Single fraction of HDR brachytherapy for prostate cancer: Results of the SiFEPI phase II prospective trial.

Autor:	Hannoun-Levi JM; Department of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France.; Department of Clinical Research and Innovation, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France., Chand-Fouche ME; Department of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France., Pace-Loscos T; Department of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France., Gautier M; Department of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France., Gal J; Department of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France., Schiappa R; Department of Statistics, Antoine Lacassagne Cancer Center - University of Côte d'Azur, Nice, France., Pujol N; Department of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Côte d'Azur, 33 avenue Valombrose, 06189 Nice Cedex 2, Nice, France.
Jazyk:	angličtina
Zdroj:	Clinical and translational radiation oncology [Clin Transl Radiat Oncol] 2022 Aug 18; Vol. 37, pp. 64-70. Date of Electronic Publication: 2022 Aug 18 (Print Publication: 2022).
DOI:	10.1016/j.ctro.2022.08.007
Abstrakt:	Purpose: To report the results of the Single Fraction Early Prostate Irradiation (SiFEPI) phase 2 prospective trial. Materials/methods: The SiFEPI trial (NCT02104362) evaluated a single fraction of high-dose rate brachytherapy (HDB) for low- (LR) and favorable-intermediate (FIR) risk prostate cancers. After rectal spacer placement, a single fraction of 20 Gy was delivered to the prostate. Oncological outcome (biochemical (bRFS) and local (lRFS) relapses, disease-free (DFS) and overall (OS) survivals and toxicity (acute/late genito-urinary (GU), gastro-intestinal (GI) and sexual (S) toxicities were investigated. Results: From 03/2014 to 10/2017, 35 pts were enrolled, of whom 33 were evaluable. With a median age of 66 y [46-79], 25 (76 %) and 8 (24 %) pts were LR and FIR respectively. With a MFU of 72.8 months [64-86], 6y-bRFS, lRFS and mRFS were 62 % [45-85], 61 % [44-85] and 93 % [85-100] respectively while 6y-DFS, CSS and OS were 54 % [37-77], 100 % and 89 % [77-100] respectively. Late GU, GI and S toxicities were observed in 11 pts (33 %;18G1), 4 pts (12 %;4G1) and 7 pts (21 %;1G1,5G2,1G3) respectively. Biochemical relapse (BR) was observed in 11 pts (33 %;7LR,4FIR) with a median time interval between HDB and BR of 51 months [24-69]. Nine of these pts (82 %) presented a histologically proven isolated local recurrence. Conclusions: Long-term results of the SiFEPI trial show that a single fraction of 20 Gy leads to sub-optimal biochemical control for LR/FIR prostate cancers. The late GU and GI toxicity profile is encouraging, leading to consideration of HDB as a safe irradiation technique. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2022 The Author(s).)
Databáze:	MEDLINE
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