Mortality results from the Göteborg randomised population-based prostate-cancer screening trial.
Mortality results from the Göteborg randomised population-based prostate-cancer screening trial.
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死亡率来自Göteborg随机基于人群的前列腺癌筛查试验。
DOI：
10.1016/s1470-2045(10)70146-7
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发表时间：
2010-08
期刊：
影响因子：
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通讯作者：
Lilja H
中科院分区：
文献类型：
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作者：
Hugosson J;Carlsson S;Aus G;Bergdahl S;Khatami A;Lodding P;Pihl CG;Stranne J;Holmberg E;Lilja H
前列腺癌是西方世界男性恶性疾病死亡的主要原因之一。降低死于这种疾病的风险的一种策略是用前列腺特异性抗原（PSA）进行筛查;然而，这种筛查的益处和危害程度正在持续辩论中。1994年12月，从人口登记处随机抽取了2万名1930年至1944年出生的男性，以1：1的比例被计算机随机分配到被邀请进行两年一次的PSA测试的筛查组或未被邀请的对照组。在每组中，48名男性因随机化日期前死亡或移民或患有前列腺癌而从分析中排除。主要终点是根据意向筛查原则分析的前列腺癌特异性死亡率。筛选组中的男性被邀请到年龄上限（中位数69，范围67-71岁），只有PSA升高的男性被提供额外的检查，如直肠指检和前列腺活检。这项研究仍在进行中，邀请尚未达到年龄上限的男子参加。这是截至2008年12月31日计算的累积前列腺癌发病率和死亡率的第一份计划报告。本研究注册为[国际标准随机对照试验]，编号[ISRCTN 49127736]。在随机接受筛选的男性中，7578/9952（76%）至少参加过一次（参加者）。在中位随访14年期间，筛查组有1138名男性和对照组有718名男性被诊断为前列腺癌，导致筛查组前列腺癌的累积发病率为12.7%，对照组为8.2%（风险比1.64; 95%置信区间[CI] 1.50-1.80; p<0.0001）。14年时前列腺癌死亡的绝对累积风险降低为0.40%（95% CI 0.17-0.64%），从对照组的0.90%降至筛选组的0.50%。与对照组相比，筛选时前列腺癌死亡的发生率比值为0.56（95% CI 0.39-0.82; p=0.002）。与对照组相比，参与者的发病率比值为0.44（95% CI 0.28-0.68; p=0.0002）。总的来说，需要邀请293名男性进行筛查，并诊断12名男性，以防止一例前列腺癌死亡。前列腺癌筛查的益处优于其他癌症筛查计划，在这项研究中，前列腺癌死亡率在14年内几乎降低了一半。然而，过度诊断的风险很大，需要治疗的人数至少与乳腺癌筛查一样高。瑞典癌症协会、瑞典研究理事会和国家癌症研究所。
Prostate cancer is one of the leading causes of death from malignant disease among men in the Western world. One strategy to decrease the risk of dying from this disease is screening with Prostate-Specific Antigen (PSA); however, the extent of benefit and harm with such screening is under continuous debate. In December 1994, 20 000 men born 1930 to 1944, randomly sampled from the Population Register, were computer randomised in a 1:1 ratio to a screening group invited for biennial PSA testing or to a control group not invited. In each arm, 48 men were excluded from analysis due to either death or emigration before randomization date or prevalent prostate cancer. The primary endpoint was prostate cancer specific mortality analyzed according to the intention-to-screen principle. Men in the screening group were invited up to the upper age limit (median 69, range 67–71 years) and only men with elevated PSA were offered additional tests such as digital rectal examination and prostate biopsies. The study is still ongoing inviting men who have not yet reached the upper age limit. This is the first planned report on cumulative prostate cancer incidence and mortality calculated up to Dec 31 2008. This study is registered [as an International Standard Randomised Controlled Trial], number [ISRCTN49127736]. Among men randomised to screening 7578/9952 (76%) attended at least once (attendees). During a median follow-up of 14 years, 1138 men in the screening group and 718 in the control group were diagnosed with prostate cancer resulting in a cumulative incidence of prostate cancer of 12.7% in the screening arm and 8.2% in the control arm (hazard ratio 1.64; 95% confidence interval [CI] 1.50–1.80; p<0.0001). The absolute cumulative risk reduction of death from prostate cancer at 14 years was 0.40% (95% CI 0.17–0.64%), from 0.90% in the control group to 0.50% in the screening group. The incidence rate ratio for death from prostate cancer was 0.56 (95% CI 0.39–0.82; p=0.002) in the screening compared to the control group. The incidence rate ratio of attendees compared to the control group was 0.44 (95% CI 0.28–0.68; p=0.0002). Overall, 293 men needed to be invited for screening and 12 to be diagnosed to prevent one prostate cancer death. The benefit of prostate cancer screening compares favourably to other cancer screening programs and in this study prostate cancer mortality was reduced almost by half over 14 years. However, the risk of over diagnosis is substantial and the number needed to treat is at least as high as in breast cancer screening. The Swedish Cancer Society, the Swedish Research Council and the National Cancer Institute.