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Nimotuzumab for the treatment of patients with malignant glioma. Comparison between pre-registration and post-approved studies

Abstract:

Nimotuzumab is a monoclonal antibody targeted against the epidermal growth factor receptor approved for the High-Grade Gliomas in combination with radiotherapy. Those studies pre and post-marketing have shown results of safety and efficacy equivalent; but the magnitude of such similarities is unknown. This paper compares the survival and the safety profile form pre and post-approval studies. We designed a database, corresponding to four clinical trials, which involved 262 adult patients with high-grade glioma, exposed to nimotuzumab (61 patients from pre-registration and 201 from post-approval studies). The median survivals for patients with Glioblastoma were 14.2 and 11.9 months; while for Anaplastic astrocytoma were 43.9 and 21.4 respectively, without differences statistically significant. Nimotuzumab was safe in both populations studied, with a low frequency of events. The appearance of dermatological reactions was negligible and mild. Nimotuzumab combined with radiotherapy in patients with High grade glioma tumors confirms clinical efficacy in terms of survival, in real conditions as pre-registration studies. The safety profile for both populations studied of nimotuzumab is consistent. This multimodal treatment can be recommended in patients with High-grade malignant gliomas.