Purpose: A multicentric, Phase IV clinical trial to evaluate safety and effectiveness of nimotuzumab, a monoclonal antibody against epidermal growth factor receptor added to standard therapy for newly diagnosed high grade glioma.
Methods: Patients were recluted after surgery to receive nimotuzumab 200 mg weekly in combination with radiotherapy (RT) or chemoradiation (CRT), followed by the same doses biweekly until clinical worsening or intolerance toxicity. Safety profile, Progression-free survival (PFS) and overall survival (OS) were main endpoints based in Common Toxicity Criteria, Macdonald criteria and time to death since inclusion date.
Results: 127 patients were treated, 93 glioblastoma, 25 anaplastic astrocytoma and 9 anaplastic oligoastrocytoma. Mostly patients received nimotuzumab in combination with radiation: concurrently 54.3 %, sequentially to RT 15.7 % and 6.3 % in combination to RT and Temozolomide; however 23.6 % received nimotuzumab as monotherapy. Completed induction phase 87.4% of patients and continued in maintenance beyond 2 years 11.1 %. Only 10.5 % of adverse events were related to nimotuzumab. Headache, transaminase increased, fever and skin rash, were the most frequents as mild intensity. Median PFS time was 8.97 and 21.77 months and OS was 10.57 and 28.27 months for glioblastoma and anaplastic astrocytoma patients respectively.
Conclusions: This study was consistent to safety and adherence as continues maintenance treatment, prior described in controlled trials. Nimotuzumab in combination with RT might improve survival over RT alone, but it was marginal with respect to chemoradiation. For enhance the clinical benefit patients would be select according predictor biomarkers unknown yet.