Table 3

Second-generation phase III studies of adjuvant taxane therapy in breast cancer

Study

Patients

Design

Follow up (months)

DFS

OS


CALGB-9741 [31]

2,005

A × 4 → P × 4 → C × 4 all q3w (conventional interval, sequential) versus A × 4 → P × 4 → C × 4 all q2w with filgrastim (dose-dense, sequential) versus AC × 4 → P × 4 all q3w (conventional interval, concurrent) versus AC × 4 → P × 4 all q2w with filgrastim (dose-dense, concurrent)

36

Dose-dense versus conventional interval: 82% versus 75% (4-year); HR = 0.74, P = 0.010 Concurrent versus sequential administration: HR = 0.93, P = 0.58 (NS)

Dose-dense versus conventional interval: 92% versus 90% (3-year); HR = 0.69, P = 0.013 Concurrent versus sequential administration: HR = 0.89, P = 0.48 (NS)

ECOG E1199 [32]

4,950

AC × 4 → P × 4 all q3w (1) versus AC × 4 → P × 12 w (2) versus AC × 4 → D × 4 all q3w (3) versus AC × 4 → D × 12w (4)

63.8

76.9% (1) versus 81.5% (2) versus 81.2% (3) versus 77.6% (4; 5-year) Compared with standard (P q3w): HR = 1.27, P = 0.006 (2); HR = 1.23, P = 0.02 (3); HR = 1.09, P = 0.29 (4)

86.5% (1) versus 89.7% (2) versus 87.3% (3) versus 86.2% (4) (5-year) Compared with standard (P q3w): HR = 1.32, P = 0.01 (2); HR = 1.13, P = 0.25 (3); HR = 1.02, P = 0.80 (4)

tAnGo [33]

3,152

EC → P × 4 versus EC → GP × 4

34.9

HR = 1.0; P = 0.96

HR = 1.1; P = 0.35

NSABP B-30 [34]

5,357

AC × 4 → D × 4 versus AD × 4 versus ACD × 4

73

AC → D versus ACD: HR = 0.83, P = 0.006 AC → D versus AD: HR = 0.80, P = 0.001 ACD versus AD: HR = 0.96, P = 0.58

AC → D versus ACD: HR = 0.86, P = 0.086 AC → D versus AD: HR = 0.83, P = 0.034 ACD versus AD: HR = 0.96, P = 0.67

BCIRG-005 [35]

3,298

ACD × 6 versus AC × 4 → D100 × 4

65

78.9% versus 78.6% (5-year); HR = 1.002, P = 0.98

88.1% versus 88.9% (5-year); HR = 0.91, P = 0.37


Second-generation phase III studies evaluating the role of taxanes in the adjuvant treatment of breast cancer. A, doxorubicin; C, cyclophosphamide; D, docetaxel; DFS, disease-free survival; E, epirubicin; F, 5-fluorouracil; G, gemcitabine; HR, hazard ratio; NS, not significant; OS, overall survival; P, paclitaxel; w, weekly.

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