2020年8月12日，英国《柳叶刀》肿瘤学分册在线发表英国伦敦大学玛丽王后学院和国王学院、邓迪大学、赫特福德大学、诺丁汉大学、以色列特拉维夫大学、美国癌症学会的UK Age研究23年随访最终结果，比较了39～41岁与50岁开始乳腺钼靶筛查对乳腺癌所致死亡结局的影响。
该全国多中心随机对照研究于1990年10月14日～1997年9月24日从英国23个乳腺筛查单位入组16万0921例无乳腺癌女性，按1∶2的比例通过个体随机分组全科医师分层分为两组：
干预组5万3883例（33.5%）39～41岁开始至48岁每年进行乳腺钼靶筛查，随后开始首次全民医保计划免费乳腺钼靶筛查
对照组10万6953例（66.5%）大约50岁开始首次全民医保计划免费乳腺钼靶筛查
干预组女性通过邮件邀请，对照组女性对该研究单盲。主要研究终点为干预期间至首次全民医保计划乳腺钼靶筛查之前的乳腺癌所致死亡比例。为了研究时间对死亡的影响，对随访时间<10年与≥10年的结果进行分析。对全部女性的主要研究终点进行比较，无论是否服从随机分组状态，即意向分析。本文报告了长期随访分析结果。该研究的国际标准随机对照研究编号：ISRCTN 24647151。
结果，从随机分组至2017年2月28日，中位随访22.8年（四分位：21.8～24.0）。
干预组与对照组相比，乳腺癌所致死亡比例：
随访<10年：1.54‰比2.05‰（比值比：0.75，95%置信区间：0.58～0.97，P=0.029）
随访≥10年：2.34‰比2.38‰（比值比：0.98，95%置信区间：0.79～1.22，P=0.86）
因此，该研究结果表明，每年乳腺钼靶筛查开始年龄40岁与50岁相比，10年内乳腺癌所致死亡比例显著较低，10年后乳腺癌所致死亡比例仍然较低但不显著，故将筛查年龄下限由50岁降至40岁可能减少乳腺癌所致死亡。
对此，加拿大多伦多大学达拉·拉娜公共卫生学院发表同期评论：关于乳腺癌筛查年龄的英国随机对照研究最终结果。
Lancet Oncol. 2020 Aug 12. Online ahead of print.
Effect of mammographic screening from age 40 years on breast cancer mortality (UK Age trial): final results of a randomised, controlled trial.
Stephen W Duffy, Daniel Vulkan, Howard Cuckle, Dharmishta Parmar, Shama Sheikh, Robert A Smith, Andrew Evans, Oleg Blyuss, Louise Johns, Ian O Ellis, Jonathan Myles, Peter D Sasieni, Sue M Moss.
Queen Mary University of London, London, UK; Tel Aviv University, Tel Aviv, Israel; King's College London, London, UK; American Cancer Society, Atlanta, GA, USA; University of Dundee, Dundee, UK; University of Hertfordshire, Hatfield, UK; Sechenov First Moscow State Medical University, Moscow, Russia; University of Nottingham, Nottingham, UK.
BACKGROUND: The appropriate age range for breast cancer screening remains a matter of debate. We aimed to estimate the effect of mammographic screening at ages 40-48 years on breast cancer mortality.
METHODS: We did a randomised, controlled trial involving 23 breast screening units across Great Britain. We randomly assigned women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen at approximately age 50 years (control group). Women in the intervention group were recruited by postal invitation. Women in the control group were unaware of the study. The primary endpoint was mortality from breast cancers (with breast cancer coded as the underlying cause of death) diagnosed during the intervention period, before the participant's first NHSBSP screen. To study the timing of the mortality effect, we analysed the results in different follow-up periods. Women were included in the primary comparison regardless of compliance with randomisation status (intention-to-treat analysis). This Article reports on long-term follow-up analysis. The trial is registered with the ISRCTN registry, ISRCTN24647151.
FINDINGS: 160921 women were recruited between Oct 14, 1990, and Sept 24, 1997. 53883 women (33.5%) were randomly assigned to the intervention group and 106953 (66.5%) to the control group. Between randomisation and Feb 28, 2017, women were followed up for a median of 22.8 years (IQR 21.8-24.0). We observed a significant reduction in breast cancer mortality at 10 years of follow-up, with 83 breast cancer deaths in the intervention group versus 219 in the control group (relative rate [RR] 0.75 [95% CI 0.58-0.97]; p=0.029). No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0.98 [0.79-1.22]; p=0.86).
INTERPRETATION: Yearly mammography before age 50 years, commencing at age 40 or 41 years, was associated with a relative reduction in breast cancer mortality, which was attenuated after 10 years, although the absolute reduction remained constant. Reducing the lower age limit for screening from 50 to 40 years could potentially reduce breast cancer mortality.
FUNDING: National Institute for Health Research Health Technology Assessment programme
DOI: 10.1016/S1470-2045(20)30398-3
Lancet Oncol. 2020 Aug 12. Online ahead of print.
Final results of the UK Age trial on breast cancer screening age.
Anthony B Miller.
Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
DOI: 10.1016/S1470-2045(20)30428-9
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