Table 1

First-generation phase III pure adjuvant studies of paclitaxel in breast cancer

Study

Patients

Design

Follow up (months)

DFS

OS

CALGB 9344-INT 08 [14]

3,121

AC × 4 versus AC × 4 → P × 4

69

65% versus 70% (5-year); HR = 0.83, P = 0.0023

77% versus 80% (5-year); HR = 0.82, P = 0.0064

NSABP B-28 [15]

3,060

AC × 4 versus AC × 4 → P × 4

64.6

72% versus 76% (5-year); HR = 0.83, P = 0.006

85% versus 85% (5-year); HR = 0.93, P = 0.46

GEICAM 9906 [16]

1,248

FEC × 6 versus FEC × 4 → wP × 8

66

72.1% versus 78.5% (5-year); HR = 0.74, P = 0.006

87.1% versus 89.9% (5-year); HR = 0.78, P = 0.109

HeCOG 10/97 [17]

604

E × 4 → CMF × 4 versus E × 3 → P × 3 → CMF × 3^a

62

68% versus 70% (5-year); P = 0.55

81% versus 84% (5-year); P = 0.38

NCIC CTG MA.21 [18]

2,104

CEF versus AC → P versus dose-dense EC → P

30.4

90.1% (CEF) versus 85% (AC → P) versus 89.5% (dose-dense EC → P) (3-year RFS) AC → P versus CEF: HR = 1.49, P = 0.005 AC → P versus dose-dense EC → P: HR = 1.68, P = 0.0006 Dose-dense EC → P versus CEF: HR = 0.89, P = 0.46

NA

GONO-MIG5 [19]

1,055

CEF × 6 versus ET × 4

98.4

71% versus 70% (5-year); P = 0.8

89% versus 88% (5-year); P = NS

First-generation phase III pure adjuvant studies evaluating the role of paclitaxel in the adjuvant treatment of breast cancer. ^aSchedule every 2 weeks. →, followed by; DFS, disease-free survival; HR, hazard ratio; NS, not significant; OS, overall survival; A, doxorubicin; C, cyclophosphamide; E, epirubicin; F, 5-fluorouracil; P, paclitaxel; w, weekly; RFS, recurrence free survival. NA, not available.

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