TABLE 2.
Subset Analyses: ABC Protocols
| IDFS End Point | |||||||
|---|---|---|---|---|---|---|---|
| Characteristic | Patients | Events | HR (95% CI) | P | Interaction P Value | ||
| TaxAC | TC | TaxAC | TC | ||||
| Protocola | |||||||
| USOR 06-090 | 642 | 645 | 97 | 140 | 1.39 (1.07 to 1.80) | .01 | |
| B-46-I/07132 | 522 | 529 | 75 | 88 | 1.21 (0.89 to 1.65) | .23 | .11 |
| B-49 | 915 | 928 | 170 | 161 | 0.96 (0.78 to 1.20) | .74 | |
| Hormone receptora | |||||||
| Negative | 657 | 647 | 114 | 139 | 1.30 (1.02 to 1.67) | .04 | .21 |
| Positive | 1,422 | 1,455 | 228 | 250 | 1.06 (0.89 to 1.27) | .50 | |
| Positive nodesa | |||||||
| 0 | 824 | 866 | 120 | 141 | 1.10 (0.86 to 1.40) | .45 | |
| 1-3 | 934 | 914 | 130 | 145 | 1.16 (0.91 to 1.47) | .23 | .82 |
| 4+ | 321 | 322 | 92 | 103 | 1.14 (0.86 to 1.51) | .36 | |
| Raceb | |||||||
| White | 1,747 | 1,803 | 280 | 331 | 1.17 (1.0 to 1.37) | .06 | .58 |
| Black | 223 | 238 | 43 | 50 | 1.09 (0.71 to 1.68) | .69 | |
| Histologic gradeb | |||||||
| Low/intermediate | 977 | 994 | 138 | 153 | 1.08 (0.86 to 1.36) | .51 | .71 |
| High | 1,062 | 1,073 | 199 | 230 | 1.15 (0.95 to 1.39) | .15 | |
| Overall | 2,079 | 2,102 | 342 | 389 | 1.14 (0.99 to 1.32) | .08 | |
| RFI End Point | |||||||
| Patients | Events | ||||||
| Characteristic | TaxAC | TC | TaxAC | TC | HR (95% CI) | P | Interaction P Value |
| Protocola | |||||||
| USOR 06-090 | 642 | 645 | 61 | 111 | 1.76 (1.29 to 2.40) | .0003 | |
| B-46-I/07132 | 522 | 529 | 50 | 68 | 1.40 (0.97 to 2.03) | .07 | .13 |
| B-49 | 915 | 928 | 105 | 116 | 1.15 (0.88 to 1.49) | .32 | |
| Hormone receptora | |||||||
| Negative | 657 | 647 | 62 | 107 | 1.90 (1.39 to 2.61) | <.0001 | .02 |
| Positive | 1,422 | 1,455 | 154 | 188 | 1.19 (0.96 to 1.47) | .11 | |
| Positive nodesa | |||||||
| 0 | 824 | 866 | 64 | 104 | 1.52 (1.11 to 2.07) | .008 | |
| 1-3 | 934 | 914 | 84 | 105 | 1.30 (0.97 to 1.73) | .08 | .41 |
| 4+ | 321 | 322 | 68 | 86 | 1.29 (0.94 to 1.77) | .12 | |
| Raceb | |||||||
| White | 1,747 | 1,803 | 177 | 249 | 1.40 (1.15 to 1.70) | .0007 | .87 |
| Black | 223 | 238 | 27 | 40 | 1.52 (0.90 to 2.54) | .11 | |
| Histologic gradeb | |||||||
| Low/intermediate | 977 | 994 | 86 | 110 | 1.23 (0.93 to 1.64) | .15 | .41 |
| High | 1,062 | 1,073 | 127 | 181 | 1.44 (1.15 to 1.82) | .002 | |
| Overall | 2,079 | 2,102 | 216 | 295 | 1.38 (1.16 to 1.65) | .0003 | |
| OS End Point | |||||||
| Patients | Events | ||||||
| Characteristic | TaxAC | TC | TaxAC | TC | HR (95% CI) | P | Interaction P Value |
| Protocola | |||||||
| USOR 06-090 | 642 | 645 | 71 | 89 | 1.18 (0.87 to 1.62) | .29 | |
| B-46-I/07132 | 522 | 529 | 45 | 58 | 1.27 (0.86 to 1.88) | .23 | .21 |
| B-49 | 915 | 928 | 105 | 87 | 0.85 (0.64 to 1.13) | .27 | |
| Hormone receptora | |||||||
| Negative | 657 | 647 | 75 | 94 | 1.30 (0.96 to 1.77) | .09 | .10 |
| Positive | 1,422 | 1,455 | 146 | 140 | 0.92 (0.73 to 1.16) | .49 | |
| Positive nodesa | |||||||
| 0 | 824 | 866 | 76 | 84 | 1.01 (0.74 to 1.38) | .93 | |
| 1-3 | 934 | 914 | 77 | 80 | 1.08 (0.79 to 1.48) | .64 | .92 |
| 4+ | 321 | 322 | 68 | 70 | 1.02 (0.73 to 1.43) | .90 | |
| Raceb | |||||||
| White | 1,747 | 1,803 | 181 | 196 | 1.06 (0.86 to 1.30) | .58 | .94 |
| Black | 223 | 238 | 28 | 34 | 1.12 (0.66 to 1.90) | .67 | |
| Histologic gradeb | |||||||
| Low/intermediate | 977 | 994 | 78 | 80 | 0.98 (0.72 to 1.35) | .91 | .84 |
| High | 1,062 | 1,073 | 141 | 150 | 1.03 (0.81 to 1.30) | .82 | |
| Overall | 2,079 | 2,102 | 221 | 234 | 1.05 (0.87 to 1.26) | .64 | |
Abbreviations: ABC, anthracyclines in early breast cancer; HR, hazard ratio; IDFS, invasive disease-free survival; OS, overall survival; RFI, recurrence-free interval; TaxAC, docetaxel or paclitaxel with cyclophosphamide and doxorubicin; TC, docetaxel with cyclophosphamide.
aPrespecified subset analysis.
bExploratory subset analysis.