| General information |
| Database: | DB01038 |
| Objective: | A Study of Avastin (Bevacizumab) Plus TaxaneBased Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer. |
| Authors: | Antonio LlombartCussac |
| Title: | A prognostic factor index for overall survival in patients receiving firstline chemotherapy for human epidermal growth factor receptor 2negative advanced breast cancer: an analysis of the ATHENA trial. |
| Journal: | The Breast |
| Year: | 2014 |
| PMID: | 25047747 |
| Trial Design |
| Clinical Trial Id: | NCT00448591 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | chemotherapy plus bevacizumab |
| Study Type: | multinational ATHENA study, IIII64 patients with ABC were treated with firstline bevacizumab in combination with nonanthracyclinecontaining chemotherapy in the context of routine oncology practice |
| Key Patients Feature: | patients with ABC received firstline bevacizumab in combination with chemotherapy (taxane or standard nonanthracyclinecontaining chemotherapy at the investigator's discretion) in the context of routine oncology practice. Key eligibility criteria were: no prior chemotherapy for ABC; age 18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0e2; no concomitant endocrine therapy for locally recurrent/metastatic breast cancer (LR/mBC); and no major surgery within 28 days before starting study therapy. Bevacizumab was administered at a dose of 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks (depending on the chemotherapy schedule and investigator's preference) and continued until disease progression, unacceptable toxicity or physician/patient decision to stop. |
| Biomarker: | a prognostic factor index |
| Biomark Analysis: | This prognostic index may enable identification of patients with a poorer prognosis in whom more intensive systemic regimens may be appropriate. The index may also be considered in designing new trials, although it requires validation in other datasets before extrapolation to nonbevacizumabcontaining therapy. |
| Control Group Info: | NA |
| Treatment Info: | firstline chemotherapy plus bevacizumab |
| Primary End Point: | safety. |
| Secondary End Point: | Efficacy, including time to disease progression and OS (defined as the time from first dose offirstline therapy until death from any cause) |
| Patients Number: | 2203 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Median OS was 25.2 months (95% confidence interval [CI] 23.9e27.0 months). |
| Adverse Event(agent arm): | NA |
| Conclusions: | The risk factors most closely associated with worse OS they were diseasefree interval 24 months; liver metastases or 3 involved organ sites; prior anthracycline andor taxane therapy; triplenegative breast cancer (TNBC); and performance status 2 or prior analgesiccorticosteroid treatment. Risk of death was increased threefold in patients with 3 versus 1 risk factors (hazard ratio 3.0 [95% CI 2.6 e3.4; p 0.001]; median 16.0 vs 38.8 months, respectively). This prognostic index may enable identification of patients with a poorer prognosis in whom more intensive systemic regimens may be appropriate. The index may also be considered in designing new trials, although it requires validation in other datasets before extrapolation to nonbevacizumabcontaining therapy. |