Does an integrated boost increase acute toxicity in prone hypofractionated breast irradiation? A randomized controlled trial

Background and purpose: The safety of a simultaneous integrated boost (SIB) in combination with prone hypofractionated whole-breast irradiation (WBI) was investigated. Materials and methods: 167 patients were randomized between WBI with a sequential boost (SeB) or SIB. All patients were treated in prone position to 40.05 Gy in 15 fractions to the whole breast. In the control arm, a SeB of 10 Gy in 4 fractions (negative surgical margins) or 14.88 Gy in 6 fractions (transsection) was prescribed. In the experimental arm a SIB of 46.8 or 49.95 Gy (negative and positive surgical margins, respectively) was prescribed. Results: Patient age was the only significantly different parameter between treatment arms with patients in the SIB arm being slightly older. In both arms, 6/83 patients developed moist desquamation. Grade 2/3 dermatitis was significantly more frequent in the SeB arm (38/83 vs 24/83 patients, p = 0.037). In the SIB and SeB arm, respectively, 36 patients (43%) and 51 patients (61%) developed pruritus (p = 0.015). The incidence of oedema was lower in the SIB arm (59 vs 68 patients), but not statistically significant (p = 0.071). Conclusions: The primary endpoint, moist desquamation, was not significantly different between treatment arms. (C) 2016 Elsevier Ireland Ltd. All rights reserved.