Introduction: The treatment of metastatic urothelial cancer (mUC) following first-line standard platinum-based chemotherapy and immune checkpoint inhibitors (ICIs) is not yet established.
Material and methods: We investigated the activity and toxicity of vinflunine at the dose, due to previous treatments, of 280 mg i.v. every 21 days until disease progression or limiting toxicity, with instrumental disease reassessment every 3 cycles, in 6 patients aged ≥18 years, with metastatic urothelial carcinoma of the upper or lower urinary tract, with performance status (PS) according to the Eastern Cooperative Oncology Group (ECOG) of 0-2, adequate hematologic function and progressive disease (PD) following first-line platinum-based chemotherapy and second-line ICI.
Results: The median age of the 6 patients was 67.5 years (range 63-77) and median PS 1 (range, 0-2). Four patients (67%) had a disease partial response (PR). With a median follow-up of 4.5 months (range, 3-9), 3 patients are alive (50%). The median progression-free survival following vinflunine (PFS-3) was 4 months (range, 1-8), as compared to the PFS-2 (following ICI) of 4 months (range, 2-9) and the PFS-1 (after platinum-based chemotherapy) of 6 months (range, 2-13). The PRs were not associated with the length of PFS-2 of PFS-1, the histologic subtype, primary and metastatic site of the tumour. No grade 3-4 toxicity has been observed; grade 2 asthenia occurred in 3 patients (50%), grade 1 nausea and constipation were observed in one patient (17%), respectively.
Conclusion: Despite the low number of patients treated, the activity of vinflunine was substantial and suggests its role as chemotherapy line following previous chemotherapy and immunotherapy, deserving further retrospective or prospective investigations in this setting.