The BCIRG 001 study has shown that a combination of Taxotere, doxorubicin, and cyclophosphomide (TAC regimen) is more effec- tive than the standard FAC (5-fluorouracil, doxorubicin, cyclophosphomide) regimen in adjuvant chemotherapy of operable breast cancer (BC) with mestastases to regional lymph nodes. With higher efficacy, TAC regimen was more toxic: the incidence of febrile neu- tropenia was 24.7%. According to the current EORTC and ASCO guidelines, the use of granulocyte colony-stimulating

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... factors (G-CSF) for primary prophylaxis is indicated when the risk of febrile neutropenia is ≥20%. This study was designed to evaluate the safety of TAC regimen with G-CSF primary prophylaxis in adjuvant chemotherapy (CT) of BC .Patients with operable BC (T1—3N1M0) and Karnofsky performance status 80% received adjuvant TAC regimen after radical surgery: Taxotere 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphomide 500 mg/m2. G-CSFs were administered in the standard doses for 5—7 days starting from cycle 1 of CT, for primary prophylaxis of febrile neutropenia.One hundred and one patients have been treated since 2006. Mean age was 47.5 years (range 25—67 years). Almost half (48.5%) of the patients had Stage IIIa disease, Stages IIa and IIb had 18.8 and 27.7% of patients, respectively.The tumor was estrogen receptor-positive in 57.4% of the patients and progesterone receptor-positive in 62.4%. Overexpression of Her- 2/neu receptor was documented in 49.5% of cases. The mean number of cycles per patient was 5.8. Ninety-one (90.1%) patients have received a complete course of 6 TAC cycles. The duration of prophylactic use of lenograstim or filgrastim during one CT cycle was 5.9 and 5.6 days, respectively.Episodes of febrile neutropenia were observed at 19 (3.2%) CT cycles in 9 (8.9%) patients. Neutropenic infections were recorded at 4 (0.78%) cycles in 3 (3%) patients.Thus, the use of GCSF substantially reduces the incidence of TAC-associated febrile neutropenia and infectious complications and ensures a safe and complete course [...]