| General information |
| Database: | DB00633 |
| Objective: | To evaluate singleagent activity of bevacizumab in patients with recurrent glioblastoma. |
| Authors: | Kreisl TN, et al |
| Title: | Phase II trial of singleagent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. |
| Journal: | J Clin Oncol. |
| Year: | 2009 |
| PMID: | 19114704 |
| 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: | singleagent bevacizumab followed by bevacizumab plus irinotecan |
| Study Type: | Phase II Trial |
| Key Patients Feature: | Patients 18 years of age with histologically confirmed glioblastoma, recurrent after standard externalbeam fractionated radiotherapy and temozolomide chemotherapy, were eligible. patients were required to have aKarnofsky performance status (KPS) of 60%, normal metabolic and endorgan function, and an estimated survival of at least 2 months. Competentpatients or their Designated Potheyr of Attorney/Health Care Proxy were required to sign informed consent of for this National Cancer Institute institutional review board-approved trial. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with bevacizumab 10 mg/kg every 2 weeks. After tumor progression, patients were immediately treated with bevacizumab in combination with irinotecan 340 mg/m(2) or 125 mg/m(2) every 2 weeks, depending on use of enzymeinducing antiepileptic drugs. Complete patient evaluations were repeated every 4 weeks. |
| Primary End Point: | PFS at 6 months (PFS6) |
| Secondary End Point: | MRI and PET response rates and exploratory analyses of how those responses are correlated with PFS. |
| Patients Number: | 48 |
| Trial Results |
| DLT_MTD: | thromboembolic events occurring in six patients (12.5%) were themost frequently observed |
| Objective Response Rate: | The median PFS is 16 weeks (95% CI, 12 to 26 weeks). The PFS6is 29% (95% CI, 18% to 48%; Fig 1A) The overall radiographic response rate based on the Levin criteriawas 71% (34 PRs), whereas the response rate based on Macdonaldcriteria was 35% (one CR, 16 PRs) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 16 weeks (95% CI, 12 to 26 weeks). |
| Median OS A vs. C: | 31 weeks (95% CI, 21 to 54 weeks). |
| Adverse Event(agent arm): | Thromboembolic events (12.5%), hypertension (12.5%), hypophosphatemia (6%), and thrombocytopenia (6%) were the most common drugassociated adverse events. Six patients (12.5%) were removed from study for drugassociated toxicity (five thromboembolic events, one botheyl perforation). |
| Conclusions: | They conclude that singleagent bevacizumab has significant biologic and antiglioma activity in patients with recurrent glioblastoma. |