前列腺癌发病率和死亡率的延长随访研究：前列腺、肺、大肠和卵巢随机癌症筛查试验的参与者。
Extended follow-up for prostate cancer incidence and mortality among participants in the Prostate, Lung, Colorectal and Ovarian randomized cancer screening trial.
机构信息
Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, MD, USA.
Medical University of South Carolina, Charleston, SC, USA.
出版信息
BJU Int. 2019 May;123(5):854-860. doi: 10.1111/bju.14580. Epub 2018 Nov 2.
OBJECTIVE
To examine prostate cancer (PCa) incidence and mortality by arm in the randomized Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial.
PATIENTS AND METHODS
Patients aged 55-74 years at 10 screening centres were randomized between 1993 and 2001 to an intervention or usual care arm. Patients in the intervention arm received six annual prostate-specific antigen (PSA) tests and four annual digital rectal examinations. The patients were followed for PCa incidence and for mortality via active follow-up processes and by linkage to state cancer registries and the National Death Index. For cancers identified through active follow-up, trial abstractors recorded the mode of diagnosis (screen-detected, symptomatic, other).
RESULTS
A total of 38 340 patients were randomized to the intervention arm and 38 343 to a usual care arm. The median follow-up for mortality was 16.9 (intervention) and 16.7 years (usual care). There were 333 (intervention) and 352 (usual care) PCa cancer deaths, giving rates (per 10 000 person-years) of 5.5 and 5.9, respectively, and a rate ratio (RR) of 0.93 (95% confidence interval [CI] 0.81-1.08; P = 0.38). The RR for overall PCa incidence was 1.05 (95% CI 1.01-1.09). The RRs by Gleason category were 1.17 (95% CI 1.11-1.23) for Gleason 2-6, 1.00 (95% CI 0.93-1.07) for Gleason 7 and 0.89 (95% CI 0.80-0.99) for Gleason 8-10 disease. By mode of detection, during the trial's screening phase, 13% of intervention arm vs 27% of usual care arm cases were symptomatic; post-screening, these percentages were 18% in each arm.
CONCLUSION
After almost 17 years of median follow-up, there was no significant reduction in PCa mortality in the intervention compared with the usual care arm. There was a significant increase in Gleason 2-6 disease and a significant reduction in Gleason 8-10 disease in the intervention compared with the usual care arm.
目的
在前列腺、肺、大肠和卵巢（PLCO）癌症筛查试验的随机分组中，按手臂检查前列腺癌（PCa）的发病率和死亡率。
患者和方法
1993 年至 2001 年期间，10 个筛查中心的年龄在 55-74 岁的患者被随机分为干预组或常规护理组。干预组的患者接受了 6 次年度前列腺特异性抗原（PSA）检测和 4 次年度直肠指检。通过主动随访流程和与州癌症登记处和国家死亡指数的联系，对患者进行 PCa 发病率和死亡率的随访。对于通过主动随访发现的癌症，试验摘要记录员记录了诊断模式（筛查发现、症状性、其他）。
结果
共有 38340 名患者被随机分配到干预组，38343 名患者被分配到常规护理组。死亡率的中位随访时间为 16.9（干预）和 16.7 年（常规护理）。干预组有 333 例（333/38340）和常规护理组有 352 例（352/38343）PCa 癌症死亡，发生率（每 10000 人年）分别为 5.5 和 5.9，比率比（RR）为 0.93（95%置信区间[CI]0.81-1.08；P=0.38）。总的 PCa 发病率的 RR 为 1.05（95%CI1.01-1.09）。按 Gleason 分级的 RR 分别为 Gleason 2-6 为 1.17（95%CI1.11-1.23），Gleason 7 为 1.00（95%CI0.93-1.07），Gleason 8-10 疾病为 0.89（95%CI0.80-0.99）。按检测方式，在试验的筛查阶段，干预组有 13%的病例为症状性，而常规护理组有 27%的病例为症状性；在筛查后，两组的百分比分别为 18%。
结论
在中位随访近 17 年后，与常规护理组相比，干预组的 PCa 死亡率没有显著降低。与常规护理组相比，干预组的 Gleason 2-6 疾病显著增加，Gleason 8-10 疾病显著减少。
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