过去,乳腺癌治疗主要根据雌激素受体状态,如果肿瘤细胞核雌激素受体免疫组织化学染色阳性比例≥10%,被认为雌激素受体阳性,符合内分泌治疗指征。对于雌激素受体阳性乳腺癌,内分泌治疗5年与2~3年相比,患者生存显著获益。不过,美国临床肿瘤学会和美国病理学会于2020年联合更新了乳腺癌雌激素和孕激素受体检测指南,将肿瘤细胞核雌激素受体免疫组织化学染色阳性比例仅1%~10%归入新的报告分类:雌激素受体弱阳性。目前,针对雌激素受体弱阳性乳腺癌的临床研究数据样本量较小且互相矛盾,尚不明确该亚组是否仍需5年内分泌治疗。 2022年2月25日,美国癌症学会《癌症》在线发表复旦大学附属肿瘤医院蔡毓文、邵志敏、余科达等学者的研究报告,对雌激素受体弱阳性乳腺癌术后5年与2~3年辅助内分泌治疗的患者结局进行了比较。 该研究对复旦大学附属肿瘤医院前瞻维护的乳腺外科患者随访数据库进行倾向匹配分析,主要终点为无病生存。通过多因素比例风险回归模型分析和倾向评分匹配,对患者年龄、肿瘤大小、淋巴结转移与否、肿瘤分级、HER2阳性与否、术后辅助化疗与否、术后辅助放疗与否、术后辅助内分泌疗程等其他影响因素进行校正和匹配,计算无病生存风险比及其95%置信区间。全部统计学检验均为双侧。 结果,2012~2017年连续2万2768例女性经病理证实有早期乳腺癌,其中1013例(4.45%)为雌激素受体弱阳性。 随后,剔除原位癌82例、进展癌67例、数据不完整59例,内分泌治疗不规范138例、其他原因33例,将其余634例患者分为3组:
中位随访65个月,内分泌治疗2~3年与5年的患者相比,无病生存无显著差异(风险比:0.82,95%置信区间:0.51~1.33,P=0.43)。 对倾向评分匹配样本进行多因素比例风险回归模型分析,内分泌治疗5年与2~3年的患者相比,无病生存仍无显著差异(风险比:0.74,95%置信区间:0.41~1.31,P=0.30)。 因此,该单中心小样本回顾研究结果表明,2~3年短期内分泌治疗可能作为雌激素受体弱阳性乳腺癌患者的选择之一,或可取代5年治疗标准,故有必要进一步开展多中心大样本前瞻研究进行验证。 对此,美国癌症学会《癌症》编委、美国威斯康星大学教授卡丽·威辛斯基等学者发表同期社论:雌激素受体弱阳性乳腺癌内分泌治疗简化,与内分泌治疗强化之战。本文还被美国癌症学会《癌症》官方推特转发: 相关链接 Cancer. 2022 Feb 25. Online ahead of print. De-escalation of five-year adjuvant endocrine therapy in patients with estrogen receptor-low positive (immunohistochemistry staining 1%-10%) breast cancer: Propensity-matched analysis from a prospectively maintained cohort. Cai YW, Shao ZM, Yu KD. Fudan University Shanghai Cancer Center, Shanghai, China; Shanghai Medical College, Fudan University, Shanghai, China; Shanghai Key Laboratory of Breast Cancer, Shanghai, China. BACKGROUND: The standard 5 years of endocrine therapy has demonstrated additional benefits compared with short-term (2-3 years) treatment in patients with estrogen receptor (ER)-positive breast cancer; however, data specific to ER-low positive breast cancer (1%-10% by immunohistochemistry) are limited, and it is unclear whether long-term treatment is still necessary for this subgroup. METHODS: The authors used the prospectively maintained Breast Surgery Database of Fudan University Shanghai Cancer Center for this propensity-matched analysis. The primary end point was disease-free survival. Multivariate Cox regression analysis and propensity score-matching methods were used to minimize bias. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated. All statistics were 2-sided. RESULTS: From 2012 to 2017, 22,768 consecutive women had pathologically confirmed, early stage breast cancer, and 1013 (4.45%) were identified with ER-low positive disease. Among these, 634 patients met the inclusion criteria and were divided into 3 groups: those who received no endocrine therapy (n = 89), those who received 2 to 3 years of endocrine therapy (n = 185), and those who received approximately 5 years of endocrine therapy (n = 360). At a median follow-up of 65 months, there was no significant difference in disease-free survival between patients who received 2 to 3 years and 5 years of endocrine therapy (HR, 0.82; 95% CI, 0.51-1.33; P = .43). The findings were consistent after multivariate Cox analysis of the propensity score-matched samples (5 vs 2-3 years of treatment: HR, 0.74; 95% CI, 0.41-1.31; P = .30). CONCLUSIONS: Short-term endocrine therapy for 2 to 3 years might be an alternative for patients who have ER-low positive breast cancer instead of the standard 5 years of treatment. KEYWORDS: breast cancer; endocrine therapy; estrogen receptor low-positive; short-term. PMID: 35213037 DOI: 10.1002/cncr.34155 2021版CBCS指南与规范完整版 2021版CBCS指南与规范精编版 |
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