Effectiveness, toxicity, and economic evaluation of vinflunine for the treatment of patients with transitional cell carcinoma in the Spanish outpatient setting.
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.
aDepartment of Pharmacy, Doctor Peset University Hospital of Valencia bDepartment of Pharmacy, University Clinical Hospital of Valencia, Valencia, Spain.
Beatriz
B
Guglieri-López
Alejandro
A
Pérez-Pitarch
Begoña
B
Porta-Oltra
Francisco
F
Ferriols-Lisart
Mónica
M
Climente-Martí
Manuel
M
Alós-Almiñana
D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000191:economics; D003362:Cost-Benefit Analysis; D005260:Female; D006746:Hospital Bed Capacity, 500 and over; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013030:Spain; D016019:Survival Analysis; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000191:economics; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
D000970:Antineoplastic Agents; C111217:vinflunine; D014747:Vinblastine