Japanese journal of clinical oncology · 2026
Age-stratified clinical outcomes and adverse events in patients with metastatic castration-sensitive prostate cancer receiving triplet therapy with darolutamide, androgen deprivation therapy, and docetaxel.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Uchimoto Taizo, Hirosuna Kensuke, Niigawa Heima, Jo Taisuke, Morinaka Hirofumi, Fukuokaya Wataru, Yoshizawa Atsuhiko, Saruta Masanobu, Morita Tsuyoshi, Fujimoto Saizo, Yamamoto Yutaka, Sakamoto Moritoshi, Nishimura Kazuki, Maenosono Ryoichi, Tsujino Takuya, Nishio Kyosuke, Yoshikawa Yuki, Ichihashi Atsushi, Urabe Fumihiko, Mori Keiichiro, Yanagisawa Takafumi, Tsuzuki Shunsuke, Takahara Kiyoshi, Inamoto Teruo, Fujita Kazutoshi, Azuma Haruhito, Kimura Takahiro, Komura Kazumasa
Аннотация
BACKGROUND: Triplet therapy with darolutamide, androgen deprivation therapy, and docetaxel (DOC) has emerged as an intensified treatment option for metastatic castration-sensitive prostate cancer (mCSPC). This study evaluated real-world prostate specific antigen (PSA) responses and adverse events (AEs) associated with triplet therapy, with a focus on age-specific differences.
METHODS: We performed a retrospective cohort study across six academic institutions in Japan between February 2023 and February 2025. A total of 137 patients with mCSPC who received triplet therapy were analyzed. PSA responses and AEs were assessed, including subgroup analyses by age (<75 vs ≥75 years).
RESULTS: The median age was 71 years, and 40 patients (29.2%) were aged ≥75 years. Six cycles of DOC were completed at similar rates in patients aged <75 years (66.0%) and ≥ 75 years (57.5%) (P = .435). The median baseline PSA was 298 ng/ml, and 107 patients (78.1%) met the CHAARTED high-volume criteria. At three months, the median [interquartile range] PSA decline was 99.8% [99.0-99.9]; 113 patients (92.6%) achieved a PSA decline >90%, and 35 patients (28.7%) achieved a PSA <0.2 ng/ml. During follow-up, the proportion achieving a PSA nadir <0.2 ng/ml did not differ significantly between patients aged <75 years (63.9%) and ≥ 75 years (55.0%) (P = .341). Grade ≥ 3 AEs occurred in 56 patients (40.9%), including febrile neutropenia in 29 patients (21.2%). The incidence of AEs did not differ significantly by age.
CONCLUSIONS: In this real-world cohort, triplet therapy showed substantial PSA declines and acceptable tolerability, with no significant differences in short-term efficacy or safety between patients aged <75 and ≥ 75 years. These findings suggest that chronological age alone should not preclude consideration of triplet therapy in appropriately selected patients.
METHODS: We performed a retrospective cohort study across six academic institutions in Japan between February 2023 and February 2025. A total of 137 patients with mCSPC who received triplet therapy were analyzed. PSA responses and AEs were assessed, including subgroup analyses by age (<75 vs ≥75 years).
RESULTS: The median age was 71 years, and 40 patients (29.2%) were aged ≥75 years. Six cycles of DOC were completed at similar rates in patients aged <75 years (66.0%) and ≥ 75 years (57.5%) (P = .435). The median baseline PSA was 298 ng/ml, and 107 patients (78.1%) met the CHAARTED high-volume criteria. At three months, the median [interquartile range] PSA decline was 99.8% [99.0-99.9]; 113 patients (92.6%) achieved a PSA decline >90%, and 35 patients (28.7%) achieved a PSA <0.2 ng/ml. During follow-up, the proportion achieving a PSA nadir <0.2 ng/ml did not differ significantly between patients aged <75 years (63.9%) and ≥ 75 years (55.0%) (P = .341). Grade ≥ 3 AEs occurred in 56 patients (40.9%), including febrile neutropenia in 29 patients (21.2%). The incidence of AEs did not differ significantly by age.
CONCLUSIONS: In this real-world cohort, triplet therapy showed substantial PSA declines and acceptable tolerability, with no significant differences in short-term efficacy or safety between patients aged <75 and ≥ 75 years. These findings suggest that chronological age alone should not preclude consideration of triplet therapy in appropriately selected patients.