Anne-Vibeke Lænkholm, Jens Ole Eriksen, and Torben Kibøl, Zealand University Hospital, Slagelse; Maj-Britt Jensen, Ann S. Knoop, Maj-Lis Møller Talman, and Bent Ejlertsen, Rigshospitalet, Copenhagen; Birgitte Bruun Rasmussen, Herlev Hospital, Herlev; Anne Marie Bak Jylling, Odense University Hospital, Odense; Tomasz Piotr Tabor, Vejle Hospital, Vejle, Denmark; Wesley Buckingham, Sean Ferree, Carl Schaper, and Taryn Haffner, NanoString Technologies, Seattle, WA; and Torsten O. Nielsen, University of British Columbia, Vancouver, British Columbia, Canada.
J Clin Oncol. 2018 Mar 10;36(8):735-740. doi: 10.1200/JCO.2017.74.6586. Epub 2018 Jan 25.
Purpose The PAM50-based Prosigna risk of recurrence (ROR) score has been validated in randomized clinical trials to predict 10-year distant recurrence (DR). The value of Prosigna for predicting DR was examined in a comprehensive nationwide Danish cohort consisting of postmenopausal women with hormone receptor-positive early breast cancer treated with 5 years of endocrine therapy alone. Patients and Methods Using the population-based Danish Breast Cancer Cooperative Group database, follow-up data were collected on all patients diagnosed from 2000 through 2003 who, by nationwide guidelines, were treated with endocrine therapy for 5 years. Primary tumor blocks from 2,740 patients were tested with Prosigna and, after determination of human epidermal growth factor receptor 2 (HER2) status, data from 2,558 hormone receptor-positive/HER2-negative samples were analyzed, including 1,395 node-positive patients. Fine and Gray models were applied to determine the prognostic value of ROR for DR. Results Median follow-up for recurrence was 9.2 years. Twenty-six percent of the node-positive patients were classified as low ROR (n = 359) with a DR risk of 3.5% (95% confidence interval [CI], 1.9% to 6.1%) versus a DR risk of 22.1% (95% CI, 18.6% to 25.8%) at 10 years for patients classified as high ROR (n = 648). Node-negative patients classified as low and high ROR had a risk of DR of 5.0% (95% CI, 2.9% to 8.0%) and 17.8% (95% CI, 14.0% to 22.0%), respectively. Luminal B tumors (n = 947; DR risk, 18.4% [95% CI: 15.7% to 21.3%]) had a significantly worse outcome than luminal A tumors (n = 1,474,;DR risk, 7.6% [95% CI: 6.1% to 9.2%]; P < .001). Conclusion Prosigna ROR score improved the prediction of outcome in this nationwide Danish population. In a real-world setting, Prosigna can reliably identify node-negative patients and a significant proportion of patients with one to three positive nodes who can be spared treatment with adjuvant chemotherapy.
基于 PAM50 的 Prosigna 复发风险 (ROR) 评分已在随机临床试验中得到验证，可预测 10 年远处复发 (DR)。本研究旨在全面考察 Prosigna 在丹麦全国激素受体阳性早期乳腺癌队列中的预测价值，该队列患者接受单纯内分泌治疗 5 年。
使用基于人群的丹麦乳腺癌合作组数据库，收集了 2000 年至 2003 年期间诊断的所有患者的随访数据。根据全国指南，这些患者接受了 5 年的内分泌治疗。对 2740 例患者的原发性肿瘤块进行了 Prosigna 检测，在确定人表皮生长因子受体 2 (HER2) 状态后，对 2558 例激素受体阳性/HER2 阴性样本（包括 1395 例淋巴结阳性患者）的数据进行了分析。应用 Fine 和 Gray 模型确定 ROR 对 DR 的预后价值。
中位随访时间为复发时间 9.2 年。26%的淋巴结阳性患者被分为低 ROR（n=359），10 年时 DR 风险为 3.5%（95%CI，1.9%至 6.1%），而高 ROR（n=648）患者的 DR 风险为 22.1%（95%CI，18.6%至 25.8%）。淋巴结阴性患者分为低和高 ROR 后，DR 风险分别为 5.0%（95%CI，2.9%至 8.0%）和 17.8%（95%CI，14.0%至 22.0%）。Luminal B 型肿瘤（n=947；DR 风险，18.4%[95%CI：15.7%至 21.3%]）的结局明显差于 Luminal A 型肿瘤（n=1474；DR 风险，7.6%[95%CI：6.1%至 9.2%]；P<.001）。
在本丹麦全国人群中，Prosigna ROR 评分提高了对结局的预测。在实际环境中，Prosigna 可以可靠地识别淋巴结阴性患者和相当比例的 1 至 3 个阳性淋巴结患者，使这些患者避免接受辅助化疗。
