Table 1.
Characteristic | Sequential-ACT Group (N = 1783) | Doxorubicin–Docetaxel Group (N = 1784) | Concurrent-ACT Group (N = 1784) |
---|---|---|---|
Age at study entry | |||
Median (yr) | 51 | 50 | 51 |
<50 yr (%) | 46 | 46 | 44 |
Menopausal status (%) | |||
Premenopausal or perimenopausal | 45 | 47 | 45 |
Postmenopausal | 54 | 51 | 54 |
Unknown | 1 | 1 | 1 |
No. of positive nodes (%) | |||
1–3 | 64 | 65 | 65 |
4–9 | 25 | 24 | 25 |
≥10 | 8 | 8 | 8 |
Unknown | 3 | 3 | 2 |
Estrogen-receptor status (%)* | |||
Positive | 75 | 75 | 75 |
Negative | 25 | 25 | 25 |
Tumor size (%) | |||
≤2 cm | 42 | 42 | 43 |
>2–4 cm | 40 | 41 | 40 |
>4 cm | 15 | 14 | 15 |
Unknown | 3 | 3 | 2 |
Type of surgery (%)† | |||
Lumpectomy | 49 | 49 | 49 |
Mastectomy | 51 | 51 | 51 |
Type of radiotherapy (%) | |||
None after mastectomy | 23 | 21 | 22 |
Local after mastectomy | 28 | 30 | 29 |
Local after lumpectomy | 24 | 23 | 24 |
Local or regional after lumpectomy | 24 | 25 | 24 |
None after lumpectomy | 1 | 1 | 1 |
Assessment of estrogen-receptor (ER) and progesterone-receptor status was required before randomization. ER-positive tumors were defined by a finding of ≥10 fmol of cytosol protein per milligram by the dextrancoated charcoal or sucrose-density gradient method or as positive by the enzyme immunoassay method or by immunocytochemical assay. Patients without definitive negative results (e.g., those with results deemed to be marginal or borderline) were considered to have positive results.
Patients were required to have undergone primary breast-cancer surgery to be eligible for study entry.