The addition of docetaxel and 5-fluorouracil (D-5FU) after pre-operative dose-intensive epirubicin-cyclophosphamide (EC) and standard local therapy did not improve disease-free survival in patients with inflammatory breast cancer, a new study published online early in the Journal of Clinical Oncology has shown.
For the multicenter, open-label, phase III study, researchers enrolled 174 patients with inflammatory breast cancer.
All patients received four cycles of dose-dense epirubicin 150mg/m2 and cyclophosamide 4000mg/m2 every 3 weeks, then mastectomy with axillary lymph node dissection.
Patients were then randomly assigned to receive radiotherapy (Arm A) or radiotherapy followed by four cycles of docetaxel 85mg/m2 on day 1 and 5-FU 750mg/m2/day continuous infusion, days 1-5 every 3 weeks (Arm B). Patients with hormone receptor-positive tumors also received hormonal therapy.
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Results showed that the estimated 5-year disease-free survival rates were 55% (95% CI: 43.9-64.7) in arm A and 55.5% (95% CI: 44.3-65.3) in arm B (HR = 0.94; 95% CI: 0.61-1.48; P = 0.81).
Researchers found that 5-year overall survival rates were 70.2% (95% CI: 59.1-78.8) and 70% (95% CI: 58.8-78.7) in arms A and B, respectively (HR = 0.93; 95% CI: 0.55-1.60; P = 0.814).
The findings suggest that post-operative D-5FU after neoadjuvant dose-intense chemotherapy does not improve disease-free survival in patients with inflammatory breast cancer.
- Goncalves A, Pierga J-Y, Ferrero J-M, et al. UNICANCER-PEGASE 07 study: a randomized phase 3 trial evaluating post-operative docetaxel-5FU regimen after neo-adjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv216.