英国牛津大学Freddie C. Hamdy团队研究了前列腺癌监测、手术或放疗后15年的患者结局。该研究于2023年3月11日发表在《新英格兰医学杂志》上。

1999至2009年间，英国有82429名50岁至69岁的男性接受了前列腺特异性抗原（PSA）检测。2664名男性被诊断为局限性前列腺癌。在这些男性中，1643人参加了一项评估治疗效果的试验，其中545人被随机分配接受积极监测，553人接受前列腺切除术，545人接受放射治疗。

在15年的中位随访中，研究组比较了该人群前列腺癌死亡（主要结局）和全因死亡、转移、疾病进展和开始长期雄激素替代治疗（次要结局）的结果。

1610名患者（98%）完成了随访。一项风险分层分析显示，超过三分之一的男性在诊断时患有中度或高危疾病。45名男性（2.7%）死于前列腺癌症：积极监测组17人（3.1%），前列腺切除组12人（2.2%），放射治疗组16人（2.9%）。356名男性（21.7%）全因死亡，三组的死亡人数相似。

积极监测组有51名男性（9.4%）发生转移，前列腺切除组有26名男性（4.7%）发生，放射治疗组有27名男性（5.0%）发生。三组中分别有69名男性（12.7%）、40名男性（7.2%）和42名男性（7.7%）开始了长期雄激素剥夺治疗；141名男性（25.9%）、58名男性（10.5%）和60名男性（11.0%）分别出现临床进展。在积极监测组中，133名男性（24.4%）在随访结束时未接受任何前列腺癌症治疗。基线PSA水平、肿瘤分期或分级或风险分层评分对癌症特异性死亡率无差异影响。10年分析后未报告任何治疗并发症。

研究结果表明，经过15年的随访，无论指定何种治疗，前列腺癌特异性死亡率都很低。因此，治疗的选择涉及权衡局部前列腺癌症治疗的利弊。

附：英文原文

Title: Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer | NEJM

Author: Freddie C. Hamdy, F.R.C.S.(Urol.), F.Med.Sci.,, Jenny L. Donovan, Ph.D., F.Med.Sci.,, J. Athene Lane, Ph.D.,, Chris Metcalfe, Ph.D.,, Michael Davis, M.Sc.,, Emma L. Turner, Ph.D.,, Richard M. Martin, B.M., B.S., Ph.D.,, Grace J. Young, M.Sc.,, Eleanor I. Walsh, M.Sc.,, Richard J. Bryant, Ph.D., F.R.C.S.(Urol.),, Prasad Bollina, M.B., B.S., F.R.C.S.(Urol.),, Andrew Doble, F.R.C.S.(Urol.),, Alan Doherty, F.R.C.S.(Urol.),, David Gillatt, F.R.C.S.(Urol.),, Vincent Gnanapragasam, Ph.D., F.R.C.S.(Urol.),, Owen Hughes, F.R.C.S.(Urol.), D.M.,, Roger Kockelbergh, D.M., F.R.C.S.(Urol.),, Howard Kynaston, M.D., F.R.C.S.(Urol.),, Alan Paul, M.D., F.R.C.S.(Urol.),, Edgar Paez, F.R.C.S.(Urol.),, Philip Powell, M.D., F.R.C.S.,, Derek J. Rosario, M.D., F.R.C.S.(Urol.),, Edward Rowe, M.D., F.R.C.S.(Urol.),, Malcolm Mason, M.D., F.R.C.R.,, James W.F. Catto, Ph.D., F.R.C.S.(Urol.),, Tim J. Peters, Ph.D., F.Med.Sci.,, Jon Oxley, M.D., F.R.C.Path.,, Naomi J. Williams, Ph.D.,, John Staffurth, F.R.C.R., F.R.C.P.,, and David E. Neal, F.Med.Sci.

Issue&Volume: 2023-03-11

Abstract:

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.

DOI: 10.1056/NEJMoa2214122

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2214122