歐洲前列腺癌隨機(jī)篩查研究（ERSPC）結(jié)果提示應(yīng)用前列腺特異性抗原對前列腺癌進(jìn)行篩查能降低前列腺癌的死亡率,。來自芬蘭Tampere大學(xué)的Tuomas P等評估了芬蘭前列腺癌篩查研究（ERSPC的最大的組成部分）中死亡率的相關(guān)的結(jié)果,。本研究的主要終點(diǎn)事件為前列腺癌特異性死亡率。他們的研究結(jié)果發(fā)表在JNCI 3月的在線期刊上,。
研究者從登記在冊的人口中共納入了80144名男性,，他們被隨機(jī)分為2組,，一組為篩查組（SA），另一組為對照組（CA）,。在篩查組的受試者每隔4年進(jìn)行一次PSA篩查,，共進(jìn)行3次測定，如果其PSA濃度大于等于4.0ng/mL或PSA濃度介于3.0至3.9ng/mL但游離PSA/總PSA小于等于16%的話,，那么研究者建議其進(jìn)行前列腺活檢,。在研究中，研究者對所有入組的受試者都進(jìn)行了為期長達(dá)12年的隨訪,。研究者采用Cox風(fēng)險(xiǎn)比例模型估計(jì)了前列腺癌發(fā)病率和死亡率的風(fēng)險(xiǎn)比,。所有的統(tǒng)計(jì)檢驗(yàn)都在雙側(cè)進(jìn)行。
前列腺癌的發(fā)病率在篩查組中為8.8/1000人-年,，在對照組則為6.6/1000人-年,，風(fēng)險(xiǎn)比為1.34，95%可信區(qū)間為1.27至1.40,。與對照組相比,，篩查組的晚期前列腺癌發(fā)病率更低，兩組分別為1.6和1.2,，風(fēng)險(xiǎn)比為0.73,，兩組差異具有顯著統(tǒng)計(jì)學(xué)意義。研究者需要就1199人進(jìn)行篩查且在其中發(fā)現(xiàn)25例前列腺癌患者才能避免1例前列腺癌特異性死亡事件,。研究者沒有觀察到所有原因造成的死亡率在兩組中存在差異,。
本研究結(jié)果提示，在第12年時(shí),，一項(xiàng)相對保守的篩查方案僅能帶來前列腺癌特異性死亡率的微弱及不具統(tǒng)計(jì)學(xué)顯著意義的降低,，但是其所付出的代價(jià)則是對患者的過度診斷。（生物谷Bioon.com）
doi:10.1093/jnci/djt038
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Prostate Cancer Mortality in the Finnish Randomized Screening Trial
Kilpel?inen TP Tammela TL Malila N Hakama M Santti H M??tt?nen L Stenman UH Kujala P Auvinen A
Prostate cancer (PC) screening with prostate-specific antigen (PSA) has been shown to decrease PC mortality by the European Randomized Study of Screening for Prostate Cancer (ERSPC). We evaluated mortality results in the Finnish Prostate Cancer Screening Trial, the largest component of ERSPC. The primary endpoint was PC-specific mortality.MethodsA total of 80 144 men were identified from the population registry and randomized to either a screening arm (SA) or a control arm (CA). Men in the SA were invited to serum PSA determination up to three times with a 4-year interval between each scan and referred to biopsy if the PSA concentration was greater than or equal to 4.0ng/mL or 3.0 to 3.99ng/mL with a free/total PSA ratio less than or equal to 16%. Men in the CA received usual care. The analysis covers follow-up to 12 years from randomization for all men. Hazard ratios (HRs) were estimated for incidence and mortality using Cox proportional hazard model. All statistical tests were two-sided.ResultsPC incidence was 8.8 per 1000 person-years in the SA and 6.6 in the CA (HR = 1.34, 95% confidence interval [CI] = 1.27 to 1.40). The incidence of advanced PC was lower in the SA vs CA arm (1.2 vs 1.6, respectively; HR = 0.73, 95% CI = 0.64 to 0.82; P < .001). For PC mortality, no statistically significant difference was observed between the SA and CA (HR = 0.85, 95% CI = 0.69 to 1.04) (with intention-to-screen analysis). To avoid one PC death, we needed to invite 1199 men to screening and to detect 25 PCs. We observed no difference in all-cause mortality between trial arms.ConclusionsAt 12 years, a relatively conservative screening protocol produced a small, non-statistically significant PC-specific mortality reduction in the Finnish trial, at the cost of moderate overdiagnosis.
