Slow accrual of elderly patients with metastatic breast cancer in the Dutch multicentre OMEGA study |
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| Authors: | ME Hamaker C Seynaeve JWR Nortier M Wymenga E Maartense E Boven AE van Leeuwen-Stok SE de Rooij BC van Munster CH Smorenburg |
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| Institution: | 1. Department of Geriatric Medicine, Diakonessenhuis, Utrecht, The Netherlands;2. Department of Medical Oncology, Erasmus University Medical Centre – Daniel den Hoed Cancer Centre, Rotterdam, The Netherlands;3. Department of Medical Oncology, Leiden University Medical Centre, Leiden, The Netherlands;4. Department of Medical Oncology, Medisch Spectrum Twente, Enschede, The Netherlands;5. Department of Medical Oncology, Reinier de Graaf Hospital, Delft, The Netherlands;6. Department of Medical Oncology, Vrije Universiteit Medical Centre, Amsterdam, The Netherlands;7. Dutch Breast Cancer Trialists'' Group BOOG, Amsterdam, The Netherlands;8. Department of Internal Medicine, Geriatric Division, Academic Medical Centre Amsterdam, The Netherlands;9. Department of Geriatric Medicine, Gelre Hospitals, Apeldoorn, The Netherlands;10. Department of Medical Oncology, Medical Centre Alkmaar, The Netherlands;1. Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA;2. Lynn Sage Comprehensive Breast Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA;1. Division of Cancer Care and Epidemiology, Cancer Research Institute, Queen''s University, Kingston, Canada;2. Dept of Oncology, Queen''s University, Kingston, Canada;3. Cancer Centre of Southeastern Ontario, Queen''s University, Kingston, Canada;4. Ontario Institute for Cancer Research, Dept of Family and Community Medicine, University of Toronto, Toronto, Canada;5. Ottawa Hospital Cancer Centre, Ottawa, Canada;6. BC Cancer Agency, Vancouver, Canada;1. Department of Oncology, Sahlgrenska Academy and University Hospital, Gothenburg, Sweden;2. Department of Oncology/Pathology, Karolinska Institutet, Stockholm, Sweden;3. Department of Oncology/Pathology, Cancer Centre Karolinska, Karolinska Institutet, Stockholm, Sweden;4. Department of Surgery, Linköping University Hospital, Linköping, Sweden;5. Department of Clinical and Experimental Medicine, Division of Oncology, Faculty of Health Sciences, Linköping University, County Council of Östergötland, Linköping, Sweden;1. Nuclear Medicine Department, Germans Trias i Pujol University Hospital, Carretera del Canyet, Badalona, Spain;2. Oncology Department, Catalan Institute of Oncology, Germans Trias i Pujol University Hospital, Carretera del Canyet, Badalona, Spain;3. Pathology Department, Germans Trias i Pujol University Hospital, Carretera del Canyet, Badalona, Spain;4. Radiology Department, Germans Trias i Pujol University Hospital, Carretera del Canyet, Badalona, Spain;5. Surgery Department, Germans Trias i Pujol University Hospital, Carretera del Canyet, Badalona, Spain;6. Gynecology Department, Germans Trias i Pujol University Hospital, Carretera del Canyet, Badalona, Spain |
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| Abstract: | BackgroundIn a Dutch multicentre study, elderly (65 + year) metastatic breast cancer patients, eligible for first-line chemotherapy, were randomised between two types of single-agent chemotherapy. As accrual was slow, with 78 randomised patients between April 2007 and September 2011, we explored potential barriers in the accrual process and their consequences for characteristics of included patients.MethodsWe sent surveys on the reasons for non-inclusion to all coordinating investigators. We also examined inclusion in a concurrent, non-elderly breast cancer study of the trialists' group and analysed baseline geriatric characteristics of included patients.ResultsInvestigators from fifteen participating centres returned the survey. Most commonly reported barriers to inclusion were: patient's refusal of chemotherapy (n = 8) or of randomisation (n = 9), impaired cognition (n = 3) and insufficient cardiac function (n = 2). Oncologists' preference for combination regimens over single-agent chemotherapy was reported twice. Twenty-eight potentially eligible patients, aged 65–71 years, were included in a concurrent, study investigating combination chemotherapy in fit non-elderly patients with metastatic breast cancer. However, baseline characteristics of the included patients showed that the OMEGA study succeeded in including frail and older patients, with a performance status of 2 in 22% of patients and 54% of patients aged 75 years or older.ConclusionAccrual in this study was mainly hampered by patient's refusal or preference for a particular type of treatment, and an overall condition considered as too fit or too frail for inclusion. Future trials in elderly metastatic breast cancer patients should focus on non-restrictive inclusion criteria as well as on education of physicians and elderly patients on the advantages of trial participation. |
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