Atkin Wendy, Wooldrage Kate, Parkin D Maxwell, Kralj-Hans Ines, MacRae Eilidh, Shah Urvi, Duffy Stephen, Cross Amanda J
Cancer Screening and Prevention Research Group, Department of Surgery and Cancer, Imperial College London, London, UK.
Cancer Screening and Prevention Research Group, Department of Surgery and Cancer, Imperial College London, London, UK.
Lancet. 2017 Apr 1;389(10076):1299-1311. doi: 10.1016/S0140-6736(17)30396-3. Epub 2017 Feb 22.
Colorectal cancer is the third most common cancer worldwide. Previous analyses have only reported follow-up after flexible sigmoidoscopy for a maximum of 12 years. We aimed to examine colorectal cancer incidence and mortality after a single flexible sigmoidoscopy screening and 17 years of follow-up.
In this multicentre randomised trial (UK Flexible Sigmoidoscopy Screening Trial), done between Nov 14, 1994, and March 30, 1999, 170 432 eligible men and women, who had indicated on a previous questionnaire that they would probably attend screening if invited, were randomly assigned (1:2) to an intervention group (offered flexible sigmoidoscopy screening) or a control group (not contacted). Randomisation was done centrally in blocks of 12, and stratified by trial centre, general practice, and household type. The nature of the intervention did not allow the staff to be masked to arm of the trial; however, randomisation was done in batches so that the control group and participants not yet randomised were unaware of their allocation status. The primary outcomes were incidence and mortality of colorectal cancer. Hazard ratios (HRs) and 95% CIs for colorectal cancer incidence and mortality were estimated for intention-to-treat and per-protocol analyses. The trial is registered with ISRCTN, number 28352761.
Our cohort analysis included 170 034 people: 112 936 in the control group and 57 098 in the intervention group, 40 621 (71%) of whom were screened and 16 477 (29%) were not screened. During screening and a median of 17·1 years' follow-up, colorectal cancer was diagnosed in 1230 individuals in the intervention group and 3253 in the control group, and 353 individuals in the intervention group versus 996 individuals in the control group died from colorectal cancer. In intention-to-treat analyses, colorectal cancer incidence was reduced by 26% (HR 0·74 [95% CI 0·70-0·80]; p<0·0001) in the intervention group versus the control group and colorectal cancer mortality was reduced by 30% (0·70 [0·62-0·79]; p<0·0001) in the intervention group versus the control group. In per-protocol analyses, adjusted for non-compliance, colorectal cancer incidence and mortality were 35% (HR 0·65 [95% CI 0·59-0·71]) and 41% (0·59 [0·49-0·70]) lower in the screened group.
A single flexible sigmoidoscopy continues to provide substantial protection from colorectal cancer diagnosis and death, with protection lasting at least 17 years.
National Institute for Health Research Efficacy and Mechanism Evaluation.
结直肠癌是全球第三大常见癌症。以往分析仅报告了乙状结肠镜检查后最长12年的随访情况。我们旨在研究单次乙状结肠镜检查筛查及17年随访后的结直肠癌发病率和死亡率。
在这项多中心随机试验（英国乙状结肠镜检查筛查试验）中，于1994年11月14日至1999年3月30日期间，170432名符合条件的男性和女性（他们在之前的问卷中表示若受邀很可能参加筛查）被随机分配（1:2）至干预组（接受乙状结肠镜检查筛查）或对照组（未被联系）。随机分组在中心以12人为一组进行，按试验中心、全科医疗和家庭类型分层。干预措施的性质使工作人员无法对试验组进行盲法操作；然而，随机分组是分批进行的，以便对照组和尚未随机分组的参与者不知道他们的分配情况。主要结局是结直肠癌的发病率和死亡率。对意向性分析和符合方案分析估计了结直肠癌发病率和死亡率的风险比（HRs）及95%置信区间（CIs）。该试验已在国际标准随机对照试验编号注册库（ISRCTN）注册，编号为28352761。
我们的队列分析纳入了170034人：对照组112936人，干预组57098人，其中40621人（71%）接受了筛查，16477人（29%）未接受筛查。在筛查期间及中位17.1年的随访中，干预组有1230人被诊断为结直肠癌，对照组有3253人；干预组有353人死于结直肠癌，对照组有996人。在意向性分析中，干预组与对照组相比，结直肠癌发病率降低了26%（HR 0.74 [95%CI 0.70 - 0.80]；p<0.0001），结直肠癌死亡率降低了30%（0.70 [0.62 - 0.79]；p<0.0001）。在符合方案分析中，对未依从情况进行调整后，筛查组的结直肠癌发病率和死亡率分别降低了35%（HR 0.65 [95%CI 0.59 - 0.71]）和41%（0.59 [0.49 - 0.70]）。
单次乙状结肠镜检查继续为预防结直肠癌诊断和死亡提供了实质性保护，且保护作用至少持续17年。
英国国家卫生研究院疗效与机制评估项目。
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