Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study.
Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study.
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DOI：
10.1038/npjbcancer.2016.17
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发表时间：
2016
影响因子：
5.9
通讯作者：
Shak S
中科院分区：
文献类型：
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作者：
Petkov VI;Miller DP;Howlader N;Gliner N;Howe W;Schussler N;Cronin K;Baehner FL;Cress R;Deapen D;Glaser SL;Hernandez BY;Lynch CF;Mueller L;Schwartz AG;Schwartz SM;Stroup A;Sweeney C;Tucker TC;Ward KC;Wiggins C;Wu XC;Penberthy L;Shak S
在激素受体阳性(HR+)浸润性乳腺癌中，21基因复发评分分析被证实可以预测复发风险和化疗益处。为了通过基线复发评分结果和临床协变量确定预期的乳腺癌特异性死亡率(BCSM)结果，美国国家癌症研究所与基因组健康和14个基于人群的登记机构在监测、流行病学和最终结果(SEER)计划中合作，以电子方式补充癌症监测数据的复发评分结果。预先指定的主要分析队列年龄为40-84岁，在2004年1月至2011年12月期间在整个SEER人群中诊断为淋巴结阴性、HR+、HER2阴性、非转移性疾病，并有复发评分结果(N=38,568)。未调整的5年BCSM分别为0.4%(n=21,023；95%可信区间，0.3-0.6%)、1.4%(n=14,494；95%CI，1.1-1.7%)和4.4%(n=3,051；95%CI，3.4-5.6%)(P<；0.001)。在对年龄、肿瘤大小、分级和种族进行调整的多变量分析中，复发评分结果预测了良性脊髓瘤(P<；0.001)。在淋巴结阳性患者(微转移和最多3个阳性淋巴结；N=4,691)中，5年复发率分别为1.0%(n=2,694；95%CI，0.5~2.0%)、2.3%(n=1,669；95%CI，1.3~4.1%)和14.3%(n=328；95%CI，8.4~23.8%)；18、18~30、⩾31组(P<；0.001)。根据复发评分分组，报告了重要患者亚组的5年BCSM，包括年龄、种族、肿瘤大小、分级和社会经济状况。这项SEER研究是基于复发评分结果对HR+、HER2阴性、结节阴性或结节阳性乳腺癌患者的预期BCSM结果的最大报告，包括临床试验中经常代表不足的亚组。
The 21-gene Recurrence Score assay is validated to predict recurrence risk and chemotherapy benefit in hormone-receptor-positive (HR+) invasive breast cancer. To determine prospective breast-cancer-specific mortality (BCSM) outcomes by baseline Recurrence Score results and clinical covariates, the National Cancer Institute collaborated with Genomic Health and 14 population-based registries in the the Surveillance, Epidemiology, and End Results (SEER) Program to electronically supplement cancer surveillance data with Recurrence Score results. The prespecified primary analysis cohort was 40–84 years of age, and had node-negative, HR+, HER2-negative, nonmetastatic disease diagnosed between January 2004 and December 2011 in the entire SEER population, and Recurrence Score results (N=38,568). Unadjusted 5-year BCSM were 0.4% (n=21,023; 95% confidence interval (CI), 0.3–0.6%), 1.4% (n=14,494; 95% CI, 1.1–1.7%), and 4.4% (n=3,051; 95% CI, 3.4–5.6%) for Recurrence Score <18, 18–30, and ⩾31 groups, respectively (P<0.001). In multivariable analysis adjusted for age, tumor size, grade, and race, the Recurrence Score result predicted BCSM (P<0.001). Among patients with node-positive disease (micrometastases and up to three positive nodes; N=4,691), 5-year BCSM (unadjusted) was 1.0% (n=2,694; 95% CI, 0.5–2.0%), 2.3% (n=1,669; 95% CI, 1.3–4.1%), and 14.3% (n=328; 95% CI, 8.4–23.8%) for Recurrence Score <18, 18–30, ⩾31 groups, respectively (P<0.001). Five-year BCSM by Recurrence Score group are reported for important patient subgroups, including age, race, tumor size, grade, and socioeconomic status. This SEER study represents the largest report of prospective BCSM outcomes based on Recurrence Score results for patients with HR+, HER2-negative, node-negative, or node-positive breast cancer, including subgroups often under-represented in clinical trials.