TY - JOUR
T1 - Evaluating the Protective Effect of Intravesical Bacillus Calmette-Guerin against SARS-CoV-2 in Non-Muscle Invasive Bladder Cancer Patients
T2 - A Multicenter Observational Trial
AU - Hurle, Rodolfo
AU - Soria, Francesco
AU - Contieri, Roberto
AU - Avolio, Pier Paolo
AU - Mancon, Stefano
AU - Lazzeri, Massimo
AU - Bernasconi, Valentina
AU - Mazzoli, Simone
AU - Pizzuto, Giuseppe
AU - De Bellis, Matteo
AU - Rosazza, Matteo
AU - Livoti, Simone
AU - Lupia, Tommaso
AU - Corcione, Silvia
AU - Lillaz, Beatrice
AU - De Rosa, Francesco Giuseppe
AU - Buffi, Nicolò Maria
AU - Kamat, Ashish M.
AU - Gontero, Paolo
AU - Casale, Paolo
N1 - Publisher Copyright:
© 2023 by the authors.
PY - 2023/3
Y1 - 2023/3
N2 - We aim to evaluate the potential protective role of intravesical Bacillus Calmette-Guerin (BCG) against SARS-CoV-2 in patients with non-muscle invasive bladder cancer (NMIBC). Patients treated with intravesical adjuvant therapy for NMIBC between January 2018 and December 2019 at two Italian referral centers were divided into two groups based on the received intravesical treatment regimen (BCG vs. chemotherapy). The study’s primary endpoint was evaluating SARS-CoV-2 disease incidence and severity among patients treated with intravesical BCG compared to the control group. The study’s secondary endpoint was the evaluation of SARS-CoV-2 infection (estimated with serology testing) in the study groups. Overall, 340 patients treated with BCG and 166 treated with intravesical chemotherapy were included in the study. Among patients treated with BCG, 165 (49%) experienced BCG-related adverse events, and serious adverse events occurred in 33 (10%) patients. Receiving BCG or experiencing systemic BCG-related adverse events were not associated with symptomatic proven SARS-CoV-2 infection (p = 0.9) nor with a positive serology test (p = 0.5). The main limitations are related to the retrospective nature of the study. In this multicenter observational trial, a protective role of intravesical BCG against SARS-CoV-2 could not be demonstrated. These results may be used for decision-making regarding ongoing and future trials.
AB - We aim to evaluate the potential protective role of intravesical Bacillus Calmette-Guerin (BCG) against SARS-CoV-2 in patients with non-muscle invasive bladder cancer (NMIBC). Patients treated with intravesical adjuvant therapy for NMIBC between January 2018 and December 2019 at two Italian referral centers were divided into two groups based on the received intravesical treatment regimen (BCG vs. chemotherapy). The study’s primary endpoint was evaluating SARS-CoV-2 disease incidence and severity among patients treated with intravesical BCG compared to the control group. The study’s secondary endpoint was the evaluation of SARS-CoV-2 infection (estimated with serology testing) in the study groups. Overall, 340 patients treated with BCG and 166 treated with intravesical chemotherapy were included in the study. Among patients treated with BCG, 165 (49%) experienced BCG-related adverse events, and serious adverse events occurred in 33 (10%) patients. Receiving BCG or experiencing systemic BCG-related adverse events were not associated with symptomatic proven SARS-CoV-2 infection (p = 0.9) nor with a positive serology test (p = 0.5). The main limitations are related to the retrospective nature of the study. In this multicenter observational trial, a protective role of intravesical BCG against SARS-CoV-2 could not be demonstrated. These results may be used for decision-making regarding ongoing and future trials.
KW - Bacillus Calmette-Guerin
KW - non-muscle invasive bladder cancer
KW - SARS-CoV-2 infection
UR - http://www.scopus.com/inward/record.url?scp=85149862796&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85149862796&partnerID=8YFLogxK
U2 - 10.3390/cancers15051618
DO - 10.3390/cancers15051618
M3 - Article
C2 - 36900409
AN - SCOPUS:85149862796
SN - 2072-6694
VL - 15
JO - Cancers
JF - Cancers
IS - 5
M1 - 1618
ER -