局限性前列腺癌监测、手术或放疗 10 年后的结果。
10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer.
机构信息
From the Nuffield Department of Surgical Sciences, University of Oxford, Oxford (F.C.H., P.H., D.E.N.), the School of Social and Community Medicine (J.L.D., J.A.L., C.M., M.D., E.L.T., R.M.M., E.W.), the Bristol Randomized Trials Collaboration (J.A.L., C.M.), and School of Clinical Sciences (T.J.P.), University of Bristol, the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West, University Hospitals Bristol NHS Foundation Trust (J.L.D.), the Department of Cellular Pathology, North Bristol NHS Trust (J.O.), and the Department of Urology, Southmead Hospital and Bristol Urological Institute (D.G., E.R.), Bristol, the School of Medicine (M.M.) and Division of Cancer and Genetics, School of Medicine (J.S.), Cardiff University, and the Department of Urology, Cardiff and Vale University Health Board (H.K.), Cardiff, the Department of Cellular Pathology, Royal Victoria Infirmary (M.R.), and the Department of Urology, Freeman Hospital (P.P.), Newcastle-upon-Tyne, the Department of Urology and Surgery, Western General Hospital, University of Edinburgh, Edinburgh (P.B.), the Academic Urology Unit, University of Sheffield, Sheffield (J.C., D.J.R.), the Department of Urology, Addenbrooke's Hospital (A. Doble), and the Academic Urology Group, University of Cambridge (D.E.N.), Cambridge, the Department of Urology, Queen Elizabeth Hospital, Birmingham (A. Doherty), the Department of Urology, University Hospitals of Leicester, Leicester (R.K.), and the Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds (A.P., S.P.) - all in the United Kingdom.
出版信息
N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.
BACKGROUND
The comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen (PSA) testing remains uncertain.
METHODS
We compared active monitoring, radical prostatectomy, and external-beam radiotherapy for the treatment of clinically localized prostate cancer. Between 1999 and 2009, a total of 82,429 men 50 to 69 years of age received a PSA test; 2664 received a diagnosis of localized prostate cancer, and 1643 agreed to undergo randomization to active monitoring (545 men), surgery (553), or radiotherapy (545). The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up. Secondary outcomes included the rates of disease progression, metastases, and all-cause deaths.
RESULTS
There were 17 prostate-cancer-specific deaths overall: 8 in the active-monitoring group (1.5 deaths per 1000 person-years; 95% confidence interval [CI], 0.7 to 3.0), 5 in the surgery group (0.9 per 1000 person-years; 95% CI, 0.4 to 2.2), and 4 in the radiotherapy group (0.7 per 1000 person-years; 95% CI, 0.3 to 2.0); the difference among the groups was not significant (P=0.48 for the overall comparison). In addition, no significant difference was seen among the groups in the number of deaths from any cause (169 deaths overall; P=0.87 for the comparison among the three groups). Metastases developed in more men in the active-monitoring group (33 men; 6.3 events per 1000 person-years; 95% CI, 4.5 to 8.8) than in the surgery group (13 men; 2.4 per 1000 person-years; 95% CI, 1.4 to 4.2) or the radiotherapy group (16 men; 3.0 per 1000 person-years; 95% CI, 1.9 to 4.9) (P=0.004 for the overall comparison). Higher rates of disease progression were seen in the active-monitoring group (112 men; 22.9 events per 1000 person-years; 95% CI, 19.0 to 27.5) than in the surgery group (46 men; 8.9 events per 1000 person-years; 95% CI, 6.7 to 11.9) or the radiotherapy group (46 men; 9.0 events per 1000 person-years; 95% CI, 6.7 to 12.0) (P<0.001 for the overall comparison).
CONCLUSIONS
At a median of 10 years, prostate-cancer-specific mortality was low irrespective of the treatment assigned, with no significant difference among treatments. Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring. (Funded by the National Institute for Health Research; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).
背景
通过前列腺特异性抗原（PSA）检测发现的前列腺癌的治疗方法的疗效比较仍不确定。
方法
我们比较了主动监测、根治性前列腺切除术和外照射放疗治疗局限性前列腺癌的效果。1999 年至 2009 年间，共有 82429 名 50 至 69 岁的男性接受了 PSA 检测；2664 名被诊断为局限性前列腺癌，其中 1643 名同意接受随机分组，分别接受主动监测（545 名男性）、手术（553 名）或放疗（545 名）。主要结局是在中位随访 10 年后的前列腺癌死亡率。次要结局包括疾病进展、转移和全因死亡率。
结果
总体上有 17 例前列腺癌特异性死亡：主动监测组 8 例（每 1000 人年 1.5 例死亡；95%置信区间 [CI]，0.7 至 3.0），手术组 5 例（每 1000 人年 0.9 例死亡；95%CI，0.4 至 2.2），放疗组 4 例（每 1000 人年 0.7 例死亡；95%CI，0.3 至 2.0）；各组之间的差异无统计学意义（总体比较 P=0.48）。此外，三组之间任何原因导致的死亡人数也无显著差异（总死亡 169 例；P=0.87）。主动监测组中有更多的男性出现转移（33 例；每 1000 人年 6.3 例；95%CI，4.5 至 8.8），而手术组（13 例；每 1000 人年 2.4 例；95%CI，1.4 至 4.2）或放疗组（16 例；每 1000 人年 3.0 例；95%CI，1.9 至 4.9）（总体比较 P=0.004）。主动监测组的疾病进展率较高（112 例；每 1000 人年 22.9 例；95%CI，19.0 至 27.5），而手术组（46 例；每 1000 人年 8.9 例；95%CI，6.7 至 11.9）或放疗组（46 例；每 1000 人年 9.0 例；95%CI，6.7 至 12.0）（总体比较 P<0.001）。
结论
在中位数为 10 年的时间里，无论接受何种治疗，前列腺癌特异性死亡率均较低，且治疗方法之间无显著差异。手术和放疗与主动监测相比，疾病进展和转移的发生率较低。（由英国国家卫生研究院资助；ProtecT 目前的对照试验编号为 ISRCTN82105264；ClinicalTrials.gov 注册号为 NCT02044172）。
Zotero 插件