TY - JOUR
T1 - Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin
AU - Talukder, Rafee
AU - Makrakis, Dimitrios
AU - Diamantopoulos, Leonidas N.
AU - Carril-Ajuria, Lucia
AU - Castellano, Daniel
AU - De Kouchkovsky, Ivan
AU - Koshkin, Vadim S.
AU - Park, Joseph J.
AU - Alva, Ajjai
AU - Bilen, Mehmet A.
AU - Stewart, Tyler F.
AU - McKay, Rana R.
AU - Santos, Victor S.
AU - Agarwal, Neeraj
AU - Jain, Jayanshu
AU - Zakharia, Yousef
AU - Morales-Barrera, Rafael
AU - Devitt, Michael E.
AU - Grant, Michael
AU - Lythgoe, Mark P.
AU - Pinato, David J.
AU - Nelson, Ariel
AU - Hoimes, Christopher J.
AU - Shreck, Evan
AU - Gartrell, Benjamin A.
AU - Sankin, Alex
AU - Tripathi, Abhishek
AU - Zakopoulou, Roubini
AU - Bamias, Aristotelis
AU - Murgic, Jure
AU - Fröbe, Ana
AU - Rodriguez-Vida, Alejo
AU - Drakaki, Alexandra
AU - Liu, Sandy
AU - Kumar, Vivek
AU - Lorenzo, Giuseppe Di
AU - Joshi, Monika
AU - Velho, Pedro Isaacsson
AU - Buznego, Lucia Alonso
AU - Duran, Ignacio
AU - Moses, Marcus
AU - Barata, Pedro
AU - Sonpavde, Guru
AU - Yu, Evan Y.
AU - Wright, Jonathan L.
AU - Grivas, Petros
AU - Khaki, Ali Raza
N1 - Publisher Copyright:
© 2021
PY - 2022/4
Y1 - 2022/4
N2 - 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.
AB - 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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U2 - 10.1016/j.clgc.2021.12.012
DO - 10.1016/j.clgc.2021.12.012
M3 - Article
C2 - 35078711
AN - SCOPUS:85123348408
SN - 1558-7673
VL - 20
SP - 165
EP - 175
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
IS - 2
ER -