PREPARE trial: A randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel, and CMF versus a standard-dosed epirubicin-cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer-outcome on prognosis Full Text
Annals of Oncology, 03/21/2011
Clinical Article
Untch M et al. – Neoadjuvant dose-intensified chemotherapy compared with standard chemotherapy did not improve DFS, whereas the addition of darbepoetin might have detrimental effects on DFS.
Methods- 733 patients received either 4 cycles of neoadjuvant epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks followed by 4 cycles of paclitaxel 175 mg/m2 every 3 weeks (EC-T), or 3 cycles of epirubicin 150 mg/m2 every 2 weeks followed by 3 cycles of paclitaxel 225 mg/m2 every 2 weeks followed by 3 cycles of combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (Edd-Tdd-CMF)
- Randomly assigned to receive darbepoetin or none
- Primary objective was to demonstrate superior DFS of Edd-Tdd-CMF compared with EC?T
- Estimated 3-year DFS 75.8% with EC-T versus 78.8% with Edd-Tdd-CMF [HR 1.14; P = 0.37] and OS 88.4% versus 91.5% (HR 1.26; P = 0.237)
- 3-year DFS 74.3% with darbepoetin versus 80.0% without (HR 1.31; P = 0.061) and OS 88.0% versus 91.8% (HR 1.33; P = 0.139)
- Patients with pathologically documented complete response [pathological complete response (pCR)] had significantly better DFS compared with those without achieving pCR (estimated 3-year DFS: 89.2% versus 74.9%; HR 2.27; P = 0.001)
