Moderate hypofractionated radiotherapy (HFRT) is a standard treatment for prostate cancer patients. We compared 2 moderate HFRT regimens, with a biologically equivalent dose of 80 Gy in 2 Gy fractions, with a modest simultaneous integrated boost to the dominant intraprostatic lesion.
This is a multicenter, non-inferiority, randomized phase 3 trial with acute toxicity as the primary endpoint, comparing: - 56Gy in 4 weeks (16x3.5Gy, 4 days/week, Arm A). - 67Gy in 5 weeks (25x2.68Gy, 5 days/week, Arm B). The H0 hypothesis is that both regimens are equivalent in terms of acute grade≥2 gastro-intestinal toxicity, defined as a difference in acute grade≥2 gastro-intestinal toxicity of ≤10%. Here we report on acute and late toxicity.
We included 170 patients in Arm A and 172 patients in Arm B. The median follow-up time for all patients was 42 months. Acute grade≥2 gastrointestinal toxicity was reported by 24% of patients in both groups. Acute grade 2 and 3 urinary toxicity was observed in 52% and 9% of patients in Arm A and 53% and 7% in Arm B. Late grade 2 and grade≥3 gastrointestinal toxicity occurred in 19% and 4% of patients in Arm A compared with 15% and 4% in Arm B. Late grade 2 and grade≥3 urinary toxicity was observed in 37% and 10% of patients in Arm A and 36% and 6% in Arm B.
This analysis confirms that both HFRT regimens are safe and equivalent in terms of acute grade≥2 gastrointestinal toxicity.
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2024 Jan 24 [Epub ahead of print]
V Fonteyne, C Berghen, C Van Praet, B Vanderstraeten, S Verbeke, G Villeirs, R Colman, B Vanneste, P Ost, G De Meerleer, N Lumen
Department of Radiotherapy Oncology, Ghent University Hospital, Belgium; Department Human Structure and Repair, Ghent University, Ghent, Belgium. Electronic address: ., Department of Radiotherapy and Oncology, Leuven University Hospitals, Belgium., Department of Urology, ERN accredited centre, Ghent University Hospital, Belgium., Department of Radiotherapy Oncology, Ghent University Hospital, Belgium; Department Human Structure and Repair, Ghent University, Ghent, Belgium., Department of Pathology, Ghent University Hospital, Belgium., Department of Radiology, Ghent University Hospital, Belgium., Biostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium., Department Human Structure and Repair, Ghent University, Ghent, Belgium.