Table 1.

Distribution of Patient Characteristics in Sample Compared With Not-in-Sample Cohort

Factor	In Sample (n = 465)		Not in Sample (n = 1,503)
	%	SE	%	SE
Chemotherapy
AT arm	50.1	1.1	50.2	1.1
AC arm	49.9	1.1	49.8	1.1
Age, years
≤ 45	23.7	2.0	27.1	1.2
46-65	63.7	2.3	63.0	1.3
> 65	12.7	1.6	9.9	0.8
Menopausal status
Premenopausal	41.4	2.4	47.6	1.3
Postmenopausal	58.6	2.4	52.4	1.3
Tumor size, cm
≤ 2.0	53.9	2.4	57.5	1.3
2.1-5.0	42.5	2.4	39.3	1.3
> 5.0	3.6	0.9	3.2	0.5
Axillary nodes
Negative	56.5	1.1	58.1	1.1
One positive	24.0	1.6	26.1	1.1
Two positive	13.5	1.4	10.5	0.8
Three positive	6.1	1.0	5.3	0.6
Local tumor grade
Low	12.3	1.6	14.4	0.9
Intermediate	48.6	2.4	48.8	1.3
High	33.2	2.2	29.7	1.2
Unknown	5.9	1.2	7.1	0.7
Central tumor grade
Low	22.6	2.1	NA
Intermediate	47.5	2.4	NA
High	29.9	2.2	NA
Local HER2/neu*
Positive	21.9	2.0	23.4	1.1
Negative	44.0	2.4	45.1	1.3
Unknown	34.1	2.3	31.5	1.2
Recurrence and survival
5-year RFI	90.0	0.7	91.1	0.7
5-year OS	92.3	1.1	94.3	0.6
Median follow-up, years	6.3		6.3

NOTE. The not-in-sample cohort included all patients with hormone receptor–positive disease (determined locally) not included in this analysis. There were no significant differences in the characteristics of sample patients included in this analysis compared with the not-in-sample group with hormone receptor–positive disease, with the exception of estimated menopause distributions (P = .03) and the proportion with two to three nodes positive (P = .05).

Abbreviations: AT, doxorubicin plus docetaxel; AC, doxorubicin plus cyclophosphamide; RFI, relapse-free interval; OS, overall survival; NA, not applicable (patients not in sample did not have tumor grade centrally reviewed).

^*Local HER2 positive included IHC 2+.