Table 1.
Demographic and disease characteristics of patients.
| Variables | Derivation Cohort | Training Group (n=84) |
Testing Group (n=36) |
P a | Validation Cohort (n=45) | P b |
|---|---|---|---|---|---|---|
| n | 120 | 84 | 36 | 45 | ||
| Age | 49.07 ± 8.19 | 48.83 ± 8.02 | 49.61 ± 8.69 | 0.636 | 52.51 ± 10.44 | 0.027 |
| Immunological Comorbidities | ||||||
| Recent Blood Transfusion History (%) | / | / | ||||
| Yes | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| No | 120 (100.0) | 72 (100.0) | 36 (100.0) | 45 (100.0) | ||
| Immunological Diseases (%) | / | / | ||||
| Yes | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| No | 120 (100.0) | 72 (100.0) | 36 (100.0) | 45 (100.0) | ||
| Tumor Burden | ||||||
| T (%) | 0.402 | 0.461 | ||||
| T0 | 2 (1.7) | 1 (50.0) | 1 (50.0) | 0 (0.0) | ||
| T1 | 13 (10.8) | 8 (9.5) | 5 (13.9). | 4 (9.1) | ||
| T2 | 57 (47.5) | 37 (44.0) | 20 (55.6) | 21 (47.7) | ||
| T3 | 23 (19.2) | 17 (20.2) | 6 (16.7) | 5 (11.4) | ||
| T4 | 25 (20.8) | 21 (25.0) | 4 (11.1) | 14 (31.8) | ||
| N (%) | / | |||||
| N3c | 120 (100) | 84 (100) | 36 (100) | 45 (100.0) | ||
| Pretreatment Histological Characteristics | ||||||
| Histological Subtype (%) | 0.142 | 0.055 | ||||
| IDC | 97 (80.8) | 65 (77.4) | 32 (88.9) | 41 (93.2) | ||
| Others | 23 (19.2) | 19 (22.6) | 4 (11.1) | 3 (6.8) | ||
| ER Status (%) | 0.686 | 0.748 | ||||
| positive | 70 (58.3) | 48 (57.1) | 22 (61.1) | 25 (55.6) | ||
| negative | 50 (41.7) | 36 (42.9) | 14 (38.9) | 20 (44.4) | ||
| PR Status (%) | 0.354 | 0.392 | ||||
| positive | 69 (57.5) | 46 (54.8) | 23 (63.9) | 22 (50.0) | ||
| negative | 51 (42.5) | 38 (45.2) | 13 (36.1) | 22 (50.0) | ||
| HR Status (%) | 0.228 | 0.450 | ||||
| positive | 77 (64.2) | 51 (60.7) | 26 (72.2) | 26 (57.8) | ||
| negative | 43 (35.8) | 33 (39.3) | 10 (27.8) | 19 (42.2) | ||
| HER-2 Status (%) | 0.543 | |||||
| positive | 48 (40.0) | 31 (36.9) | 17 (47.2) | 17 (37.8) | ||
| negative | 67 (55.8) | 49 (58.3) | 18 (50.0) | 28 (62.2) | ||
| uncertain | 5 (4.2) | 4 (4.8) | 1 (2.8) | 0 (0.0) | ||
| Grade | 0.886 | 0.008 | ||||
| II | 33 (27.5) | 22 (26.2) | 11 (30.6) | 24 (53.3) | ||
| III/IV | 49 (40.8) | 35 (41.7) | 14 (38.9) | 12 (26.7) | ||
| uncertain | 38 (31.7) | 27 (32.1) | 11 (30.6) | 9 (20.0) | ||
| Treatment Therapy | ||||||
| NAC Regimen (%) | 0.035 | 0.018 | ||||
| Anthracycline-based | 37 (40.8) | 31 (36.9) | 6 (16.7) | 5 (11.1) | ||
| Paclitaxel-based | 18 (15.0) | 11 (13.1) | 7 (19.4) | 8 (17.8) | ||
| Anthracycline and Paclitaxel combined |
53 (44.2) | 37 (44.0) | 16 (44.4) | 21 (46.7) | ||
| Others | 12 (10.0) | 5 (6.0) | 7 (19.4) | 11 (24.4) | ||
| NAC Cycles (%) | 0.282 | <0.001 | ||||
| < 4 cycles | 10 (8.3) | 9 (10.7) | 1 (2.8) | 0 (0.0) | ||
