| General information |
| Database: | DB00635 |
| Objective: | They hypothesized that a window period between bevacizumab and cytotoxic agents may enhance drug delivery into tumor tissue through bevacizumabinduced vascular normalization in patients with brain metastases of breast cancer (BMBC). |
| Authors: | Lu YS, et al |
| Title: | Bevacizumab preconditioning followed by Etoposide and Cisplatin is highly effective in treating brain metastases of breast cancer progressing from wholebrain radiotherapy. |
| Journal: | Clin Cancer Res. |
| Year: | 2015 |
| PMID: | 25700303 |
| Trial Design |
| Clinical Trial Id: | NCT01281696 |
| 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 preconditioning followed by Etoposide and Cisplatin |
| Study Type: | A singlearmphase II study |
| Key Patients Feature: | brain metastases of breast cancer pts |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | In a 21day cycle, patients received bevacizumab (15 mg/kg) on day 1, which, with a 1day window period, was followed by etoposide (70 mg/m(2)/day; days 24) and cisplatin (70 mg/m(2); day 2; BEEP regimen). The BEEP regimen was administered for a maximum of 6 cycles. |
| Primary End Point: | the central nervous system (CNS)objective response rate |
| Secondary End Point: | NA |
| Patients Number: | 35 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Twentyseven patients [77.1%; 95% confidence interval (CI), 59.989.6] achieved a CNSobjective response, including 13 patients (37.1%) with a more than and equal to 80% volumetric reduction of CNS lesions. |
| 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): | Common grade 3 or 4 toxicities included neutropenia (30.8%) and infection (21.3%). |
| Conclusions: | By administering bevacizumab 1 day before etoposide and cisplatin, the BEEP regimen appeared highly effective in BMBC refractory to WBRT. Further study of vascular normalization window concept is warranted. |