Accelerated partial breast irradiation using intensity modulated radiotherapy versus whole breast irradiation: Health-related quality of life final analysis from the Florence phase 3 trial
Affiliation:
1. Radiation Oncology Unit, Azienda Ospedaliero Universitaria Careggi, University of Florence, Italy;2. Cancer Risk Factors and Lifestyle Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), Italy;3. Clinical Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), Italy;4. Medical Physics Unit, Azienda Ospedaliero Universitaria Careggi, University of Florence, Italy;5. Breast Surgery Unit, Azienda Ospedaliero Universitaria Careggi, University of Florence, Italy;6. Radiology Senology Unit, Azienda Ospedaliero Universitaria Careggi, Italy;7. Pathology Unit, University of Florence, Florence, Italy;1. Department of Human Structure and Repair, Ghent University, Belgium;2. Department of Radiation Oncology, Ghent University Hospital, Belgium;3. Department of Industrial Systems Engineering and Product Design, Kortrijk, Belgium;1. Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland;2. Department of Surgical Oncology, University of Maryland School of Medicine, Baltimore, Maryland;3. Department of Medical Oncology, University of Maryland School of Medicine, Baltimore, Maryland;4. Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland;1. Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan;2. Department of Radiation Oncology, The Sheba Medical Center, Ramat Gan, Israel;3. Biostatistics Unit, University of Michigan, Ann Arbor, Michigan;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. Faculty of Science, School of Psychology, The University of Sydney, Sydney, NSW, Australia;2. Behavioural Sciences Unit, Department of Cancer Experiences Research, Melbourne, VIC, Australia;3. Peter MacCallum Cancer Centre, Melbourne, VIC, Australia;4. Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia;5. Department of Oncology, McMaster University, Hamilton, ON, Canada;6. University of Calgary, Calgary, AB, Canada;7. Edinburgh Cancer Research Centre, Institute of Genetic and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK;8. Radiotherapiegroep Arnhem, Arnhem, The Netherlands;9. Institute for Radiotherapy, Klinik Hirslanden, Zurich, Switzerland;10. Department of Psychology, and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, VIC, Australia;11. University of New South Wales, UNSW Medicine, Sydney, NSW, Australia;1. University of Texas Southwestern Medical Center, Dallas, Texas;2. Department of Surgery, University of Texas Southwestern Medical Center, Dallas, Texas;3. Department of Radiology, University of Texas Southwestern Medical Center, Dallas, Texas;4. Department of Medical Oncology, University of Texas Southwestern Medical Center, Dallas, Texas;6. Department of Surgery, Johns Hopkins University, Baltimore, Maryland;5. Department of Radiation Oncology, Levine Cancer Institute, Charlotte, North Carolina
Abstract:
BackgroundAccelerated partial breast irradiation (APBI) represents a valid option for selected early breast cancer (BC). We recently published the 5-year results of the APBI-IMRT-Florence phase 3 randomised trial (NCT02104895), showing a very low rate of disease failure, with acute and early–late toxicity in favour of APBI. We present the early and 2-year follow-up health-related quality of life (HRQoL) results.MethodsEligible patients were women aged more than 40 years with early BC suitable for breast-conserving surgery. APBI consisted of 30 Gy in five fractions delivered with IMRT technique. Standard whole breast irradiation (WBI) consisted of 50 Gy in 25 fractions plus a 10 Gy in five fractions boost on tumour bed. A total of 520 patients were enrolled in the phase 3 trial. Overall, 205 patients (105 APBI and 100 WBI) fully completed all the given questionnaires and were therefore included in the present analysis. As HRQoL assessment, patients were asked to complete the European Organisation for Research and Treatment of Cancer QLQ-C30, and the BR23 questionnaires at the beginning (T0), at the end (T1) and after 2 years from radiation (T2).FindingsNo significant difference between the two arms at QLQ-C30 and BR23 scores emerged at T0. Global health status (p = 0.0001), and most scores of the functional and symptom scales of QLQ-C30 at T1 showed significant differences in favour of the APBI arm. Concerning the BR23 functional and symptom scales, the body image perception, future perspective and breast and arm symptoms were significantly better in the APBI group. Similar significant results emerged at T2: significant differences in favour of APBI emerged for GHS (p = 0.0001), and most functional and symptom QLQ-C30 scales. According to QLQ-BR23 module, among the functional scales, the body image perception and the future perspective were significantly better in the APBI group (p = 0.0001), whereas among the symptom scales significant difference emerged by breast and arm symptoms with better outcomes in APBI arm (p < 0.01).InterpretationEarly BC treated with APBI showed an improved short-term, and 2-year follow-up HRQoL outcome as compared with WBI. Early BC treated with APBI showed an improved short-term, and 2-year follow-up HRQoL outcome as compared with WBI. APBI should be strongly considered in the treatment choice for selected low-risk patients. Mature local control results from ongoing adequately powered randomised trials are awaited.
