Clinicopathologic characteristics and marker distribution according to CCND1 amplification status for all and ER-positive tumors
| . | CCND1 amplified, n = 44 (%) . | CCND1 nonamplified, n = 236 (%) . | P . | CCND1 amplified ER+, n = 42 (%) . | CCND1 nonamplified ER+, n = 151 (%) . | P . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age (y) | ||||||||||||
| Median (range) | 44.5 (33-52) | 44 (25-57) | 0.81* | 44.5 (33-52) | 45 (26-57) | 0.78* | ||||||
| <40 | 7 (15.9) | 52 (22.0) | 0.53† | 6 (14.3) | 27 (17.9) | 0.59† | ||||||
| 40-49 | 32 (72.7) | 151 (64.0) | 31 (73.8) | 99 (65.6) | ||||||||
| >50 | 5 (11.4) | 33 (13.0) | 5 (11.9) | 25 (16.5) | ||||||||
| Randomization | ||||||||||||
| Tamoxifen | 23 (52.3) | 111 (47.0) | 0.63† | 21 | 72 (47.7) | 0.79† | ||||||
| Control | 21 (47.7) | 125 (53.0) | 21 | 79 (52.3) | ||||||||
| Tumor size (mm) | ||||||||||||
| Median (range) | 20.5 (4-50) | 25 (2-55) | 0.11* | 20 (4-50) | 23 (7-50) | 0.32* | ||||||
| <20 | 22 (50.0) | 91 (38.6) | 0.21† | 22 (5.5) | 64 (42.4) | 0.25† | ||||||
| >20 | 22 (50.0) | 145 (61.4) | 20 (47.6) | 87 (57.6) | ||||||||
| Node status | ||||||||||||
| 0 | 8 (18.2) | 67 (28.4) | 0.02† | 8 (19.0) | 32 (21.2) | 0.42† | ||||||
| 1-3 | 28 (63.6) | 114 (48.3) | 27 (64.3) | 81 (53.6) | ||||||||
| >4 | 7 (15.9) | 55 (23.3) | 7 (16.7) | 38 (25.2) | ||||||||
| Not evaluated | 1 (2.3) | 2 | — | — | ||||||||
| NHG | ||||||||||||
| 1 | 2 (4.5) | 34 (14.4) | 0.001† | 2 (4.8) | 30 (19.9) | 0.03† | ||||||
| 2 | 30 (68.2) | 86 (36.4) | 29 (69.0) | 75 (49.7) | ||||||||
| 3 | 12 (27.3) | 109 (46.2) | 11 (26.2) | 45 (29.8) | ||||||||
| Not evaluated | — | 7 (3.0) | — | 1 (0.6) | ||||||||
| ER | ||||||||||||
| Negative | 1 (2.3) | 80 (33.9) | <0.001 | — | — | — | ||||||
| Positive | 42 (95.4) | 151 (64.0) | — | — | ||||||||
| Not evaluated | 1 (2.3) | 5 (2.1) | — | — | ||||||||
| PR | ||||||||||||
| Negative | 5 (11.4) | 82 (34.7) | 0.001 | 3 (7.1) | 14 (9.3) | 0.89† | ||||||
| Positive | 38 (86.4) | 141 (59.7) | 38 (90.5) | 132 (87.4) | ||||||||
| Not evaluated | 1 (2.3) | 13 (5.5) | 1 (2.4) | 5 (3.3) | ||||||||
| Ki-67 index (%) | ||||||||||||
| 0-1 | 2 (4.5) | 36 (15.2) | 0.03† | 2 (4.8) | 24 (15.9) | 0.27† | ||||||
| 2-10 | 21 (47.8) | 68 (28.8) | 20 (47.6) | 57 (37.8) | ||||||||
| 10-25 | 15 (34.1) | 53 (22.4) | 15 (35.7) | 35 (23.2) | ||||||||
| 25-50 | 4 (9.1) | 26 (11.0) | 4 (9.5) | 16 (10.6) | ||||||||
| >50 | 2 (4.5) | 30 (12.7) | 1 (2.4) | 4 (2.6) | ||||||||
| Not evaluated | — | 23 (9.7) | — | 15 (9.9) | ||||||||
| D1 nuclear fraction (%) | ||||||||||||
| 0 | 0 | 56 (23.7) | <0.001† | 0 | 10 (6.6) | <0.001† | ||||||
| 1-25 | 9 (20.4) | 100 (42.4) | 9 (21.4) | 71 (47.0) | ||||||||
