| General information |
| Database: | DB00615 |
| Objective: | The combination of irinotecan and bevacizumab has shown efficacy in the treatment of recurrent glioblastoma multiforme (GBM). A prospective, phase II study of 85 patients with various recurrent brain tumors was carried out. Primary endpoints were progression free survival (PFS) and response rate. |
| Authors: | M ller S, et al |
| Title: | a phase II trial with bevacizumab and irinotecan for patients with primary brain tumors and progression after standard therapy. |
| Journal: | Acta Oncol. |
| Year: | 2012 |
| PMID: | 22548369 |
| Trial Design |
| Clinical Trial Id: | NCT00463203 |
| 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: | bevacizumab and irinotecan after standard therapy |
| Study Type: | A single arm, prospectivephase II study |
| Key Patients Feature: | measurable [bycomputed tomography (CT)/magnetic resonanceimaging (MRI) scan] recurrent or progressive diseaseafter standard treatment, ECOG PS 0-2, age 18, life expectancy 3 months, normal blood tests(hemoglobin 6.2 mmol/l, platelets 125 109, leukocytes 3 109, neutrofiles 1.5 109, AST orALT 3 upper normal limit, bilirubin 1.5 uppernormal limit, creatinine clearance 45 ml/min, APTT normal limit, INR normal limit), use ofcontraceptives/preservatives when relevant and signed, informed consent. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Intravenous bevacizumab 10 mg/kg and irinotecan 125/340 mg/m(2) were administered every 14 days. Evaluation was carried out every eight weeks using MRI and Macdonald response criteria. Treatment was continued until progression. |
| Primary End Point: | response rate |
| Secondary End Point: | NA |
| Patients Number: | 85 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Patients received a median of four cycles. ORR (overall response rate) for glioblastoma was 25% and 59% achieved stable disease (SD).No objective responses occurred in grade II gliomas. In the nonglioma population, one PR were observed. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | in a majority of patients with recurrent grade IV and III gliom: PFS was 5.2 months and 3.7 months, respectively. |
| Median OS A vs. C: | 8.3 months |
| Adverse Event(agent arm): | Fatigue, nausea and diarrhea were the most common grade 1-2 side effects to treatment, each suffered by 40% of all patients at some point during treatment. Manageable hypertension (grade 1-2) or proteinuria (grade 3-4) was experienced by 18% and 16%, respectively. |
| Conclusions: | The combination of bevacizumab and irinotecan is well tolerated and moderately efficacious in glioblastoma and glioma WHO gr. III. A majority of patients achieve at least disease stabilization. Prolonged progression free survival in nonglioma patients warrants further research. |