Background: We aimed to evaluate the effects of apalutamide dose reduction on skin-related adverse events (AEs) and castration-resistant prostate cancer (CRPC)-free survival in patients with advanced prostate cancer (PC).
Methods: We retrospectively evaluated 35 patients with nonmetastatic CRPC and 72 patients with treatment-naïve metastatic castration-sensitive PC (mCSPC) who were treated with apalutamide. The primary outcome was the effect of apalutamide dose reduction on skin-related AEs. The secondary outcomes were the effect of apalutamide dose reduction on skin-related AEs in patients with small body size, postskin AE apalutamide discontinuation rate, and CRPC-free survival in patients with mCSPC treated with upfront apalutamide plus androgen deprivation therapy.
Results: Of the 107 patients, 65 (60.7%) and 42 (39.3%) were treated with full and reduced doses of apalutamide, respectively. The skin-related AE rate was not significantly different between the groups (55% vs. 43%, p = 0.761). In the group receiving reduced apalutamide dose, the incidence of skin-related AEs was significantly lower in patients with small body sizes (body weight <67 kg and body mass index <24 kg/m ) than in those with other body sizes. The postskin AE apalutamide discontinuation rate was significantly differed between patients receiving the full (50%) and reduced (16.7%) doses. In the 72 patients with mCSPC, CRPC-free survival was not significantly different between the full and reduced dose groups.
Conclusion: Apalutamide dose reduction was not significantly associated with the incidence of skin-related AEs. However, dose reduction in patients with small body sizes may alleviate skin-related AEs without sacrificing oncological outcomes.
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http://dx.doi.org/10.1002/pros.24453 | DOI Listing |
Cancer Med
December 2024
Department of Urology, Hirosaki University School of Medicine, Hirosaki, Japan.
Objective: We aimed to examine trends in novel antiandrogen receptor signal inhibitor (ARSI) usage and medical costs by collecting real-world big data included in The National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data, covering most of the clinical practices throughout Japan.
Methods: Usage data for outpatient prescriptions from 2016 to 2021 were extracted from the NDB Open Data. Among the 459,610 million tablets/capsules prescribed, prostate cancer-specific agents (bicalutamide, estramustine phosphate, flutamide, abiraterone, enzalutamide, apalutamide, and darolutamide) were selected to investigate the trends of usage and medical costs.
Clin Genitourin Cancer
October 2024
Division of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Background: A survival advantage with apalutamide (APA) combined with androgen deprivation therapy for metastatic castration-sensitive prostate cancer (mCSPC) has been demonstrated in the clinical trial, irrespective of race. However, the incidence of APA-induced skin rash in the Japanese subpopulation is higher than that in the global population. In the present study, we investigated the predictive value of APA dose per body weight for the incidence of skin rash.
View Article and Find Full Text PDFJ Cancer Res Clin Oncol
September 2024
Urologen am Ludwigsplatz, Giessen, Germany.
Purpose: Apalutamide plus androgen-deprivation therapy (ADT) improved outcomes in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nevertheless real-world data are limited. The aim of this multicenter study was to generate real-world data from nmCRPC patients treated with ADT plus apalutamide.
View Article and Find Full Text PDFOncol Ther
September 2024
Hospital Clínic de Barcelona, Barcelona, Spain.
Apalutamide is a selective androgen receptor signalling inhibitor that is used in the treatment of prostate cancer. Skin rash is one of the most common adverse events with apalutamide. Although the majority of rash events are grade 1 and 2, the appearance of skin rash during treatment can lead to dose reduction, a pause in treatment or even treatment discontinuation, especially if patients present late when the rash has become severe.
View Article and Find Full Text PDFCrit Rev Oncol Hematol
August 2024
Vita-Salute San Raffaele University, Milan, Italy; Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy.
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