| General information |
| Database: | DB00597 |
| Objective: | The BELOB study, a randomised controlledphase 2 trial comparing lomustine, bevacizumab and combined lomustine and bevacizumab in patients with recurrent glioblastoma, showed that the 9month overall survival rate was most promising in the combination arm. Here they report the healthrelated quality of life (HRQoL) results, a secondary trial endpoint. |
| Authors: | Dirven L, et al |
| Title: | The impact of bevacizumab on healthrelated quality of life in patients treated for recurrent glioblastoma: results of the randomised controlledphase 2 BELOB trial. |
| Journal: | Eur J Cancer. |
| Year: | 2015 |
| PMID: | 25899986 |
| 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 with or without lomustine |
| Study Type: | analysis of results of the randomised controlledphase II BELOB trial |
| Key Patients Feature: | patients with recurrent glioblastoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | bevacizumab with or without lomustine |
| Treatment Info: | HRQoL was measured at baseline and every 6weeks until progression using the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (QLQC30) and brain module (QLQBN20). HRQoL was assessed over time for five preselected scales (global health (GH), physical (PF) and social functioning (SF), motor dysfunction (MD) and communication deficit (CD)). Moreover, mean changes in HRQoL from baseline until progression were determined. |
| Primary End Point: | HRQoL assessed over time (a) from the start of treatment up to cycle seven (9 month followup, comparable to the primary endpoint of theBELOB trial, i.e. 9month OS rate) and (b) as mean change compared to baseline, plotted in graphs tovisually evaluate the longitudinal course. |
| Secondary End Point: | NA |
| Patients Number: | 148 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| 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: | Bevacizumab, whether or not in combination with lomustine, did not negatively affect HRQoL in patients treated for recurrent glioblastoma in this randomised study. |