Ultra-Hypofractionated Whole Breast Radiotherapy with Automated Hybrid-VMAT Technique: A Pilot Study on Safety, Skin Toxicity and Aesthetic Outcomes

Mariangela Boccardi,1 Savino Cilla,2 Mara Fanelli,3 Carmela Romano,2 Paolo Bonome,1 Milena Ferro,1 Donato Pezzulla,1 Roberto Di Marco,4 Francesco Deodato,1,5,* Gabriella Macchia1,* 1Radiation Oncology Unit, Responsible Research Hospital, Campobasso, Italy; 2Medical Physics Unit, Responsible Research Hospital, Campobasso, Italy; 3Research Laboratories, Responsible Research Hospital, Campobasso, Italy; 4Department of Medicina e Scienze della Salute “V. Tiberio”, Università degli Studi del Molise, Campobasso, Italy; 5Istituto di Radiologia, Università Cattolica del Sacro Cuore, Roma, Italy*These authors contributed equally to this workCorrespondence: Milena Ferro, Responsible Research Hospital, L.go Gemelli, 1, Campobasso, 86100, Italy, Email [email protected]: The most prevalent treatment-related side effect related to adjuvant radiotherapy (RT) for breast cancer is acute skin toxicity in the irradiated area. The purpose of this single-institution pilot study is to provide preliminary clinical results on the feasibility and safety of a breast ultra-hypofractionated radiation treatment delivered using an automated hybrid-VMAT technique. Skin damage was assessed both with clinical examination and objectively using a Cutometer equipment.Patients and Methods: Patients received 26 Gy to the whole breast and 30 Gy to the tumoral bed in 5 fractions using an automated hybrid-VMAT approach with the option for the breath hold technique if necessary. Acute and late toxicities were clinically evaluated at baseline, 1- and 6-months after treatment using the CTC-AE v.5.0 scale. An instrumental evaluation of the skin elasticity was performed using a Cutometer® Dual MP580. Two parameters per patient, R0 (the total skin firmness) and Q1 (the elastic recovery), were registered at the different timelines.Results: From June 2022 to January 2024, 30 patients, stage T1-T2, N0 were enrolled in the study. Four out of 30 (13.3%) patients reported G2 acute skin toxicities. At 6 months, G2 late toxicity was registered in 3 patients (10%). A total of 2160 measures of R0 and Q1 were recorded. At 1 month after treatment, no correlation was found between measured values of R0 and Q1 and clinical evaluation. At 6 months after treatment, clinical late toxicity ≥ 1 was strongly associated with decreased R0 and Q1 values ≥ 24% (p = 0.003) and ≥ 18% (p = 0.022), respectively.Conclusion: Ultra-hypofractionated whole-breast radiotherapy, when supported by advanced treatment techniques, is both feasible and safe. No severe adverse effects were observed at any of the different timeframes. Acute and late skin toxicities were shown to be lower in contrast to data presented in the literature.Keywords: breast cancer, ultra-hypofractionated radiotherapy, Cutometer, hybrid-VMAT technique