Yoichiro Tohi1, Takuma Kato2, Hideo Fukuhara3, Keita Kobayashi4, Shin Ohira5, Kenichiro Ikeda6, Kei Daizumoto7, Satoshi Katayama8, Ryutaro Shimizu9, Kenichi Nishimura10, Taichi Nagami11, Yushi Hayashida12, Hiromi Hirama13, Atsushi Takamoto14, Teruki Dainichi15, Mikio Sugimoto2. 1. Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan. yoto716yotoyoto@gmail.com. 2. Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan. 3. Department of Urology, Kochi Medical School, Kochi, Japan. 4. Department of Urology, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan. 5. Department of Urology, Kawasaki Medical School, Okayama, Japan. 6. Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. 7. Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan. 8. Department of Urology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan. 9. Division of Urology, Department of Surgery, Faculty of Medicine, Tottori University, Tottori, Japan. 10. Department of Urology, Ehime University, Ehime, Japan. 11. Department of Urology, Faculty of Medicine, Shimane University, Shimane, Japan. 12. Department of Urology, Sakaide City Hospital, Kagawa, Japan. 13. Department of Urology, KKR Takamatsu Hospital, Kagawa, Japan. 14. Department of Urology, Fukuyama City Hospital, Hiroshima, Japan. 15. Department of Dermatology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Abstract
BACKGROUND: Apalutamide-associated skin adverse events are more common in the Japanese than in the global population. However, limited clinical data have hampered further understanding. This real-world study investigated the clinical characteristics of skin adverse events in patients with advanced prostate cancer. METHODS: We retrospectively reviewed 119 patient records from 16 institutions in Japan. Skin adverse events were graded according to the Common Terminology Criteria for Adverse Events (v5.0). The incidence and characteristics of skin adverse events (along with the clinical risk factors for their incidence, worsening, and recurrence) were evaluated. RESULTS: Fifty-five patients (46.2%) experienced skin adverse events. The median times to the incidence and remission of skin adverse events were 62 and 30 days, respectively. Grade 3 skin adverse events were observed in 15 patients (12.6%). The median time from the first incidence to apalutamide interruption was significantly longer in patients with progression to grade 3 skin adverse events than in those without such a progression (8 vs. 0 days, p = 0.005). Skin adverse events were observed in 45.2% of patients who resumed apalutamide treatment (median treatment interruption time: 31.5 days). Sixteen patients (13.4%) permanently discontinued apalutamide due to skin adverse events. No significant clinical risk factors for the incidence, worsening and recurrence of apalutamide-associated skin adverse events were observed. CONCLUSIONS: Nearly half of the Japanese patients in this study experienced skin adverse events following apalutamide administration. The time to apalutamide discontinuation after the incidence of skin adverse events was positively correlated with the worsening of these events.
BACKGROUND: Apalutamide-associated skin adverse events are more common in the Japanese than in the global population. However, limited clinical data have hampered further understanding. This real-world study investigated the clinical characteristics of skin adverse events in patients with advanced prostate cancer. METHODS: We retrospectively reviewed 119 patient records from 16 institutions in Japan. Skin adverse events were graded according to the Common Terminology Criteria for Adverse Events (v5.0). The incidence and characteristics of skin adverse events (along with the clinical risk factors for their incidence, worsening, and recurrence) were evaluated. RESULTS: Fifty-five patients (46.2%) experienced skin adverse events. The median times to the incidence and remission of skin adverse events were 62 and 30 days, respectively. Grade 3 skin adverse events were observed in 15 patients (12.6%). The median time from the first incidence to apalutamide interruption was significantly longer in patients with progression to grade 3 skin adverse events than in those without such a progression (8 vs. 0 days, p = 0.005). Skin adverse events were observed in 45.2% of patients who resumed apalutamide treatment (median treatment interruption time: 31.5 days). Sixteen patients (13.4%) permanently discontinued apalutamide due to skin adverse events. No significant clinical risk factors for the incidence, worsening and recurrence of apalutamide-associated skin adverse events were observed. CONCLUSIONS: Nearly half of the Japanese patients in this study experienced skin adverse events following apalutamide administration. The time to apalutamide discontinuation after the incidence of skin adverse events was positively correlated with the worsening of these events.
Authors: Alexander Pan; Rachel E Reingold; Jimmy L Zhao; Andrea Moy; Lukas Kraehenbuehl; George Dranitsaris; Sean M McBride; Howard I Scher; Marisa A Kollmeier; Han Xiao; Dana E Rathkopf; Mario E Lacouture Journal: J Urol Date: 2022-01-12 Impact factor: 7.600