A multicenter pilot study of adjuvant docetaxel, epirubicin and cyclophosphamide (TEC) in patients (p) with stage II/III and node-positive breast cancer (BC)

Abstract

11029 Background: Based on wide experience with docetaxel, adriamicin and cyclophosphamide (TAC regimen) for adjuvant therapy of node-positive BC but taking into account the high incidence of febrile neutropenia and mucositis, we performed the present study with TEC aiming for a better toxicity profile at doses equipotent to TAC. Methods: 300 p with histological diagnosis of stage II-III BC, positive axillary lymph nodes, age 18 year old, ECOG PS 0–2 and adequate bone marrow, renal, hepatic and cardiac function were accrued after surgery. Prior chemotherapy, hormone therapy and radiotherapy for BC were not allowed. Treatment: T 75 mg/m2 iv d1, E 75 mg/m2 iv d1 and C 500 mg/m2 iv d1 every 21 days for 6 cycles. G-CSF 5 mcg/Kg /day s.c. was given on days 5 to 9. Results: Two hundred and one p having completed adjuvant therapy have been evaluated in this interim analysis. Median age: 53 years (range 25–77), ECOG PS 0/1 89%/11%, infiltrating ductal carcinoma 77%. Hormone receptor status was ER+ 79% and PR+ 60%. Surgery was mastectomy in 49% and conservative surgery in 51% of pts. Median number of positive axillary lymph nodes was 3. To date, 1,085 cycles were administered (median 6). Median relative dose intensity was 99% for T and 98% for E and C. There were 11 dose reductions for non- hematological toxicity and 4 for hematological toxicity. Toxicity: grade 3–4 neutropenia occurred in 15 p (7.5%), 8 of them were episodes of febrile neutropenia (4.0%). Other grade 3–4 toxicities per p were: leukopenia (7.0%), thrombocytopenia (0.5%), asthenia (6.5%), vomiting (4.5%), nausea (3.5%) and diarrhoea (3.0%). Four p (2.0%) discontinued therapy due to toxicity: 1 p with toxicodermic reaction, 1 p with hematological toxicity, 1 p with febrile neutropenia and 1 p with an allergic reaction to T. After study treatment, radiotherapy was administered to 63% of p and hormonotherapy to 66% of p. Conclusions: These preliminary results show that adjuvant TEC in p with stage II/III BC and positive axillary lymph nodes is feasible and well tolerated. No significant financial relationships to disclose.