Nimotuzumab, a humanized antibody targeting epidermal growth factor receptor, 
has potent anti-proliferative, anti-angiogenic, and pro-apoptotic effects in 
vitro and in vivo. It also reduces the number of radio-resistant CD133(+) glioma 
stem cells. The antibody has been extensively evaluated in patients with 
advanced head and neck, glioma, lung, esophageal, pancreatic, and gastric 
cancer. In this single institution experience, 35 patients with anaplastic 
astrocytoma (AA) or glioblastoma multiforme (GBM) were treated with irradiation 
and 200 mg doses of nimotuzumab. The first 6 doses were administered weekly, 
together with radiotherapy, and then treatment continued every 21 days until 1 
year. The median number of doses was 12, and the median cumulative dose was thus 
2400 mg of nimotuzumab. The most frequent treatment-related toxicities were 
increase in liver function tests, fever, nausea, anorexia, asthenia, dizziness, 
and tremors. These adverse reactions were classified as mild and moderate. The 
median survival time was 12.4 mo or 27.0 mo for patients with GBM or AA 
patients, respectively, who received curative-intent radiotherapy in combination 
with the antibody. The survival time of a matched population treated at the same 
hospital with irradiation alone was decreased (median 8.0 and 12.2 mo for GBM 
and AA patients, respectively) compared with that of the patients who received 
nimotuzumab and curative-intent radiotherapy. We have thus confirmed that 
nimotuzumab is a very well-tolerated drug, lacking cumulative toxicity after 
maintenance doses. This study, in a poor prognosis population, validates the 
previous data of survival gain after combining nimotuzumab and radiotherapy, in 
newly diagnosed high-grade glioma patients.