Critical reviews in oncology/hematology · 2026
Bacillus Calmette-Guérin (BCG) with or without immune checkpoint blockade in BCG-naïve high-risk non-muscle-invasive bladder cancer: A systematic review and reconstructed individual patient data meta-analysis.
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Saâd Mohammed Amine, Antari Abdelkarim, Taleb Imad, El Omri Sofia, Traoré Hamadoun, Chahbounia Imane, Sella Imane, Poudiougou Abdoulkarim, Sano Faman Douaya, Omri Loubna, Elm'hadi Choukri, Lamine Saïda, Mokhlis Mohammed Anouar, Aalaoui Lamia, Debbagh Adil, Khmamouche Mohamed Reda, Slimani Khaoula Alaoui, Sbitti Yassir, Mahfoud Tarik, Errihani Hassan, Tanz Rachid
Аннотация
BACKGROUND: Non-muscle-invasive bladder cancer (NMIBC) accounts for 75% of bladder cancers. Despite standard treatment with transurethral resection followed by BCG instillation, 30-40% of patients relapse. We conducted a meta-analysis evaluating immune checkpoint inhibitor (ICI) plus BCG versus BCG alone in BCG-naïve high-risk NMIBC.
METHODS: We performed a systematic review and reconstructed individual patient data (rIPD) meta-analysis of phase 3 randomized controlled trials (RCTs). Individual patient data were reconstructed from published Kaplan-Meier curves using the IPDfromKM method. The primary endpoint was event-free survival (EFS) for ICI plus BCG induction and maintenance (I+M) versus BCG I + M alone. Secondary endpoints included EFS for ICI plus BCG induction only, overall survival, subgroup analyses (age, sex, BCG strain, concomitant CIS), and safety.
RESULTS: Three phase 3 trials (CREST, POTOMAC, ALBAN; n = 2590) were included. ICI plus BCG I + M significantly improved EFS versus BCG alone (HR 0.77, 95% CI 0.64-0.93; p = 0.006), corroborated by pooled aggregate-data analysis (HR 0.77, 95% CI 0.60-0.97; I²=40%). ICI plus BCG induction only conferred no benefit (HR 1.03, 95% CI 0.85-1.25; p = 0.754). Overall survival data were immature (HR 0.90; p = 0.36). Grade ≥ 3 adverse events were more frequent with combination therapy (24.5% vs 6.1%).
CONCLUSION: ICI combined with full BCG maintenance significantly improves EFS in BCG-naïve high-risk NMIBC. This benefit is contingent on BCG maintenance; induction-only BCG provides no synergistic effect. Incremental toxicity warrants careful patient selection and biomarker-stratified validation before universal adoption.
METHODS: We performed a systematic review and reconstructed individual patient data (rIPD) meta-analysis of phase 3 randomized controlled trials (RCTs). Individual patient data were reconstructed from published Kaplan-Meier curves using the IPDfromKM method. The primary endpoint was event-free survival (EFS) for ICI plus BCG induction and maintenance (I+M) versus BCG I + M alone. Secondary endpoints included EFS for ICI plus BCG induction only, overall survival, subgroup analyses (age, sex, BCG strain, concomitant CIS), and safety.
RESULTS: Three phase 3 trials (CREST, POTOMAC, ALBAN; n = 2590) were included. ICI plus BCG I + M significantly improved EFS versus BCG alone (HR 0.77, 95% CI 0.64-0.93; p = 0.006), corroborated by pooled aggregate-data analysis (HR 0.77, 95% CI 0.60-0.97; I²=40%). ICI plus BCG induction only conferred no benefit (HR 1.03, 95% CI 0.85-1.25; p = 0.754). Overall survival data were immature (HR 0.90; p = 0.36). Grade ≥ 3 adverse events were more frequent with combination therapy (24.5% vs 6.1%).
CONCLUSION: ICI combined with full BCG maintenance significantly improves EFS in BCG-naïve high-risk NMIBC. This benefit is contingent on BCG maintenance; induction-only BCG provides no synergistic effect. Incremental toxicity warrants careful patient selection and biomarker-stratified validation before universal adoption.