Are we ready for a paradigm shift from high-dose conventional to moderate hypofractionated radiotherapy in intermediate-high risk prostate cancer? A systematic review of randomized controlled trials with trial sequential analysis.

to evaluate efficacy and late toxicity of moderate hypofractionated (HFRT) over high-dose (>76 Gy) conventional radiotherapy (CRT) in a non-inferiority perspective.

Randomized controlled trials (RCTs) were included. HFRT regimens were deemed non-inferior to high-dose CRT if the computed CI for the overall RR did not exceed the non-inferiority margin of 7%.

When the prespecified margin, corresponding to a critical RR of 0.930 for CCS, OS and BFS, was used all efficacy outcomes satisfied the criteria for the non-inferiority analysis indicating the non-inferiority of HFRT regimens over high-dose CRT in the medium term period. Differently, the evidence concerning the late toxicity was inconclusive.

Noninferiority analysis indicates that moderate HFRT regimes are non-inferior over high-dose CRT in the medium-term. Inconclusive is the evidence for the late toxicity. Longer follow-up will provide a more clear answer concerning the non-inferiority of HFRT regimens in the long-term period.

Critical reviews in oncology/hematology. 2019 Apr 27 [Epub ahead of print]

Letizia Ferella, Erika Limoncin, Francesca Vittorini, Agnieszka Chalaszczyk, Claudia Sorce, Gianmarco Grimaldi, Pietro Franzese, Valeria Ruggieri, Emilia Varrassi, Mario Di Staso, Ramon Gimenez De Lorenzo, Francesco Marampon, Vincenzo Tombolini, Carlo Masciocchi, Giovanni Luca Gravina

Radiation Oncology, ThomoTherapy Unit, Hospistal of Aosta, Italy; University of L'Aquila, Service of Medical Physic, Italy; University of L'Aquila, Division of Radiotherapy, Italy., Department of Systems Medicine, University of Tor Vergata, Italy., University of L'Aquila, Service of Medical Physic, Italy., University of L'Aquila, Division of Radiotherapy, Italy., La Sapienza University, Division of Radiotherapy, Italy., University of L'Aquila, Division of Radiology, Italy., University of L'Aquila, Division of Radiotherapy, Italy. Electronic address: .