Search

Objective: To evaluate usage patterns for nimotuzumab, safety and effectiveness in terms of survival in patients with high-grade gliomas treated in medical practice. Methods: A cohort prospective, longitudinal, multicenter study was designed in adult patients with histological confirmation of high grade malignant glioma newly diagnosis to receive nimotuzumab according to prescription recommendations. Patients were followed for 3 years. We collected data on patterns of use, dosage and time of exposure to nimotuzumab. Reported adverse events were classified acc ording to type, intensity and seriousness and also it was evaluated the survival time in months. Results: Between December 2005 and August 2012, seventy patients received nimotuzumab grouped according to histology in 44 glioblastoma, 24 astrocytoma, anaplastic and 2 anaplastic oligoastrocytoma. All patients received nimotuzumab in combination with radiation, mostly concurrent (78.6%); the remainder received it sequentially (21.4%). Completed the induction phase planned 94.3% of patients and continued in maintenance beyond 1 year 21.4%. The events related to nimotuzumab were 24.1%. The most common were fever, chills, and cutaneous erythema of light and moderate intensity. It was founded no association between toxicity and therapeutic modality, neither with the number of doses received. Patients with anaplastic astrocytoma had a survival at diagnosis over 45 months and with glioblastoma of 14.8 months; with a survival rate at 3 years the 50.8% and 20.2% respectively. Conclusions: The results of this observational study accompaniment those described in controlled studies. Nimotuzumab can be a therapeutic alternative safe, advantageous and feasible as part of conventional treatment in health care conditions. [ABSTRACT FROM AUTHOR]