Table 1.
Patient characteristics from the per‐protocol population (N = 226) enrolled in the clinical trial [11, 12] and from sub‐cohort of patients (N = 141) whose tumors were analyzed using the BC360™ panel to obtain gene expression data. ddCTX, dose‐dense chemotherapy; stCTX, standard chemotherapy.
| Per‐protocol population | Patients with gene expression data | |||||
|---|---|---|---|---|---|---|
| ddCTX (N = 113) | stCTX (N = 113) | P value a | ddCTX (N = 70) | stCTX (N = 71) | P value a | |
| Median age, years (range) | 55 (25–71) | 55 (32–71) | 0.875 | 55 (31–71) | 56 (32–71) | 0.800 |
| Menopausal status, N (%) | 0.892 | 0.320 | ||||
| Premenopausal | 44 (38.9) | 45 (39.8) | 22 (31.4) | 28 (39.4) | ||
| Postmenopausal | 69 (61.1) | 68 (60.2) | 48 (68.6) | 43 (60.6) | ||
| Laterality, n (%) | 0.287 | 0.804 | ||||
| Left | 63 (55.8) | 55 (48.7) | 36 (51.4) | 38 (53.5) | ||
| Right | 50 (44.2) | 58 (51.3) | 34 (48.6) | 33 (46.5) | ||
| pT stage | 0.799 | 0.965 | ||||
| 1 | 33 (29.2) | 28 (24.8) | 17 (24.3) | 18 (25.4) | ||
| 2 | 55 (48.7) | 60 (53.1) | 34 (48.6) | 33 (46.5) | ||
| 3 | 20 (17.7) | 19 (16.8) | 12 (17.1) | 14 (19.7) | ||
| 4 | 5 (4.4) | 5 (4.4) | 3 (4.3) | 4 (5.6) | ||
| Missing | 0 | 1 (0.9) | 4 (5.7) | 2 (2.8) | ||
| Median number of lymph nodes removed (range) | 21 (8–38) | 19 (8–92) | 0.893 | 21 (9–38) | 18 (8–92) | 0.671 |
| Number of involved lymph nodes, N (%) | 0.438 | 0.890 | ||||
| 4–9 | 83 (73.5) | 88 (77.9) | 51 (72.9) | 54 (76.1) | ||
| >9 | 30 (26.5) | 25 (22.1) | 15 (21.4) | 15 (21.1) | ||
| Missing | 0 | 0 | 4 (5.7) | 2 (2.8) | ||
| Grade, n (%) | 0.870 | 0.958 | ||||
| G1 | 7 (6.2) | 6 (5.3) | 4 (5.7) | 4 (5.6) | ||
| G2 | 54 (47.8) | 53 (46.9) | 34 (48.6) | 34 (47.9) | ||
| G3 | 48 (42.5) | 52 (46.0) | 28 (40.0) | 31 (43.7) | ||
| Missing | 4 (3.5) | 2 (1.8) | 4 (5.7) | 2 (2.8) | ||
| Hormone receptor status, N (%) | 0.251 | 0.150 | ||||
| Negative | 27 (23.9) | 20 (17.7) | 20 (28.6) | 13 (18.3) | ||
| Positive | 86 (76.1) | 93 (82.3) | 50 (71.4) | 58 (81.7) | ||
| Type of surgery, N (%) | 0.684 | 0.857 | ||||
| Breast‐conserving surgery | 44 (38.9) | 47 (41.6) | 22 (31.4) | 22 (31.0) | ||
| Mastectomy | 69 (61.1) | 66 (58.4) | 44 (62.9) | 47 (66.2) | ||
| Missing | 0 | 0 | 4 (5.7) | 2 (2.8) | ||
a
Categorical variable distributions were compared between arms using Fisher's exact test, while the means of continuous variables were compared using Student's t‐test.