前列腺癌监测、手术或放疗后 15 年的结果。
Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.
机构信息
From the Nuffield Department of Surgical Sciences, University of Oxford, Oxford (F.C.H., R.J.B., D.E.N.), Population Health Sciences (J.L.D., J.A.L., C.M., M.D., E.L.T., R.M.M., G.J.Y., E.I.W., T.J.P., N.J.W.) and Bristol Trials Centre (J.A.L., C.M., G.J.Y.), Bristol Medical School, University of Bristol, the Department of Urology, Southmead Hospital and Bristol Urological Institute (E.R.), and the Department of Cellular Pathology, North Bristol NHS Trust (J.O.), Bristol, the Department of Urology and Surgery, Western General Hospital, University of Edinburgh, Edinburgh (P.B.), the Department of Urology (A. Doble) and the Division of Urology, Department of Surgery and Cambridge Urology Translational Research and Clinical Trials Office, Cambridge Biomedical Campus (V.G., D.E.N.), Addenbrooke's Hospital, Cambridge, the Department of Urology, Queen Elizabeth Hospital, Birmingham (A. Doherty), the Department of Urology, Cardiff and Vale University Health Board (O.H., H.K.), and the School of Medicine (M.M.) and the Division of Cancer and Genetics (J.S.), Cardiff University, Cardiff, the Department of Urology, University Hospitals of Leicester, Leicester (R.K.), the Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds (A.P.), the Department of Urology, Freeman Hospital, Newcastle-upon-Tyne (E.P., P.P.), and the Department of Urology, Royal Hallamshire Hospital (D.J.R., J.W.F.C.), and the Academic Urology Unit, Medical School, University of Sheffield (J.W.F.C.), Sheffield - all in the United Kingdom; and the Department of Urological Oncology and Robotic Surgery, Macquarie University, Sydney (D.G.).
出版信息
N Engl J Med. 2023 Apr 27;388(17):1547-1558. doi: 10.1056/NEJMoa2214122. Epub 2023 Mar 11.
BACKGROUND
Between 1999 and 2009 in the United Kingdom, 82,429 men between 50 and 69 years of age received a prostate-specific antigen (PSA) test. Localized prostate cancer was diagnosed in 2664 men. Of these men, 1643 were enrolled in a trial to evaluate the effectiveness of treatments, with 545 randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to undergo radiotherapy.
METHODS
At a median follow-up of 15 years (range, 11 to 21), we compared the results in this population with respect to death from prostate cancer (the primary outcome) and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy (secondary outcomes).
RESULTS
Follow-up was complete for 1610 patients (98%). A risk-stratification analysis showed that more than one third of the men had intermediate or high-risk disease at diagnosis. Death from prostate cancer occurred in 45 men (2.7%): 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (P = 0.53 for the overall comparison). Death from any cause occurred in 356 men (21.7%), with similar numbers in all three groups. Metastases developed in 51 men (9.4%) in the active-monitoring group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group. Long-term androgen-deprivation therapy was initiated in 69 men (12.7%), 40 (7.2%), and 42 (7.7%), respectively; clinical progression occurred in 141 men (25.9%), 58 (10.5%), and 60 (11.0%), respectively. In the active-monitoring group, 133 men (24.4%) were alive without any prostate cancer treatment at the end of follow-up. No differential effects on cancer-specific mortality were noted in relation to the baseline PSA level, tumor stage or grade, or risk-stratification score. No treatment complications were reported after the 10-year analysis.
CONCLUSIONS
After 15 years of follow-up, prostate cancer-specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer. (Funded by the National Institute for Health and Care Research; ProtecT Current Controlled Trials number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.).
背景
1999 年至 2009 年间，英国有 82429 名 50 至 69 岁的男性接受了前列腺特异性抗原（PSA）检测。2664 名男性被诊断出患有局限性前列腺癌。这些男性中，有 1643 名被纳入一项评估治疗效果的试验，其中 545 名随机接受主动监测，553 名接受前列腺切除术，545 名接受放疗。
方法
中位随访时间为 15 年（范围为 11 至 21 年），我们比较了该人群中前列腺癌死亡（主要结局）和任何原因死亡、转移、疾病进展和开始长期雄激素剥夺治疗（次要结局）的结果。
结果
1610 名患者（98%）的随访完整。风险分层分析显示，超过三分之一的男性在诊断时患有中高危疾病。45 名男性（2.7%）死于前列腺癌：主动监测组 17 名（3.1%），前列腺切除术组 12 名（2.2%），放疗组 16 名（2.9%）（总体比较 P=0.53）。356 名男性（21.7%）死于任何原因，三组中死亡人数相似。主动监测组 51 名（9.4%）发生转移，前列腺切除术组 26 名（4.7%），放疗组 27 名（5.0%）。69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；69 名男性（12.7%）、40 名（7.2%）和 42 名（7.7%）分别开始长期雄激素剥夺治疗；在主动监测组中，有 133 名男性（24.4%）在随访结束时未接受任何前列腺癌治疗仍存活。未发现基线 PSA 水平、肿瘤分期或分级或风险分层评分与癌症特异性死亡率的差异。10 年分析后未报告治疗相关并发症。
结论
无论接受何种治疗，15 年随访后前列腺癌特异性死亡率均较低。因此，治疗方法的选择涉及权衡局限性前列腺癌治疗相关的益处和危害之间的利弊权衡。（由英国国家卫生与保健研究院资助；ProtecT 正在进行的对照试验，注册号 ISRCTN82634102；ClinicalTrials.gov 注册号 NCT02044172）。
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