title: Nimotuzumab in combination with radiotherapy in high grade glioma patients: a single institution experience.
abstract: 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.
authors: Calixto García Hospital; Havana, Cuba.
authors: Maria Teresa
authors: MT
authors: Solomon
authors: Calixto García Hospital; Havana, Cuba.
authors: Nederlay
authors: N
authors: Miranda
authors: Calixto García Hospital; Havana, Cuba.
authors: Eugenia
authors: E
authors: Jorrín
authors: National Institute of Oncology and Radiobiology; Havana, Cuba.
authors: Ivonne
authors: I
authors: Chon
authors: National Institute of Oncology and Radiobiology; Havana, Cuba.
authors: Jorge Juan
authors: JJ
authors: Marinello
authors: National Institute of Oncology and Radiobiology; Havana, Cuba.
authors: José
authors: J
authors: Alert
authors: Center of Molecular Immunology; Havana, Cuba.
authors: Patricia
authors: P
authors: Lorenzo-Luaces
authors: Center of Molecular Immunology; Havana, Cuba.
authors: Tania
authors: T
authors: Crombet
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001254:Astrocytoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C501466:nimotuzumab
keywords: anaplastic astrocytoma; glioblastoma multiforme; high grade glioma; monoclonal antibody; nimotuzumab; radiotherapy