Real-world data of atezolizumab in patients with previously treated locally advanced or metastatic urothelial bladder cancer

• Published in: International journal of clinical pharmacy Vol. 46; no. 2; pp. 382 - 389
• Main Authors: Díaz Acedo, Rocío, Galvan Banqueri, Mercedes, Artacho Criado, Silvia, Fernández Parra, Eva María, Jiménez Galán, Rocío, Gago Sánchez, Ana Isabel, Marín Pozo, Juan Francisco, Martínez Bautista, María José
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.04.2024; Springer
• Subjects: Aged; Analysis; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Transitional Cell - drug therapy; Carcinoma, Transitional Cell - pathology; Care and treatment; Female; Glycosylated hemoglobin; Hemoglobins; Humans; Internal Medicine; Liver; Liver cancer; Liver Neoplasms - drug therapy; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Metastasis; Pharmacy; Research Article; Retrospective Studies; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Real world data; Metastatic urothelial bladder cancer; Previously treated patients; Atezolizumab
• ISSN: 2210-7703; 2210-7711
• DOI: 10.1007/s11096-023-01667-w

Background Clinical trials of atezolizumab for locally advanced or metastatic urothelial bladder cancer (mUBC) report controversial efficacy data. Furthermore, real-world evidence about this use is limited. Aim We aimed to evaluate the effectiveness of atezolizumab in a real-world population with mUBC, to explore effectiveness with regard to selected poor prognostic criteria such as performance status by Eastern Oncology Cooperative Group (ECOG), hemoglobin levels and liver metastases, and to determine the safety profile of atezolizumab. Method Multicenter, retrospective real-world study including previously treated mUBC patients who received atezolizumab. The primary endpoint was overall survival (OS). Additionally, progression-free survival (PFS), best response reached and safety data were analyzed. A descriptive analysis was performed, while OS and PFS were estimated by Kaplan–Meier method. Results A total of 185 patients (84.9% men, median age 69 years) were included. Median PFS was 4.8 months [95% confidence interval (CI) 3.6–6.0], and median OS was 20.0 months (95% CI 11.8–28.5), with an objective response rate of 28.1%. OS was higher for patients with ECOG 0–1 versus 2–3 [24.5 months (95% CI 14.5–34.6) vs. 5.2 (95% CI 4.4–6.0), p  = 0.004]; and for patients without liver metastases [25.4 months (95% CI 16.2–34.6) vs. 6.4 months (95% CI 4.0–8.1), p  = 0.006]. Regarding hemoglobin levels, no survival differences were detected. Adverse events were registered in 55.1% of patients. Conclusion In a real-world population with previously treated mUBC, atezolizumab seems to provide clinically relevant benefit, which is even higher for patients with ECOG 0–1 and without liver metastases, with an acceptable safety profile.