Gerd Fastner1, Roland Reitsamer2, Bartosz Urbański3, Peter Kopp4, Dawid Murawa5, Beata Adamczyk6, Aldona Karzcewska7, Piotr Milecki8, Eva Hager9, Juliann Reiland10, Antonella Ciabattoni11, Christiane Matuschek12, Wilfried Budach12, Kerri Nowell13, Claudia Schumacher14, Angelika Ricke15, Vincenzo Fusco16, Cristiana Vidali17, Marina Alessandro18, Giovanni B Ivaldi19, Ingrid Ziegler4, Christoph Fussl4, Franz Zehentmayr4, Brane Grambozov4, Andreas Sir2, Wolfgang Hitzl20, Umberto Ricardi21, Felix Sedlmayer4. 1. Department of Radiotherapy and Radio-Oncology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria. Electronic address: g.fastner@salk.at. 2. Department of Gynecology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria. 3. Department of Radiotherapy and Gynecological Oncology, Greater Poland Cancer Centre, Poznań, Poland. 4. Department of Radiotherapy and Radio-Oncology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria. 5. Clinic of General Surgery and Surgical Oncology, Faculty of Medicine and Health Sciences University, Zielona Gora, Poland. 6. Department of Surgical Oncology, Greater Poland Cancer Centre, Poznań, Poland. 7. Centre of Radiotherapy Affidea, Koszalin, Poland. 8. Department of Radiotherapy Greater Poland Cancer Center and Chair of Electroradiology Poznan University of Medical Sciences, Poznań, Poland. 9. Department of Radiotherapy/Radiooncology, Klagenfurt, Austria. 10. Avera McKennan Hospitals and University Health System, Avera Medical Group, Comprehensive Breast Care, Sioux Falls, United States. 11. U.O.C. Radioterapia, San Filippo Neri Hospital, Rome, Italy. 12. Medical Faculty, Department of Radiation Oncology, Heinrich Heine University, Düsseldorf, Germany. 13. Department of General Surgery, UnityPoint Health-St.Lukes Hospital, Cedar Rapids, United States. 14. Breast Center/Department of Senology, St.-Elisabeth Hospital Cologne-Hohenlind, Germany. 15. Radiation Institute-CDT-center for Diagnostic and Therapy GmbH, Cologne, Germany. 16. Radioterapia, IRCCS-CROB Reference Cancer Center Basilicata, Rionero in Vulture, Italy. 17. Department of Radiation Oncology, Azienda Sanitaria Universitaria Integrata di Trieste (ASUITS), Italy. 18. Division of Radiation Oncology, Ospedale di Città di Castello, USL UMBRIA 1, Città di Castello, Italy. 19. Department of Radiation Oncology, ICS Maugeri - IRCCS, Pavia, Italy. 20. Research Office - Biostatistics, Paracelsus Medical University Salzburg, Austria; Department of Ophthalmology and Optometry, Paracelsus Medical University Salzburg, University Hospital Salzburg, Landeskrankenhaus, Salzburg, Austria. 21. Department of Oncology, University of Turin, Italy.
Abstract
BACKGROUND AND PURPOSE: To assess the role of intraoperative radiation with electrons (IOERT) as tumor bed boost followed by hypofractionated whole breast irradiation (HWBI) after breast conserving surgery (BCS) of patients with low to intermediate risk breast cancer focusing on acute/late toxicity and cosmetic outcome. MATERIAL AND METHODS: In 2011, a prospective multicenter trial (NCT01343459) was started. Treatment consisted of BCS, IOERT (11.1 Gy) and HWBI (40.5 Gy in 15 fractions). In a single-arm design, 5-year IBR-rates are benchmarked by a sequential ratio test (SQRT) against best published evidences in 3 age groups (35-40 y, 41-50 y, >50 y). Acute/late toxicity and cosmesis were evaluated by validated scorings systems. RESULTS: Of 627 eligible patients, 44 were excluded, leaving 583 to analyze. After a median follow-up (FUP) of 45 months (range 0-74), for acute effects CTCAE-score 0/1 was noted in 91% (end of HWBI) and 92% (4 weeks later), respectively. Late toxicity Grading 0/1 (mean values, ranges) by LENT-SOMA criteria were observed in 92.7% (89-97.3) at 4/5 months, rising to 96.5% (91-100) at 6 years post HWBI. Baseline cosmesis after wound healing prior to HWBI was scored as excellent/good in 86% of cases by subjective (patient) and in 74% by objective (doctor) assessment with no impairment thereafter. CONCLUSIONS: Acute and late treatment tolerance of a combined Boost-IOERT/HWBI regimen is excellent in short/mid-term assessment. Postoperative cosmetic appearance is not impaired after 3 years FUP.
BACKGROUND AND PURPOSE: To assess the role of intraoperative radiation with electrons (IOERT) as tumor bed boost followed by hypofractionated whole breast irradiation (HWBI) after breast conserving surgery (BCS) of patients with low to intermediate risk breast cancer focusing on acute/late toxicity and cosmetic outcome. MATERIAL AND METHODS: In 2011, a prospective multicenter trial (NCT01343459) was started. Treatment consisted of BCS, IOERT (11.1 Gy) and HWBI (40.5 Gy in 15 fractions). In a single-arm design, 5-year IBR-rates are benchmarked by a sequential ratio test (SQRT) against best published evidences in 3 age groups (35-40 y, 41-50 y, >50 y). Acute/late toxicity and cosmesis were evaluated by validated scorings systems. RESULTS: Of 627 eligible patients, 44 were excluded, leaving 583 to analyze. After a median follow-up (FUP) of 45 months (range 0-74), for acute effects CTCAE-score 0/1 was noted in 91% (end of HWBI) and 92% (4 weeks later), respectively. Late toxicity Grading 0/1 (mean values, ranges) by LENT-SOMA criteria were observed in 92.7% (89-97.3) at 4/5 months, rising to 96.5% (91-100) at 6 years post HWBI. Baseline cosmesis after wound healing prior to HWBI was scored as excellent/good in 86% of cases by subjective (patient) and in 74% by objective (doctor) assessment with no impairment thereafter. CONCLUSIONS: Acute and late treatment tolerance of a combined Boost-IOERT/HWBI regimen is excellent in short/mid-term assessment. Postoperative cosmetic appearance is not impaired after 3 years FUP.
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