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.

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.