Japanese journal of clinical oncology · 2026
Real-world comparison of enzalutamide and apalutamide in metastatic hormone-sensitive prostate cancer: a multi-institutional propensity score-matched analysis.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Nishimura Kazuki, Hirosuna Kensuke, Niigawa Heima, Kakumae Sho, Morinaka Hirofumi, Fukuokaya Wataru, Yoshizawa Atsuhiko, Saruta Masanobu, Fujimoto Saizo, Morita Tsuyoshi, Yamamoto Yutaka, Sakamoto Moritoshi, Uchimoto Taizo, Maenosono Ryoichi, Tsujino Takuya, Nishio Kyosuke, Yoshikawa Yuki, Ichihashi Atsushi, Yamamoto Shutaro, Iwatani Kosuke, Urabe Fumihiko, Mori Keiichiro, Yanagisawa Takafumi, Tsuduki Shunsuke, Takahara Kiyoshi, Inamoto Teruo, Fujita Kazutoshi, Azuma Haruhito, Kimura Takahiro, Komura Kazumasa
Аннотация
BACKGROUND: Androgen receptor signaling inhibitors (ARSIs) such as enzalutamide (Enz) and apalutamide (Apa), in combination with androgen deprivation therapy (ADT), are standard for metastatic hormone-sensitive prostate cancer (mHSPC). However, direct real-world comparisons, particularly in Japanese populations, are limited.
METHODS: We retrospectively reviewed 227 mHSPC patients treated with Enz (n = 112) or Apa (n = 115) plus ADT. Propensity score matching (PSM) adjusted for baseline differences. Primary endpoints were prostate-specific antigen (PSA) response, time to castration resistance (TTCR), and overall survival (OS).
RESULTS: In the matched cohort after PSM, PSA nadir <0.2 ng/ml was achieved in 63.1% of Enz-treated and 60.3% of Apa-treated patients; ≥90% PSA decline occurred 94.5% and 92.0%, respectively. TTCR and OS were similar between groups (TTCR: P = .415; OS: P = .202). Time to treatment failure (TTF) was significantly shorter with Apa than with Enz (P = .0016). Reduced-dose initiation was more frequent with Apa (22.1% vs 9.8%, P = .0118), and TTCR did not differ across subgroups stratified by treatment and starting dose (P = .8465). Adverse events (AEs) leading to treatment discontinuation were more frequent in the Apa group than in the Enz group (20.9% vs 4.5%). Second-line therapy use after treatment failure was similar (86.4% Enz vs 90.2% Apa), with abiraterone being the most common.
CONCLUSIONS: In this real-world Japanese cohort, Enz and Apa plus ADT showed comparable PSA responses, TTCR, and OS after PSM; however, Apa was associated with shorter TTF and more frequent AE-related treatment discontinuation. Reduced-dose initiation was more common with Apa without apparent TTCR disadvantage. Given the limited number of events, these findings should be interpreted with caution.
METHODS: We retrospectively reviewed 227 mHSPC patients treated with Enz (n = 112) or Apa (n = 115) plus ADT. Propensity score matching (PSM) adjusted for baseline differences. Primary endpoints were prostate-specific antigen (PSA) response, time to castration resistance (TTCR), and overall survival (OS).
RESULTS: In the matched cohort after PSM, PSA nadir <0.2 ng/ml was achieved in 63.1% of Enz-treated and 60.3% of Apa-treated patients; ≥90% PSA decline occurred 94.5% and 92.0%, respectively. TTCR and OS were similar between groups (TTCR: P = .415; OS: P = .202). Time to treatment failure (TTF) was significantly shorter with Apa than with Enz (P = .0016). Reduced-dose initiation was more frequent with Apa (22.1% vs 9.8%, P = .0118), and TTCR did not differ across subgroups stratified by treatment and starting dose (P = .8465). Adverse events (AEs) leading to treatment discontinuation were more frequent in the Apa group than in the Enz group (20.9% vs 4.5%). Second-line therapy use after treatment failure was similar (86.4% Enz vs 90.2% Apa), with abiraterone being the most common.
CONCLUSIONS: In this real-world Japanese cohort, Enz and Apa plus ADT showed comparable PSA responses, TTCR, and OS after PSM; however, Apa was associated with shorter TTF and more frequent AE-related treatment discontinuation. Reduced-dose initiation was more common with Apa without apparent TTCR disadvantage. Given the limited number of events, these findings should be interpreted with caution.