| General information |
| Database: | DB00616 |
| Objective: | The presence of angiogenesis is a hallmark of glioblastoma (GBM). Vascular endothelial growth factor (VEGF), which drives angiogenesis, provides an additional target for conventional therapy. The authors conducted a prospective clinical trial to test the effectiveness of bevacizumab, an inhibitor of VEGF, in newly diagnosed GBM. |
| Authors: | Narayana A, et al |
| Title: | A clinical trial of bevacizumab, temozolomide, and radiation for newly diagnosed glioblastoma. |
| Journal: | J Neurosurg |
| Year: | 2012 |
| PMID: | 22035272 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | glioblastoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | bevacizumab, temozolomide, and radiation |
| Study Type: | an openlabel, singlearm clinical trial |
| Key Patients Feature: | at least 18 yearsof age and had a KPS score of 70 or higher. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with involvedfield radiation therapy and concomitant temozolomide (75 mg/m(2) daily for 42 days) along with bevacizumab (10 mg/kg every 2 weeks), starting 29 days after surgery. This was followed by 6 cycles of adjuvant temozolomide therapy (150 mg/m(2) on Days 17 of a 28day cycle) with bevacizumab administered at 10 mg/kg on Days 8 and 22 of each 28day cycle. |
| Primary End Point: | PFS |
| Secondary End Point: | NA |
| Patients Number: | 51 |
| Trial Results |
| DLT_MTD: | Grade III/IV toxicities were noted in 10 patients (19.6%). No treatmentrelated deaths were observed. Asymptomatic intracranial bleeding was noted in5 patients |
| Objective Response Rate: | The 6 and 12month progression free survival (PFS) rates were 85.1% and 51%, respectively. The 12and 24month overall survival (OS) rates were 85.1% and 42.5%, respectively |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 13 months |
| Median OS A vs. C: | 23 months |
| Adverse Event(agent arm): | Grade III/IV toxicities were noted in 10 patients (19.6%). No treatmentrelated deaths were observed. |
| Conclusions: | The addition of bevacizumab to conventional therapy in newly diagnosed GBM appears to improve both PFS and OS in patients with newly diagnosed GBM, with acceptable morbidity. A shift toward diffuse relapse was noted in a significant number of patients. Ongoingphase III clinical trials will show the true benefit of this antiangiogenic approach. |