Efficacy and Safety of Androgen-Deprivation Therapy Combined with Docetaxel Plus Prednisone in High-Burden Metastatic Hormone-Sensitive Prostate Cancer.

Abstract

PurposeThe aim of this study was to evaluate the efficacy and safety of hormonal and synchronous docetaxel plus prednisone (DocP) in metastatic hormone-sensitive prostate cancer (mHSPC).MethodsOne hundred fifty-one cases with high-burden mHSPC diagnosed at 1 single center from January 2014 to August 2018 were analyzed retrospectively. Among them, 85 cases received androgen-deprivation therapy (ADT) within 3 months, along with 6 cycles of docetaxel + prednisone (treatment group), whereas 66 received ADT alone (control group). The primary end point was the median overall survival (OS), while the secondary outcomes included prostate-specific antigen (PSA) progression-free survival (PFS), radiographic PFS, and the proportion of PSA falling to 0.2 ng/mL.ResultsA total of 151 patients were included and followed up for a median of 34 months in this study. The median OS time in the treatment group was unavailable, but it was remarkably longer than that of the control group (P<0.001). In addition, the PFS of PSA in the treatment group and control group was 17.9 months and 9.2 months, respectively (P<0.001). Meanwhile, the radiographic PFS was 43 months in the treatment group and 19.8 months in the control group, respectively (P<0.001). The proportions of PSA falling to 0.2 ng/mL were 53.7% and 23.3%, respectively (P<0.001). However, there was no significant difference in the incidence of ≥3 toxic side effects between these 2 groups (P=0. 21).ConclusionADT combined with 6 cycles of docetaxel + prednisone chemotherapy benefits patients diagnosed with high-burden mHSPC in terms of the OS, PFS of PSA and radiographic, and the ratio of PSA falling to 0.2 ng/mL.