Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
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DOI：
10.1016/s1470-2045(09)70314-6
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发表时间：
2010-01
期刊：
影响因子：
51.1
通讯作者：
Hayes, Daniel F.
中科院分区：
文献类型：
--
作者：
Albain, Kathy S.;Barlow, William E.;Shak, Steven;Hortobagyi, Gabriel N.;Livingston, Robert B.;Yeh, I-Tien;Ravdin, Peter;Bugarini, Roberto;Boehner, Frederick L.;Davidson, Nancy E.;Sledge, George W.;Winer, Eric P.;Hudis, Clifford;Ingle, James N.;Perez, Edith A.;Pritchard, Kathleen I.;Shepherd, Lois;Gralow, Julie R.;Yoshizawa, Carl;Allred, D. Craig;Osborne, C. Kent;Hayes, Daniel F.
21基因复发评分测定（RS）可用于经他莫昔芬治疗的淋巴结阴性、雌激素受体（ER）阳性乳腺癌（BC）患者的预后。低RS预示着化疗的益处不大。对于淋巴结阳性的BC，我们研究了单独接受他莫昔芬治疗的女性是否有RS预后，以及它是否确定了那些尽管复发风险较高但可能无法从蒽环类化疗中获益的女性。针对淋巴结阳性，er阳性BC的绝经后妇女的III期试验S8814显示，在他莫昔芬（caft）之前进行CAF化疗比单独使用他莫昔芬增加了生存益处。可选的肿瘤库产生用于RT-PCR测定RS的标本。采用Cox回归校正阳性淋巴结数，我们评估了RS对治疗组（他莫昔芬vs cat - t）无病生存（DFS）的影响。有367个标本（占母试验的40%）具有足够的RNA（他莫昔芬，148;caft, 219）。他莫昔芬组RS与预后有关（p=0.006）。低RS组没有CAF获益（logrank p=0.97； HR=1.02, 95% CI(0.54,1.93)），但在调整阳性节点数后，高RS组的DFS显著改善（logrank p= 0.03； HR=0.59, 95% CI(0.35, 1.01)）。rs -治疗的相互作用在前5年是显著的（p=0.029）， 5年后没有额外的预测（p=0.58），尽管累积获益保持在10年。总生存期和bc特异性生存期的结果相似。在这项回顾性分析中，RS是他莫昔芬治疗的淋巴结阳性患者的预后指标，并预测高RS肿瘤的显著CAF获益。低RS表明，尽管淋巴结阳性，但可能无法从蒽环类药物化疗中获益。
The 21-gene Recurrence Score assay (RS) is prognostic for women with node-negative, estrogen receptor (ER)-positive breast cancer (BC) treated with tamoxifen. A low RS predicts little benefit of chemotherapy. For node-positive BC, we investigated whether RS was prognostic in women treated with tamoxifen alone and whether it identified those who might not benefit from anthracycline-based chemotherapy, despite higher recurrence risks. The phase III trial S8814 for postmenopausal women with node-positive, ER-positive BC showed that CAF chemotherapy prior to tamoxifen (CAF-T) added survival benefit to tamoxifen alone. Optional tumor banking yielded specimens for RS determination by RT-PCR. We evaluated the effect of RS on disease-free survival (DFS) by treatment group (tamoxifen versus CAF-T) using Cox regression adjusting for number of positive nodes. There were 367 specimens (40% of parent trial) with sufficient RNA (tamoxifen, 148; CAF-T, 219). The RS was prognostic in the tamoxifen arm (p=0.006). There was no CAF benefit in the low RS group (logrank p=0.97; HR=1.02, 95% CI (0.54,1.93)), but major DFS improvement for the high RS subset (logrank p=.03; HR=0.59, 95% CI (0.35, 1.01)), adjusting for number of positive nodes. The RS-by-treatment interaction was significant in the first 5 years (p=0.029), with no additional prediction beyond 5 years (p=0.58), though the cumulative benefit remained at 10 years. Results were similar for overall survival and BC-specific survival. In this retrospective analysis, the RS is prognostic for tamoxifen-treated patients with positive nodes and predicts significant CAF benefit in tumors with a high RS. A low RS identifies women who may not benefit from anthracycline-based chemotherapy despite positive nodes.