Novel hormonal therapies have been recently investigated in non-metastatic castration-resistant prostate cancer (CRPC). We performed a meta-analysis to assess the efficacy and safety of novel hormonal therapies in non-metastatic CRPC.
The primary outcome was metastasis-free survival (MFS). The secondary endpoints were overall survival (OS), time to PSA progression and safety. We planned a subgroup analysis according to the PSA doubling time (> 6 vs < 6 months), Eastern Cooperative Oncology Group (ECOG) performance status (1 vs 0) and concomitant use of bone-targeting agent (yes vs no).
Pooled analysis of novel hormonal therapies revealed significantly increased MFS compared with placebo (hazard ratio (HR): HR = 0.32, 95% CI 0.25-0.41; p < 0.00001). The subgroup analysis showed a statistically significant MFS advantage in favour of men with the lower ECOG performance status. Other secondary endpoints favoured the novel hormonal therapies. The relative risk (RR) of grade ≥ 3 adverse events and ≥ 3 hypertension was 1.31 and 1.39, respectively.
This study confirmed the efficacy and safety of the novel hormonal therapies in non-metastatic CRPC.
Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico. 2019 Oct 15 [Epub ahead of print]
G Roviello, M R Gatta Michelet, A D'Angelo, S Nobili, E Mini
Department of Health Sciences, University of Florence, viale Pieraccini, 6, 50139, Florence, Italy. ., School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy., Department of Biology and Biochemistry, University of Bath, Bath, B2 7AY, UK., Department of Health Sciences, University of Florence, viale Pieraccini, 6, 50139, Florence, Italy.