BJUI compass · 2026
Addition of immune checkpoint inhibitors to intravesical BCG for high-risk BCG-naïve non-muscle invasive bladder cancer: Systematic review and meta-analysis.
СтатьяОбзорНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Titus Renil S, Riveros Carlos, Velasquez Eusebio Luna, Nguyen David-Dan, Somawardana Suran, Singh Amar, Kaushik Dharam, Sonpavde Guru, Zlotta Alexandre, Kulkarni Girish, Sridhar Srikala S, Wallis Christopher J D, Satkunasivam Raj
Аннотация
OBJECTIVE: The objective of this study is to assess the efficacy, safety and change in quality of life associated with ICI-BCG (I + M) compared to BCG (I + M) in patients with BCG-naïve HR-NMIBC.
MATERIAL AND METHODS: A systematic search was run on PubMed, Embase and CENTRAL from inception to 29 October 2025. Phase 3 randomized controlled trials comparing safety, efficacy and quality of life (QOL) for patients with BCG-naïve HR-NMIBC receiving ICI-BCG (I + M) versus BCG (I + M): hazard ratios (HR) and 95% confidence interval (95% CI) for HG-RFS (high-grade recurrence free survival), odds ratio (OR) and 95% CI for Grade ≥3 treatment-related adverse events (G3 + TRAEs), and mean difference (MD) and 95% CI for changes in quality of life (QOL measured using EORTC QLQ C30). A priori defined subgroups included presence of CIS, presence of papillary tumours, age <65 or ≥65 years, male/female, and BCG strain.
RESULTS: Pooled results indicated that ICI-BCG (I + M) was not associated with a reduction in HG-RFS (HR: 0.78; 95% CI: 0.59-1.02). However, on sensitivity analysis excluding ALBAN (for differences in trial design and patients included), ICI-BCG (I + M) was associated with a reduction in HG-RFS (HR: 0.68; 95% CI: 0.54-0.85) with an absolute risk reduction of 4.4-7.3% in 36-month HG-RFS. ICI-BCG (I + M) was associated with an increased risk of G3 + TRAEs (OR: 4.76; 95% CI: 3.01-7.53). ICI-BCG (I + M) was associated with a non-clinically significant decline in QOL (MD: -3.25; 95% CI: -5.11 to -1.39). Heterogeneity between trials was minimal (τ 2 < 1). Risk of bias was low in all included studies.
CONCLUSION: This pooled analysis provides data for patient-specific counselling on the use of ICI-BCG (I + M) for BCG-naive HR-NMIBC.
MATERIAL AND METHODS: A systematic search was run on PubMed, Embase and CENTRAL from inception to 29 October 2025. Phase 3 randomized controlled trials comparing safety, efficacy and quality of life (QOL) for patients with BCG-naïve HR-NMIBC receiving ICI-BCG (I + M) versus BCG (I + M): hazard ratios (HR) and 95% confidence interval (95% CI) for HG-RFS (high-grade recurrence free survival), odds ratio (OR) and 95% CI for Grade ≥3 treatment-related adverse events (G3 + TRAEs), and mean difference (MD) and 95% CI for changes in quality of life (QOL measured using EORTC QLQ C30). A priori defined subgroups included presence of CIS, presence of papillary tumours, age <65 or ≥65 years, male/female, and BCG strain.
RESULTS: Pooled results indicated that ICI-BCG (I + M) was not associated with a reduction in HG-RFS (HR: 0.78; 95% CI: 0.59-1.02). However, on sensitivity analysis excluding ALBAN (for differences in trial design and patients included), ICI-BCG (I + M) was associated with a reduction in HG-RFS (HR: 0.68; 95% CI: 0.54-0.85) with an absolute risk reduction of 4.4-7.3% in 36-month HG-RFS. ICI-BCG (I + M) was associated with an increased risk of G3 + TRAEs (OR: 4.76; 95% CI: 3.01-7.53). ICI-BCG (I + M) was associated with a non-clinically significant decline in QOL (MD: -3.25; 95% CI: -5.11 to -1.39). Heterogeneity between trials was minimal (τ 2 < 1). Risk of bias was low in all included studies.
CONCLUSION: This pooled analysis provides data for patient-specific counselling on the use of ICI-BCG (I + M) for BCG-naive HR-NMIBC.