| General information |
| Database: | DB00600 |
| Objective: | Treatment options for recurrent glioblastoma are scarce, with secondline chemotherapy showing only modest activity against the tumour. Despite the absence of well controlled trials, bevacizumab is widely used in the treatment of recurrent glioblastoma. Nonetheless, whether the high response rates reported after treatment with this drug translate into an overall survival benefit remains unclear. they report the results of the first randomised controlledphase 2 trial of bevacizumab in recurrent glioblastoma. |
| Authors: | Taal W, et al |
| Title: | Singleagent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomised controlledphase 2 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2014 |
| PMID: | 25035291 |
| Trial Design |
| Clinical Trial Id: | www.trialregister.nl, number NTR1929 |
| 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 lomustine |
| Study Type: | a randomisedcontrolledphase II trial |
| Key Patients Feature: | patients wereeligible for inclusion in the trial if they had histologically provenglioblastoma with a first progression after previouschemoradiotherapy with temozolomide, documented by MRIwith at least one bidimensionally measurable target lesionwith one diameter of at least 10 mm, visible on two or moreaxial slices 5 mm apart; had not received previous chemotherapyfor recurrent disease; had not previously received treatmentwith an antiVEGF agent or nitrosoureas; were on a stable ordecreasing dose of steroids for 7 days before the baseline MRIscan; had not received radiotherapy within the 3 months beforethe diagnosis of progression; had not received chemotherapy inthe past 4 weeks; were at least 18 years of age; had WHOperformance status of 0-2; and had adequate bone marrow, renal, and hepatic function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Singleagent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine |
| Treatment Info: | patients were randomly allocated by a theybbased program to treatment with oral lomustine 110 mg/m(2) once every 6 weeks, intravenous bevacizumab 10 mg/kg once every 2 weeks, or combination treatment with lomustine 110 mg/m(2) every 6 weeks and bevacizumab 10 mg/kg every 2 weeks. |
| Primary End Point: | overall survival at 9 months;safety analysis |
| Secondary End Point: | NA |
| Patients Number: | 153 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3 (3-4) in Bevacizumab; 1 (1-3) in Lomustine; 11 (1-27) in BEV/LOM 110; 4 (3-8)) in BEV/LOM 90; 4 (3-8) in BEV/LOM ALL |
| Median OS A vs. C: | 8 (6-9) in Bevacizumab; 8 (6-11) in Lomustine; 16 (2-34) in BEV/LOM 110; 11 (8-12) in BEV/LOM 90; 12 (8-13) in BEV/LOM ALL |
| Adverse Event(agent arm): | The most frequent grade 3 or worse toxicities were hypertension (13 [26%] of 50 patients in the bevacizumab group, three [7%] of 46 in the lomustine group, and 11 [25%] of 44 in the bevacizumab and lomustine 90 mg/m2 group), fatigue (two [4%], four [9%], and eight [18%]), and infections (three [6%], two [4%], and five [11%]). |
| Conclusions: | The combination of bevacizumab and lomustine met prespecified criteria for assessment of this treatment in furtherphase 3 studies. Hotheyver, the results in the bevacizumab alone group do not justify further studies of this treatment. |