Prostate Cancer Screening in the Randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: Mortality Results after 13 Years of Follow-up
Prostate Cancer Screening in the Randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: Mortality Results after 13 Years of Follow-up
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DOI：
10.1093/jnci/djr500
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发表时间：
2012-01-01
期刊：
影响因子：
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通讯作者：
Prorok, Philip C.
中科院分区：
文献类型：
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作者：
Andriole, Gerald L.;Crawford, E. David;Prorok, Philip C.
背景：前列腺癌、肺癌、结直肠癌和卵巢癌(PLCO)筛查试验中的前列腺癌部分被用来确定通过血清前列腺特异性抗原(PSA)检测和直肠指诊(DRE)筛查是否可以降低前列腺癌死亡率。经过7-10年随访的死亡率以前也有过报道。方法1993年11月至2001年7月，在10个筛查中心登记了76 685名男性，年龄55-74岁，随机分配到干预组(每年进行6年的PSA筛查和4年的DRE筛查；38340名男性)和对照组(通常的护理，有时包括机会性筛查；38345名男性)。筛查工作于2006年10月完成。通过13年的随访或截至2009年12月31日，确定了所有前列腺癌事件和前列腺癌死亡病例。相对危险度(RR)被估计为干预组和对照组中观察率的比率，95%的可信区间(CI)被计算出来，假设事件数量服从泊松分布。泊松回归模型被用来检验试验组和年龄、共病状态和试验前PSA检测之间与前列腺癌死亡率的交互作用。结果约92%的受试者随访时间为10年，57%的受试者随访时间为13年。在13岁时，干预组有4250名参与者被诊断出患有前列腺癌，而对照组只有3815名。干预组和对照组前列腺癌累积发病率分别为108.4/万人年和97.1/万人年，相对增加12%(RR=1.12，95%CI=1.07~1.17)。经13年随访，干预组和对照组前列腺癌累积死亡率分别为3.7/万人年和3.4/万人年，差异无统计学意义(RR=1.09，95%CI=0.87~1.36)。在试验组和年龄(P(交互作用)=.81)、试验前PSA检测(P(交互作用)=.52)和合并症(P(交互作用)=.68)方面，没有观察到有统计学意义的交互作用。结论经过13年的随访，在PLCO试验中，与构成常规护理一部分的机会性筛查相比，没有证据表明有组织的年度筛查对死亡率有好处，而且与年龄、基线合并症或试验前PSA检测没有明显的交互作用。
Background The prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial was undertaken to determine whether there is a reduction in prostate cancer mortality from screening using serum prostate-specific antigen (PSA) testing and digital rectal examination (DRE). Mortality after 7-10 years of follow-up has been reported previously. We report extended follow-up to 13 years after the trial.Methods A total of 76 685 men, aged 55-74 years, were enrolled at 10 screening centers between November 1993 and July 2001 and randomly assigned to the intervention (organized screening of annual PSA testing for 6 years and annual DRE for 4 years; 38 340 men) and control (usual care, which sometimes included opportunistic screening; 38 345 men) arms. Screening was completed in October 2006. All incident prostate cancers and deaths from prostate cancer through 13 years of follow-up or through December 31, 2009, were ascertained. Relative risks (RRs) were estimated as the ratio of observed rates in the intervention and control arms, and 95% confidence intervals (CIs) were calculated assuming a Poisson distribution for the number of events. Poisson regression modeling was used to examine the interactions with respect to prostate cancer mortality between trial arm and age, comorbidity status, and pretrial PSA testing. All statistical tests were two-sided.Results Approximately 92% of the study participants were followed to 10 years and 57% to 13 years. At 13 years, 4250 participants had been diagnosed with prostate cancer in the intervention arm compared with 3815 in the control arm. Cumulative incidence rates for prostate cancer in the intervention and control arms were 108.4 and 97.1 per 10 000 person-years, respectively, resulting in a relative increase of 12% in the intervention arm (RR = 1.12, 95% CI = 1.07 to 1.17). After 13 years of follow-up, the cumulative mortality rates from prostate cancer in the intervention and control arms were 3.7 and 3.4 deaths per 10 000 person-years, respectively, resulting in a non-statistically significant difference between the two arms (RR = 1.09, 95% CI = 0.87 to 1.36). No statistically significant interactions with respect to prostate cancer mortality were observed between trial arm and age (P(interaction) = .81), pretrial PSA testing (P(interaction) = .52), and comorbidity (P(interaction) = .68).Conclusions After 13 years of follow-up, there was no evidence of a mortality benefit for organized annual screening in the PLCO trial compared with opportunistic screening, which forms part of usual care, and there was no apparent interaction with age, baseline comorbidity, or pretrial PSA testing.