雌激素受体阳性早期乳腺癌女性的远处复发在诊断后 20 多年内以恒定的比率持续存在，而雌激素受体阴性乳腺癌的同等数据却很少。使用早期乳腺癌试验者合作组 (EBCTCG) 的数据库，我们研究了雌激素受体阳性和雌激素受体阴性肿瘤的远处乳腺癌复发率以及随时间推移的结果趋势。在这项随机对照试验的汇总分析中数据显示，EBCTCG 数据库中有超过 650000 名参与早期乳腺癌治疗试验的女性患者进行了资格筛查。如果女性在 1990 年至 2009 年间入组，新诊断出患有雌激素受体阳性乳腺癌并计划接受至少 5 年的内分泌治疗，或雌激素受体阴性疾病，并且诊断时年龄小于 75 岁，则符合资格。肿瘤直径小于或等于50毫米，腋窝淋巴结阳性少于10个，并且入口处没有远处转移的证据。新辅助治疗的试验，或辅助治疗不清楚的试验，以及患有雌激素受体阴性、孕激素受体阳性疾病的女性，或那些结果或基线数据缺失的女性被排除在外。主要结局是每项试验定义的首次远处复发的时间，忽略任何局部区域复发或对侧乳腺癌。使用根据患者和肿瘤特征、试验和分配治疗进行调整的 Cox 回归，比较不同诊断时期的 10 年远处复发风险。2023 年 1 月 17 日 EBCTCG 数据库中的 652 258 名早期乳腺癌女性中，患者-水平数据来自 151 项随机试验，其中包括 155 746 名女性。雌激素受体阳性和雌激素受体阴性肿瘤女性的远处肿瘤复发率也有类似的改善。雌激素受体阳性疾病的 80·5% 的改善和雌激素受体阴性疾病的 89·8% 的改善是通过患者和肿瘤特征的变化以及治疗的改进来解释的，但仍然显着 (p<0·0001) 。最近诊断的患者更有可能患有淋巴结阴性疾病。 1990-99 年与 2000-09 年的 10 年远处复发风险如下：对于淋巴结阴性疾病，雌激素受体阳性疾病分别为 10·1% 和 7·3%；对于淋巴结阴性疾病，分别为 18·3% 和 11·9%。雌激素受体阴性疾病；对于具有 1 至 3 个阳性淋巴结的疾病，雌激素受体阳性疾病为 19·9% 对比 14·7%，雌激素受体阴性疾病为 31·9% 对比 22·1%；对于有 4 至 9 个阳性淋巴结的疾病，雌激素受体阳性疾病为 39·6% 对比 28·5%，雌激素受体阴性疾病为 47·8% 对比 36·5%。调整治疗后，与 1990 年代相比，2000 年之后的发病率下降了 25%（雌激素受体阳性疾病）和 19%（雌激素受体阴性疾病），并且在 5 年后观察到雌激素受体阳性疾病也有类似的改善。试验结果的改善是由于更多患有低风险疾病的女性参加试验以及辅助治疗得到改善。调整后，2000 年以来确诊的女性远处复发率比 1990 年代低约五分之一。雌激素受体阳性疾病远处复发的长期风险仍然存在，但比我们之前的报告低约十分之一。英国癌症研究中心、英国医学研究理事会。版权所有 © 2024 作者。由 Elsevier Ltd 出版。这是一篇采用 CC BY 4.0 许可的开放获取文章。由爱思唯尔有限公司出版。保留所有权利。

Distant recurrence in women with oestrogen receptor-positive early breast cancer persists at a constant rate for more than 20 years after diagnosis, with little equivalent data for oestrogen receptor-negative breast cancer. Using the database of the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) we investigated rates of distant breast-cancer recurrence in oestrogen receptor-positive and oestrogen receptor-negative tumours and trends in outcomes over time.In this pooled analysis of randomised controlled trial data, patients in the EBCTCG database of more than 650 000 women in trials of treatment for early-stage breast cancer were screened for eligibility. Women were eligible if they were enrolled between 1990 and 2009 and newly diagnosed with oestrogen receptor-positive breast cancer and scheduled for at least 5 years of endocrine therapy, or oestrogen receptor-negative disease, and if they were younger than 75 years at diagnosis, had a tumour diameter of 50 mm or less, and fewer than ten positive axillary lymph nodes, and no evidence of distant metastases at entry. Trial of neoadjuvant therapy, or those in which adjuvant therapy was unclear, and women with oestrogen receptor-negative, progesterone receptor-positive disease, or those for whom outcome or baseline data were missing were excluded. The primary outcome was time to first distant recurrence as defined by each trial, ignoring any locoregional recurrence or contralateral breast cancer. 10-year risks of distant recurrence by period of diagnosis were compared using Cox regression adjusted for patient and tumour characteristics, trial, and assigned treatment.Of the 652 258 women with early breast cancer in the EBCTCG database on Jan 17, 2023, patient-level data were available from 151 randomised trials that included 155 746 women. Rates of distant tumour recurrence improved similarly in women with oestrogen receptor-positive and oestrogen receptor-negative tumours. 80·5% of the improvement for oestrogen receptor-positive disease and 89·8% of the improvement for eostrogen receptor-negative disease was explained by changes in patient and tumour characteristics and improved treatments, but remained significant (p<0·0001). More recently diagnosed patients were more likely to have node-negative disease. 10-year distant recurrence risks during 1990-99 versus 2000-09 were as follows: for node-negative disease, 10·1% versus 7·3% for oestrogen receptor-positive disease and 18·3% versus 11·9% for oestrogen receptor-negative disease; for disease with one to three positive nodes, 19·9% versus 14·7% for oestrogen receptor-positive disease and 31·9% versus 22·1% for oestrogen receptor-negative disease; and for disease with four to nine positive nodes, 39·6% versus 28·5% for oestrogen receptor-positive disease and 47·8% versus 36·5% for oestrogen receptor-negative disease. After adjustment for therapy, rates were reduced by 25% (oestrogen receptor-positive disease) and 19% (oestrogen receptor-negative disease) after 2000 versus the 1990s, with similar improvements observed in oestrogen receptor-positive disease beyond 5 years.Most of the improvement in trial outcomes is explained by a greater proportion of women with lower-risk disease entering trials and improved adjuvant treatment. After adjustment, women diagnosed since 2000 have about a fifth lower rate of distant recurrence than the 1990s. Long-term risks of distant recurrence for oestrogen receptor-positive disease remain, but are about a tenth lower now than in our previous report.Cancer Research UK, UK Medical Research Council.Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.