International journal of clinical oncology · 2026
Patient-reported outcome sub-analysis of a phase 2 trial of bladder preservation therapy with atezolizumab and radiation therapy (BPT-ART) for invasive bladder cancer.
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Mathis Bryan J, Nagumo Yoshiyuki, Kimura Tomokazu, Ishikawa Hitoshi, Sekino Yuta, Maruo Kazushi, Kageyama Yukio, Ushijima Hiroki, Kamei Jun, Yamashita Hideomi, Azuma Haruhito, Nihei Keiji, Naiki Taku, Tomita Natsuo, Kobayashi Yasuyuki, Yoshio Kotaro, Matsumoto Takashi, Yoshitake Tadamasa, Osawa Takahiro, Nishioka Kentaro, Kita Yuki, Mizowaki Takashi, Tsuzuki Toyonori, Hashimoto Koichi, Nishiyama Hiroyuki
Аннотация
BACKGROUND: Impacts on quality of life (QoL) from bladder preservation therapy with atezolizumab and radiation therapy (BPT-ART), as assessed by patient reported outcomes (PROs), remains unanalyzed. We delineated temporal effects of BPT-ART on urinary QoL across multiple domains using established PRO tools.
METHODS: This was a planned sub-analysis for the Phase 2 BPT-ART trial. PRO instruments included the EuroQol 5-item 5-point questionnaire (EQ-5D-5L), OABSS (Overactive Bladder Symptom Score) and IPSS (International Prostate Symptom Score). Forty-four total participants from 9 Japanese hospitals were surveyed from January 2019 to June 2024. Changes from baseline for each PRO tool were summarized over time as mean changes with 95% confidence intervals.
RESULTS: EQ-5D-5L utility showed a transient decline during treatment, followed by recovery during follow-up. At the dimension level, pain/discomfort showed the largest transient decrease during radiotherapy (mean change - 0.60, 95% CI -0.90 to -0.31), followed by recovery after treatment. Total OABSS showed a modest increase during radiotherapy and recovered after treatment. Among OABSS components, urgency showed the largest increase (+ 0.95, 95% CI 0.44 to 1.46), followed by urgency incontinence (+ 0.53, 95% CI 0.11 to 0.96) and nighttime frequency (+ 0.33, 95% CI 0.04 to 0.62), while daytime frequency remained stable (+ 0.05, 95% CI -0.17 to 0.26). Baseline symptom burden was associated with absolute scores, but trajectories appeared comparable, and global health status remained stable across subgroups.
CONCLUSION: PROs outlined a temporal pattern of QoL decline but progressive recovery, as measured across patient-reported functional domains. These results support BPT-ART as effective for maintaining patient QoL.
METHODS: This was a planned sub-analysis for the Phase 2 BPT-ART trial. PRO instruments included the EuroQol 5-item 5-point questionnaire (EQ-5D-5L), OABSS (Overactive Bladder Symptom Score) and IPSS (International Prostate Symptom Score). Forty-four total participants from 9 Japanese hospitals were surveyed from January 2019 to June 2024. Changes from baseline for each PRO tool were summarized over time as mean changes with 95% confidence intervals.
RESULTS: EQ-5D-5L utility showed a transient decline during treatment, followed by recovery during follow-up. At the dimension level, pain/discomfort showed the largest transient decrease during radiotherapy (mean change - 0.60, 95% CI -0.90 to -0.31), followed by recovery after treatment. Total OABSS showed a modest increase during radiotherapy and recovered after treatment. Among OABSS components, urgency showed the largest increase (+ 0.95, 95% CI 0.44 to 1.46), followed by urgency incontinence (+ 0.53, 95% CI 0.11 to 0.96) and nighttime frequency (+ 0.33, 95% CI 0.04 to 0.62), while daytime frequency remained stable (+ 0.05, 95% CI -0.17 to 0.26). Baseline symptom burden was associated with absolute scores, but trajectories appeared comparable, and global health status remained stable across subgroups.
CONCLUSION: PROs outlined a temporal pattern of QoL decline but progressive recovery, as measured across patient-reported functional domains. These results support BPT-ART as effective for maintaining patient QoL.