Docetaxel for post-surgery treatment of breast cancer patients 1491 women with node positive breast cancer underwent randomization post surgery 745 women randomized to TAC 746 women randomized to FAC 1 woman in the TAC group and 10 assigned to receive FAC did not receive treatment for the following reasons: 8 withdrew consent, 1 was lost to follow up, and 2 did not receive treatment for other reasons TAC group: 144 (19.3%) relapsed with breast cancer FAC group: 197 (26.4%) relapsed with breast cancer Figure 1 Adjuvant therapy for node positive breast cancer. Adapted from Martin et al (2005). Abbreviations: FAC, ﬂuorouracil, doxorubicin, and cyclophosphamide;TAC, docetaxel, doxorubicin, and cyclophosphamide. fevers in patients on the TAC regimen, and that prophylaxis with G-CSF after the ﬁrst episode can decrease the incidence of neutropenic complications. Combination or sequential docetaxel was compared with a nontaxane regimen in 2887 patients with node-positive breast cancer (Crown et al 2006). Patients were randomized to 4 arms: 4 cycles of doxorubicin (A) (75 mg/m2) fol- lowed by 3 cycles of cyclophosphamide, methotrexate, and 5-ﬂuorouracil (CMF), 4 cycles of doxorubicin and cyclo- phosphamide (AC) followed by 3 cycles of CMF, 3 cycles of doxorubicin followed by 3 cycles of docetaxel (T) (100 mg/m2) followed by 3 cycles of CMF, or, ﬁnally, 4 cycles of doxorubicin (50 mg/m2) and docetaxel (75 mg/m2) followed by 3 cycles of CMF. The primary end-point of the study was DFS. The A→T→CMF arm demonstrated a signiﬁcantly improved DFS over the AT→CMF (p = 0.047) and A→CMF (p = 0.035) arms. The French FNCLCC-PACS 01 trial randomly assigned 1999 patients with node-positive breast cancer to 6 cycles of ﬂuorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 (FEC) or to 3 cycles of the same regimen followed by 3 cycles of 100 mg/m2 of docetaxel (D) (Roché et al 2006). After a median follow-up of 60 months, switching over to docetaxel after 3 cycles of FEC resulted in an improvement in 5-year disease-free (78.4% vs 73.2%; p = 0.01) and overall survival (90.7% vs 86.7%; p = 0.02). The rate of distant metastasis was lower in patients who received FEC-D (18.1% vs 14.9%). Similar to the BCIRG study, among the patients with 1–3 positive nodes there was a signiﬁcant reduction in the Table 1 Phase III trials of docetaxel as adjuvant therapy in patients with node-positive breast cancer Study Regimen Number of patients Disease-free survival Overall survival BCIRG 001 TAC vs FAC 1,491 75% vs 68% p = 0.001 87% vs 81% p = 0.008 FNCLCC PACS 01 FEC X 3→docetaxel × 3 vs FEC X 6 1,999 78% vs 74% p = 0.041 91% vs 87% p = 0.05 BIG 2-098 A→T + AT vs A + AC 2,887 HR 0.86 p = 0.051 HR 0.92 p = 0.34 Abbreviations: HR, hazard ratio; A, doxorubicin; AC, doxorubicin and cyclophosphamide; AT, adriamycin, docetaxel; FAC, ﬂuorouracil, doxorubicin, and cyclophosphamide; TAC, docetaxel, doxorubicin, and cyclophosphamide; FEC, ﬂuorouracil, epirubicin, and cyclophosphamide. Therapeutics and Clinical Risk Management 2008:4(2) 421