| General information |
| Database: | DB00614 |
| Objective: | To evaluate the efficacy of adding bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and everolimus, a mammalian target of rapamycin (mTOR inhibitor), to standard radiation therapy/temozolomide in the firstline treatment of patients with glioblastoma. |
| Authors: | Hainsworth JD, et al |
| Title: | Phase II study of concurrent radiation therapy, temozolomide, and bevacizumab followed by bevacizumab/everolimus as firstline treatment for patients with glioblastoma. |
| Journal: | Clin Adv Hematol Oncol. |
| Year: | 2012 |
| PMID: | 22706484 |
| 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: | 4 |
| Therapeutic Combination Content: | concurrent radiation therapy, temozolomide, and bevacizumab followed by bevacizumab/everolimus |
| Study Type: | a phase II study |
| Key Patients Feature: | recurrent glioblatoma patients (n=99) who received subsequent therapy after progression on one of five consecutive |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Following surgical resection or biopsy, patients received standard radiation therapy/temozolomide plus bevacizumab 10 mg/kg intravenously (IV) every 2 weeks. Four weeks after the completion of radiation therapy, patients began oral everolimus 10 mg daily, and continued bevacizumab every 2 weeks; therapy continued until tumor progression or unacceptable toxicity. |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 68 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Thirtyone of 51 patients (61%) with measurable tumor had objective responses. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | The use of bevacizumab and everolimus as part of firstline combined modality therapy for glioblastoma was feasible and efficacious. The PFS compared favorably to previous reports with standard radiation therapytemozolomide therapy, and is similar to results achieved in otherphase II trials in which bevacizumab was added to fistline treatment. Ongoing randomizedphase III trials will clarify the role of bevacizumab in this setting. |