10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer

被引：2003

作者：

Hamdy, F. C. ^{[1
]}

Donovan, J. L. ^{[2
,5
]}

Lane, J. A. ^{[2
,3
]}

Mason, M. ^{[9
]}

Metcalfe, C. ^{[2
,3
]}

Holding, P. ^{[1
]}

Davis, M. ^{[2
]}

Peters, T. J. ^{[4
]}

Turner, E. L. ^{[2
]}

Martin, R. M. ^{[2
]}

Oxley, J. ^{[6
]}

Robinson, M. ^{[12
]}

Staffurth, J. ^{[10
]}

Walsh, E. ^{[2
]}

Bollina, P. ^{[14
]}

Catto, J. ^{[15
]}

Doble, A. ^{[16
]}

Doherty, A. ^{[18
]}

Gillatt, D. ^{[7
,8
]}

Kockelbergh, R. ^{[19
]}

Kynaston, H. ^{[11
]}

Paul, A. ^{[20
]}

Powell, P. ^{[13
]}

Prescott, S. ^{[20
]}

Rosario, D. J. ^{[15
]}

Rowe, E. ^{[7
,8
]}

Neal, D. E. ^{[1
,17
]}

机构：

[1] Univ Oxford, Nuffield Dept Surg Sci, Old Rd Campus Res Bldg,Roosevelt Dr, Oxford OX3 7DQ, England

[2] Univ Bristol, Sch Social & Community Med, Bristol, Avon, England

[3] Univ Bristol, Bristol Randomized Trials Collaborat, Bristol, Avon, England

[4] Univ Bristol, Sch Clin Sci, Bristol, Avon, England

[5] Univ Hosp Bristol NHS Fdn Trust, Natl Inst Hlth Res Collaborat Leadership Appl Hlt, Bristol, Avon, England

[6] North Bristol NHS Trust, Dept Cellular Pathol, Bristol, Avon, England

[7] Southmead Hosp, Dept Urol, Bristol, Avon, England

[8] Bristol Urol Inst, Bristol, Avon, England

[9] Cardiff Univ, Sch Med, Cardiff, S Glam, Wales

[10] Cardiff Univ, Sch Med, Div Canc & Genet, Cardiff, S Glam, Wales

[11] Cardiff & Vale Univ Hlth Board, Dept Urol, Cardiff, S Glam, Wales

[12] Royal Victoria Infirm, Dept Cellular Pathol, Newcastle Upon Tyne, Tyne & Wear, England

[13] Freeman Rd Hosp, Dept Urol, Newcastle Upon Tyne, Tyne & Wear, England

[14] Univ Edinburgh, Western Gen Hosp, Dept Urol & Surg, Edinburgh, Midlothian, Scotland

[15] Univ Sheffield, Acad Urol Unit, Sheffield, S Yorkshire, England

[16] Addenbrookes Hosp, Dept Urol, Cambridge, England

[17] Univ Cambridge, Acad Urol Grp, Cambridge, England

[18] Queen Elizabeth Hosp, Dept Urol, Birmingham, W Midlands, England

[19] Univ Hosp Leicester, Dept Urol, Leicester, Leics, England

[20] Leeds Teaching Hosp NHS Trust, Dept Urol, Leeds, W Yorkshire, England

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2016年 / 375卷 / 15期

关键词：

CLUSTER RANDOMIZED-TRIAL; RADICAL PROSTATECTOMY; ACTIVE-SURVEILLANCE; CONFORMAL RADIOTHERAPY; SCREENING TRIAL; RT01; TRIAL; MORTALITY; DESIGN; DEATH; ERSPC;

D O I：

10.1056/NEJMoa1606220

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.)

引用

页码：1415 / 1424

页数：10

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