Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment.

Autor: Donovan JL; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Hamdy FC; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom., Lane JA; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.; Bristol Trials Centre, Bristol Medical School, University of Bristol, United Kingdom., Young GJ; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.; Bristol Trials Centre, Bristol Medical School, University of Bristol, United Kingdom., Metcalfe C; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.; Bristol Trials Centre, Bristol Medical School, University of Bristol, United Kingdom., Walsh EI; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Davis M; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Steuart-Feilding T; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Blazeby JM; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Avery KNL; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Martin RM; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Bollina P; Department of Urology and Surgery, Western General Hospital, University of Edinburgh, United Kingdom., Doble A; Department of Urology, Addenbrooke's Hospital, Cambridge, United Kingdom., Doherty A; Department of Urology, Queen Elizabeth Hospital, Birmingham, United Kingdom., Gillatt D; Department of Urological Oncology and Robotic Surgery, Macquarie University, Sydney., Gnanapragasam V; Division of Urology, Department of Surgery and Cambridge Urology Translational Research and Clinical Trials Office, Cambridge, United Kingdom., Hughes O; Department of Urology, Cardiff and Vale University Health Board, Cardiff, United Kingdom., Kockelbergh R; Department of Urology, University Hospitals of Leicester, Leicester, United Kingdom., Kynaston H; Department of Urology, Cardiff and Vale University Health Board, Cardiff, United Kingdom., Paul A; Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom., Paez E; Department of Urology, Freeman Hospital, Newcastle upon Tyne, United Kingdom., Powell P; Department of Urology, Freeman Hospital, Newcastle upon Tyne, United Kingdom., Rosario DJ; Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom., Rowe E; Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, United Kingdom., Mason M; School of Medicine, Cardiff University, Cardiff, United Kingdom., Catto JWF; Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom.; Academic Urology Unit, Medical School, University of Sheffield, Sheffield, United Kingdom., Peters TJ; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Wade J; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Turner EL; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Williams NJ; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom., Oxley J; Department of Cellular Pathology, North Bristol NHS Trust, Bristol, United Kingdom., Staffurth J; Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, United Kingdom., Bryant RJ; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom., Neal DE; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.; Division of Urology, Department of Surgery and Cambridge Urology Translational Research and Clinical Trials Office, Cambridge, United Kingdom.
Jazyk: angličtina
Zdroj: NEJM evidence [NEJM Evid] 2023 Apr; Vol. 2 (4), pp. EVIDoa2300018. Date of Electronic Publication: 2023 Mar 11.
DOI: 10.1056/EVIDoa2300018
Abstrakt: BACKGROUND: Long-term patient-reported outcomes are needed to inform treatment decisions for localized prostate cancer. METHODS: Patient-reported outcomes of 1643 randomly assigned participants in the ProtecT (Prostate Testing for Cancer and Treatment) trial were evaluated to assess the functional and quality-of-life impacts of prostatectomy, radiotherapy with neoadjuvant androgen deprivation, and active monitoring. This article focuses on the outcomes of the randomly assigned participants from 7 to 12 years using mixed effects linear and logistic models. RESULTS: Response rates exceeded 80% for most measures. Among the randomized groups over 7 to 12 years, generic quality-of-life scores were similar. Among those in the prostatectomy group, urinary leakage requiring pads occurred in 18 to 24% of patients over 7 to 12 years, compared with 9 to 11% in the active monitoring group and 3 to 8% in the radiotherapy group. In the prostatectomy group, 18% reported erections sufficient for intercourse at 7 years, compared with 30% in the active monitoring and 27% in the radiotherapy groups; all converged to low levels of potency by year 12. Nocturia (voiding at least twice per night) occurred in 34% in the prostatectomy group compared with 48% in the radiotherapy group and 47% in the active monitoring group at 12 years. Fecal leakage affected 12% in the radiotherapy group compared with 6% in the other groups by year 12. The active monitoring group experienced gradual age-related declines in sexual and urinary function, avoiding radical treatment effects unless they changed management. CONCLUSIONS: ProtecT provides robust evidence about continued impacts of treatments in the long term. These data allow patients newly diagnosed with localized prostate cancer and their clinicians to assess the trade-offs between treatment harms and benefits and enable better informed and prudent treatment decisions. (Funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme projects 96/20/06 and 96/20/99; ISRCTN number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.)
Databáze: MEDLINE