Table 1.
Clinical characteristics of patients according to the 10-miRNA classifier in the training, internal and two external validation groups.
| Variables | Training groupa |
Internal validation groupa |
External validation group-1b |
External validation group-2c |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | Low risk |
High risk |
P |
Total | Low risk |
High risk |
P |
Total | Low risk |
High risk |
P |
Total | Low risk |
High risk |
P |
||
| (%) | (%) | value | (%) | (%) | value | (%) | (%) | value | (%) | (%) | value | ||||||
| Age | ≤ 40 years | 17 | 12 (70.6%) | 5 (29.4%) | 0.299 | 16 | 10 (62.5%) | 6 (37.5%) | 0.003 | 26 | 18 (69.2%) | 8 (30.8%) | 0.571 | 27 | 24 (88.9%) | 3 (11.1%) | 0.139 |
| > 40 years | 185 | 150 (81.1%) | 35 (18.9%) | 85 | 77 (90.6%) | 8 (9.4%) | 126 | 94 (74.6%) | 32 (25.4%) | 129 | 98 (76.0%) | 31 (24.0%) | |||||
| Menopause | Yes | 127 | 98 (77.2%) | 29(22.8%) | 0.201 | 62 | 53 (85.5%) | 9(14.5%) | 0.81 | 83 | 54(65.1%) | 29(34.9%) | 0.01 | 101 | 81(80.2%) | 20(19.8%) | 0.424 |
| No | 75 | 64 (85.3%) | 11(14.7%) | 39 | 34 (87.2%) | 5(12.8%) | 69 | 58(84.1%) | 11(15.9%) | 55 | 41(74.5%) | 14(25.5%) | |||||
| Tumor size | ≤ 2 cm | 72 | 61 (84.7%) | 11 (15.3%) | 0.23 | 35 | 34 (97.1%) | 1 (2.9%) | 0.02 | 33 | 26 (78.8%) | 7 (21.2%) | 0.452 | 39 | 34 (87.2%) | 5 (12.8%) | 0.117 |
| > 2 cm | 130 | 101 (77.7%) | 29 (22.3%) | 66 | 53 (80.3%) | 13 (19.7%) | 119 | 86 (72.3%) | 33 (27.7%) | 117 | 88 (75.2%) | 29 (24.8%) | |||||
| Lymph node | Negative | 97 | 88 (90.7%) | 9 (9.3%) | < 0.0001 | 57 | 57 (100%) | 0 (0.0%) | < 0.0001 | 85 | 71 (83.5%) | 14 (16.5%) | 0.002 | 46 | 41 (89.1%) | 5 (10.9%) | 0.033 |
| Positive | 105 | 74 (70.5%) | 31 (29.5%) | 44 | 30 (68.2%) | 14 (31.8%) | 67 | 41 (61.2%) | 26 (38.8%) | 110 | 81 (73.6%) | 29 (26.4%) | |||||
| TNM stage | I | 45 | 43 (95.6%) | 2 (4.4%) | < 0.0001 | 26 | 26 (100%) | 0 (0.0%) | < 0.0001 | 22 | 20 (90.9%) | 2 (9.1%) | 0.05 | 35 | 29 (82.9%) | 6 (17.1%) | 0.006 |
| II | 100 | 87 (87.0%) | 13 (13.0%) | 53 | 52 (98.1%) | 1 (1.9%) | 90 | 67 (74.4%) | 23 (25.6%) | 69 | 60 (87.0%) | 9 (13.0%) | |||||
| III | 57 | 32 (56.1%) | 25 (43.9%) | 22 | 9 (40.9%) | 13 (59.1%) | 40 | 25 (62.5%) | 15 (37.5%) | 52 | 33 (63.5%) | 19 (36.5%) | |||||
| Tumor grade | I | 25 | 23 (92.0%) | 2 (8.0%) | 0.114 | 16 | 16 (100%) | 0 (0.0%) | 0.08 | 13 | 9 (69.2%) | 4 (30.8%) | 0.703 | 10 | 9 (90.0%) | 1 (10.0%) | 0.35 |
| II-III | 177 | 139 (78.5%) | 38 (21.5%) | 85 | 71 (83.5%) | 14 (16.5%) | 139 | 103 (74.1%) | 36 (25.9%) | 146 | 113 (77.4%) | 33 (22.6%) | |||||
