Introduction: Transurethral resection of the bladder tumor (TURBT) followed by intravesical Bacillus Calmette-Guérin (BCG) immunotherapy is a standard treatment for high-risk non muscle-invasive bladder cancer (NMIBC). However, due to potential risk of dissemination, current guidelines recommend caution when proposing BCG treatment in immunocompromised patients. Our aim was to assess the efficacy and safety of BCG treatment in immunocompromised patients. Materials and methods: Patients aged ≥18 with a diagnosis of bladder cancer (BC) who underwent BCG therapy in 2007-2021, were identified in the MerativeTM Marketscan® Research Commercial and Medicare databases. Multivariable Cox proportion hazard regressions adjusted by relevant confounders were performed to investigate the influence of immunosuppression on the events associated with progression and recurrence of BC, both in the unmatched cohort and after 1:2 propensity score matching (PSM). Also, subgroup analysis on progression in patients without cancer other than BC was conducted. Results: Immunocompromised and immunocompetent patients had similar rates of disseminated BCG infection after intravesical immunotherapy. However, immunocompromised patients had shorter progression-free survival and higher probability of progression (aHR: 1.23, 95% CI: 1.11-1.38), as well as shorter recurrence-free survival and a higher probability of recurrence (aHR: 1.13, 95% CI: 1.05-1.20). Similar significant associations were observed in the PSM cohort. A subgroup analysis of patients without any additional oncological diagnoses beyond BC confirmed a higher likelihood of progression in the immunocompromised group (aHR: 1.34, 95% CI: 1.15-1.56). Conclusions: BCG immunotherapy is safe in immunocompromised patients. Nevertheless, the efficacy of intravesical BCG in these patients might be suboptimal thus advocating the need for appropriate counselling and a possible lower threshold to consider radical treatment.

The influence of immunocompromised status on recurrence and progression free survival among nonmuscle invasive bladder cancers (NMIBCs) undergoing transurethral resection of bladder tumor (TURBT) and adjuvant intravesical bacillus Calmette Guerin (BCG): Analysis of USA insurance claim data / Del Giudice, Francesco; Santarelli, Valerio; Łaszkiewicz, Jan; Li, Shufeng; Krajewski, Wojciech; Nowak, Łukasz; Szydełko, Tomasz; Ferro, Matteo; Rocco, Bernardo; Crocetto, Felice; Barone, Biagio; Buonerba, Carlo; Contieri, Roberto; Pichler, Renate; Subiela, José Daniel; Pradere, Benjamin; Moschini, Marco; Mari, Andrea; Mori, Keiichiro; Soria, Francesco; Mayr, Roman; Jo, Jung Ki; Gad, Mohamed; Challacombe, Ben; Abu-Ghanem, Yasmin; Mensah, Elsie; Nair, Rajesh; Thurairaja, Ramesh; Khan, Muhammad Shamim; Chung, Benjamin I. - In: UROLOGIC ONCOLOGY. - ISSN 1078-1439. - 43:12(2025), pp. 9-18. [10.1016/j.urolonc.2025.07.005]

The influence of immunocompromised status on recurrence and progression free survival among nonmuscle invasive bladder cancers (NMIBCs) undergoing transurethral resection of bladder tumor (TURBT) and adjuvant intravesical bacillus Calmette Guerin (BCG): Analysis of USA insurance claim data

Del Giudice, Francesco
;
Santarelli, Valerio
;
Ferro, Matteo;Rocco, Bernardo;Mari, Andrea;Gad, Mohamed;
2025

Abstract

Introduction: Transurethral resection of the bladder tumor (TURBT) followed by intravesical Bacillus Calmette-Guérin (BCG) immunotherapy is a standard treatment for high-risk non muscle-invasive bladder cancer (NMIBC). However, due to potential risk of dissemination, current guidelines recommend caution when proposing BCG treatment in immunocompromised patients. Our aim was to assess the efficacy and safety of BCG treatment in immunocompromised patients. Materials and methods: Patients aged ≥18 with a diagnosis of bladder cancer (BC) who underwent BCG therapy in 2007-2021, were identified in the MerativeTM Marketscan® Research Commercial and Medicare databases. Multivariable Cox proportion hazard regressions adjusted by relevant confounders were performed to investigate the influence of immunosuppression on the events associated with progression and recurrence of BC, both in the unmatched cohort and after 1:2 propensity score matching (PSM). Also, subgroup analysis on progression in patients without cancer other than BC was conducted. Results: Immunocompromised and immunocompetent patients had similar rates of disseminated BCG infection after intravesical immunotherapy. However, immunocompromised patients had shorter progression-free survival and higher probability of progression (aHR: 1.23, 95% CI: 1.11-1.38), as well as shorter recurrence-free survival and a higher probability of recurrence (aHR: 1.13, 95% CI: 1.05-1.20). Similar significant associations were observed in the PSM cohort. A subgroup analysis of patients without any additional oncological diagnoses beyond BC confirmed a higher likelihood of progression in the immunocompromised group (aHR: 1.34, 95% CI: 1.15-1.56). Conclusions: BCG immunotherapy is safe in immunocompromised patients. Nevertheless, the efficacy of intravesical BCG in these patients might be suboptimal thus advocating the need for appropriate counselling and a possible lower threshold to consider radical treatment.
2025
Bacillus Calmette-Guérin (BCG); Bladder cancer (BC); Immunodepression; Transurethral resection of bladder tumor (TURBT)
01 Pubblicazione su rivista::01a Articolo in rivista
The influence of immunocompromised status on recurrence and progression free survival among nonmuscle invasive bladder cancers (NMIBCs) undergoing transurethral resection of bladder tumor (TURBT) and adjuvant intravesical bacillus Calmette Guerin (BCG): Analysis of USA insurance claim data / Del Giudice, Francesco; Santarelli, Valerio; Łaszkiewicz, Jan; Li, Shufeng; Krajewski, Wojciech; Nowak, Łukasz; Szydełko, Tomasz; Ferro, Matteo; Rocco, Bernardo; Crocetto, Felice; Barone, Biagio; Buonerba, Carlo; Contieri, Roberto; Pichler, Renate; Subiela, José Daniel; Pradere, Benjamin; Moschini, Marco; Mari, Andrea; Mori, Keiichiro; Soria, Francesco; Mayr, Roman; Jo, Jung Ki; Gad, Mohamed; Challacombe, Ben; Abu-Ghanem, Yasmin; Mensah, Elsie; Nair, Rajesh; Thurairaja, Ramesh; Khan, Muhammad Shamim; Chung, Benjamin I. - In: UROLOGIC ONCOLOGY. - ISSN 1078-1439. - 43:12(2025), pp. 9-18. [10.1016/j.urolonc.2025.07.005]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1747098
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