| 26-50 | 15 (34.1) | 49 (20.8) | 14 (33.13) | 43 (28.5) | ||||||||
| 51-75 | 11 (25.0) | 23 (9.7) | 11 (26.2) | 21 (13.9) | ||||||||
| >75 | 8 (18.2) | 4 (1.7) | 8 (19.0) | 4 (2.6) | ||||||||
| Not evaluated | 1 (2.3) | 4 (1.7) | — | 2 (1.3) | ||||||||
| D1 nuclear intensity | ||||||||||||
| 0 | 0 | 56 (23.7) | <0.001† | 0 | 10 (6.6) | <0.001† | ||||||
| 1 | 8 (18.2) | 91 (38.6) | 8 (19.0) | 61 (40.4) | ||||||||
| 2 | 22 (50.0) | 70 (29.7) | 21 (50.0) | 64 (42.4) | ||||||||
| 3 | 13 (29.5) | 15 (6.3) | 13 (31.0) | 14 (9.3) | ||||||||
| Not evaluated | 1 (2.3) | 4 (1.7) | — | 2 (1.3) | ||||||||
| D1 cytoplasmic intensity | ||||||||||||
| 0 | 1 (2.3) | 16 (6.8) | 0.04† | 0 | 2 (1.3) | 0.31† | ||||||
| 1 | 13 (29.5) | 96 (40.7) | 13 (31.0) | 50 (33.1) | ||||||||
| 2 | 14 (31.8) | 83 (35.2) | 14 (33.3) | 65 (43.1) | ||||||||
| 3 | 15 (34.1) | 37 (15.7) | 15 (35.7) | 32 (21.2) | ||||||||
| 3+++ | 0 | 2 (0.8) | 0 | 2 (1.3) | ||||||||
| Not evaluated | 1 (2.3) | 2 (0.8) | — | — | ||||||||
| A2 nuclear fraction (%) | ||||||||||||
| 0-1 | 1 (2.3) | 30 (12.7) | 0.04† | 1 (2.4) | 21 (13.9) | 0.14† | ||||||
| 2-10 | 23 (52.3) | 78 (33.0) | 22 (52.4) | 61 (40.4) | ||||||||
| 11-25 | 16 (36.3) | 75 (31.8) | 16 (38.1) | 46 (30.5) | ||||||||
| 26-50 | 1 (2.3) | 24 (10.2) | 0 | 5 (3.3) | ||||||||
| 51-100 | 0 | 2 (0.8) | 0 | 1 (0.7) | ||||||||
| Not evaluated | 3 (6.8) | 27 (11.4) | 3 (7.1) | 17 (11.2) | ||||||||
| . | CCND1 amplified, n = 44 (%) . | CCND1 nonamplified, n = 236 (%) . | P . | CCND1 amplified ER+, n = 42 (%) . | CCND1 nonamplified ER+, n = 151 (%) . | P . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age (y) | ||||||||||||
| Median (range) | 44.5 (33-52) | 44 (25-57) | 0.81* | 44.5 (33-52) | 45 (26-57) | 0.78* | ||||||
| <40 | 7 (15.9) | 52 (22.0) | 0.53† | 6 (14.3) | 27 (17.9) | 0.59† | ||||||
| 40-49 | 32 (72.7) | 151 (64.0) | 31 (73.8) | 99 (65.6) | ||||||||
| >50 | 5 (11.4) | 33 (13.0) | 5 (11.9) | 25 (16.5) | ||||||||
| Randomization | ||||||||||||
| Tamoxifen | 23 (52.3) | 111 (47.0) | 0.63† | 21 | 72 (47.7) | 0.79† | ||||||
| Control | 21 (47.7) | 125 (53.0) | 21 | 79 (52.3) | ||||||||
| Tumor size (mm) | ||||||||||||
| Median (range) | 20.5 (4-50) | 25 (2-55) | 0.11* | 20 (4-50) | 23 (7-50) | 0.32* | ||||||
| <20 | 22 (50.0) | 91 (38.6) | 0.21† | 22 (5.5) | 64 (42.4) | 0.25† | ||||||
| >20 | 22 (50.0) | 145 (61.4) | 20 (47.6) | 87 (57.6) | ||||||||
| Node status | ||||||||||||
| 0 | 8 (18.2) | 67 (28.4) | 0.02† | 8 (19.0) | 32 (21.2) | 0.42† | ||||||
| 1-3 | 28 (63.6) | 114 (48.3) | 27 (64.3) | 81 (53.6) | ||||||||
| >4 | 7 (15.9) | 55 (23.3) | 7 (16.7) | 38 (25.2) | ||||||||
| Not evaluated | 1 (2.3) | 2 | — | — | ||||||||
| NHG | ||||||||||||
