Zhang Y N, Zhou Y D, Mao F, Sun Q
Neoplasma. 2015;62(4):658-65. doi: 10.4149/neo_2015_079.
The 21-Gene Recurrence Score Assay has been intensively studied and recommended by major guidelines for treatment decision in early breast cancer. Its impact in adjuvant chemotherapy selection for Chinese population has not been revealed.The prospective part of this study enrolled consecutive node-negative, hormone receptor-positive patients who underwent 21-gene RS testing at Breast Surgery Department of PUMCH (n=134) between May 2012 and August 2013(21-gene RS group). Risk categories were assigned based on the RS and on standard clinicopathologic criteria according to St. Gallen and Adjuvant! Online. The chemotherapy selection and the oncologists' confidence in decision-making before and after RS testing were recorded. The retrospective part of this study compared the chemotherapy decision in the 21-gene RS group and a control group without RS testing (diagnosed between Jan 2011 and Apr 2012,n=170). A total of 304 patients were included in the analysis (134 21-gene RS group, 170 controls). Based on RS, 97 patients were classified as low risk, 29 patients as intermediate risk, and 8 patients as high risk. Tumor grade (P=0.002), PR expression (P<0.001) and Ki-67 index (P<0.001) were significantly different between the 3 risk cohorts.Comparing the St. Gallen guidelines and RS, there was a 41% concordance between risk groups. By using Adjuvant! Online, the correlation between the predicted BCSM and RS was nominal (r=0.10). A total of 29% 21-gene RS group patients changed their treatment decisions after RS testing (P<0.001, 95% CI, 0.18 to 0.49) with 6% (8/134) patients changing to receive chemotherapy besides endocrine therapy and 23% (31/134) changing to reject chemotherapy. After RS testing, more than one half of the oncologists increased their confidence level in treatment recommendation. In the control group, 67.6% (115/170) patients chose chemotherapy plus endocrine therapy. The chemotherapy percentage was much higher than that of 21-gene RS group (30/134, 22%).This is the first study to demonstrate a reduction in the use of adjuvant chemotherapy in women with node-negative hormone receptor-positive breast cancer, based on use of the RS. The RS had an impact on the physicians' treatment decision-making.
21基因复发评分检测已得到深入研究，并被各大指南推荐用于早期乳腺癌的治疗决策。其对中国人群辅助化疗选择的影响尚未明确。本研究的前瞻性部分纳入了2012年5月至2013年8月期间在中国医学科学院北京协和医院乳腺外科接受21基因复发评分（RS）检测的连续的淋巴结阴性、激素受体阳性患者（n = 134）（21基因RS组）。根据RS以及圣加仑和辅助治疗在线的标准临床病理标准对风险类别进行划分。记录RS检测前后的化疗选择以及肿瘤学家的决策信心。本研究的回顾性部分比较了21基因RS组与未进行RS检测的对照组（2011年1月至2012年4月期间诊断，n = 170）的化疗决策。共有304例患者纳入分析（134例21基因RS组，170例对照组）。根据RS，97例患者被分类为低风险，29例为中风险，8例为高风险。3个风险队列之间的肿瘤分级（P = 0.002）、PR表达（P < 0.001）和Ki-67指数（P < 0.001）存在显著差异。比较圣加仑指南和RS，风险组之间的一致性为41%。通过使用辅助治疗在线，预测的保乳手术、化疗和放疗（BCSM）与RS之间的相关性较弱（r = 0.10）。21基因RS组共有29%的患者在RS检测后改变了治疗决策（P < 0.001，95%CI，0.18至0.49），其中6%（8/134）的患者除接受内分泌治疗外改为接受化疗，23%（31/134）的患者改为拒绝化疗。RS检测后，超过一半的肿瘤学家对治疗建议的信心水平有所提高。在对照组中，67.6%（115/170）的患者选择化疗加内分泌治疗。化疗比例远高于21基因RS组（30/134，22%）。这是第一项基于RS使用证明淋巴结阴性激素受体阳性乳腺癌女性辅助化疗使用减少的研究。RS对医生的治疗决策产生了影响。
