Association of initial adjustment dose of apalutamide with progression to castration-resistant prostate cancer and skin-adverse events in men with metastatic castration-sensitive prostate cancer: A multicenter retrospective study of CsJUC cohort.

Authors

null

Yoichiro Tohi

Kagawa University, Kita-Gun, Japan

Yoichiro Tohi , Takuma Kato , Keita Kobayashi , Kei Daizumoto , Hideo Fukuhara , Shin Ohira , Satoshi Katayama , Ryutaro Shimizu , Atsushi Takamoto , Kenichi Nishimura , Kenichiro Ikeda , Taichi Nagami , Mikio Sugimoto

Organizations

Kagawa University, Kita-Gun, Japan, Yamaguchi University, Yamaguchi, Japan, Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan, Kochi Medical School, Kochi, Japan, Department of Urology, Kawasaki Medical School, Kurashiki, Japan, Okayama University Graduate School of Medicine, Okayama, Japan, Tottori University Faculty of Medicine, Tottori, Japan, Fukuyama City Hospital, Fukuyama, Japan, Department of Urology, Ehime University Hospital, Matsuyama, Japan, Hiroshima University, Hiroshima, Japan, Shimane University, Shimane, Japan, Kagawa University, Kagawa, Japan

Research Funding

No funding sources reported

Background: Japanese patients with prostate cancer (PC) treated with apalutamide often encounter skin-adverse events (AE), which might lead to adjust the initial-dose of apalutamide. However, concerns have emerged regarding the potential impact of these dose adjustments on the overall efficacy of apalutamide in real-world clinical practice. We aimed to evaluate the association between adjustment of apalutamide dose and clinical outcome in Japanese men with metastatic castration-sensitive PC (mCSPC). Methods: We retrospectively evaluated 108 mCSPC patients treated with apalutamide. We divided patients into two groups: initial full-dose and reduced-dose recipients. The primary outcome was the impact of apalutamide dose adjustment on progression to castration-resistant prostate cancer (CRPC) and PSA response. The secondary outcomes were the impact of apalutamide dose adjustment on the incidence of the skin-AE. Results: Initial reduced-dose recipients of apalutamide were observed in 16.7%. There were no differences in cancer characteristics, such as CHAARTED criteria between the groups. Initial full-dose recipients were significantly associated with a longer time to CRPC than initial reduced-dose recipients [median NA (NA - NA) vs. 19 months (95% CI, 10 - NA), P=0.0161], although the percentages of the initial full-dose recipients who reduced apalutamide dose were 30%, 44.4%, 60%, and 63.3% at 3, 6, 9, and 12 months, respectively. The percentage of PSA <0.2 decline at 3 months did not differ between the groups (59.1% vs 50%, P=0.602), but overall PSA 90% decline was higher in the initial full-dose recipients (88.8% vs 66.7%, P=0.027). Skin-AE occurred 50% in initial reduced-dose recipients and 51.1% in initial full-dose recipients, with no difference between the groups (P>0.999). Furthermore, time to skin-AE was not different between the groups (74 days vs. 69 days, P=0.992). Conclusions: Our study suggested the potential negative implications of initial apalutamide dose adjustments on clinical outcomes in Japanese men with mCSPC.

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Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Therapeutics

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 137)

DOI

10.1200/JCO.2024.42.4_suppl.137

Abstract #

137

Poster Bd #

F8

Abstract Disclosures