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    Radiotherapy to the prostate for men with metastatic prostate cancer in the UK and Switzerland: Long-term results from the STAMPEDE randomised controlled trial

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    Authors
    Parker, C. C.
    James, N. D.
    Brawley, C. D.
    Clarke, Noel W
    Ali, Adnan
    Amos, C. L.
    Attard, G.
    Chowdhury, S.
    Cook, A.
    Cross, W.
    Dearnaley, D. P.
    Douis, H.
    Gilbert, D. C.
    Gilson, C.
    Gillessen, S.
    Hoyle, Alex P
    Jones, R. J.
    Langley, R. E.
    Malik, Z. I.
    Mason, M. D.
    Matheson, D.
    Millman, R.
    Rauchenberger, M.
    Rush, H.
    Russell, J. M.
    Sweeney, H.
    Bahl, A.
    Birtle, A.
    Capaldi, L.
    Din, O.
    Ford, D.
    Gale, J.
    Henry, A.
    Hoskin, P.
    Kagzi, M.
    Lydon, A.
    O'Sullivan, J. M.
    Paisey, S. A.
    Parikh, O.
    Pudney, D.
    Ramani, Vijay A C
    Robson, P.
    Srihari, N. N.
    Tanguay, J.
    Parmar, M. K. B.
    Sydes, M. R.
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    Affiliation
    The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    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.
    Citation
    Parker CC, James ND, Brawley CD, Clarke NW, Ali A, Amos CL, et al. Radiotherapy to the prostate for men with metastatic prostate cancer in the UK and Switzerland: Long-term results from the STAMPEDE randomised controlled trial. Brenton JD, editor. Vol. 19, PLOS Medicine. Public Library of Science (PLoS); 2022. p. e1003998.
    Journal
    PLoS Medicine
    URI
    http://hdl.handle.net/10541/625360
    DOI
    10.1371/journal.pmed.1003998
    PubMed ID
    35671327
    Additional Links
    https://dx.doi.org/10.1371/journal.pmed.1003998
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1371/journal.pmed.1003998
    Scopus Count
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