelihood of change from HT to CHT (P < 0.001) and from CHT to HT (P < 0.001). Confidence of oncologists in treatment recommendations increased for 60% of cases. Higher tumor grade (P = 0.007) and a high proliferative index (Ki-67) (P = 0.023) were significantly associated with a greater chance of changing from HT to CHT, while positive progesterone receptor status (P = 0.002) with a greater probability of changing from CHT to HT.Conclusions: Results from the first prospective European study are consistent with published experience and use of the RS as proposed in European clinical practice guidelines and provide evidence on how Oncotype DX and clinicopathological factors are complementary and patient selection may be improved.