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Table 2 First-generation phase III studies of adjuvant docetaxel in breast cancer

From: Recent advances in systemic therapy. Advances in adjuvant systemic chemotherapy of early breast cancer

Study Patients Design Follow up (months) DFS OS
BCIRG-001 [20] 1,491 FAC × 6 versus TAC × 6 55 68% versus 75% (5-year); HR = 0.72, P = 0.001 81% versus 87% (5-year); HR = 0.70, P = 0.008
PACS-01 [21] 1,999 FEC × 6 versus FEC × 3 → D × 3 60 73% versus 78% (5-year); HR = 0.82, P = 0.012 87% versus 91% (5-year); HR = 0.73, P = 0.017
ECOG 2197 [22] 2,952 AC × 4 versus AD × 4 79.5 85% versus 85% (5-year); HR = 1.03, P = 0.78 91% versus 92% (5-year); HR = 1.06, P = 0.62
USO 9735 [23, 24] 1,016 AC × 4 versus DC × 4 84 75% versus 81% (7-year); HR = 0.74, P = 0.033 82% versus 87% (7-year); HR = 0.69, P = 0.032
BIG 02-98 [25] 2,887 A × 4 → CMF × 3 versus AC × 4 → CMF × 3 versus A × 3 → D × 3 → CMF × 3 versus AD × 4 → CMF × 3 62 D versus non-D: HR = 0.86, P = 0.051 Sequential D versus A-CMF: 78% versus 73% (5-year); HR = 0.79, P = 0.035 Concurrent AD versus AC-CMF: 74% versus 72% (5-year); HR = 0.93, P = 0.48 (NS) NA
TAXIT 216 [26] 972 E × 4 → CMF × 4 versus E × 4 → D × 4 → CMF × 4 54 HR = 0.79, P = 0.0576 HR = 0.72, P = 0.0797
TACT [27] 4,162 FEC × 8 or E × 4 → CMF × 4 versus FEC × 4 → D × 4 52 74% versus 75% (4-year); HR = 0.97 (NS) 82% versus 82% (4-year); HR = 0.98 (NS)
GEICAM 9805 [28] 1,059 FAC × 6 versus TAC × 6 72 86% versus 91% (5-year); HR = 0.66, P = 0.02 95% versus 97% (5-year); HR = 0.72, P = 0.27
Mavroudis et al. [29] 756 FEC × 6 versus D × 4 → EC × 4 62.5 69% versus 75% (5-year); P = 0.029 -
WSG/AGO AM02 [30] 2,012 FEC × 6 versus EC × 4 → D × 4 46 85.8% versus 90.2% (5-year); HR = 1.51, P = 0.009 92.6% versus 94.8% (5-year); HR = 1.59, P = 0.04
  1. First-generation phase III studies evaluating the role of docetaxel in the adjuvant treatment of breast cancer. →, followed by; A, doxorubicin; C, cyclophosphamide; D, docetaxel; DFS, disease-free survival; E, epirubicin; F, 5-fluorouracil; HR, hazard ratio; NS, not significant; OS, overall survival; TAC, docetaxel, doxorubicin, and cyclophosphamide.