Paik Soonmyung, Tang Gong, Shak Steven, Kim Chungyeul, Baker Joffre, Kim Wanseop, Cronin Maureen, Baehner Frederick L, Watson Drew, Bryant John, Costantino Joseph P, Geyer Charles E, Wickerham D Lawrence, Wolmark Norman
Division of Pathology, Operations Center, and Biostatistical Center, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA 15212, USA.
J Clin Oncol. 2006 Aug 10;24(23):3726-34. doi: 10.1200/JCO.2005.04.7985. Epub 2006 May 23.
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.
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.
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 (> or = 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.
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.
21基因复发评分（RS）检测可量化接受辅助他莫昔芬治疗的雌激素受体阳性、淋巴结阴性乳腺癌女性远处复发的可能性。RS与化疗获益之间的关系尚不清楚。
在国家外科辅助乳腺和肠道项目（NSABP）B20试验中，对接受他莫昔芬治疗和他莫昔芬加化疗治疗的患者的肿瘤进行RS检测。采用Cox比例风险模型检验化疗治疗与RS之间的相互作用。
共有651例患者可评估（227例随机分配至他莫昔芬组，424例随机分配至他莫昔芬加化疗组）。化疗治疗与RS之间的相互作用检验具有统计学意义（P = 0.038）。RS高（≥31）的肿瘤患者（即复发风险高）从化疗中获益显著（相对风险，0.26；95%可信区间，0.13至0.53；10年远处复发率的绝对降低：平均值，27.6%；标准误，8.0%）。RS低（<18）的肿瘤患者从化疗治疗中获益极小（相对风险，1.31；95%可信区间，0.46至3.78；10年远处复发率的绝对降低：平均值，-1.1%；标准误，2.2%）。RS中等的肿瘤患者似乎没有显著获益，但估计值的不确定性不能排除临床重要获益。
RS检测不仅可量化淋巴结阴性、雌激素受体阳性乳腺癌女性乳腺癌复发的可能性，还可预测化疗获益的程度。
