Atezolizumab is an established treatment option for pretreated urothelial carcinoma, demonstrating efficacy in phase II/III trials. The SAUL study enrolled a broader patient population to determine safety and efficacy in under-represented subgroups.
Patients with metastatic urinary tract carcinoma received atezolizumab 1,200 mg every 3 weeks until disease progression, unacceptable toxicity, loss of clinical benefit or patient/physician decision. The primary endpoint was safety. Efficacy was a secondary endpoint. Analyses by PD-L1 status, age, ECOG performance status (PS) and renal impairment were prespecified; post hoc analyses explored outcomes by tumor location.
1004 patients were enrolled. Subgroup analyses in patients with older age, renal impairment or upper tract urothelial carcinoma showed safety and efficacy similar to those in patients without these characteristics. Patients with ECOG PS 2 had clinical features typically associated with aggressive disease; median overall survival was 2.3 months versus 10.0 months in patients with ECOG PS 0/1. Patients with PD-L1 expression on ≥5% of tumor-infiltrating immune cells tended to have better outcomes than those with <5% PD-L1 expression, although conclusions on the relative efficacy of atezolizumab cannot be drawn from this single-arm study.
The understudied populations included in the SAUL study had similar outcomes to those in more selected populations included in phase II/III trials of atezolizumab, except for those with ECOG performance status 2. Age ≥80 years and/or creatinine clearance <30 mL/min does not preclude administration of atezolizumab; however, treatment risk vs benefit must be carefully assessed in patients with ECOG PS 2.
The Journal of urology. 2021 Apr 09 [Epub ahead of print]
Axel S Merseburger, Daniel Castellano, Thomas Powles, Yohann Loriot, Margitta Retz, Jens Voortman, Robert A Huddart, Craig Gedye, Michiel S Van Der Heijden, Howard Gurney, Michael Ong, Sabine de Ducla, Julie Pavlova, Simon Fear, Cora N Sternberg
Department of Urology, Campus Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany., Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain., Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK., Department of Cancer Medicine and INSERM U981, Université Paris-Sud, Université Paris-Saclay, Gustave Roussy, Villejuif, France., Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany., Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, The Netherlands., Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, UK., Calvary Mater Newcastle, Waratah, Australia., The Netherlands Cancer Institute, Amsterdam, The Netherlands., Macquarie University, Sydney, Australia., The Ottawa Hospital Cancer Center, Ottawa, Canada., F. Hoffmann-La Roche Ltd, Basel, Switzerland., San Camillo and Forlanini Hospitals, Rome, Italy (present address: Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York, USA).