Vinflunine as second-line therapy for advanced urothelial carcinoma: Russian observational study

Objective: to assess safety, responses rate and duration, progression-free and overall survival in patients with advanced urothelial carcinoma receiving vinflunine as second-line therapy in routine clinical practice, after additional patient recruitment.

Materials and methods. This retrospective observational multicenter study included medical data of 34 patients with verified advanced urothelial carcinoma receiving vinflunine for tumor progression after first-line chemotherapy in 11 Russian clinical centers from March 23, 2013 to June 3, 2017. The median age of the patients was 60 (44–81) years. ECOG performance status was 0 in 2 (5.9 %), ECOG 1 – in 21 (61.7 %), ECOG 2 – in 9 (26.5 %), and ECOG 3 – in 2 (5.9 %) patients. Visceral metastases were present in 14 (41.2 %), non-visceral – in 20 (58.8 %) cases. Anemia was recorded in 20 (58.8 %) patients. According to Bellmunt scale 2 (5.9 %) patients had none risk factors, 6 (17.6 %) had 1 risk factor, 18 (52.9 %) and 8 (23.5 %) had 2 and 3 risk factors, respectively. Initial vinflunine dosage was 320 mg/m2 in 6 (17.6 %) patients, 280 mg/m2 in 22 (64.8 %) or 250 mg/m2 in 6 (17.6 %). Patient received a median of 4 (1–10) cycles of therapy.

Results. Adverse events (AE) were recorded in 33 (97.1 %) cases. The most frequent were general (70.6 %), hematologic (58.8 %), and gastrointestinal AE (41.1 %). Most AE were grades I–II and well-controlled. There were no deaths caused by adverse events. The best response was assessed as complete in 1 (2.9 %), partial – in 5 (14.7 %), stabilization – in 19 (55.9 %), and progression – in 9 (26.5 %) of the 34 patients. Complete response duration was 9.0 months, median partial response duration was 8.0 months (95 % confidence interval (CI) 5.5–13.0); median stabilization duration – 3.5 months (95 % CI 0.7–12.8). Median progression-free and overall survival were 3.9 (95 % CI 3.5‒4.3) and 6.4 (95 % CI 0.1–17.0) months, respectively. Univariate analysis indicated that the low somatic ECOG status and the initial vinflunine dosage of 250 mg/m2 had adverse impact on overall survival.

Conclusion. The efficacy and safety of vinflunine as second-line therapy for first-line chemotherapy-resistant advanced urothelial carcinoma in unselected patients are similar to the results of Phase III randomized trial and early results of the Russian observational study.

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