(UroToday.com) The 2024 European Association of Urology (EAU) annual meeting featured a session on metastatic urothelial cancer, and a presentation by Dr. Peter Goebell discussing preliminary results of the prospective CARAT-UBC registry assessing first-line maintenance therapy in patients with locally advanced or metastatic urothelial carcinoma in routine care in Germany.
Real-world evidence is important to facilitate clinical research and to evaluate treatment outcomes in routine clinical practice. In Europe, the only currently approved first-line maintenance therapy for patients with advanced urothelial carcinoma is avelumab, authorized in January 2021 based on the results of the phase 3 JAVELIN Bladder 100 trial.1 The JAVELIN Bladder 100 trial included patients with ECOG 0/1 who were progression-free following 4-6 cycles of first-line platinum-based chemotherapy followed by a treatment-free interval of 4-10 weeks since last dose of chemotherapy. Currently, platinum-based chemotherapy followed by treatment with avelumab is considered the standard of care for the treatment of advanced or metastatic urothelial carcinoma. However, prospective real-world evidence on maintenance therapy for advanced urothelial carcinoma is still limited.
At the 2024 EAU annual meeting, Dr. Goebell and colleagues presented results from CARAT-UBC (NCT03374267), a prospective, multicenter, longitudinal, non-interventional cohort study that collects data on patients with advanced urothelial carcinoma in Germany since October 2021.
Until the database cut (August 31, 2023), 241 patients recruited by 74 sites had started systemic therapy, 158 of them received first-line platinum-based chemotherapy. There were 87 patients progression-free after first-line platinum-based chemotherapy and therefore qualified for maintenance therapy. Avelumab maintenance was started in 40 of the 87 patients (46%):
Patients who qualified for maintenance therapy according to the label were more likely to be older, female, and had fewer bone and lung metastases at diagnosis. Patients who received maintenance therapy with avelumab were more likely to be younger, in better general health condition, and had more lymph node and lung metastases. In total, 43 patients received avelumab in the first-line regardless of their eligibility for maintenance treatment (67% male, median age 67 years, 12% ECOG ≥2, 17% with less than 4 cycles of prior chemotherapy):
The median duration of chemotherapy and maintenance avelumab was 2.7 and 1.9 months, respectively, for patients who had already completed their first-line therapy (n = 28):
Median progression free survival for the group of patients treated with maintenance avelumab (n = 43) in routine care was 7.5 (95% CI 5.5-8.2) months from the start of first-line therapy:
Median overall survival was 11.2 months (95% CI 8.2-12.1) from the start of first-line therapy:
Dr. Goebell concluded his presentation discussing the preliminary results of the prospective CARAT-UBC registry assessing first-line maintenance therapy in patients with locally advanced or metastatic urothelial carcinoma in routine care in Germany with the following statements:
- The CARAT-UBC interim results reveal that currently in real-world approximately one third of patients with advanced urothelial carcinoma are progression-free following first-line platinum-based chemotherapy and, thus, qualify for maintenance therapy
- Of those patients who qualify, only 50% of patients receive first-line maintenance therapy with avelumab
- Overall survival in the real-world is shorter than in the pivotal trial, most likely due to differences in patient characteristics
- Since the interim analysis was still based on low patient numbers, data should be interpreted with caution
Presented by: Peter J. Goebell, MD, PhD, University Clinic Erlangen, Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany
Written by: Zachary Klaassen, MD, MSc - Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, WellStar MCG Health, @zklaassen_md on Twitter during the 2024 European Association of Urology (EAU) annual congress, Paris, France, April 5th - April 8th, 2024
References:
- Powles T, Park SH, Voog E, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med 2020 Sept 24;383(13):1218-1230.