Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial |
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| Affiliation: | 1. Department of Radiation Oncology, University of Florence, Florence, Italy;2. Medical Physics Unit, University of Florence, Florence, Italy;3. Molecular and Nutritional Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), University of Florence, Florence, Italy;4. Radiotherapy Unit, Azienda Sanitaria 10, University of Florence, Florence, Italy;5. Department of Surgery, University of Florence, Florence, Italy;6. Diagnostic Senology Unit, University of Florence, Florence, Italy;7. Gynecologic and Obstetrics Unit, University of Florence, Florence, Italy;8. Division of Pathological Anatomy, Department of Medical and Surgical Critical Care, University of Florence, Florence, Italy;1. Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University, Assiut, Egypt;2. Department of Clinical Medicine, Trinity Centre for Health Sciences, St. James’s Hospital, Dublin 8, Ireland;3. Department of Surgery, Trinity Centre for Health Sciences, St. James’s Hospital, Dublin 8, Ireland;1. Department of Radiation Oncology, University of Florence, Florence, Italy;2. Molecular and Nutritional Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), Florence, Italy;1. Department of Oncology, University of Calgary, Calgary, Alberta, Canada;2. Tom Baker Cancer Centre, Calgary, Alberta, Canada;3. Central Alberta Cancer Centre, Red Deer, Alberta, Canada;4. Jack Ady Cancer Centre, Lethbridge, Alberta, Canada;1. Department of Radiation Oncology, University Hospital Erlangen, Germany;2. Department of Radiation Oncology, University Hospital Leipzig, Germany;3. Department of Radiation Oncology, University Hospital Rostock, Germany;4. Department of Radiation Oncology, University Hospital AKH Wien, Austria;5. Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary;6. Brachytherapy Department, Centrum Onkologii – Instytut im Marii Skłodowskej, Warsaw, Poland;7. Podkarpacki Hospital Cancer Center Brzozów, Poland;8. Department of Radiation Oncology, Valencian Institute of Oncology, Spain;9. Department of Radiation Oncology, University Hospital Kiel, Germany;10. Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain;11. Department of Radiation Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic;12. Department of Radiation Oncology, University Hospital Inselspital Bern, Switzerland;13. Department of Radiation Oncology, Hospital Barmherzige Brüder Regensburg, Germany;14. Interdisciplinary Brachytherapy Unit, University Hospital Lübeck/UKSH Campus Lübeck, Germany;15. Department of Radiation Oncology, Clemenshospital, Münster, Germany;p. Department of Radiation Oncology, University Hospital Würzburg, Germany;q. Department of Radiation Oncology, University Hospital Jena, Germany;r. Department of Radiotherapy, Municipal Hospital Cologne, University Witten-Herdecke, Germany;s. Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Germany;1. 21st Century Oncology, Michigan Healthcare Professionals, Farmington Hills, MI;2. Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH;3. Department of Radiation Oncology, Ohio State University, Columbus, OH;4. Department of Radiation Oncology, Massey Cancer Center, Virgina Commonwealth University, Richmond, VA;5. Department of Radiation Oncology, Robert Wood Johnson University Hospital/Cancer Institute of New Jersey, New Brunswick, NJ;6. Department of Radiation Oncology, Tufts University School of Medicine, Boston, MA;7. Department of Radiation Oncology, Brown University, Providence, RI;8. Cancer HealthCare Associates, Miami, FL;1. Division of Surgery and Interventional Science, University College London, London, UK;2. Department of Surgery, Royal Free Hospital, London, UK;3. Department of Surgery, Whittington Health, London, UK;4. Department of Biostatistics, University of Notre Dame, Fremantle, WA, Australia;6. Department of Radiation Oncology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany;5. Department of Surgery, Great Western Hospital, Swindon, UK;7. Croydon University Hospital, Croydon, UK;11. National Cancer Institute, Centro di Riferimento Oncologico, Aviano, Italy;12. School of Surgery, University of Western Australia, Perth, WA, Australia;8. Department of Surgery, Kings College London, London, UK;10. Departments of Radiation Oncology, and Surgery, Sir Charles Gairdner Hospital, Perth, WA, Australia;9. Department of Clinical Oncology, University College London Hospitals, London, UK |
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| Abstract: | BackgroundAccelerated partial breast irradiation (APBI) has been introduced as an alternative treatment method for selected patients with early stage breast cancer (BC). Intensity-modulated radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques, with more normal tissue sparing. The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI) in early stage BC.MethodsThis study was performed at the University of Florence (Florence, Italy). Women aged more than 40 years affected by early BC, with a maximum pathological tumour size of 25 mm, were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT. Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions. The WBI arm received 50 Gy in 25 fractions, followed by a boost on the tumour bed of 10 Gy in five fractions. The primary end-point was occurrence of ipsilateral breast tumour recurrences (IBTRs); the main analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT02104895.FindingsA total of 520 patients were randomised (260 to external WBI and 260 to APBI with IMRT) between March 2005 and June 2013. At a median follow-up of 5.0 years (Interquartile Range (IQR) 3.4–7.0), the IBTR rate was 1.5% (three cases) in the APBI group (95% confidence interval (CI) 0.1–3.0) and in the WBI group (three cases; 95% CI 0.0–2.8). No significant difference emerged between the two groups (log rank test p = 0.86). We identified seven deaths in the WBI group and only one in the APBI group (p = 0.057). The 5-year overall survival was 96.6% for the WBI group and 99.4% for the APBI group. The APBI group presented significantly better results considering acute (p = 0.0001), late (p = 0.004), and cosmetic outcome (p = 0.045).InterpretationTo our knowledge, this is the first randomised study using the IMRT technique for APBI delivery. No significant difference in terms of IBTR and overall survival was observed between the two arms. APBI displayed a significantly better toxicity profile. |
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| Keywords: | Accelerated partial breast irradiation Whole breast irradiation Intensity-modulated radiotherapy IMRT Phase 3 trial |
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