Effectiveness, toxicity, and economic evaluation of vinflunine for the treatment of patients with transitional cell carcinoma in the Spanish outpatient setting

Abstract

The aim of this study was to evaluate the effectiveness and toxicity profile of the vinflunine chemotherapy regimen and to examine the cost-effectiveness relation in a real-world sample of patients with transitional cell carcinoma of the bladder. This is a multicenter, observational, retrospective cohort study. To assess the effectiveness and safety of vinflunine treatment, progression-free survival, overall survival, and adverse events were registered. An economic evaluation was performed and cost-effectiveness ratios were calculated. A total of 37 patients were included in the study, with a mean age of 67 (SD=9) years. The median progression-free survival was 2.61 months (95% confidence interval 1.79-4.23) and the median overall survival was 5.72 months (95% confidence interval 3.34-10.35). An objective response was achieved in eight (22%) patients. Statistically significant differences were found between patients treated with vinflunine as a second-line therapy and those treated with vinflunine as a third-line therapy (P=0.036). The most commonly reported analytical adverse event was anemia (n=34; 92%), and the most severe was neutropenia (n=19; 51%), with nine patients developing grade 4 neutropenia (9/19; 47%). The total cost of vinflunine treatment was &OV0556;553 873, with a median of &OV0556;8524 (interquartile range, &OV0556;9220) per patient. The median-based cost-effectiveness ratio was &OV0556;44 789 (&OV0556;31 706-58 022) per progression-free year gained and &OV0556;22 750 (&OV0556;14 526-34 085) per life-year gained. The data from this study fill an important need for information on the relative value of this treatment in terms of cost-effectiveness and might help achieve an optimal quality healthcare system.

Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract: an evidence-based review of safety, efficacy, and place in therapy

“…Guglieri-Lopez et al performed an economic analysis of VIN, finding a median treatment cost of €8,524 per patient, a €44,789 per progression-free year gained, and €22,750 per life-year granted. 32 We know that bladder cancer is the most expensive among cancer diagnoses per patient lifetime and carries annual costs of $3.98 billion in the US. 33 , 34 Although we are unable to directly compare this study to the cost-effectiveness data of other UC therapies, the high cost associated with VIN makes patient selection an extremely important factor, specifically when considering the modest survival benefit to patients in higher-risk categories.…”

Better characterization of vinflunine pharmacokinetics variability and exposure/toxicity relationship to improve its use: Analyses from 18 trials

“…Recently, several studies have evaluated efficacy and safety of vinflunine (VFL) in patients with relapsed urothelial cancer in clinical practice [21][22][23][24][25][26][27][28]. Among them is the French CURVE study, the main objective of which was to retrospectively assess the efficacy and safety of VFL under routine conditions.…”

Effectiveness of capecitabine with or without docetaxel therapy for the treatment of patients with advanced urothelial carcinoma: a single-institution experience

“…Till now there are no standard palliative regimens for patients who failed platinum-based therapy. The optional second-line agents include taxanes (docetaxel and paclitaxel) [ 6 , 7 ], pemetrexed [ 8 – 10 ], vinflunine [ 11 , 12 ] and so on. Single-agent regimen is preferred for palliative chemotherapy.…”