title: Effectiveness, toxicity, and economic evaluation of ipilimumab for the treatment of patients with metastatic melanoma in the Spanish outpatient setting.
abstract: To evaluate the effectiveness and toxicity profile of ipilimumab treatment and to examine the cost-effectiveness relation in a real-world sample of patients with metastasic melanoma. This was a multicenter, observational, retrospective cohorts study. To assess the effectiveness and safety of ipilimumab treatment progression-free survival (PFS), overall survival (OS) and adverse events were registered. An economic evaluation was performed and cost-effectiveness ratios (CERs) were calculated. Eleven patients were included, mean age 59 (SD=11) years. The median PFS was 3.83 months (95% confidence interval 0.98-9.80) and the median OS was 5.15 months (95% confidence interval 1.70-8.48). None of the patients included in the study achieved an objective response. A stable disease was achieved in four (36%) patients. The most commonly reported analytical adverse event was anemia, with all patients developing anemia in any grade. The most severe adverse event was neutropenia (n=6; 55%), with three patients developing grade 4 neutropenia (3/11; 27%). The total cost of ipilimumab treatment was &OV0556;483 397, with a median of 43 033 (interquartile range=9555) euros per patient. The median-based CER was 136 675 (28 539-474 865) euros per progression-free year gained and the median-based CER was 100 112 (23 107-374 893) euros per life-year gained. PFS observed in real-world patients was higher than that reported in clinical trials and OS was lower. The incidence of adverse events was higher. The additional cost per progression-free year gained was ∼&OV0556;136 675. The data from this study fill an important need for information on the relative value of this treatment in terms of cost-effectiveness.
authors.affiliation: Departments of aPharmacy bMedical Oncology, Dr Peset University Hospital of Valencia cDepartment of Pharmacy, University Clinical Hospital of Valencia, Valencia, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Guglieri-López
authors.forename: Alejandro
authors.initials: A
authors.lastname: Pérez-Pitarch
authors.forename: Begoña
authors.initials: B
authors.lastname: Porta Oltra
authors.forename: Francisco
authors.initials: F
authors.lastname: Ferriols-Lisart
authors.forename: Ángeles
authors.initials: Á
authors.lastname: Royo-Peiró
authors.forename: Mónica
authors.initials: M
authors.lastname: Climente-Martí
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D000074324:Ipilimumab; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000191:economics / Q000473:pathology; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012189:Retrospective Studies
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000074324:Ipilimumab