Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated anal
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RESEARCH ARTICLE
Open Access
Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study Hiroji Uemura1, Yosuke Koroki2* , Yuki Iwaki3, Keiichiro Imanaka4, Takeshi Kambara5, Angela Lopez-Gitlitz6, Andressa Smith6 and Hirotsugu Uemura7
Abstract Background: A higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC). Methods: This integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN (NCT019462 04; 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. Results: Data 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. (Continued on next page)
* Correspondence: [email protected] 2 Medical Affairs, Janssen Pharmaceutical K.K., Tokyo, Japan Full list of author information is available at the end of the article
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