意大利柔性乙状结肠镜筛查试验的长期随访。
Long-Term Follow-up of the Italian Flexible Sigmoidoscopy Screening Trial.
机构信息
University Hospital Città della Salute e della Scienza, Turin, Italy (C.S., E.R., P.A., N.S.).
IRCCS Ospedale Policlinico San Martino, Genoa, Italy (L.B., S.S., C.C.).
出版信息
Ann Intern Med. 2022 Jan;175(1):36-45. doi: 10.7326/M21-0977. Epub 2021 Nov 9.
BACKGROUND
Recent reports showed that the protective effect of flexible sigmoidoscopy (FS) screening was maintained up to17 years, although differences were reported by sex.
OBJECTIVE
To assess long-term reduction of colorectal cancer (CRC) incidence and mortality after a single FS screening.
DESIGN
Parallel randomized controlled trial. (ISRCTN registry number: 27814061).
SETTING
6 centers in Italy.
PARTICIPANTS
Persons aged 55 to 64 years expressing interest in having FS screening if invited, recruited from 1995 to 1999 and followed until 2012 (incidence) and 2014 to 2016 (mortality).
INTERVENTION
Eligible persons were randomly assigned (1:1 ratio) to either the once-only FS screening group or control (usual care) group.
MEASUREMENTS
Incidence and mortality rate ratios (RRs) and rate differences.
RESULTS
A total of 34 272 persons (17 136 in each group) were included in the analysis; 9911 participants had screening in the intervention group. Median follow-up was 15.4 years for incidence and 18.8 years for mortality. Incidence of CRC was reduced by 19% (RR, 0.81 [95% CI, 0.71 to 0.93]) in the intention-to-treat (ITT) analysis, comparing the intervention with the control group, and by 33% (RR, 0.67 [CI, 0.56 to 0.81]) in the per protocol (PP) analysis, comparing participants screened in the intervention group with the control persons. Colorectal cancer mortality was reduced by 22% (RR, 0.78 [CI, 0.61 to 0.98]) in the ITT analysis and by 39% (RR, 0.61 [CI, 0.44 to 0.84]) in the PP analysis. Incidence of CRC was statistically significantly reduced among both men and women. Colorectal cancer mortality was statistically significantly reduced among men (ITT RR, 0.73 [CI, 0.54 to 0.97]) but not among women (ITT RR, 0.90 [CI, 0.59 to 1.37]).
LIMITATION
Self-selection of volunteers from the general population sample targeted for recruitment may limit generalizability.
CONCLUSION
The strong protective effect of a single FS screening for CRC incidence and mortality was maintained up to 15 and 19 years, respectively.
PRIMARY FUNDING SOURCE
Italian Association for Cancer Research, Italian National Research Council, Istituto Oncologico Romagnolo, Fondo "E. Tempia," University of Milan, and Local Health Unit ASL-Torino.
背景
最近的报告显示，尽管存在性别差异，但软性乙状结肠镜检查（FS）筛查的保护作用可维持长达 17 年。
目的
评估单次 FS 筛查后结直肠癌（CRC）发病率和死亡率的长期降低情况。
设计
平行随机对照试验。（ISRCTN 注册号：27814061）。
地点
意大利 6 个中心。
参与者
1995 年至 1999 年招募的 55 岁至 64 岁有兴趣进行 FS 筛查的人群（如果受邀），并随访至 2012 年（发病率）和 2014 年至 2016 年（死亡率）。
干预
符合条件的人被随机分配（1:1 比例）至单次 FS 筛查组或对照组（常规护理）。
测量
发病率和死亡率比值（RR）和率差。
结果
共纳入 34272 人（每组 17136 人）进行分析；17136 名参与者在干预组中进行了筛查。发病率的中位随访时间为 15.4 年，死亡率的中位随访时间为 18.8 年。在意向治疗（ITT）分析中，与对照组相比，CRC 的发病率降低了 19%（RR，0.81 [95%CI，0.71 至 0.93]），在方案依从性（PP）分析中，与对照组相比，在干预组中进行筛查的参与者的发病率降低了 33%（RR，0.67 [CI，0.56 至 0.81]）。在 ITT 分析中，CRC 死亡率降低了 22%（RR，0.78 [CI，0.61 至 0.98]），在 PP 分析中，CRC 死亡率降低了 39%（RR，0.61 [CI，0.44 至 0.84]）。CRC 的发病率在男性和女性中均有统计学显著降低。CRC 死亡率在男性中具有统计学显著降低（ITT RR，0.73 [CI，0.54 至 0.97]），但在女性中无统计学显著降低（ITT RR，0.90 [CI，0.59 至 1.37]）。
局限性
从目标招募的一般人群样本中自愿选择志愿者可能会限制其普遍性。
结论
单次 FS 筛查对 CRC 发病率和死亡率的强烈保护作用分别持续了 15 年和 19 年。
主要资金来源
意大利癌症研究协会、意大利国家研究委员会、罗曼尼奥肿瘤研究所、“E. Tempia”基金、米兰大学和都灵地方卫生局。
Zotero 插件