| 4-6 cycles | 87 (72.5) | 58 (69.0) | 29 (80.6) | 25 (55.6) | ||
| >6 cycles | 23 (19.2) | 17 (20.2) | 6 (16.7) | 20 (44.4) | ||
| Anti-HER2 Regimen (%) | 0.690 | 0.201 | ||||
| Yes | 24 (20.0) | 16 (19.0) | 8 (22.2) | 17 (37.8) | ||
| No | 96 (80.0) | 68 (81.0) | 28 (77.8) | 28 (62.2) | ||
| Breast Surgery (%) | 0.203 | 0.014 | ||||
| BCS | 2 (1.7) | 2 (2.4) | 0 (0) | 1 (2.2) | ||
| mastectomy | 113 (94.2) | 77 (91.7) | 36 (100) | 36 (80.0) | ||
| contralateral mastectomy | 5 (4.2) | 5 (6.0) | 0 (0) | 8 (17.8) | ||
| Postoperative Radiotherapy (%) | 0.082 | 0.253 | ||||
| Yes | 106 (88.3) | 77 (91.7) | 29 (80.6) | 35 (81.4) | ||
| No | 14 (11.7) | 7 (8.3) | 7 (19.4) | 8 (18.6) | ||
| Laboratory Results | ||||||
| Pre-treatment | ||||||
| neutrophils | 3.92 (2.14) | 3.93 (2.37) | 3.91 (1.85) | 0.731 | 3.56 (1.92) | 0.119 |
| lymphocytes | 1.65 (0.82) | 1.66 (0.73) | 1.63 (0.88) | 0.49 | 1.68 (0.6) | 0.727 |
| platelet | 193.5 (88.5) | 193.5 (89.25) | 195.0 (88.50) | 0.817 | 220.0 (82.50) | 0.157 |
| SII | 437.07 (389.04) | 441.71 (354.35) | 420.04 (430.34) | 0.606 | 441.43 (228.08) | 0.733 |
| NLR | 2.32 (1.3) | 2.41 (1.09) | 1.97 (1.44) | 0.41 | 2.06 (1.09) | 0.250 |
| Pre-operative | ||||||
| neutrophils | 2.63 (2.25) | 2.51 (2.35) | 2.76 (1.82) | 0.966 | 2.77 (1.63) | 0.438 |
| lymphocytes | 1.23 (0.5) | 1.21 (0.46) | 1.37 (0.6) | 0.168 | 1.22 (0.59) | 0.632 |
| platelet | 197.5 (102.75) | 190.5 (93.5) | 211 (126) | 0.254 | 188 (70) | 0.663 |
| SII | 390.51 (385.08) | 383.42 (379.6) | 408.41 (397.37) | 0.832 | 429.6 (346.57) | 0.997 |
| NLR | 2.04 (2.3) | 2.12 (2.48) | 1.76 (1.82) | 0.443 | 2.08 (1.68) | 0.690 |
| CEA<2.2 | 58 (48.3) | 40 (47.6) | 18 (50.0) | 0.881 | 26 (57.8) | 0.280 |
| CA15-3<18 | 57 (47.5) | 45 (53.6) | 12 (33.3) | 0.042 | 34 (75.6) | 0.001 |
| NAC Efficacy | ||||||
| Breast pCR | 18 (15.0) | 14 (16.7) | 4 (11.1) | 0.435 | 8 (17.8) | 0.663 |
| Axillary pCR | 15 (12.5) | 9 (10.7) | 6 (16.7) | 0.366 | 14 (34.1) | 0.002 |
| ISLN pCR | 32 (26.7) | 22 (26.2) | 10 (27.8) | 0.857 | 20 (44.4) | 0.029 |
| Total pCR | 7 (5.8) | 4 (4.8) | 3 (8.3) | 0.444 | 5 (11.1) | 0.245 |
IDC, invasive ductal carcinoma; ER, estrogen receptor; PR, progesterone receptor; HR, hormone receptor; HER-2, human epidermal growth factor receptor-2; BCS, breast conserving surgery; SII, systemic Immune-inflammation Index; NLR, neutrophil-to-lymphocyte ratio; CEA, carcinoembryonic antigen; CA15-3, carbohydrate antigen 15-3; pCR, pathological complete response.
Data are presented as the number of patients (%) and mean ± SD.
a
P value refers to the comparison between training and testing groups.
b
P value refers to the comparison between derivation and validation cohort.
P < 0.05 was considered statistically significant.