| PR | Negative | 75 | 63(84.0%) | 12(16.0%) | 0.362 | 43 | 36(83.7%) | 7(16.3%) | 0.572 | 59 | 41(69.5%) | 18(30.5%) | 0.45 | 59 | 46(78.0%) | 13(22.0%) | 0.955 |
| Positive | 127 | 99(78.0%) | 28(22.0%) | 58 | 51(87.9%) | 7(12.1%) | 93 | 71(76.3%) | 22(23.7%) | 97 | 76(78.4%) | 21(21.6%) | |||||
| Ki67 | ≤ 14% | 74 | 63 (85.1%) | 11 (14.9%) | 0.181 | 40 | 38 (95%) | 2 (5.0%) | 0.037 | 84 | 67 (79.8%) | 17 (20.2%) | 0.059 | 73 | 63 (86.3%) | 10 (13.7%) | 0.022 |
| > 14% | 128 | 99 (77.3%) | 29 (22.7%) | 61 | 49 (80.3%) | 12 (19.7%) | 68 | 45 (66.2%) | 23 (33.8%) | 83 | 59 (71.1%) | 24 (28.9%) | |||||
| Surgery | Mastectomy | 112 | 89 (79.5%) | 23 (20.5%) | 0.77 | 60 | 49 (81.7%) | 11 (18.3%) | 0.116 | 142 | 106 (74.6%) | 36 (25.4%) | 0.309 | 147 | 114 (77.6%) | 33 (22.4%) | 0.508 |
| BCS | 90 | 73 (81.1%) | 17 (18.9%) | 41 | 38 (92.7%) | 3 (7.3%) | 10 | 6 (60.0%) | 4 (40%) | 8 | 7 (87.5%) | 1 (12.5%) | |||||
| Chemotherapy | No | 43 | 32 (74.4%) | 11 (25.6%) | 0.284 | 17 | 13 (76.5%) | 4 (23.5%) | 0.206 | 44 | 30 (68.2%) | 14 (31.8%) | 0.325 | 38 | 29 (76.3%) | 9 (23.7%) | 0.746 |
| Yes | 159 | 130 (81.8%) | 29 (18.2%) | 84 | 74 (88.1%) | 10 (11.9%) | 108 | 82 (75.9%) | 26 (24.1%) | 118 | 93 (78.8%) | 25 (21.2%) | |||||
| ET | TAM | 101 | 79(78.2%) | 22(21.8%) | 0.775 | 65 | 54(83.1%) | 11(16.9%) | 0.396 | 81 | 63(77.8%) | 18(22.2%) | 0.214 | 87 | 67(77.0%) | 20(23.0%) | 0.764 |
| AI | 89 | 73(82.0%) | 16(18.0%) | 30 | 28(93.3%) | 2(6.7%) | 63 | 42(66.7%) | 21(33.3%) | 58 | 47(81.0%) | 11(19.0%) | |||||
| TAM → AI | 12 | 10(83.3%) | 2(16.7%) | 6 | 5(83.3%) | 1(16.7%) | 8 | 7(87.5%) | 1(12.5%) | 11 | 8(72.7%) | 3(27.3%) | |||||
| IHC4 score | Low risk | 36 | 31 (86.1%) | 5 (13.9%) | 0.367 | 25 | 23 (92.0%) | 2 (8%) | 0.358 | 53 | 45 (84.9%) | 8 (15.1%) | 0.015 | 43 | 38 (88.4%) | 5 (11.6%) | 0.124 |
| Median risk | 127 | 98 (77.2%) | 29 (22.8%) | 59 | 51 (86.4%) | 8 (13.6%) | 49 | 37 (75.5%) | 12 (24.5%) | 61 | 47 (77.0%) | 14 (23.0%) | |||||
| High risk | 39 | 33 (84.6%) | 6 (15.4%) | 17 | 13 (76.5%) | 4 (23.5%) | 50 | 30 (60.0%) | 20 (40.0%) | 52 | 37 (71.2%) | 15 (28.8%) | |||||
| Total | 202 | 162 (80.2%) | 40 (19.8%) | 101 | 87 (86.1%) | 14 (13.9%) | 152 | 112 (73.7%) | 40 (26.3%) | 156 | 122 (78.2%) | 34 (21.8%) | |||||
Data are mean (SD) or n (%), unless otherwise stated; P value is calculated by χ2 test or Fisher's exact test; a: Cohort 1 includes training group and internal validation group; b: external validation group-1 = Cohort 2; c: external validation group-2 = Cohort 3; PR: progesterone receptor; BCS: breast conserving surgery; ET: endocrine therapy; TAM → AI: tamoxifen followed by aromatase inhibitor.