编者按：根据与乳腺癌相关的50个基因表达谱（PAM50）对复发风险进行评分，已被随机临床研究证实可以预测10年远处复发，但是对于“真实世界”的预测效果尚不明确。
2018年1月25日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表丹麦哥本哈根大学、南丹麦大学、美国西雅图纳米串技术公司、加拿大不列颠哥伦比亚大学的“真实世界”研究报告，对PAM50复发风险评分预测丹麦全国绝经后女性队列激素受体阳性早期乳腺癌单用5年内分泌治疗的10年远处复发进行了验证。
该人群队列研究通过丹麦乳腺癌协作组数据库收集了2000年1月～2003年12月丹麦全国绝经后女性被诊断为激素受体阳性早期乳腺癌并根据全国指南接受5年内分泌治疗的患者随访数据，对2740例患者的原发肿瘤标本进行PAM50检测，并对其中2558例激素受体阳性且人表皮生长因子受体2（HER2）阴性患者进行统计学分析。通过竞争风险回归模型确定复发风险评分对远处复发的预后价值。
结果，经过中位随访9.2年：
对于1395例淋巴结阳性患者
359例（26%）复发风险评分低的实际10年远处复发风险低： 3.5%（95%置信区间： 1.9%～ 6.1%）
648例（46%）复发风险评分高的实际10年远处复发风险高：22.1%（95%置信区间，18.6%～25.8%）
对于1163例淋巴结阴性患者
复发风险评分低的实际10年远处复发风险低： 5.0%（95%置信区间： 2.9%～ 8.0%）
复发风险评分高的实际10年远处复发风险高：17.8%（95%置信区间：14.0%～22.0%）
对于2421例管腔型肿瘤
947例管腔B型肿瘤的实际10年远处复发风险高：18.4%（95%置信区间：15.7%～21.3%）
1474例管腔A型肿瘤的实际10年远处复发风险低： 7.6%（95%置信区间： 6.1%～ 9.2%，P<0.001）
因此，对于该丹麦全国人群，PAM50复发风险评分提高了结局预测水平。对于“现实世界”，PAM50能够可靠确定哪些淋巴结阴性患者和相当比例1～3个淋巴结阳性患者远处复发风险较低，不必接受辅助化疗。
J Clin Oncol. 2018 Jan 25. [Epub ahead of print]
PAM50 Risk of Recurrence Score Predicts 10-Year Distant Recurrence in a Comprehensive Danish Cohort of Postmenopausal Women Allocated to 5 Years of Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer.
Laenkholm AV, Jensen MB, Eriksen JO, Rasmussen BB, Knoop AS, Buckingham W, Ferree S, Schaper C, Nielsen TO, Haffner T, Kibol T, Moller Talman ML, Bak Jylling AM, Tabor TP, Ejlertsen B.
Zealand University Hospital, Slagelse; Rigshospitalet, Copenhagen; Herlev Hospital, Herlev; Odense University Hospital, Odense; Vejle Hospital, Vejle, Denmark; NanoString Technologies, Seattle, WA; University of British Columbia, Vancouver, British Columbia, Canada.
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.
PMID: 29369732
DOI: 10.1200/JCO.2017.74.6586
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