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Product Centers | ELLENCE® (epirubicin hydrochloride injection)
 
ELLENCE(R) (epirubicin hydrochloride injection) Indication Statement ELLENCE Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

Efficacy
Survival data at 10 years

ELLENCE in 10-year relapse-free survival (RFS) with FEC-1001

Line chart showing FASG 05: FEC-100 vs FEC-50

A phase 3, open-label, multicenter, randomized trial in patients with axillary node-positive breast cancer. A total of 565 pre- or postmenopausal women were randomly selected to receive 6 cycles of either 5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 IV on Day 1 of each 21-day cycle (FEC-100) or 5-fluorouracil 500 mg/m2, epirubicin 50 mg/m2, and cyclophosphamide 500 mg/m2 IV on Day 1 of each 21-day cycle (FEC-50). All medications in the combinations were administered on Day 1 of each cycle; cycles were to be repeated every 21 days. Postmenopausal women receiving tamoxifen began treatment no later than on the first day of chemotherapy and continued for 3 years. All patients were to receive local regional radiation beginning 30 days after the end of the 6 cycles of chemotherapy. The primary end point was relapse-free survival.

  • 33% relative reduction in the risk of relapse at 10 years (Wilcoxon, P=0.01; CI=0.62, 0.99; 22% on log-rank, P=0.04)1
  • 31% relative reduction in the risk of death at 10 years (Wilcoxon, P=0.03; CI=0.58, 0.96; 25% on log-rank, P=0.02)1

Overall survival of FEC-100 versus FEC-50
           - 5-year: 76% vs 65% (log-rank, P=0.007; CI=0.51, 0.92)1
           - 10-year: 56% vs 50% (Wilcoxon, P=0.03; log-rank, P=0.02; CI=0.62,                   0.99)1

For combination adjuvant therapy in patients with resected node-positive breast cancer

The difference at 10 years is significant

Significantly greater 10-year RFS with CEF 12011

Line chart showing NCIC MA-5:CEF 120 vs CMF

A phase 3, open-label, multicenter, randomized trial in patients with axillary node-positive breast cancer who had undergone a radical mastectomy or lumpectomy plus axillary dissection. A total of 716 pre- or perimenopausal women were randomly selected to receive either 6 cycles every 4 weeks of cyclophosphamide 75 mg/m2 po x 14 days + epirubicin 60 mg/m2 IV Days 1 and 8 + 5-fluorouracil 500 mg/m2 IV Days 1 and 8 (CEF) + prophylactic antibiotics or 6 cycles every 4 weeks of cyclophosphamide 100 mg/m2 po x 14 days + methotrexate 40 mg/m2 IV Days 1 and 8 + 5-fluorouracil 600 mg/m2 IV Days 1 and 8 (CMF). Patients who underwent lumpectomy received breast irradiation after completion of chemotherapy. Local regional radiation was not permitted. The primary end point was relapse-free survival.

  • 31% relative reduction in the risk of relapse at 10 years (Wilcoxon, P=0.010; 22% on log-rank, P=0.017)1

Overall survival of CEF 120 versus CMF
           - 5-year: 77% vs 70% (log-rank, P=0.043)1
           - 10-year: 61% vs 57% (Wilcoxon, P=0.053; log-rank, P=0.10)1

View the safety and tolerability information related to this study.

Reference: 1. Data on file. Pfizer Inc, New York, NY.