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.
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.
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.
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.
Clinical genitourinary cancer. 2021 Dec 17 [Epub ahead of print]
Rafee Talukder, Dimitrios Makrakis, Leonidas N Diamantopoulos, Lucia Carril-Ajuria, Daniel Castellano, Ivan De Kouchkovsky, Vadim S Koshkin, Joseph J Park, Ajjai Alva, Mehmet A Bilen, Tyler F Stewart, Rana R McKay, Victor S Santos, Neeraj Agarwal, Jayanshu Jain, Yousef Zakharia, Rafael Morales-Barrera, Michael E Devitt, Michael Grant, Mark P Lythgoe, David J Pinato, Ariel Nelson, Christopher J Hoimes, Evan Shreck, Benjamin A Gartrell, Alex Sankin, Abhishek Tripathi, Roubini Zakopoulou, Aristotelis Bamias, Jure Murgic, Ana Fröbe, Alejo Rodriguez-Vida, Alexandra Drakaki, Sandy Liu, Vivek Kumar, Giuseppe Di Lorenzo, Monika Joshi, Pedro Isaacsson Velho, Lucia Alonso Buznego, Ignacio Duran, Marcus Moses, Pedro Barata, Guru Sonpavde, Evan Y Yu, Jonathan L Wright, Petros Grivas, Ali Raza Khaki
Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA., Department of Medicine, University of Pittsburgh, Pittsburgh, PA., Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain., Division of Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA., Division of Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI., Winship Cancer Institute of Emory University, Atlanta, GA., Division of Hematology/Oncology, Department of Medicine, University of California San Diego, La Jolla, CA., Division of Oncology, Department of Medicine, University of Utah, Salt Lake City, UT., Department of Medicine, University of Iowa, Iowa City, IA., Division of Oncology, Department of Medicine, University of Iowa, Iowa City, IA., Vall d'Hebron Institute of Oncology, Vall d' Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain., Division of Hematology/Oncology, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA., Department of Surgery and Cancer, Imperial College London, London, UK., Division of Medical Oncology, Seidman Cancer Center at Case Comprehensive Cancer Center, Cleveland, OH; Division of Hematology and Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI., Division of Medical Oncology, Seidman Cancer Center at Case Comprehensive Cancer Center, Cleveland, OH; Division of Medical Oncology, Duke University, Durham, NC., Departments of Medical Oncology and Urology, Montefiore Medical Center, Bronx, NY., Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK., Department of Clinical Therapeutics, Alexandra General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece., 2nd Propaedeutic Dept of Internal Medicine, ATTIKON University Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece., Department of Oncology and Nuclear Medicine, University Hospital Center Sestre Milosrdnice, Zagreb, School of Dental Medicine, Zagreb, Croatia., Medical Oncology Department, Hospital del Mar Research Institute, Barcelona, Spain., Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA., Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA., Oncology University of Molise and ASL, Salerno, Italy., Division of Hematology/Oncology, Department of Medicine, Penn State Cancer Institute, Hershey, PA., Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD., Hospital Universitario Marques de Valdecilla. IDIVAL. Santander, Spain., Deming Department of Medicine, Section of Hematology/Oncology, Tulane University, New Orleans, LA., Genitourinary Oncology Program, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA., Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA., Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; Department of Urology, University of Washington, Seattle, WA., Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA. Electronic address: ., Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA; Division of Oncology, Department of Medicine, Stanford University, Palo Alto, CA. Electronic address: .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/35078711