Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection
Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection
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DOI：
10.1200/jco.2008.20.2119
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发表时间：
2010-04-01
影响因子：
45.3
通讯作者：
Albain, Kathy S.
中科院分区：
文献类型：
--
作者：
Lo, Shelly S.;Mumby, Patricia B.;Albain, Kathy S.
目的21基因复发评分(RS)分析已被证实可用于量化接受他莫昔芬治疗的淋巴结阴性、雌激素受体阳性的乳腺癌患者的远处复发风险，并预测化疗受益的程度。这项多中心研究旨在前瞻性地检查RS是否影响医生和患者的辅助治疗选择和满意度。患者和方法在获得21基因RS分析之前和之后，医学肿瘤学家陈述了他们的辅助治疗建议和对它的信心。患者还表明了他们在RS检测前后的治疗选择。患者完成了决策冲突、焦虑和生活质量的测量。结果来自一个社区和三个学术机构的17名内科肿瘤学家连续招募了89名可评估的患者。28名患者(31.5%)的肿瘤内科医生治疗建议发生了变化。24名患者(27%)改变了治疗决定。RS结果后最大的变化是20例(22.5%)从内科肿瘤学家试验前建议的化疗加激素治疗(CHT)转为试验后建议激素治疗(HT)。9例(10.1%)患者的治疗决定由CHT改为HT。RS结果增加了68例(76%)肿瘤内科医生对他们的治疗建议的信心。患者焦虑和决策冲突在RS结果后显著降低。结论本研究结果表明RS分析影响肿瘤内科医生辅助治疗建议、患者治疗选择和患者焦虑。J Clin Oncol28：1671-1676。(C)2010年美国临床肿瘤学会
PurposeThe 21-gene Recurrence Score (RS) assay has been validated to quantify the risk of distant recurrence in tamoxifen-treated patients with lymph node-negative, estrogen receptor-positive breast cancer and predict magnitude of chemotherapy benefit. This multicenter study was designed to prospectively examine whether RS affects physician and patient adjuvant treatment selection and satisfaction.Patients and MethodsBefore and after obtaining the 21-gene RS assay, medical oncologists stated their adjuvant treatment recommendation and confidence in it. Patients also indicated their treatment choice pre- and post-RS assay. Patients completed measures for decisional conflict, anxiety, and quality of life.ResultsSeventeen medical oncologists at one community and three academic practices consecutively enrolled 89 assessable patients. The medical oncologist treatment recommendation changed for 28 patients (31.5%). Twenty-four patients (27%) changed their treatment decision. The largest change after the RS results was conversion from the medical oncologist's pretest recommendation for chemotherapy plus hormonal therapy (CHT) to post-test recommendation for hormone therapy (HT) in 20 cases (22.5%). Nine patients (10.1%) changed their treatment decision from CHT to HT. RS results increased medical oncologist confidence in their treatment recommendation in 68 cases (76%). Patient anxiety and decisional conflict were significantly lower after RS results.ConclusionThe results of this study indicate that the RS assay impacts medical oncologist adjuvant treatment recommendations, patient treatment choice, and patient anxiety. J Clin Oncol 28: 1671-1676. (C) 2010 by American Society of Clinical Oncology