Radiotherapy to the prostate for men with metastatic prostate cancer in the UK and Switzerland: Long-term results from the STAMPEDE randomised controlled trial.
Date
2022-06-01Author
Parker, CC
James, ND
Brawley, CD
Clarke, NW
Ali, A
Amos, CL
Attard, G
Chowdhury, S
Cook, A
Cross, W
Dearnaley, DP
Douis, H
Gilbert, DC
Gilson, C
Gillessen, S
Hoyle, A
Jones, RJ
Langley, RE
Malik, ZI
Mason, MD
Matheson, D
Millman, R
Rauchenberger, M
Rush, H
Russell, JM
Sweeney, H
Bahl, A
Birtle, A
Capaldi, L
Din, O
Ford, D
Gale, J
Henry, A
Hoskin, P
Kagzi, M
Lydon, A
O'Sullivan, JM
Paisey, SA
Parikh, O
Pudney, D
Ramani, V
Robson, P
Srihari, NN
Tanguay, J
Parmar, MKB
Sydes, MR
STAMPEDE Trial Collaborative Group,
Brenton JD
Type
Journal Article
Metadata
Show full item recordAbstract
BACKGROUND: STAMPEDE has previously reported that radiotherapy (RT) to the prostate improved overall survival (OS) for patients with newly diagnosed prostate cancer with low metastatic burden, but not those with high-burden disease. In this final analysis, we report long-term findings on the primary outcome measure of OS and on the secondary outcome measures of symptomatic local events, RT toxicity events, and quality of life (QoL). METHODS AND FINDINGS: Patients were randomised at secondary care sites in the United Kingdom and Switzerland between January 2013 and September 2016, with 1:1 stratified allocation: 1,029 to standard of care (SOC) and 1,032 to SOC+RT. No masking of the treatment allocation was employed. A total of 1,939 had metastatic burden classifiable, with 42% low burden and 58% high burden, balanced by treatment allocation. Intention-to-treat (ITT) analyses used Cox regression and flexible parametric models (FPMs), adjusted for stratification factors age, nodal involvement, the World Health Organization (WHO) performance status, regular aspirin or nonsteroidal anti-inflammatory drug (NSAID) use, and planned docetaxel use. QoL in the first 2 years on trial was assessed using prospectively collected patient responses to QLQ-30 questionnaire. Patients were followed for a median of 61.3 months. Prostate RT improved OS in patients with low, but not high, metastatic burden (respectively: 202 deaths in SOC versus 156 in SOC+RT, hazard ratio (HR) = 0·64, 95% CI 0.52, 0.79, p < 0.001; 375 SOC versus 386 SOC+RT, HR = 1.11, 95% CI 0.96, 1.28, p = 0·164; interaction p < 0.001). No evidence of difference in time to symptomatic local events was found. There was no evidence of difference in Global QoL or QLQ-30 Summary Score. Long-term urinary toxicity of grade 3 or worse was reported for 10 SOC and 10 SOC+RT; long-term bowel toxicity of grade 3 or worse was reported for 15 and 11, respectively. CONCLUSIONS: Prostate RT improves OS, without detriment in QoL, in men with low-burden, newly diagnosed, metastatic prostate cancer, indicating that it should be recommended as a SOC. TRIAL REGISTRATION: ClinicalTrials.gov NCT00268476, ISRCTN.com ISRCTN78818544.
Collections
Subject
Docetaxel
Humans
Male
Prostate
Prostatic Neoplasms
Quality of Life
Switzerland
Research team
Prostate & Bladder Cancer
Clinic Acad RT Dearnaley
Language
eng
Date accepted
2022-04-22
License start date
2022-06-01
Citation
PLoS Medicine, 2022, 19 (6), pp. e1003998 -
Publisher
PUBLIC LIBRARY SCIENCE