Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial
Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial
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DOI：
10.1016/s0140-6736(10)60551-x
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发表时间：
2010-05-08
期刊：
影响因子：
168.9
通讯作者：
Cuzick, Jack
中科院分区：
文献类型：
--
作者：
Atkin, Wendy S.;Edwards, Rob;Cuzick, Jack
结直肠癌是世界上第三大常见癌症，死亡率高。我们测试的假设，只有一个灵活的乙状结肠镜筛查55岁至64岁之间可以大大降低结直肠癌的发病率和mortality.Methods这个随机对照试验进行了14个英国中心。170432名符合条件的男性和女性，他们在之前的问卷调查中表示愿意接受筛查邀请，被随机分配到干预组（提供柔性乙状结肠镜筛查）或对照组（未联系）。通过连续数字生成的随机化集中在12个区组中进行，并按试验中心、全科医学和家庭类型分层。主要结果是结直肠癌的发病率，包括筛查时发现的流行病例和结直肠癌的死亡率。分析为意向治疗和符合方案。该试验已注册，编号为ISRCTN 28352761。结果113195人被分配到对照组，57237人被分配到干预组，其中112939人和57099人分别被纳入最终分析。40674例（71%）患者接受了乙状结肠镜检查。在筛查和中位随访11.2年（IQR 10.7-11.9）期间，2524名参与者被诊断出患有结直肠癌（对照组1818人，干预组706人），20543人死亡（13768人vs 6775人; 727人确诊患有结直肠癌[538 vs 189]）。在意向治疗分析中，干预组的结直肠癌发病率降低了23%（风险比0.77，95%CI 0.70 -0.84），死亡率降低了31%（0.69，0.59-0.82）。在符合方案分析中，调整干预组的自我选择偏倚，参加筛查的人结直肠癌发病率降低了33%（0.67，0.60-0.76），死亡率降低了43%（0.57，0.45-0.72）。远端结直肠癌（直肠和乙状结肠）的发病率降低了50%（0.50，0.42-0.59;次要结局）。在研究结束时，需要筛查以预防结直肠癌诊断或死亡的人数分别为191人（95%CI 145-277）和489人（343-852）。
Background Colorectal cancer is the third most common cancer worldwide and has a high mortality rate. We tested the hypothesis that only one flexible sigmoidoscopy screening between 55 and 64 years of age can substantially reduce colorectal cancer incidence and mortality.Methods This randomised controlled trial was undertaken in 14 UK centres. 170 432 eligible men and women, who had indicated on a previous questionnaire that they would accept an invitation for screening, were randomly allocated to the intervention group (offered flexible sigmoidoscopy screening) or the control group (not contacted). Randomisation by sequential number generation was done centrally in blocks of 12, with stratification by trial centre, general practice, and household type. The primary outcomes were the incidence of colorectal cancer, including prevalent cases detected at screening, and mortality from colorectal cancer. Analyses were intention to treat and per protocol. The trial is registered, number ISRCTN28352761.Findings 113 195 people were assigned to the control group and 57 237 to the intervention group, of whom 112 939 and 57099, respectively, were included in the final analyses. 40 674 (71%) people underwent flexible sigmoidoscopy. During screening and median follow-up of 11.2 years (IQR 10.7-11.9), 2524 participants were diagnosed with colorectal cancer (1818 in control group vs 706 in intervention group) and 20 543 died (13 768 vs 6775; 727 certified from colorectal cancer [538 vs 189]). In intention-to-treat analyses, colorectal cancer incidence in the intervention group was reduced by 23% (hazard ratio 0.77, 95% CI 0 70-0.84) and mortality by 31% (0.69, 0.59-0.82). In perprotocol analyses, adjusting for self-selection bias in the intervention group, incidence of colorectal cancer in people attending screening was reduced by 33% (0.67, 0.60-0.76) and mortality by 43% (0.57, 0.45-0.72). Incidence of distal colorectal cancer (rectum and sigmoid colon) was reduced by 50% (0.50, 0.42-0.59; secondary outcome). The numbers needed to be screened to prevent one colorectal cancer diagnosis or death, by the end of the study period, were 191 (95% CI 145-277) and 489 (343-852), respectively.Interpretation Flexible sigmoidoscopy is a safe and practical test and, when offered only once between ages 55 and 64 years, confers a substantial and longlasting benefit.