| General information |
| Database: | DB00627 |
| Objective: | They evaluated the efficacy of metronomic etoposide or temozolomide administered with bevacizumab among recurrent glioblastoma (GBM) patients who progressed on prior bevacizumab therapy in a phase 2, openlabel, twoarm trial. |
| Authors: | Reardon DA, et al |
| Title: | Phase II study of metronomic chemotherapy with bevacizumab for recurrent glioblastoma after progression on bevacizumab therapy. |
| Journal: | J Neurooncol |
| Year: | 2011 |
| PMID: | 20853132 |
| 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: | 2 |
| Therapeutic Combination Content: | metronomic chemotherapy with bevacizumab |
| Study Type: | openlabelphase II study |
| Key Patients Feature: | Glioblastoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients received bevacizumab (10 mg/kg) every 2 weeks with either oral etoposide (50 mg/m2) daily for 21 consecutive days each month or daily temozolomide (50 mg/m2). |
| Primary End Point: | 6month progression free survival (PFS6) |
| Secondary End Point: | safety and overall survival |
| Patients Number: | 23 |
| Trial Results |
| DLT_MTD: | The only grade 4 adverse event was reversibleneutropenia. Grade 3 toxicities included fatigue (n = 2)and infection (n = 1). |
| Objective Response Rate: | No radiographic responses wereobserved. Although 12 patients (52%) achieved stabledisease, PFS6 was 4.4% and the median PFS was7.3 weeks. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7.3 weeks. (4.0, 8.3) |
| Median OS A vs. C: | 16.4 weeks (11.0, 23.3) |
| Adverse Event(agent arm): | The only grade 4 adverse event was reversible neutropenia. Grade 3 toxicities included fatigue (n = 2) and infection (n = 1). |
| Conclusions: | Metronomic etoposide or temozolomide is ineffective when administered with bevacizumab among recurrent GBM patients who have progressed on prior bevacizumab therapy. Alternative treatment strategies remain critically needed for this indication. |