Randomized Prospective Trial Comparing 2 Schedules of Hypofractionated Adjuvant Radiotherapy 3 Weeks Against One Week Fractionation Regimen in Females with Breast Cancer

Abstract Purpose Acceleration of radiotherapy in 5 fractions for breast cancer can reduce the burden of treatment especially in Low middle income countries. We report on acute toxicity after whole breast irradiation /chest wall irradiation ± nodal irradiation, QOL score & Local recurrence incidence with ultra- hypofractionation schedule compared to modest hypofractionation protocol. Material and Methods Acute toxicity and health-related quality of life (HRQoL) of 101 patients, randomized between a 15- or 5-fractions schedule, were collected, using the RTOG acute toxicity scoring system, EORTC QLQ-C30 and BR23 questionnaire. The prescribed dose to the breast was either 15∗2.67 Gy (40.05 Gy) or 5∗5.2 Gy (26 Gy),60.1% of patients received tumor boost divided in both arms, with prescribed dose 5∗200cGy with 3D conformal radiotherapy technique. Inclusion criteria were: T1–T3 invasive breast cancer with or without axillary involvement (N0-N1&N2) after breast conserving or modified radical surgery. Results A total of 101 patients included in the study. Median age was 53±10.29 years, most of the cases enrolled were stage II with 38 patients in arm 1 (26 Gy) and 26 in arm 2(40Gy),only 19 cases had stage III breast cancer with 14 cases included in arm 2,while nodal negative status reported in 49 cases. A significant difference was observed for acute skin toxicity after radiotherapy in favor of better tolerability for arm 1 (P value <0.0001),also patients in ultra hypofractionation arm reported significant lower score for symptom scale including breast pain (P value >0.0001),swollen breast (P value <0.0001),difficulty to move arm (P value=0.0001),swollen hand (P value <0.0001)and QOL deterioration was less also in ultra fractionation arm (P value <0.0001) and none of the cases in both arms had local recurrence till time of data collection (12-20 months follow up duration). Conclusion In this single institute study, acute toxicity of accelerated breast radiotherapy in 5 fractions over 5 days seems to compare favorably to hypofractionated breast radiotherapy in 15 fractions. Less radiation dermatitis, breast edema, breast pain, difficulty to move arm and swollen hand. Quality of life is also less disturbed and patients have a better future perspective, however longer time for follow up &larger enrolled numbers needed to confirm non inferiority of this approach.