Abstract
BackgroundA higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC).MethodsThis integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN (NCT01946204; patients with non-metastatic castration-resistant PC [nmCRPC]) and TITAN (NCT02489318; patients with metastatic castration-sensitive PC [mCSPC]), and the Phase 1 study 56021927PCR1008 (NCT02162836; patients with metastatic CRPC [mCRPC]), assessed clinical risk factors of apalutamide-related skin rash as well as the potential correlation with plasma exposure to apalutamide. Kaplan-Meier method was used for time-to-event analyses. Clinical risk factors for skin rash were assessed using odds ratio.ResultsData from 68 patients (SPARTAN: n = 34, TITAN: n = 28, 56021927PCR1008: n = 6) receiving apalutamide 240 mg orally once-daily were analyzed. Rash (13 [19.1%]) and maculo-papular rash (11 [16.2%]) were the most frequently reported skin rash. All Grade and Grade 3 skin rash occurred in 35 (51.5%) and 10 (14.7%) patients, respectively. Most (85.7%) skin rash occurred within 4 months of apalutamide initiation and resolved in a median time of 1 month following the use of antihistamines, topical or systemic corticosteroids, with/without apalutamide dose interruptions/reductions. Median time-to-remission of first incidence of rash and maximum grade incidence of rash were 1.0 month (IQR: 0.36–1.81) and 1.0 month (IQR: 0.30–2.43), respectively. No significant clinical risk factors for the incidence of skin rash were observed. Areas under the curve (0–24 h) (AUC0–24, ss) at steady-state of plasma apalutamide concentration were numerically slightly higher in patients with skin rash than those without.ConclusionsNo clinical risk factors for rash could be detected. There is a potential correlation between incidence of skin rash and plasma exposure to apalutamide. In general, apalutamide-related skin rash is easily managed, with appropriate treatment with or without dose adjustment.Trial registrationRetrospective pooled analysis of NCT01946204, NCT02489318, and NCT02162836.
Highlights
A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC)
There is a potential correlation between incidence of skin rash and plasma exposure to apalutamide
Since the disease status at baseline was different in SPARTAN, TITAN, and PCR1008 studies, some of the baseline characteristics were not comparable between the three groups, with the median time from initial diagnosis, prostate-specific antigen (PSA) levels, treatment durations, and alkaline phosphatase (ALP) levels varying between the 3 patient populations
Summary
A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC). In the SPARTAN study, addition of 240 mg apalutamide once-daily (QD) to ongoing androgen-deprivation therapy (ADT) showed a significant increase in metastasis-free survival (MFS) (> 2 years) when compared to placebo, with an overall maintenance of health-related quality of life. The incidence of skin rash was higher in the apalutamide group compared to placebo (23.8% vs 5.5%) [3]. In the TITAN study, skin rash was more frequently observed in the apalutamide group compared to placebo (27.1% vs 8.5%), significant improvements in the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) were reported [4]. To be defined as a Grade 3 rash, it must cover > 30% BSA, regardless of concomitant symptoms, if any
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