World journal of surgical oncology · 2026
Bridging the evidence gap: three-year BCG maintenance therapy shows enhanced protection over one-year regimen in Chinese NMIBC.
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Du Xiang, Deng Zhenggen, Shi Yonghao, Ding Jiayang, Guo Hongqian, Yang Rong
Аннотация
BACKGROUND AND OBJECTIVE: The current recommendation of BCG therapy in China is a 1-year regimen, based on local strain variations and the absence of evidence for a 3-year instillation protocol. Our aim was to compare the protective efficacy of the 3-year BCG regimen versus a 1-year regimen in Chinese NMIBC patients.
METHODS: We collected 140 patients followed by BCG monotherapy at our center from 2017 to 2024. All patients had ≥ 1 year of follow-up. Participants were allocated based on clinical practice into a standard three-year instillation group (n = 72) and a modified one-year group (n = 68). Kaplan-Meier survival analysis evaluated the impact of both regimens, while Cox regression identified factors for recurrence. Subgroup analyses and interaction tests were performed for all categorical variables. The prognostic role of instillation regimens across different risk stratifications was assessed via interaction and subgroup analyses.
KEY FINDINGS AND LIMITATIONS: Kaplan-Meier analysis demonstrated superior RFS in the three-year group (HR 0.31; 95% CI 0.14-0.67). Multivariate Cox regression confirmed the three-year regimen as an independent protective factor against recurrence (p = 0.006, HR 0.282; 95% CI 0.114-0.697). The protective effect remained significant in high-risk subgroups. Adverse events were numerically fewer in the three-year group, though this comparison should be interpreted cautiously. This study is limited by its retrospective design, the marked imbalance in treatment completion between groups (25% vs. 51.5%), and the small number of recurrence events (n = 27), all of which preclude causal interpretation and require cautious reading of the hazard ratio estimates.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Our findings suggest that the standard 3-year regimen may offer superior recurrence risk reduction compared to the 1-year regimen in Chinese high-risk NMIBC patients. Given the retrospective design and limited sample size, these results should be considered hypothesis-generating and warrant confirmation in prospective studies. A 3-year BCG regimen may offer better protection than a 1-year regimen for Chinese high-risk NMIBC patients.
METHODS: We collected 140 patients followed by BCG monotherapy at our center from 2017 to 2024. All patients had ≥ 1 year of follow-up. Participants were allocated based on clinical practice into a standard three-year instillation group (n = 72) and a modified one-year group (n = 68). Kaplan-Meier survival analysis evaluated the impact of both regimens, while Cox regression identified factors for recurrence. Subgroup analyses and interaction tests were performed for all categorical variables. The prognostic role of instillation regimens across different risk stratifications was assessed via interaction and subgroup analyses.
KEY FINDINGS AND LIMITATIONS: Kaplan-Meier analysis demonstrated superior RFS in the three-year group (HR 0.31; 95% CI 0.14-0.67). Multivariate Cox regression confirmed the three-year regimen as an independent protective factor against recurrence (p = 0.006, HR 0.282; 95% CI 0.114-0.697). The protective effect remained significant in high-risk subgroups. Adverse events were numerically fewer in the three-year group, though this comparison should be interpreted cautiously. This study is limited by its retrospective design, the marked imbalance in treatment completion between groups (25% vs. 51.5%), and the small number of recurrence events (n = 27), all of which preclude causal interpretation and require cautious reading of the hazard ratio estimates.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Our findings suggest that the standard 3-year regimen may offer superior recurrence risk reduction compared to the 1-year regimen in Chinese high-risk NMIBC patients. Given the retrospective design and limited sample size, these results should be considered hypothesis-generating and warrant confirmation in prospective studies. A 3-year BCG regimen may offer better protection than a 1-year regimen for Chinese high-risk NMIBC patients.