Background:Adjuvant radiotherapy improves locoregional control and overall survival. The aim of this work was to identify the effectiveness and safety of a 5-fractions schedule of radiotherapy delivered in 1 week (experimental arm) compared with the 15-fractions regimen over 3 weeks (standard arm) after surgery for early breast cancer (BC).
Patients and Methods:This randomized comparative prospective phase II was carried out on 134 female patients aged from 18 to 80 years old, underwent breast conservation surgery or modified radical mastectomy, with early stage, (pT1–3, pN0–1, M0) BC including any histological type of invasive BC and all tumor grades (I, II, III). The standard arm (40 Gy group) (n=65) used a conventional hypofractionation protocol of 40 Gy, and the experimental arm (26 Gy group) (n=69) used ultra hypofractionation 26 Gy.All patients were subjected to usual history taking, full examination, and baseline imaging using CT scan for [chest-abdomen and pelvis], and sonomammographic and/or breast and axillary ultrasound.
Results: No significant variation was reported among both groups as regards death rate, locoregional failure rate, or distant recurrence.The acute skin toxicity in the form of breast edema and tender erythema were more observed with the standard arm rather than with the experimental arm with clinical significance (P =0.0001). Regularity on treatment were significantly high in 26 Gy group compared to 40 Gy group as they were regular (P= 0.0001).
Conclusions: Hypofractionation seems to compromise safety and efficacy same as that for the standard regimens but that longer follow-up was needed for a more complete assessment.