| General information |
| Database: | DB00872 |
| Objective: | Elevated vascular endothelial growth factor (VEGF) was associated with poor prognosis in leptomeningeal carcinomatosis and antiangiogenic therapy was found to prolong the survival of mice in preclinical studies. This prospective pilot study investigated the efficacy of antiVEGF therapy plus chemotherapy in patients with leptomeningeal carcinomatosis originating from breast cancer. |
| Authors: | Wu PF, et al |
| Title: | A pilot study of bevacizumab combined with etoposide and cisplatin in breast cancer patients with leptomeningeal carcinomatosis. |
| Journal: | BMC Cancer. |
| Year: | 2015 |
| PMID: | 25928457 |
| Trial Design |
| Clinical Trial Id: | NCT01281696 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer with leptomeningeal carcinomatosis |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab combined with etoposide + cisplatin |
| Study Type: | a prospective pilot study |
| Key Patients Feature: | patients with leptomeningeal carcinomatosis originating from breast cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Eligible patients were scheduled to receive bevacizumab combined with etoposide and cisplatin (BEEP) every 3 weeks for a maximum of 6 cycles or until unacceptable toxicity. |
| Primary End Point: | the central nervous system (CNS)specific response rate |
| Secondary End Point: | NA |
| Patients Number: | 8 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 60% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.7 months (95% confidence interval, CI, 0.39.0) |
| Median OS A vs. C: | 4.7 months (95% confidence interval, CI, 0.39.0) |
| Adverse Event(agent arm): | The most common grade 3/4 AEs were neutropenia (23.1%), leukopenia (23.1%), and hyponatremia (23.1%). Nonhematologic toxicity was generally modest. All AEs resolved to grade 1 or lotheyr. |
| Conclusions: | BEEP exhibited promising efficacy in breast cancer patients with leptomeningeal carcinomatosis. Additional studies are warranted to verify its efficacy and clarify the role of antiangiogenic therapy in this disease. |