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

Medientyp: E-Artikel
Titel: Radiotherapy to the prostate for men with metastatic prostate cancer in the UK and Switzerland: Long-term results from the STAMPEDE randomised controlled trial
Beteiligte: Parker, Chris C.; James, Nicholas D.; Brawley, Christopher D.; Clarke, Noel W.; Ali, Adnan; Amos, Claire L.; Attard, Gerhardt; Chowdhury, Simon; Cook, Adrian; Cross, William; Dearnaley, David P.; Douis, Hassan; Gilbert, Duncan C.; Gilson, Clare; Gillessen, Silke; Hoyle, Alex; Jones, Rob J.; Langley, Ruth E.; Malik, Zafar I.; Mason, Malcolm D.; Matheson, David; Millman, Robin; Rauchenberger, Mary; Rush, Hannah; [...]
Erschienen: Public Library of Science (PLoS), 2022
Erschienen in: PLOS Medicine
Sprache: Englisch
DOI: 10.1371/journal.pmed.1003998
ISSN: 1549-1676
Entstehung:
Anmerkungen:
Beschreibung: <jats:sec id="sec001"> <jats:title>Background</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec id="sec002"> <jats:title>Methods and findings</jats:title> <jats:p>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.</jats:p> <jats:p>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, <jats:italic>p</jats:italic> < 0.001; 375 SOC versus 386 SOC+RT, HR = 1.11, 95% CI 0.96, 1.28, <jats:italic>p</jats:italic> = 0·164; interaction <jats:italic>p</jats:italic> < 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.</jats:p> </jats:sec> <jats:sec id="sec003"> <jats:title>Conclusions</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec id="sec004"> <jats:title>Trial registration</jats:title> <jats:p>ClinicalTrials.gov <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00268476" xlink:type="simple">NCT00268476</jats:ext-link>, ISRCTN.com <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.isrctn.com/ISRCTN78818544" xlink:type="simple">ISRCTN78818544</jats:ext-link>.</jats:p> </jats:sec>
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