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Table 3 Select phase III trials of first, second, and third generation trials

From: Progress in adjuvant chemotherapy for breast cancer: an overview

Generation

Comparison (Reference)

Nodal status

Number of patients

Median follow-up (years)

Hazard ratio for disease-free survival

Hazard ratio for overall survival

First

CMF vs no chemo [22, 71]

Positive

386

28.5

0.71 (P = 0.005)

0.79 (P = 0.04)

 

CMF + Tam vs Tam (B20) [26]

Negative

2306

5

0.65 (P = 0.001)

0.64 (P = 0.03)

 

AC vs CMF (B15) [72, 73]

Positive

2194

3

P = 0.5*

P = 0.8*

 

AC vs CMF (B23) [74]

Negative

2008

5

P = 0.9*

P = 0.4*

 

FEC50 + Tam vs Tam [76]

Positive

457

9.4

0.46 (P = 0.0008)

0.65 (P = 0.07)

Second

FEC100 vs FEC50 [78]

Positive

546

5.6

0.63 (P = 0.02)

0.45 (P = 0.005)

 

ACx4-Tx4 vs ACx4 (C9344) [82]

Positive

3121

5.8

0.83 (P = 0.002)

0.82 (P = 0.006)

 

ACx4-Tx4 vs ACx4 (B28) [83]

Positive

3060

5.4

0.83 (P = 0.006)

0.93 (P = 0.46)

 

DCx4 vs ACx4 [85]

0–3 Positive

1016

7

0.74 (P = 0.033)

0.69 (P = 0.032)

 

Ex4-CMFx4 vs CMFx6/CMFx8 [84]

Positive Negative

2391

4

0.69 (P <0.001)

0.67 (P <0.001)

Third

DAC vs FAC [89, 112]

Positive

1491

10.3

0.80 (P = 0.004)

0.74 (P = 0.002)

 

DAC vs FAC [91]

Negative

1060

6.4

0.68 (P = 0.01)

0.76 (P = 0.29)

 

FEC-D vs FEC [92, 93]

Positive

1099

7.8

0.85 (P = 0.036)

0.75 (P = 0.007)

 

FEC-weekly T vs FEC [95]

Positive

1246

5.5

0.77 (P = 0.022)

0.78 (P = 0.11)

 

FAC-weekly T vs FAC [113]

Negative

1925

5.3

0.73 (P = 0.04)

0.79 (P = 0.31)

 

Q3 vs q2wk ACT [97, 98]

Positive

2005

5.8

0.80 (P = 0.01)

0.85 (P = 0.04)

 

AC-T vs AC-weekly T [100, 101]

Positive

4954

12.1

0.84 (P = 0.011)

0.87 (P = 0.09)

AC-T vs AC-D

0.79 (P = 0.001

0.86 (P = 0.054)

 

AC-D vs DAC [103]

Positive

5351

6.1

0.83 (P = 0.01)

0.86 (P = 0.09)

AC-D vs AD

0.80 (P = 0.001)

0.83 (P = 0.03)

  1. CMF, Cyclophosphamide, methotrexate, 5-flourouracil; AC, Doxorubicin, cyclophosphamide; FEC50, 5-flourouracil, epirubicin (50 mg/m2), cyclophosphamide; FEC100, 5-flourouracil, epirubicin (100 mg/m2), cyclophosphamide; DC, Docetaxel, cyclophosphamide; CAF, Cyclophosphamide, doxorubicin, 5-flourouracil; FAC, 5-flouroracil, doxorubicin, cyclophosphamide; DAC, Docetaxel, doxorubicin, cyclophosphamide; T, Paclitaxel; D, Docetaxel; E, Epirubicin
  2. *Hazard ratios were not reported in the manuscript; however P values did not reveal any statistical significance between study arms