| General information |
| Database: | DB00378 |
| Objective: | 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. |
| Authors: | Solomon MT, et al |
| Title: | Nimotuzumab in combination with radiotherapy in high grade glioma patients: a single institution experience. |
| Journal: | Cancer Biol Ther. |
| Year: | 2014 |
| PMID: | 24521695 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | nimotuzumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM) |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | Nimotuzumab + radiotherapy |
| Study Type: | single center |
| Key Patients Feature: | diagnosis confirmation by pathology, age older than 18 y, a KPS greater or equalto 50, and time from surgery between 4 and 6 wk. Other inclusion criteria were neutrophil count more than and equal to 1000/mm3, platelet countmore than and equal to 100 ¡Á 109 cells/L, hemoglobin more than and equal to 9 g/dL, serum creatinine levelless than and equal to the upper limit of normal and ALAT (alanine aminotransferase) and ASAT (alanine aspartate transaminase) level less than2.5 times the upper limit of normal according the institutionalstandards. The protocol was conducted under the principlesembodied in the Helsinki Declaration. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | 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. |
| Primary End Point: | Safety |
| Secondary End Point: | NA |
| Patients Number: | 35 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | For all GBM patients treated with nimotuzumab and irradiation, the mean and median survival time was 11.38 and 11.8 mo, respectively; for the AA subjects, mean and median survival corresponded to 25.06 and 16.5 mo, respectively. For patients who received at least 5000 cGy of radiotherapy (curative intent), the mean and median survival time was 13.97 and 12.40 mo or 28.32 and 27.0 mo for those bearing GBM or AA patients, respectively. |
| Adverse Event(agent arm): | The most frequent adverse events, irrespective of the causality attribution, consisted of altered hepatic function tests, instauration or worsening of motor deficit, hair loss, seizures, headache, anorexia, behavioral disorders (irritability, anxiety and aggressiveness), fever, loss of consciousness, dysphasia, nausea, somnolence, and cough. |
| Conclusions: | they have thus confirmed that nimotuzumab is a very welltolerated 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 highgrade glioma patients. |