| 1 | 2 (4.5) | 34 (14.4) | 0.001† | 2 (4.8) | 30 (19.9) | 0.03† | ||||||
| 2 | 30 (68.2) | 86 (36.4) | 29 (69.0) | 75 (49.7) | ||||||||
| 3 | 12 (27.3) | 109 (46.2) | 11 (26.2) | 45 (29.8) | ||||||||
| Not evaluated | — | 7 (3.0) | — | 1 (0.6) | ||||||||
| ER | ||||||||||||
| Negative | 1 (2.3) | 80 (33.9) | <0.001 | — | — | — | ||||||
| Positive | 42 (95.4) | 151 (64.0) | — | — | ||||||||
| Not evaluated | 1 (2.3) | 5 (2.1) | — | — | ||||||||
| PR | ||||||||||||
| Negative | 5 (11.4) | 82 (34.7) | 0.001 | 3 (7.1) | 14 (9.3) | 0.89† | ||||||
| Positive | 38 (86.4) | 141 (59.7) | 38 (90.5) | 132 (87.4) | ||||||||
| Not evaluated | 1 (2.3) | 13 (5.5) | 1 (2.4) | 5 (3.3) | ||||||||
| Ki-67 index (%) | ||||||||||||
| 0-1 | 2 (4.5) | 36 (15.2) | 0.03† | 2 (4.8) | 24 (15.9) | 0.27† | ||||||
| 2-10 | 21 (47.8) | 68 (28.8) | 20 (47.6) | 57 (37.8) | ||||||||
| 10-25 | 15 (34.1) | 53 (22.4) | 15 (35.7) | 35 (23.2) | ||||||||
| 25-50 | 4 (9.1) | 26 (11.0) | 4 (9.5) | 16 (10.6) | ||||||||
| >50 | 2 (4.5) | 30 (12.7) | 1 (2.4) | 4 (2.6) | ||||||||
| Not evaluated | — | 23 (9.7) | — | 15 (9.9) | ||||||||
| D1 nuclear fraction (%) | ||||||||||||
| 0 | 0 | 56 (23.7) | <0.001† | 0 | 10 (6.6) | <0.001† | ||||||
| 1-25 | 9 (20.4) | 100 (42.4) | 9 (21.4) | 71 (47.0) | ||||||||
| 26-50 | 15 (34.1) | 49 (20.8) | 14 (33.13) | 43 (28.5) | ||||||||
| 51-75 | 11 (25.0) | 23 (9.7) | 11 (26.2) | 21 (13.9) | ||||||||
| >75 | 8 (18.2) | 4 (1.7) | 8 (19.0) | 4 (2.6) | ||||||||
| Not evaluated | 1 (2.3) | 4 (1.7) | — | 2 (1.3) | ||||||||
| D1 nuclear intensity | ||||||||||||
| 0 | 0 | 56 (23.7) | <0.001† | 0 | 10 (6.6) | <0.001† | ||||||
| 1 | 8 (18.2) | 91 (38.6) | 8 (19.0) | 61 (40.4) | ||||||||
| 2 | 22 (50.0) | 70 (29.7) | 21 (50.0) | 64 (42.4) | ||||||||
| 3 | 13 (29.5) | 15 (6.3) | 13 (31.0) | 14 (9.3) | ||||||||
| Not evaluated | 1 (2.3) | 4 (1.7) | — | 2 (1.3) | ||||||||
| D1 cytoplasmic intensity | ||||||||||||
| 0 | 1 (2.3) | 16 (6.8) | 0.04† | 0 | 2 (1.3) | 0.31† | ||||||
| 1 | 13 (29.5) | 96 (40.7) | 13 (31.0) | 50 (33.1) | ||||||||
| 2 | 14 (31.8) | 83 (35.2) | 14 (33.3) | 65 (43.1) | ||||||||
| 3 | 15 (34.1) | 37 (15.7) | 15 (35.7) | 32 (21.2) | ||||||||
| 3+++ | 0 | 2 (0.8) | 0 | 2 (1.3) | ||||||||
| Not evaluated | 1 (2.3) | 2 (0.8) | — | — | ||||||||
| A2 nuclear fraction (%) | ||||||||||||
| 0-1 | 1 (2.3) | 30 (12.7) | 0.04† | 1 (2.4) | 21 (13.9) | 0.14† | ||||||
| 2-10 | 23 (52.3) | 78 (33.0) | 22 (52.4) | 61 (40.4) | ||||||||
| 11-25 | 16 (36.3) | 75 (31.8) | 16 (38.1) | 46 (30.5) | ||||||||
| 26-50 | 1 (2.3) | 24 (10.2) | 0 | 5 (3.3) | ||||||||
| 51-100 | 0 | 2 (0.8) | 0 | 1 (0.7) | ||||||||
| Not evaluated | 3 (6.8) | 27 (11.4) | 3 (7.1) | 17 (11.2) | ||||||||