Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer

被引:927
作者
Donovan, J. L. [1 ,4 ]
Hamdy, F. C. [6 ]
Lane, J. A. [1 ,2 ]
Mason, M. [7 ]
Metcalfe, C. [1 ,2 ]
Walsh, E. [1 ]
Blazeby, J. M. [1 ]
Peters, T. J. [3 ]
Holding, P. [6 ]
Bonnington, S. [9 ]
Lennon, T. [10 ]
Bradshaw, L. [5 ]
Cooper, D. [11 ]
Herbert, P. [12 ]
Howson, J. [14 ]
Jones, A. [8 ]
Lyons, N. [15 ]
Salter, E. [5 ]
Thompson, P. [16 ]
Tidball, S. [8 ]
Blaikie, J. [15 ]
Gray, C. [11 ]
Bollina, P. [15 ]
Catto, J. [14 ]
Doble, A. [12 ]
Doherty, A. [16 ]
Gillatt, D. [5 ]
Kockelbergh, R. [9 ]
Kynaston, H. [8 ]
Paul, A. [11 ]
Powell, P. [10 ]
Prescott, S. [11 ]
Rosario, D. J. [14 ]
Rowe, E. [5 ]
Davis, M. [1 ]
Turner, E. L. [1 ]
Martin, R. M. [1 ]
Neal, D. E. [6 ,13 ]
机构
[1] Univ Bristol, Sch Social & Community Med, Canynge Hall,39 Whatley Rd, Bristol BS8 2PS, Avon, England
[2] Univ Bristol, Bristol Randomised Trials Collaborat, Bristol BS8 2PS, Avon, England
[3] Univ Bristol, Sch Clin Sci, Bristol BS8 2PS, Avon, England
[4] Univ Hosp Bristol NHS Fdn Trust, Natl Inst Hlth Res Collaborat Leadership Appl Hlt, Bristol, Avon, England
[5] North Bristol NHS Trust, Bristol Urol Inst, Bristol, Avon, England
[6] Univ Oxford, Nuffield Dept Surg Sci, Oxford, England
[7] Cardiff Univ, Sch Med, Cardiff, S Glam, Wales
[8] Cardiff & Vale Univ Hlth Board, Dept Urol, Cardiff, S Glam, Wales
[9] Univ Hosp Leicester, Dept Urol, Leicester, Leics, England
[10] Freeman Rd Hosp, Dept Urol, Newcastle Upon Tyne, Tyne & Wear, England
[11] Leeds Teaching Hosp NHS Trust, Dept Urol, Leeds, W Yorkshire, England
[12] Addenbrookes Hosp, Dept Urol, Cambridge, England
[13] Univ Cambridge, Acad Urol Grp, Cambridge, England
[14] Univ Sheffield, Acad Urol Unit, Sheffield, S Yorkshire, England
[15] Western Gen Hosp, Dept Urol & Surg, Edinburgh, Midlothian, Scotland
[16] Queen Elizabeth Hosp, Dept Urol, Birmingham, W Midlands, England
关键词
QUALITY-OF-LIFE; RANDOMIZED CONTROLLED-TRIAL; RADICAL PROSTATECTOMY; URINARY-INCONTINENCE; ACTIVE SURVEILLANCE; MEN; INTERVENTION; METAANALYSIS; VALIDATION; MORTALITY;
D O I
10.1056/NEJMoa1606221
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. METHODS We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. RESULTS The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. CONCLUSIONS In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.)
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收藏
页码:1425 / 1437
页数:13
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