Translating avelumab maintenance into clinical practice: nationwide outcomes in Czech patients with advanced or metastatic urothelial carcinoma.
Abstract
Background
Platinum-based chemotherapy (PBC) followed by avelumab first-line (1L) maintenance for patients with nonprogressive disease is a standard of care in locally advanced or metastatic urothelial carcinoma (la/mUC) in the Czech Republic. We report results from a retrospective analysis of a national reimbursement registry for avelumab maintenance. The objective was to assess the effectiveness and safety in routine clinical practice.
Methods
Registry data were collected between October 2021 and January 2024. Primary endpoint was overall survival (OS) from avelumab 1L maintenance; secondary endpoints included progression-free survival (PFS) and safety.
Results
At data cutoff, 107 patients with la/mUC were treated with avelumab 1L maintenance, the median age was 72 years (range, 45-92), and the median follow-up was 8.2 months. Fifty-five patients (51.4%) received 1L cisplatin-based chemotherapy, 46 (43.0%) carboplatin-based chemotherapy, and six (5.6%) switched between regimens. Median OS was not reached, the 12- and 18-month OS rates were 79.3% and 68.0%. Limitations include low number of patients, retrospective design, and short follow-up.
Conclusions
These clinical outcomes are consistent with the JAVELIN Bladder 100 trial and other real-world studies, supporting the effectiveness and favorable safety profile of avelumab as 1L maintenance in patients with la/mUC that has not progressed with 1L PBC.