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17 年随访的英国年龄试验中 40 岁开始的乳腺 X 线筛查对乳腺癌死亡率的影响:一项随机对照试验。

Effect of mammographic screening from age 40 years on breast cancer mortality in the UK Age trial at 17 years' follow-up: a randomised controlled trial.

机构信息

Wolfson Institute, Queen Mary University of London, London, UK.

Wolfson Institute, Queen Mary University of London, London, UK.

出版信息

Lancet Oncol. 2015 Sep;16(9):1123-1132. doi: 10.1016/S1470-2045(15)00128-X. Epub 2015 Jul 20.


DOI:10.1016/S1470-2045(15)00128-X
PMID:26206144
Abstract

BACKGROUND: Age-specific effects of mammographic screening, and the timing of such effects, are a matter of debate. The results of the UK Age trial, which compared the effect of invitation to annual mammographic screening from age 40 years with commencement of screening at age 50 years on breast cancer mortality, have been reported at 10 years of follow-up and showed no significant difference in mortality between the trial groups. Here, we report the results of the UK Age trial after 17 years of follow-up. METHODS: Women aged 39-41 from 23 UK NHS Breast Screening Programme units years were randomly assigned by individual randomisation (1:2) to either an intervention group offered annual screening by mammography up to and including the calendar year of their 48th birthday or to a control group receiving usual medical care (invited for screening at age 50 years and every 3 years thereafter). Both groups were stratified by general practice. We compared breast cancer incidence and mortality by time since randomisation. Analyses included all women randomly assigned who could be traced with the National Health Service Central Register and who had not died or emigrated before entry. The primary outcome measures were mortality from breast cancer (defined as deaths with breast cancer coded as the underlying cause of death) and breast cancer incidence, including in-situ, invasive, and total incidence. Because there is an interest in the timing of the mortality effect, we analysed the results in different follow-up periods. This trial is registered, number ISRCTN24647151. FINDINGS: Between Oct 14, 1990, and Sept 25, 1997, 160 921 participants were randomly assigned; 53 883 women in the intervention group and 106 953 assigned to usual medical care were included in this analysis. After a median follow-up of 17 years (IQR 16·8-18·8), the rate ratio (RR) for breast cancer mortality was 0·88 (95% CI 0·74-1·04) from tumours diagnosed during the intervention phase. A significant reduction in breast cancer mortality was noted in the intervention group compared with the control group in the first 10 years after diagnosis (RR 0·75, 0·58-0·97) but not thereafter (RR 1·02, 0·80-1·30) from tumours diagnosed during the intervention phase. The overall breast cancer incidence during 17 year follow-up was similar between the intervention group and the control group (RR 0·98, 0·93-1·04). INTERPRETATION: Our results support an early reduction in mortality from breast cancer with annual mammography screening in women aged 40-49 years. Further data are needed to fully understand long-term effects. Cumulative incidence figures suggest at worst a small amount of overdiagnosis. FUNDING: National Institute for Health Research Health Technology Assessment programme and the American Cancer Society. Past funding was received from the Medical Research Council, Cancer Research UK, the UK Department of Health, and the US National Cancer Institute.

摘要

背景:乳腺筛查的年龄特异性效应,以及这种效应的发生时间,是一个有争议的问题。英国年龄试验比较了从 40 岁开始每年接受乳腺 X 光筛查与从 50 岁开始筛查对乳腺癌死亡率的影响,该试验的结果在 10 年的随访中已报告,结果显示两组之间死亡率无显著差异。在此,我们报告了英国年龄试验在 17 年随访后的结果。

方法:来自英国 23 个国家卫生服务局乳腺筛查计划单位的 39-41 岁女性,通过个体随机化(1:2)被随机分配到干预组或对照组。干预组接受每年一次的乳腺 X 光筛查,直至并包括她们 48 岁的生日;对照组接受常规医疗护理(在 50 岁时被邀请筛查,此后每 3 年一次)。两组均按全科医生进行分层。我们比较了随机分组后不同时间的乳腺癌发病率和死亡率。分析包括所有可通过国家卫生服务中心登记处追踪且在入组前未死亡或移民的随机分配女性。主要终点是乳腺癌死亡率(定义为乳腺癌编码为死亡根本原因的死亡)和乳腺癌发病率,包括原位癌、浸润性癌和总发病率。由于人们对死亡率的发生时间感兴趣,我们在不同的随访期分析了结果。本试验已注册,编号 ISRCTN24647151。

结果:1990 年 10 月 14 日至 1997 年 9 月 25 日期间,共随机分配了 160921 名参与者;干预组有 53883 名女性,对照组有 106953 名女性纳入本分析。在中位数为 17 年(IQR 16.8-18.8)的随访后,诊断为肿瘤的乳腺癌死亡率比值比(RR)为 0.88(95%CI 0.74-1.04)。与对照组相比,干预组在诊断后前 10 年(RR 0.75,0.58-0.97)的乳腺癌死亡率显著降低,但此后(RR 1.02,0.80-1.30)则没有。诊断为肿瘤的乳腺癌发病率在 17 年的随访期间,两组之间总体相似(RR 0.98,0.93-1.04)。

结论:我们的结果支持在 40-49 岁女性中进行年度乳腺 X 光筛查可以降低乳腺癌的死亡率。需要进一步的数据来充分了解长期影响。累积发病率数据表明,最坏的情况是存在少量过度诊断。

资金来源:英国国家卫生研究院卫生技术评估计划和美国癌症协会。过去的资金来自医学研究委员会、英国癌症研究中心、英国卫生部和美国国家癌症研究所。

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