ABSTRACT
Background
In this study, we report real-world results from the 5-year follow-up data of urothelial
carcinoma patients treated with immune checkpoint blockade therapies (ICTs).
Patients and Methods
Metastatic urothelial carcinoma patients treated with at least one course of ICT were
included in the study. The primary endpoint was overall response rate (ORR), and secondary
endpoints were overall survival (OS), progression-free survival (PFS), duration of
treatment with ICT, and safety. Median follow-up, PFS, and OS were estimated by using
the Kaplan-Meier method.
Results
Data of 201 eligible patients were analyzed. The median age of the patients was 66
(37-86) years, and 156 (84.3%) were male. The majority of patients (94.6%) had Eastern
Cooperative Oncology Group (ECOG) PS scores of 0 to 1 and primary tumor in the bladder
was predominant (87.5%). The median follow-up time was 54 (1.15-65) months. The rate
of complete response (CR) to ICT, partial response (PR) rate, and ORR were 10.4% (n = 21), 22.4% (n = 45), and 32.4% (n = 66), respectively. The median duration of response (DOR) was 34.8 months (95% confidence
interval [CI], 29.2-42.1). Of the 66 patients who responded to treatment, 28 (42%)
had an ongoing response at the time of the analysis. Median PFS and OS were 3.8 (2.6-5.8)
months and 9.4 (7.4-11.4) months, respectively. The 5-year PFS and OS rates were 9.8%
and 12.8%, respectively. Fifty-eight percent of patients experienced a treatment-related
adverse event of any grade, and 33 (16.4%) patients had a grade 3 to 4 adverse event.
Conclusion
This 5-year analysis of real-world data confirms the durable response and long-term
survival with ICT in metastatic urothelial carcinoma patients.
Keywords
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Article info
Publication history
Published online: December 19, 2022
Accepted:
November 25,
2022
Received in revised form:
November 23,
2022
Received:
August 8,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2022 Elsevier Inc. All rights reserved.
