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Gabriella Macchia,1 Savino Cilla,2 Milly Buwenge,3 Alice Zamagni,3 Ilario Ammendolia,3 Claudio Zamagni,4 Giovanni P Frezza,5 Vincenzo Valentini,6,7 Francesco Deodato,1,* Alessio G Morganti3,* 1Radiotherapy Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy; 2Medical Physics Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy; 3Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy; 4Addarii Medical Oncology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy; 5Radiation Oncology Unit, Bellaria Hospital, Bologna, Italy; 6Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Radioterapia, Rome, Italy; 7Istituto di Radiologia, Università Cattolica Del Sacro Cuore, Rome, Italy*These authors contributed equally to this workCorrespondence: Milly BuwengeRadiation Oncology Unit, Department of Experimental, Diagnostic and Specialty Medicine – DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Via Giuseppe Massarenti 9, 40138, BolognaTel +39 0512143564Fax +39 0516364336Email mbuwenge@gmail.comPurpose: A concomitant boost (CB) in patients treated with postoperative radiotherapy after conservative surgery of invasive breast cancer (BC) has been suggested for treatment time reduction and therapy intensification. The aim of this analysis was to assess long-term tolerability of a CB in patients treated with postoperative intensity Modulated Accelerated RAdiotherapy (MARA).Patients and Methods: In this phase I–II trial, 321 patients with intermediate-high risk BC (pT1-4 with at least one of the following characteristics: pre or perimenopausal status, pN2-3, positive or close margins) were enrolled. Patients were treated with forward-planned intensity modulated radiotherapy (IMRT) and CB. A total dose of 50 Gy (2 Gy/fraction) and 60 Gy (2.4 Gy/fraction) was prescribed to the whole breast and the tumor bed, respectively. The potential impact of hypertension, diabetes, smoking habit, alcohol consumption, chemotherapy, and hormone therapy on both skin and subcutaneous late toxicity-free survival (LTFS) was evaluated. Survival curves were calculated using the Kaplan–Meier method.Results: Median follow-up was 52 months (range: 3– 115). Regional node irradiation, adjuvant chemotherapy and hormonal therapy were prescribed to 29.3%, 65.4% and 81.0% of patients, respectively. Five-year G2 and G3 skin LTFS were 95.6% and 100.0%, respectively. Five-year G2 and G3 subcutaneous LTFS were 80.0% and 98.6%, respectively. Only diabetes showed a significant correlation with worse G3 subcutaneous LTFS (p: 0.024). Five-year loco-regional control, metastasis-free survival, disease-free survival, and overall survival were 98.0%, 91.8%, 89.7% and 96.3%, respectively.Conclusion: IMRT combined with CB was associated with a low risk of > G2 late toxicities (0.0% and 1.4% for skin and subcutaneous tissue, respectively). The cumulative actuarial incidence of local recurrences was 2.0% despite the exclusion of low-risk patients. Our results suggest that CB is safe and effective in patients with intermediate-high risk BC.Trial Registration: ClinicalTrials.gov: NCT03471741.Keywords: breast cancer, adjuvant radiotherapy, concomitant boost, IMRT, toxicity

Milly Buwenge,1 Silvia Cammelli,1 Ilario Ammendolia,1 Giorgio Tolento,1 Alice Zamagni,1 Alessandra Arcelli,2 Gabriella Macchia,3 Francesco Deodato,3 Savino Cilla,4 Alessio G Morganti1 1Department of Experimental, Diagnostic and Specialty Medicine – DIMES, Radiation Oncology Center, University of Bologna, S.Orsola-Malpighi Hospital, 2Radiation Oncology Unit, Bellaria Hospital, Bologna, 3Radiation Oncology Unit, 4Medical Physics Unit, Research and Care Foundation ‘Giovanni Paolo II,’ Catholic University of Sacred Heart, Campobasso, Italy Background: Owing to highly conformed dose distribution, intensity modulated radiation therapy (IMRT) has the potential to improve treatment results of radiotherapy (RT). Postoperative RT is a standard adjuvant treatment in conservative treatment of breast cancer (BC). The aim of this review is to analyze available evidence from randomized controlled trials (RCTs) on IMRT in BC, particularly in terms of reduction of side effects. Methods: A literature search of the bibliographic database PubMed, from January 1990 through November 2016, was performed. Only RCTs published in English were included. Results: Ten articles reporting data from 5 RCTs fulfilled the selection criteria and were included in our review. Three out of 5 studies enrolled only selected patients in terms of increased risk of toxicity. Three studies compared IMRT with standard tangential RT. One study compared the results of IMRT in the supine versus the prone position, and one study compared standard treatment with accelerated partial breast IMRT. Three studies reported reduced acute and/or late toxicity using IMRT compared with standard RT. No study reported improved quality of life. Conclusion: IMRT seems able to reduce toxicity in selected patients treated with postoperative RT for BC. Further analyses are needed to better define patients who are candidates for this treatment modality. Keywords: intensity modulated radiation therapy, breast cancer, literature review

Background Owing to highly conformed dose distribution, intensity modulated radiation therapy (IMRT) has the potential to improve treatment results of radiotherapy (RT). Postoperative RT is a standard adjuvant treatment in conservative treatment of breast cancer (BC). The aim of this review is to analyze available evidence from randomized controlled trials (RCTs) on IMRT in BC, particularly in terms of reduction of side effects. Methods A literature search of the bibliographic database PubMed, from January 1990 through November 2016, was performed. Only RCTs published in English were included. Results Ten articles reporting data from 5 RCTs fulfilled the selection criteria and were included in our review. Three out of 5 studies enrolled only selected patients in terms of increased risk of toxicity. Three studies compared IMRT with standard tangential RT. One study compared the results of IMRT in the supine versus the prone position, and one study compared standard treatment with accelerated partial breast IMRT. Three studies reported reduced acute and/or late toxicity using IMRT compared with standard RT. No study reported improved quality of life. Conclusion IMRT seems able to reduce toxicity in selected patients treated with postoperative RT for BC. Further analyses are needed to better define patients who are candidates for this treatment modality.