Whole Brain Radiotherapy Versus Stereotactic Radiosurgery in Poor-Prognosis Patients with One to 10 Brain Metastases: A Randomised Feasibility Study |
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| Affiliation: | 1. Department of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada;2. Department of Radiation Oncology, BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada;3. Department of Radiation Oncology, BC Cancer Agency Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada;4. Department of Radiation Oncology, BC Cancer Agency Abbostford Centre, Abbotsford, British Columbia, Canada;5. Department of Radiation Oncology, BC Cancer Agency Fraser Valley Centre, Surrey, British Columbia, Canada;7. Department of Radiation Oncology, BC Cancer Agency Vancouver Island Centre, Vancouver Island, British Columbia, Canada;11. Department of Population Oncology, British Columbia Cancer Vancouver Centre, Vancouver, British Columbia, Canada;1. Oxford University Hospital NHS Foundation Trust, Oxford, UK;2. Cardiff University, Centre for Trials Research, Cardiff, UK;3. Guy''s and St Thomas'' NHS Foundation Trust, London, UK;4. Christie NHS Foundation Trust, Manchester, UK;5. Leeds Teaching Hospitals NHS Trust, Leeds, UK;7. Royal Marsden NHS Foundation Trust, London, UK;11. Royal Devon and Exeter NHS Foundation Trust, Exeter, UK;12. NHS Highland, Inverness, UK;8. Royal Berkshire Hospital, Reading, UK;9. NIHR Oxford Biomedical Research Centre, Oxford, UK;1. Department of Clinical Oncology, Mount Vernon Cancer Centre, Northwood, UK;2. Department of Radiotherapy Physics, Mount Vernon Cancer Centre, Northwood, UK;3. Department of Acute Medicine, University Hospital Lewisham, London, UK;4. Department of Clinical Oncology, St Bartholomew''s Hospital, London, UK;5. Division of Cancer Sciences, The University of Manchester, Manchester, UK;1. The Ottawa Hospital Cancer Centre and University of Ottawa, Ottawa, Ontario, Canada;2. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel;3. Ottawa Hospital Research Institute, Ottawa, Ontario, Canada;4. University Health Network, Toronto, Ontario, Canada;5. Children''s Hospital of Eastern Ontario, Ottawa, Ontario, Canada;7. Department of Surgery, Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada;11. Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, Ontario, Canada;12. Department of Surgery, McMaster University, Hamilton, Ontario, Canada;8. Division of Urology, Department of Surgery, Western University, London, Ontario, Canada;9. Department of Surgery, Western University, London, Ontario, Canada;71. Juravinski Cancer Centre, McMaster University, Hamilton, Ontario, Canada;112. Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada;123. Division of Medical Oncology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada;84. Division of Urology, McGill University, Montreal, Quebec, Canada;95. Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada;77. Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada;1111. Laval University, Quebec City, Quebec, Canada;1212. Division of Medical Oncology, The Ottawa Hospital Cancer Centre and the University of Ottawa, Ottawa, Ontario, Canada;1. Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, Québec, Canada;2. Department of Urology, European Institute of Oncology IRCCS, Milan, Italy;3. Division of Urology, University of Montreal Hospital Center (CHUM), Montreal, Québec, Canada;4. Department of Urology, Spedali Civili Hospital, University of Brescia, Brescia, Italy;5. Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy;7. Department of Urology, IRCCS Policlinico San Donato, University of Milan, Milan, Italy;11. Department of Urology, IRCCS Fondazione Ca’ Granda-Ospedale Maggiore Policlinico, University of Milan, Milan, Italy;12. Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany;8. Department of Urology, Medical University of Vienna, Vienna, Austria;9. Dipartimento di Oncologia ed Emato-Oncologia, University of Milan, Milan, Italy;1. CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK;2. Department of Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK;3. Weston Park Cancer Centre, Sheffield, UK;4. Brighton & Sussex Medical Schools, Brighton, UK;5. National Institute for Health Research, Leeds, UK;7. The Institute of Cancer Research, London, UK;11. University of Cambridge, Cambridge, UK;12. Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia;1. Clinical Trials Research Unit, University of Leeds, Leeds, UK;2. St James''s Institute of Oncology, St James University Hospital, Leeds, UK;3. Nuffield Department of Population Health, Oxford University, Oxford, UK;4. Department of Clinical Oncology, The Beatson West of Scotland Cancer Centre, Glasgow, UK;5. Department of Medical Oncology, University Hospitals, Bristol, UK;6. Department of Medical Oncology, Velindre Hospital, Cardiff, UK;7. Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK |
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| Abstract: | AimsA significant proportion of patients with brain metastases have a poor prognosis, with a life expectancy of 3–6 months. To determine the optimal radiotherapeutic strategy for brain metastases in this population, we conducted a randomised feasibility study of whole brain radiotherapy (WBRT) versus stereotactic radiosurgery (SRS).Materials and methodsPatients with a life expectancy of 3–6 months and between one and 10 brain metastases with a diameter ≤4 cm were enrolled at six Canadian cancer centres. Patients were randomly assigned (1:1) to receive either WBRT (20 Gy in five fractions) or SRS (15 Gy in one fraction). The primary end point was the rate of accrual per month. Secondary feasibility and clinical end points included the ratio of accrued subjects to screened subjects. This trial is registered with ClinicalTrials.gov (number NCT02220491).ResultsIn total, 210 patients were screened to enrol 22 patients into the trial; 20 patients were randomised between the two arms. Two patients did not receive treatment because one patient died and another patient withdrew consent after being enrolled. Patients were accrued between January 2015 and November 2017; the accrual rate was 0.63 patients/month. The most common reasons for exclusion were anticipated median survival outside the required range (n = 40), baseline Karnofsky Performance Score below 70 (n = 28) and more than 10 brain metastases (n = 28). The median follow-up was 7.0 months and the median survival was 7.0 months for all patients in the trial. The median intracranial progression-free survival was 1.8 months in the SRS arm and 9.2 months in the WBRT arm. There were five grade 3+ toxicities in the SRS arm and one grade 3+ toxicity in the WBRT arm; no grade 5 toxicities were observed. The cumulative rates of retreatment were 40% in the SRS arm and 40% in the WBRT arm.ConclusionsA randomised trial evaluating WBRT versus SRS in patients with one to 10 metastases and a poor prognosis is feasible. A slower than expected accrual rate and difficulties with accurate prognostication were identified as issues in this feasibility study. A larger phase III randomised trial is planned to determine the optimal treatment in this patient population. |
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| Keywords: | Brain metastases stereotactic radiosurgery whole brain radiotherapy |
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