| アブストラクト | BACKGROUND: Worldwide, prostate cancer (PC) is the second most diagnosed cancer and the fifth leading cause of cancer death in men. Hormonal therapies, commonly used for PC, are associated with a range of treatment-emergent adverse events (TEAEs). The population from Japan seems to be at higher risk of developing TEAEs of skin rash compared to the overall global population. This study was conducted to get a better insight into the incidence, management, and risk factors for skin rash during active treatment for advanced PC in Japan. METHODS: A retrospective cohort of PC patients was identified and subsequently categorized, into non-metastatic and metastatic castration-resistant prostate cancer patients (nmCRPC and mCRPC), and metastatic castration-naive prostate cancer patients (mCNPC). The analysis was based on a dataset from the Medical Data Vision (MDV) database. Descriptive statistics were determined, and a multivariate Cox proportional hazards model was used to the associated risk factors for the onset of rash. RESULTS: Overall, 1,738 nmCRPC patients, 630 mCRPC patients, and 454 mCNPC patients were included in this analysis. The median age was 78 years old and similar across the three cohorts. The skin rash incidence was 19.97% for nmCRPC cohort, 28.89% for mCRPC cohort, and 28.85% for mCNPC cohort. The median duration of skin rash ranged from 29 to 42 days. Statistically significant risk factors for developing skin rash included a history of allergy or hypersensitivity (all cohorts), increased age (nmCRPC and mCRPC), a body mass index (BMI) of < 18.5 (nmCRPC and mCRPC), and a PSA level higher than the median (nmCRPC). Skin rash was commonly managed with systemic and topical corticosteroids which ranged from 41.76% to 67.03% for all cohorts. Antihistamines were infrequently used. CONCLUSION: This study provides a better understanding of the real-world incidence, onset, duration, management and risk factors of skin rash in patients on active PC treatment in Japan. It was observed that approximately 20-30% of PC patients experience skin rash. Development of skin rash was associated with previous allergy or hypersensitivity, BMI of < 18.5, increased age and higher PSA levels, and was usually treated with corticosteroids. |
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| ジャーナル名 | BMC urology |
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| 投稿日 | 2023/4/29 |
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| 投稿者 | De Moor, Raf; Koroki, Yosuke; Wu, David Bin-Chia; Yu, Dae Young; Tohyama, Mikiko; Ohyama, Chikara |
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| 組織名 | Integrated Market Access, Janssen Pharmaceutical K.K., 3 Chome-5-2 Nishikanda,;Tokyo, 101-0065, Japan. rdemoor@its.jnj.com.;Medical Affairs, Janssen Pharmaceutical K.K., Tokyo, Japan.;Janssen Pharmaceutical Companies of Johnson and Johnson, Asia Pacific Regional;Office, Singapore, Singapore.;Saw Swee Hock School of Public Health, National University of Singapore,;Singapore, Singapore.;School of Pharmacy, Monash University Malaysia, Bandar Suwnay, Malaysia.;Department of Dermatology, National Hospital Organization Shikoku Cancer Center,;Matsuyama, Japan.;Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki,;Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37118710/ |
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