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Cumulative incidence of and risk factors for BCG infection after adjuvant BCG instillations

Holmberg, Lars ; Skogmar, Sten LU ; Garmo, Hans ; Hagberg, Oskar LU ; Häggström, Christel ; Gårdmark, Truls ; Ströck, Viveka ; Aljabery, Firas ; Jahnson, Staffan and Hosseini, Abolfazl , et al. (2024) In BJU International
Abstract

Objectives: To investigate the cumulative incidence proportion of disseminated or local Bacillus Calmette-Guérin (BCG) infections after adjuvant BCG instillations in patients with non-muscle-invasive bladder cancer (NMIBC). Patients and Methods: We analysed the timing and occurrence of BCG infections and absolute and relative risk in relation to patient characteristics available in the Swedish nationwide database ‘BladderBaSe 2.0’. The cumulative incidence proportion of a BCG infection was indicated by a reported diagnosis of tuberculosis (TB) in the patient registry or filing a prescription for tuberculostatic drugs. Results: The cumulative incidence proportion was 1.1% at the 5-year follow-up in 5033 patients exposed to adjuvant BCG... (More)

Objectives: To investigate the cumulative incidence proportion of disseminated or local Bacillus Calmette-Guérin (BCG) infections after adjuvant BCG instillations in patients with non-muscle-invasive bladder cancer (NMIBC). Patients and Methods: We analysed the timing and occurrence of BCG infections and absolute and relative risk in relation to patient characteristics available in the Swedish nationwide database ‘BladderBaSe 2.0’. The cumulative incidence proportion of a BCG infection was indicated by a reported diagnosis of tuberculosis (TB) in the patient registry or filing a prescription for tuberculostatic drugs. Results: The cumulative incidence proportion was 1.1% at the 5-year follow-up in 5033 patients exposed to adjuvant BCG instillations. The incidence rate was highest during the first 2 years after start of BCG instillations. Women had a lower risk than men (hazard ratio 0.23, 95% confidence interval 0.07–0.74). Age and calendar time at diagnosis, comorbidity, tumour risk group, previous medication with corticosteroids, immunosuppressive drugs, or time between transurethral resection of the bladder tumour and commencing the adjuvant BCG instillation were not associated with risk. Conclusions: These data further supports that the overall risk of a BCG infection after BCG-instillation treatment for NMIBC is low. The great majority of infections occur in the first 2 years, calling for an awareness of the diverse symptoms of BCG infection during this period. We provide evidence for male sex as a risk factor; however, the statistical precision is low and with a risk of selection bias, making it difficult to rule out the other suggested risk factors without further studies with different approaches.

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type
Contribution to journal
publication status
epub
subject
keywords
BCG instillations, cumulative incidence proportion, local or systemic BCG infections, non-muscle-invasive bladder cancer, risk factors
in
BJU International
publisher
Wiley-Blackwell
external identifiers
  • pmid:38403809
  • scopus:85186546298
ISSN
1464-4096
DOI
10.1111/bju.16303
language
English
LU publication?
yes
id
b7dabbc7-7bb2-41f3-b9e8-bedd4ceddf2e
date added to LUP
2024-03-27 13:13:05
date last changed
2024-04-24 17:12:31
@article{b7dabbc7-7bb2-41f3-b9e8-bedd4ceddf2e,
  abstract     = {{<p>Objectives: To investigate the cumulative incidence proportion of disseminated or local Bacillus Calmette-Guérin (BCG) infections after adjuvant BCG instillations in patients with non-muscle-invasive bladder cancer (NMIBC). Patients and Methods: We analysed the timing and occurrence of BCG infections and absolute and relative risk in relation to patient characteristics available in the Swedish nationwide database ‘BladderBaSe 2.0’. The cumulative incidence proportion of a BCG infection was indicated by a reported diagnosis of tuberculosis (TB) in the patient registry or filing a prescription for tuberculostatic drugs. Results: The cumulative incidence proportion was 1.1% at the 5-year follow-up in 5033 patients exposed to adjuvant BCG instillations. The incidence rate was highest during the first 2 years after start of BCG instillations. Women had a lower risk than men (hazard ratio 0.23, 95% confidence interval 0.07–0.74). Age and calendar time at diagnosis, comorbidity, tumour risk group, previous medication with corticosteroids, immunosuppressive drugs, or time between transurethral resection of the bladder tumour and commencing the adjuvant BCG instillation were not associated with risk. Conclusions: These data further supports that the overall risk of a BCG infection after BCG-instillation treatment for NMIBC is low. The great majority of infections occur in the first 2 years, calling for an awareness of the diverse symptoms of BCG infection during this period. We provide evidence for male sex as a risk factor; however, the statistical precision is low and with a risk of selection bias, making it difficult to rule out the other suggested risk factors without further studies with different approaches.</p>}},
  author       = {{Holmberg, Lars and Skogmar, Sten and Garmo, Hans and Hagberg, Oskar and Häggström, Christel and Gårdmark, Truls and Ströck, Viveka and Aljabery, Firas and Jahnson, Staffan and Hosseini, Abolfazl and Jerlström, Tomas and Sherif, Amir and Söderkvist, Karin and Ullén, Anders and Malmström, Per Uno and Liedberg, Fredrik}},
  issn         = {{1464-4096}},
  keywords     = {{BCG instillations; cumulative incidence proportion; local or systemic BCG infections; non-muscle-invasive bladder cancer; risk factors}},
  language     = {{eng}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{BJU International}},
  title        = {{Cumulative incidence of and risk factors for BCG infection after adjuvant BCG instillations}},
  url          = {{http://dx.doi.org/10.1111/bju.16303}},
  doi          = {{10.1111/bju.16303}},
  year         = {{2024}},
}