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Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin.

Publication ,  Journal Article
Talukder, R; Makrakis, D; Diamantopoulos, LN; Carril-Ajuria, L; Castellano, D; De Kouchkovsky, I; Koshkin, VS; Park, JJ; Alva, A; Bilen, MA ...
Published in: Clin Genitourin Cancer
April 2022

BACKGROUND: Immune checkpoint inhibitors (ICI) improve overall survival (OS) in patients with locally advanced, unresectable, or metastatic urothelial carcinoma (aUC), but response rates can be modest. We compared outcomes between patients with and without prior intravesical Bacillus Calmette-Guerin (BCG), who received ICI for aUC, hypothesizing that prior intravesical BCG would be associated with worse outcomes. PATIENTS AND METHODS: We performed a retrospective cohort study across 25 institutions in US and Europe. We compared observed response rate (ORR) using logistic regression; progression-free survival (PFS) and OS using Kaplan-Meier and Cox proportional hazards. Analyses were stratified by treatment line (first line/salvage) and included multivariable models adjusting for known prognostic factors. RESULTS: A total of 1026 patients with aUC were identified; 614, 617, and 638 were included in ORR, OS, PFS analyses, respectively. Overall, 150 pts had history of prior intravesical BCG treatment. ORR to ICI was similar between those with and without prior intravesical BCG exposure in both first line and salvage settings (adjusted odds radios 0.55 [P= .08] and 1.65 [P= .12]). OS (adjusted hazard ratios 1.05 [P= .79] and 1.13 [P= .49]) and PFS (adjusted hazard ratios 1.12 [P= .55] and 0.87 [P= .39]) were similar between those with and without intravesical BCG exposure in first line and salvage settings. CONCLUSION: Prior intravesical BCG was not associated with differences in response and survival in patients with aUC treated with ICI. Limitations include retrospective nature, lack of randomization, presence of selection and confounding biases. This study provides important preliminary data that prior intravesical BCG exposure may not impact ICI efficacy in aUC.

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Published In

Clin Genitourin Cancer

DOI

EISSN

1938-0682

Publication Date

April 2022

Volume

20

Issue

2

Start / End Page

165 / 175

Location

United States

Related Subject Headings

  • Urinary Bladder Neoplasms
  • Retrospective Studies
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Immune Checkpoint Inhibitors
  • Humans
  • Carcinoma, Transitional Cell
  • BCG Vaccine
  • Administration, Intravesical
  • Adjuvants, Immunologic
 

Citation

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Talukder, R., Makrakis, D., Diamantopoulos, L. N., Carril-Ajuria, L., Castellano, D., De Kouchkovsky, I., … Khaki, A. R. (2022). Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin. Clin Genitourin Cancer, 20(2), 165–175. https://doi.org/10.1016/j.clgc.2021.12.012
Talukder, Rafee, Dimitrios Makrakis, Leonidas N. Diamantopoulos, Lucia Carril-Ajuria, Daniel Castellano, Ivan De Kouchkovsky, Vadim S. Koshkin, et al. “Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin.Clin Genitourin Cancer 20, no. 2 (April 2022): 165–75. https://doi.org/10.1016/j.clgc.2021.12.012.
Talukder R, Makrakis D, Diamantopoulos LN, Carril-Ajuria L, Castellano D, De Kouchkovsky I, et al. Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin. Clin Genitourin Cancer. 2022 Apr;20(2):165–75.
Talukder, Rafee, et al. “Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin.Clin Genitourin Cancer, vol. 20, no. 2, Apr. 2022, pp. 165–75. Pubmed, doi:10.1016/j.clgc.2021.12.012.
Talukder R, Makrakis D, Diamantopoulos LN, Carril-Ajuria L, Castellano D, De Kouchkovsky I, Koshkin VS, Park JJ, Alva A, Bilen MA, Stewart TF, McKay RR, Santos VS, Agarwal N, Jain J, Zakharia Y, Morales-Barrera R, Devitt ME, Grant M, Lythgoe MP, Pinato DJ, Nelson A, Hoimes CJ, Shreck E, Gartrell BA, Sankin A, Tripathi A, Zakopoulou R, Bamias A, Murgic J, Fröbe A, Rodriguez-Vida A, Drakaki A, Liu S, Kumar V, Lorenzo GD, Joshi M, Velho PI, Buznego LA, Duran I, Moses M, Barata P, Sonpavde G, Yu EY, Wright JL, Grivas P, Khaki AR. Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin. Clin Genitourin Cancer. 2022 Apr;20(2):165–175.
Journal cover image

Published In

Clin Genitourin Cancer

DOI

EISSN

1938-0682

Publication Date

April 2022

Volume

20

Issue

2

Start / End Page

165 / 175

Location

United States

Related Subject Headings

  • Urinary Bladder Neoplasms
  • Retrospective Studies
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Immune Checkpoint Inhibitors
  • Humans
  • Carcinoma, Transitional Cell
  • BCG Vaccine
  • Administration, Intravesical
  • Adjuvants, Immunologic