Abstract | Introduction: Methods: All patients received apalutamide and ADT and were randomly divided into two groups based on the administration of oral prednisone or not (control group). The primary endpoint was the incidence of rash. The secondary endpoint included the proportions of patients with a decline in PSA ≥50% from baseline, PSA ≥90% from baseline, and decreased to PSA ≤0.2 ng/mL. Results: Between June 2021 and March 2022, a total of 83 patients were enrolled (41 in the prednisone group and 42 in the control group). During the 6-month follow-up, the incidence of rash was significantly lower in the prednisone group compared with the control group (17.1% vs. 38.1%, P=0.049). There were no significant differences in the incidence of other adverse events, the number of patients who required dose adjustment (reduction, interruption, or discontinuation) of apalutamide due to rash, the number of patients with prostate-specific antigen (PSA) decreased by ≥50%, the number of patients with PSA decrease ≥90%, and the number of patients with PSA ≤0.2 ng/mL between the two groups. All patients with diabetes had stable glycemic control with no glucose-related adverse events. Discussion: In patients with mHSPC, the addition of short-course low-dose prednisolone to apalutamide plus ADT can reduce the incidence of rash without risk of other adverse events.
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Authors | Dingyuan Yang, Wenqiang Chen, Fei Lai, Mingxing Qiu, Jun Li |
Journal | Frontiers in oncology
(Front Oncol)
Vol. 13
Pg. 1110807
( 2023)
ISSN: 2234-943X [Print] Switzerland |
PMID | 38023146
(Publication Type: Journal Article)
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Copyright | Copyright © 2023 Yang, Chen, Lai, Qiu and Li. |