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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

  • Uemura, Hiroji1
  • Koroki, Yosuke2
  • Iwaki, Yuki3
  • Imanaka, Keiichiro4
  • Kambara, Takeshi1
  • Lopez-Gitlitz, Angela5
  • Smith, Andressa5
  • Uemura, Hirotsugu6
  • 1 Yokohama City University Medical Center, Yokohama, Japan , Yokohama (Japan)
  • 2 Medical Affairs, Janssen Pharmaceutical K.K., Tokyo, Japan , Tokyo (Japan)
  • 3 Clinical Pharmacology, Janssen Pharmaceutical K.K, Tokyo, Japan , Tokyo (Japan)
  • 4 Clinical Science, Janssen Pharmaceutical K.K, Tokyo, Japan , Tokyo (Japan)
  • 5 Janssen Global Research & Development, Spring House, PA, USA , Spring House (United States)
  • 6 Kindai University Faculty of Medicine, Osaka, Japan , Osaka (Japan)
Published Article
BMC Urology
Springer (Biomed Central Ltd.)
Publication Date
Sep 02, 2020
DOI: 10.1186/s12894-020-00689-0
Springer Nature


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.

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