| General information |
| Database: | DB00610 |
| Objective: | They conducted a phase II trial of upfront 5day temozolomide (TMZ) and bevacizumab (BV) in patients with newly diagnosed unresectable or multifocal glioblastoma. Patients received up to four cycles of TMZ at 200 mg/m(2) on days 15, and BV at 10 mg/kg on days 1 and 15 of a 28day cycle. |
| Authors: | Lou E, et al |
| Title: | Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma. |
| Journal: | Cancer Med. |
| Year: | 2013 |
| PMID: | 23634286 |
| 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: | 1 |
| Therapeutic Combination Content: | upfront bevacizumab and temozolomide |
| Study Type: | Phase II trial |
| Key Patients Feature: | Patients with newly diagnosed unresectable single or multifocal GB were enrolled into this singleinstitution, singlearm, phase II trial if they were adult patients greater than18 years of age.Criteria forenrollment also included Karnofsky performance score(KPS) 60%; no prior treatment, including radiation orchemotherapy; at least 1 week from closed biopsy; and noevidence of grade 2 or higher central nervous system(CNS) hemorrhage. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received up to four cycles of TMZ at 200 mg/m(2) on days 15, and BV at 10 mg/kg on days 1 and 15 of a 28day cycle. Brain magnetic resonance imaging (MRI) was performed monthly. |
| Primary End Point: | best tumor response |
| Secondary End Point: | NA |
| Patients Number: | 41 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Assessment for best radiographic responses was as follows: partial responses in 24.4%, stable disease in 68.3%, and progressive disease in 2.4%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.6 months |
| Median OS A vs. C: | 11.7 months (95% CI: 7.4, 15.6 months) |
| Adverse Event(agent arm): | Treatmentrelated toxicities included seven grade 4 toxicities and one grade 5 toxicity (myocardial infarction). |
| Conclusions: | From this study, it was concluded that an upfront regimen of TMZ and BV for unresectable glioblastoma was well tolerated and provided a significant level of disease stabilization. Therapeutic toxicities they were consistent with those seen in the adjuvant setting using these agents. The upfront approach to treatment of glioblastoma in the unresectable population warrants further investigation in randomized controlledphase III trials. |