@article{3118762,
    title = "Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin",
    author = "Talukder, R. and Makrakis, D. and Diamantopoulos, L.N. and Carril-Ajuria, L. and Castellano, D. and De Kouchkovsky, I. and Koshkin, V.S. and Park, J.J. and Alva, A. and Bilen, M.A. and Stewart, T.F. and McKay, R.R. and Santos, V.S. and Agarwal, N. and Jain, J. and Zakharia, Y. and Morales-Barrera, R. and Devitt, M.E. and Grant, M. and Lythgoe, M.P. and Pinato, D.J. and Nelson, A. and Hoimes, C.J. and Shreck, E. and Gartrell, B.A. and Sankin, A. and Tripathi, A. and Zakopoulou, R. and Bamias, A. and Murgic, J. and Fröbe, A. and Rodriguez-Vida, A. and Drakaki, A. and Liu, S. and Kumar, V. and Lorenzo, G.D. and Joshi, M. and Velho, P.I. and Buznego, L.A. and Duran, I. and Moses, M. and Barata, P. and Sonpavde, G. and Yu, E.Y. and Wright, J.L. and Grivas, P. and Khaki, A.R.",
    journal = "Clinical Genitourinary Cancer",
    year = "2022",
    publisher = "HANLEY & BELFUS-ELSEVIER INC",
    issn = "1558-7673",
    doi = "10.1016/j.clgc.2021.12.012",
    abstract = "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. © 2021"
}