Safety of pre- or postoperative accelerated radiotherapy in 5 fractions: A randomized pilot trial

Abstract

Objective Neo-adjuvant radiotherapy (NART) for breast cancer has shown promising survival results in retrospective trials. However, there are some obstacles such as a chemotherapy delay, an increased overall treatment time (OTT) and the risk of increasing surgical morbidity. Accelerated radiotherapy (RT) in 5 fractions allows to deliver NART in a very short time span and minimizes the delay of surgery and chemotherapy. This trial investigates this NART schedule for safety, feasibility and OTT. Material and methods Twenty patients eligible for neo-adjuvant chemotherapy (NACT) and breast conserving surgery, were randomized between NART before NACT or NACT and postoperative RT. In both arms, RT treatment was given in 5 fractions to the whole breast with a simultaneously integrated boost (SIB) on the tumor(bed). Lymph node irradiation was given concomitantly in case of lymph node involvement. OTT was defined as the time from diagnosis to last surgery in the intervention group, while in the control group the time between diagnosis and last RT-fraction was used. In the intervention group NACT-delay was defined as time between diagnosis and start of chemotherapy. Results 20 patients were included, and 19 patients completed treatment. OTT was significantly shorter in the intervention group (mean 218 days, range 196–253) compared to the control group (mean 237, range 211–268, p = 0.001). The difference in mean duration from diagnosis to the first treatment was a non-significant 4 days longer (31 vs 27 days, p = 0.28), but the start of NACT after diagnosis was delayed by 21 days (48 vs 27 days, p < 0.001). NART did not result in additional surgery complications. Conclusion This pilot trial is the first to report on accelerated NART in 5 fractions with SIB. NART before NACT resulted in a shorter OTT with good safety results.

Prognostic factors and clinical outcomes of breast cancer patients with disease progression during neoadjuvant systemic therapy

“…Recent studies have found that adjusting the frequency of neoadjuvant radiation could provide a solution. A randomized pilot trial reported that accelerated neoadjuvant radiation in 5 fractions with a simultaneously integrated boost is feasible and results in a shorter OTT without excess acute toxicity [ 30 ]. Other studies have also explored the role of radiation as a supplement to systemic therapy in this population, but there is still no consensus [ 17 , 31 ].…”

Prognostic Factors and Clinical Outcomes of Breast Cancer Patients with Disease Progression During Neoadjuvant Systemic Therapy

“…Recent studies have found that adjusting the frequency of NAR could provide a solution. A randomized pilot trial reported that accelerated NAR in 5 fractions with a simultaneously integrated boost is feasible and results in a shorter OTT without excess acute toxicity [23] . Other studies have also explored the role of radiation as a supplement to systemic therapy in this population, but there is still no consensus [10][24] .…”