Safety, Effectiveness, and Costs of Bevacizumab-Based Therapy in Southern Spain: A Real World Experience.

Abstract

To evaluate the safety and efficacy of bevacizumab in a broader patient population with solid tumors in the context of general clinical practice. Moreover, we quantified the economic impact and characterized the off-label use (OLU) of this agent in real-life prescribing practices.This is an open, retrospective, observational, real world study carried out at a regional Spanish hospital attending a population of 665,000 inhabitants. All of the patients receiving bevacizumab-containing therapy between January 2006 and February 2012 at the study hospital were included: no exclusion criteria were specified. All study variables were collected from available hospital records.The analysis comprised 240 episodes from 226 patients (male 41%; median age 57 years, 25% ≥65 years). Eighty cases (33%) of bevacizumab treatment were administered as first-line therapy. The median duration of bevacizumab treatment was 5.8 months (95% CI 5.1-6.6), without difference by age, line of treatment, or type of tumor. Typically bevacizumab-related toxicities included bleeding (25%), hypertension (5%), wound-healing complications (4%), gastrointestinal perforation (2%), and arterial thromboembolism (1%). Median progression-free survival was 7.5 months (95% CI 6.3-8.7) and median OS reached 13.1 months (95% CI 11.4-14.9). Bevacizumab increased the chemotherapy cost to 207% (from &OV0556;3,115,615 to &OV0556;9,552,405). Bevacizumab was prescribed off-label in 43% of episodes, amounting to &OV0556;3,586,420 (56% of bevacizumab total cost).The efficacy and safety profile of bevacizumab in routine clinical practice is consistent with results observed in prospective randomized clinical trials. OLU of this drug should be closely monitored.