Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer

Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer
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DOI:
10.1200/jco.2005.04.7985
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发表时间:
2006-08-10
影响因子:
45.3
通讯作者:
Wolmark, Norman
Wolmark, Norman
中科院分区:
医学1区
文献类型:
--
作者:
Paik, Soonmyung;Tang, Gong;Wolmark, Norman

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目的:21基因复发评分(RS)检测量化雌激素受体阳性、淋巴结阴性乳腺癌患者辅助三苯氧胺治疗后远处复发的可能性。RS和化疗的好处之间的关系是未知的。方法RS测量肿瘤的他莫昔芬治疗和他莫昔芬加化疗治疗的患者在国家外科辅助乳腺和肠道项目(NSABP)B20试验。考克斯比例风险模型被用来测试化疗治疗和RS之间的相互作用。结果共651例患者进行评估(227随机分配到他莫昔芬和424随机分配到他莫昔芬加化疗)。化疗治疗和RS之间相互作用的检验具有统计学显著性(P = 0.038)。高RS(≥ 31)肿瘤(即复发风险高)患者从化疗中获益较大(相对风险为0.26; 95%CI为0.13 - 0.53; 10年远处复发率绝对降低:平均0.27.6%; SE为8.0%)。低RS(< 18)肿瘤患者从化疗中获益最小(如果有的话)(相对风险,1.31; 95%CI,0.46 - 3.78; 10年时远端复发率绝对降低:平均值,-1.1%; SE,2.2%)。中间RS肿瘤患者似乎没有一个大的好处,但在估计的不确定性不能排除临床上重要的benefit.Conclusion的RS检测不仅量化的可能性乳腺癌复发的妇女与淋巴结阴性,雌激素受体阳性乳腺癌,但也预测化疗的好处的大小。
Purpose The 21-gene recurrence score (RS) assay quantifies the likelihood of distant recurrence in women with estrogen receptor-positive, lymph node-negative breast cancer treated with adjuvant tamoxifen. The relationship between the RS and chemotherapy benefit is not known.Methods The RS was measured in tumors from the tamoxifen-treated and tamoxifen plus chemotherapy-treated patients in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B20 trial. Cox proportional hazards models were utilized to test for interaction between chemotherapy treatment and the RS.Results A total of 651 patients were assessable (227 randomly assigned to tamoxifen and 424 randomly assigned to tamoxifen plus chemotherapy). The test for interaction between chemotherapy treatment and RS was statistically significant (P = .038). Patients with high-RS (>= 31) tumors (ie, high risk of recurrence) had a large benefit from chemotherapy (relative risk, 0.26; 95% CI, 0.13 to 0.53; absolute decrease in 10-year distant recurrence rate: mean,.27.6%; SE, 8.0%). Patients with low-RS (< 18) tumors derived minimal, if any, benefit from chemotherapy treatment (relative risk, 1.31; 95% CI, 0.46 to 3.78; absolute decrease in distant recurrence rate at 10 years: mean, -1.1%; SE, 2.2%). Patients with intermediate-RS tumors did not appear to have a large benefit, but the uncertainty in the estimate can not exclude a clinically important benefit.Conclusion The RS assay not only quantifies the likelihood of breast cancer recurrence in women with node-negative, estrogen receptor-positive breast cancer, but also predicts the magnitude of chemotherapy benefit.