Objective: To evaluate the oncologic outcomes of high-risk (HR) and very high-risk (VHR) non-muscle-invasive bladder cancer (NMIBC) patients treated with Bacillus Calmette-Guérin (BCG) immunotherapy and assess the new European Association of Urology (EAU) risk stratification.
Material and Methods: This retrospective cohort study analyzed data from 211 HR and VHR NMIBC patients treated with BCG therapy between January 2015 and January 2024. Risk stratification was performed using the EAU NMIBC risk calculator. Recurrence, progression, recurrence-free survival (RFS), and progression-free survival (PFS) were assessed.
Results: The cohort comprised 144 (68.2%) HR and 67 (31.8%) VHR patients. The VHR group had significantly more adverse pathological features (larger and multiple tumors, higher pT stage, CIS, variant histology, lymphovascular invasion, tumor necrosis). While there was no significant difference in overall recurrence (33.3% vs. 37.3%, p=0.572) or progression rates (10.4% vs. 9%, p=0.741) between HR and VHR groups, the 5-year RFS was significantly lower in the VHR (56% vs. 75%, p=0.003). The 5-year PFS was similar between the groups (86% vs 91%, p=0.311).
Conclusion: In spite of the fact that the VHR group presented with more aggressive tumor characteristics, BCG therapy resulted in similar overall progression rates compared to the HR group. These findings suggest that the EAU risk stratification may overestimate the risk of progression in BCG-treated patients, particularly those classified as VHR, and that BCG remains a valuable treatment option even in this population.
Abstract
Objective: To evaluate the oncologic outcomes of high-risk (HR) and very high-risk (VHR) non-muscle-invasive bladder cancer (NMIBC) patients treated with Bacillus Calmette-Guérin (BCG) immunotherapy and assess the new European Association of Urology (EAU) risk stratification.
Material and Methods: This retrospective cohort study analyzed data from 211 HR and VHR NMIBC patients treated with BCG therapy between January 2015 and January 2024. Risk stratification was performed using the EAU NMIBC risk calculator. Recurrence, progression, recurrence-free survival (RFS), and progression-free survival (PFS) were assessed.
Results: The cohort comprised 144 (68.2%) HR and 67 (31.8%) VHR patients. The VHR group had significantly more adverse pathological features (larger and multiple tumors, higher pT stage, CIS, variant histology, lymphovascular invasion, tumor necrosis). While there was no significant difference in overall recurrence (33.3% vs. 37.3%, p=0.572) or progression rates (10.4% vs. 9%, p=0.741) between HR and VHR groups, the 5-year RFS was significantly lower in the VHR (56% vs. 75%, p=0.003). The 5-year PFS was similar between the groups (86% vs 91%, p=0.311).
Conclusion: In spite of the fact that the VHR group presented with more aggressive tumor characteristics, BCG therapy resulted in similar overall progression rates compared to the HR group. These findings suggest that the EAU risk stratification may overestimate the risk of progression in BCG-treated patients, particularly those classified as VHR, and that BCG remains a valuable treatment option even in this population.