Table 2

First-generation phase III studies of adjuvant docetaxel in 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


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.

López-Tarruella and Martín Breast Cancer Research 2009 11:204   doi:10.1186/bcr2226