| General information |
| Database: | DB00987 |
| Objective: | Firstline bevacizumab combined with chemotherapy significantly improves efficacy versus chemotherapy alone in human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2)negative locally recurrent or metastatic breast cancer (LR/mBC). This large, openlabel study further assesses firstline bevacizumab with taxanebased chemotherapy in routine oncology practice |
| Authors: | Smith IE, et al |
| Title: | Firstline bevacizumab plus taxanebased chemotherapy for locally recurrent or metastatic breast cancer: safety and efficacy in an openlabel study in 2, 251 patients. |
| Journal: | Ann Oncol. |
| Year: | 2011 |
| PMID: | 20819780 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | advanced breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab+ taxanebased chemotherapy |
| Study Type: | large, openlabel study |
| Key Patients Feature: | Patients with human epidermal growth factor receptor 2negative LR/mBC, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of zero to two and no prior chemotherapy for LR/mBC |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received bevacizumab 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks plus taxanebased chemotherapy (or other nonanthracycline chemotherapy) until disease progression, unacceptable toxicity or patient withdrawal. |
| Primary End Point: | safety; |
| Secondary End Point: | time to progression (TtP) |
| Patients Number: | 2251 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 52% |
| Disease Control Rate: | 85% |
| Median Time to Progression: | 9.5 months (95% confidence interval 9.1-9.9). |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 14.6 months (95% CI 13.1-17.0). |
| Adverse Event(agent arm): | The most frequent SAEs were febrile neutropenia (5.1%), neutropenia (3.6%) and pyrexia (1.5%). |
| Conclusions: | The study population in ATHENA was more representative of general oncology practice than populations enrolled into randomised trials, although there may have been some bias towards younger, fitter patients. The safety and efficacy of bevacizumabtaxane therapy in this large study they were consistent with results from randomised firstline trials. |