TY - JOUR
T1 - Real-world analysis of apalutamide-associated skin adverse events in Japanese patients with advanced prostate cancer
T2 - a multi-institutional study in the Chu-shikoku Japan Urological Consortium
AU - Chu-shikoku Japan Urological Consortium
AU - Tohi, Yoichiro
AU - Kato, Takuma
AU - Fukuhara, Hideo
AU - Kobayashi, Keita
AU - Ohira, Shin
AU - Ikeda, Kenichiro
AU - Daizumoto, Kei
AU - Katayama, Satoshi
AU - Shimizu, Ryutaro
AU - Nishimura, Kenichi
AU - Nagami, Taichi
AU - Hayashida, Yushi
AU - Hirama, Hiromi
AU - Takamoto, Atsushi
AU - Dainichi, Teruki
AU - Sugimoto, Mikio
AU - Inoue, Keiji
AU - Yamamoto, Shinkuro
AU - Matsuyama, Hideyasu
AU - Nagai, Atsushi
AU - Hinata, Nobuyuki
AU - Kanayama, Hiroomi
AU - Nasu, Yasutomo
AU - Takenaka, Atsushi
AU - Saika, Takashi
AU - Wada, Koichiro
AU - Tohi, Yoichiro
N1 - Publisher Copyright:
© 2022, The Author(s) under exclusive licence to Japan Society of Clinical Oncology.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Adverse event
KW - Apalutamide
KW - Prostate cancer
KW - Skin rash
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U2 - 10.1007/s10147-022-02183-z
DO - 10.1007/s10147-022-02183-z
M3 - Article
C2 - 35596089
AN - SCOPUS:85132100817
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
ER -