| General information |
| Database: | DB00636 |
| Objective: | the phase II prospective, noncomparative BRAIN study (NCT00800202) investigated efficacy and safety of bevacizumab in chemotherapyna ve or pretreated patients with non small cell lung cancer (non small cell lung cancer) and asymptomatic untreated brain metastases to provide data in this previously unexplored subgroup. |
| Authors: | Besse B, et al |
| Title: | Bevacizumab in Patients with Nonsquamous non small cell lung cancer and Asymptomatic, Untreated Brain Metastases (BRAIN): A Nonrandomized, phase II Study. |
| Journal: | Clin Cancer Res. |
| Year: | 2015 |
| PMID: | 25614446 |
| Trial Design |
| Clinical Trial Id: | NCT00800202 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | nonsquamous non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab+carboplatin+paclitaxel/ secondline bevacizumab plus erlotinib |
| Study Type: | openlabel, noncomparative, nonrandomized, multicenter, phase II study |
| Key Patients Feature: | chemotherapynaive or pretreated patients with non small cell lung cancer (non small cell lung cancer) and asymptomatic untreated brain metastases |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | firstline bevacizumab (15 mg/kg) plus carboplatin (area under the curve ¡Á6) and paclitaxel (200 mg/m(2)) every 3 weeks (B + CP), or secondline bevacizumab plus erlotinib (150 mg/d; B + E) |
| Treatment Info: | pts received firstline bevacizumab (15 mg/kg) plus carboplatin (area under the curve ¡Á6) and paclitaxel (200 mg/m(2)) every 3 weeks (B + CP), or secondline bevacizumab plus erlotinib (150 mg/d; B + E). The trial could be stopped if there were more than three (B + CP) or more than two (B + E) intracranial hemorrhages. |
| Primary End Point: | sixmonth progression free survival (PFS) |
| Secondary End Point: | NA |
| Patients Number: | 91 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Investigatorassessed overall response rate (ORR) was 62.7%: 61.2% in intracranial lesions and 64.2% in extracranial lesions |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.7 months [95% confidence interval (CI), 5.7-7.1] in firstline B t CP cohort . For secondline B t E cohort 6.3 months (95% CI, 3.0-8.4) |
| Median OS A vs. C: | 16.0 months in firstline B t CP cohort. For secondline B+E cohort 12.0 months |
| Adverse Event(agent arm): | Adverse events were comparable with previous trials of bevacizumab. One grade 1 intracranial hemorrhage occurred and resolved without sequelae. |
| Conclusions: | The BRAIN study demonstrates encouraging efficacy and acceptable safety of bevacizumab with firstline paclitaxel and carboplatin in patients with non small cell lung cancer and asymptomatic, untreated brain metastases. |