Response and Outcomes to Immune Checkpoint Inhibitors in Advanced Urothelial Cancer Based on Prior Intravesical Bacillus Calmette-Guerin.
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Talukder Rafee, Makrakis Dimitrios, Diamantopoulos Leonidas N, Carril-Ajuria Lucia, Castellano Daniel, De Kouchkovsky Ivan, Koshkin Vadim S, Park Joseph J, Alva Ajjai, Bilen Mehmet A, Stewart Tyler F, McKay Rana R, Santos Victor S, Agarwal Neeraj, Jain Jayanshu, Zakharia Yousef, Morales-Barrera Rafael, Devitt Michael E, Grant Michael, Lythgoe Mark P, Pinato David J, Nelson Ariel, Hoimes Christopher J, Shreck Evan, Gartrell Benjamin A, Sankin Alex, Tripathi Abhishek, Zakopoulou Roubini, Bamias Aristotelis, Murgic Jure, Fröbe Ana, Rodriguez-Vida Alejo, Drakaki Alexandra, Liu Sandy, Kumar Vivek, Lorenzo Giuseppe Di, Joshi Monika, Velho Pedro Isaacsson, Buznego Lucia Alonso, Duran Ignacio, Moses Marcus, Barata Pedro, Sonpavde Guru, Yu Evan Y, Wright Jonathan L, Grivas Petros, Khaki Ali Raza
Аннотация
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.