S. Corradini1, L. Angelini2, A. Gaasch3, I. Meattini4, M. Braun5, N. Harbeck6, R. Würstlein7, G. Landry8, M. Niyazi1, M. Pazos9, C. Belka1, and S. Schönecker3; 1Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany, 2Radiation Oncology, Careggi University Hospital, University of Florence, Florence, Italy, 3Department of Radiation Oncology, University Hospital LMU, Munich, Germany, 4Department of Experimental and Clinical Biomedical Sciences “M. Serio”, University of Florence, Florence, Italy, 5Red Cross Breast Centre, Munich, Germany, 6Department of Obstetrics and Gynecology, Breast Centre, University Hospital LMU, Munich, Germany, 7Department of Obstetrics and Gynecology, Breast Centre, University Hospital, LMU Munich, Munich, Germany, 8Ludwig Maximilians University, Munich, Germany, 9LMU Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Munich, Germany
Purpose/Objective(s): Adjuvant radiotherapy (RT) plays an essential role in the management of early breast cancer (BC) but can lead to cardiovascular and lung toxicities. Recently, RT strategies have been developed to optimize the dose distribution to reduce the risk of treatment-related morbidities. Deep inspiration breath-hold (DIBH) increases the distance between the heart and chest wall, minimizing the radiation dose to intrathoracic organs at risk without compromising target coverage or increasing low dose scatter. This prospective study (SAVE-HEART; German Clinical Trials Register number:DRKS00011213), aimed to compare surface-guided DIBH to free-breathing (FB) in patients with left-sided BC, by evaluating individual cardiovascular risks and treatment plan dosimetry. Materials/
Methods: The study enrolled 585 patients from October 2016 to January 2021 who met the inclusion criteria of having left-sided invasive breast carcinoma or carcinoma in situ after breast conserving surgery or mastectomy and requiring adjuvant RT of the breast/thoracic wall with or without regional lymph nodes. The ability to hold breath for 20 seconds was also a prerequisite. The treatments were either hypofractionated (HF, 40.05 Gy in 15 fractions) or normofractionated (NF, 50.00 Gy in 25 fractions). DIBH was applied using the automatically triggered surface guidance system CatalystTM (C-RAD, Uppsala, Sweden) with audio and video feedback to the patient. CT and surface data were acquired during both DIBH and free-breathing states. The primary endpoint of the study is the comparative evaluation of heart dose reduction by using DIBH. Results: Treatment plan dosimetry was significantly improved with the use of deep inspiration breath-hold compared to free-breathing in both hypofractionated (HF) and normofractionated (NF) regimens. The mean and maximum doses to the heart and the near maximum dose of the left coronary artery (LAD) were significantly reduced by 36-42% in HF and NF plans (p<0.001), while the mean ipsilateral lung dose was reduced by 12-14% (p<0.001). Furthermore, the use of DIBH resulted in a 5% reduction in the cumulative 10-year cardiovascular disease risk (10y-CVD risk) compared to radiotherapy without DIBH (3.59% to 3.41%; p<0.001). Conclusion: To the best of our knowledge, this is the largest prospective study to demonstrate a significant advantage in treatment plan dosimetry for the cardiac and ipsilateral lung dose with surface-guided DIBH compared to FB in patients with left-sided BC.