| General information |
| Database: | DB00601 |
| Objective: | No established chemotherapeutic regimen exists for the treatment of recurrent malignant gliomas (rMGs). Herein, they report the activity and safety results of the bevacizumab (B) plus fotemustine (FTM) combination for the treatment of rMGs. |
| Authors: | Vaccaro V, et al |
| Title: | Activity and safety of bevacizumab plus fotemustine for recurrent malignant gliomas. |
| Journal: | Biomed Res Int. |
| Year: | 2014 |
| PMID: | 24877084 |
| 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: | bevacizumab plus fotemustine |
| Study Type: | Activity and Safety |
| Key Patients Feature: | Patients with histologically proven MGs and clinicoradiological progression after no more than two previous chemotherapy lines, temozolomide plus radiotherapy, must have beenthe upfront therapy evaluable and/or measurable disease; at least 12 weeks from asecond intracranial surgery and/or radiotherapy and 4 weeksfrom first or secondline chemotherapy; age between 18 and80 years; Karnofsky performance status (KPS) more than and equal to 60; andadequate hematological, liver, and renal function. Treatmentwith low dose of heparin for antithrombotic prophylaxis waspermitted. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | An inductionphase consisted of B 10 mg/kg days 1, 15 plus FTM 65 mg/m(2) days 1, 8, and 15. Nonprogressive patients entered the maintenancephase with B 10 mg/kg plus FTM 75 mg/m(2) every 3 weeks. |
| Primary End Point: | response rate; |
| Secondary End Point: | safety, progression free survival (PFS), and overall survival (OS) |
| Patients Number: | 26 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4 (95% C.I.: 2.8-5.1) months |
| Median OS A vs. C: | 6 months (95% C.I.: 4.2-7.8) |
| Adverse Event(agent arm): | Bevacizumabrelated adverse events included grade 3 venous thromboembolic event (8%), grade 2 epistaxis (4%), hypertension (8%), and gastrointestinal perforation (4%). |
| Conclusions: | Bevacizumab plus FTM showed activity and good tolerability in pretreated MGs. Further investigations are needed in order to verify the benefits deriving from the addition of B to a cytotoxic in this clinical setting of patients. |