Prostate cancer mortality reduction by screening:: Power and time frame with complete enrollment in the European Randomised Screening for Prostate Cancer (ERSPC) trial
Prostate cancer mortality reduction by screening:: Power and time frame with complete enrollment in the European Randomised Screening for Prostate Cancer (ERSPC) trial
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DOI：
10.1002/ijc.10188
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发表时间：
2002-03-10
影响因子：
6.4
通讯作者：
Alexander, FE
中科院分区：
文献类型：
--
作者：
de Koning, HJ;Liem, MK;Alexander, FE
从1992年至2001年，欧洲7个国家逐渐招募男性参与欧洲前列腺癌随机筛查（ERSPC）试验。中心招募不同年龄组的患者，招募设计也不同，而且各国前列腺癌的潜在风险也不同。到目前为止，招募人数已达到163 126名，年龄在55至69岁之间。我们的目的是计算试验的功效，以及在什么时间点可以预期前列腺癌死亡率的统计学显著差异。从筛查中心收集招募数据。我们根据国家统计数据和试验入组者的预期死亡率，计算了每个随访年的前列腺癌预期死亡人数。使用关于干预效果和污染率的不同假设以及ERSPC试验是否与其他试验合作计算把握度。假设在实际筛查的男性中干预效果为25%，污染率为20%，则该试验将在2008年达到0.86的功效。假设干预效果为40%，2003-2004年的功效为0.90。早期将数据与前列腺、肺、结直肠和卵巢（PLCO）试验的数据合并，预计可将把握度提高至79%（20%干预效应）至92%（40%干预效应PLCO）。增加更多依从率低于45%的中心会降低试验的效力。ERSPC试验有足够的把握度来检测两组之间前列腺癌死亡率的显著差异，如果通过筛查死亡率的真实降低是25%或更多，或者如果污染仍然限制在10%，如果真实效果是20%或更多。如果早期发现和治疗的效果更好，正如观察数据所表明的那样，ERSPC试验可能会在未来5年内最终表明这一点。(C)2002 Wiley-Liss，Inc.
From 1992-2001, 7 countries in Europe gradually recruited men for the European Randomised Screening for Prostate Cancer (ERSPC) trial. Centres recruit different age groups and have different designs for recruiting and countries have different underlying risks for prostate cancer. Recruitment has reached 163,126 men aged 55-69 at entry now. Our purpose was to calculate the power of the trial and at what point in time can statistically significant differences in prostate cancer mortality be expected. Recruitment data were collected from the screening centres. We calculated the expected number of prostate cancer deaths in each follow-up year, based on national statistics and expected rate in trial entrants. The power was calculated using different assumptions on intervention effect and contamination rate and also if the ERSPC trial would cooperate with other trials. With an assumed 25% intervention effect in men actually screened and a 20% contamination rate, the trial will reach a power of 0.86 in 2008. With an assumed intervention effect of 40%, the power reaches 0.90 in 2003-2004. Pooling data with those of the Prostate, Lung, Colorectal and Ovary (PLCO) trial early is expected to improve the power to 79% (20% intervention effect) to 92% (40% intervention effect PLCO). Adding more centres with compliance rates lower than 45% decreases the power of the trial. The ERSPC trial has sufficient power to detect a significant difference in prostate cancer mortality between the 2 arms if the true reduction in mortality by screening is 25% or more or if contamination remains limited to 10% if the true effect is 20% or more. If early detection and treatment turns out to have a stronger effect as may be suggested by observational data, the ERSPC trial is likely to conclusively show that within the next 5 years. (C) 2002 Wiley-Liss, Inc.