Table 1.
Patient and tumor characteristics
| Parameter | All patients | NACT | Adjuvant CT | No CT | p Value | p Value | |
|---|---|---|---|---|---|---|---|
| n (%) | n (%) | n (%) | n (%) | None versus NACT versus Adjuvant | NACT versus Adjuvant CT | ||
| Number of patients | 333 | 97 (29%) | 168 (51%) | 68 (20%) | |||
| Age at diagnosis (years) | Median | 55 | 48 | 55 | 75 | < 0.001 | < 0.001 |
| Range | 24–92 | 24–73 | 30–79 | 30–92 | |||
| Menopausal | Pre | 119 (36%) | 57 (59%) | 58 (35%) | 4 (6%) | < 0.001 | < 0.001 |
| Status | Post | 200 (60%) | 33 (34%) | 105 (62%) | 62 (91%) | ||
| Unknown | 14 (4%) | 7 (7%) | 5 (3%) | 2 (3%) | |||
| BRCA mutation | None | 240 (72%) | 69 (71%) | 129 (77%) | 42 (62%) | 0.086 | 0.807 |
| BRCA1 mutation | 12 (4%) | 4 (4%) | 8 (5%) | 0 | |||
| BRCA2 mutation | 7 (2%) | 2 (2%) | 5 (3%) | 0 | |||
| Unknown | 74 (22%) | 22 (23%) | 26 (15%) | 26 (38%) | |||
| Family history of breast cancer | No | 123 (55%) | 40 (56%) | 66 (54%) | 17 (55%) | 0.956 | 0.763 |
| Yes | 101 (45%) | 31 (44%) | 56 (46%) | 14 (45%) | |||
| Tumor type | Ductal | 271 (81%) | 87 (90%) | 138 (82%) | 46 (68%) | 0.004 | 0.595 |
| Lobular | 16 (5%) | 1 (1%) | 7 (4%) | 8 (15%) | |||
| Metaplastic | 15 (5%) | 4 (4%) | 6 (4%) | 5 (7%) | |||
| Medullary | 14 (4%) | 4 (4%) | 8 (5%) | 2 (3%) | |||
| Apocrine | 9 (3%) | 1 (1%) | 2 (1%) | 6 (9%) | |||
| Othera | 4 (1%) | 0 | 3 (2%) | 1 (1%) | |||
| Unknown | 4 (1%) | 0 | 4 (2%) | 0 | |||
| Tumor grade | 1 | 1 (0.5%) | 0 | 1 (1%) | 0 | < 0.001 | < 0.001 |
| 2 | 63 (19%) | 27 (28%) | 15 (9%) | 21 (31%) | |||
| 3 | 265 (79.5%) | 70 (72%) | 148 (88%) | 47 (69%) | |||
| Unknown | 4 (1%) | 0 | 4 (2%) | 0 | |||
| Basal statusb | Positive | 254 (76%) | 79 (81%) | 131 (78%) | 44 (65%) | 0.225 | 0.227 |
| Negative | 57 (17%) | 12 (12%) | 31 (18%) | 14 (20%) | |||
| Unclassified | 22 (7%) | 6 (6%) | 6 (4%) | 10 (15%) | |||
| pT stage | 1 | 78 (33%) | NA | 57 (34%) | 21 (34%) | 0.088 | NA |
| 2 | 121 (51%) | 92 (55%) | 29 (48%) | ||||
| 3 | 11 (5%) | 8 (4.5%) | 3 (5%) | ||||
| 4 | 14 (6%) | 6 (4%) | 8 (13%) | ||||
| Unknown | 12 (5%) | 5 (3%) | 7 | ||||
| pN stage | 0 | 140 (59%) | NA | 104 (62%) | 36 (53%) | 0.619 | NA |
| 1 | 43 (18%) | 33 (20%) | 10 (15%) | ||||
| 2 | 19 (8%) | 12 (7%) | 7 (10%) | ||||
| 3 | 14 (6%) | 8 (5%) | 4 (6%) | ||||
| Unknown | 22 (9%) | 11 (6%) | 11 (16%) | ||||
| ypT stage | 0 | 35 (36%) | 35 (36%) | NA | NA | NA | NA |
| In situ | 8 (8%) | 8 (8%) | |||||
| 1 | 27 (28%) | 27 (28%) | |||||
| 2 | 12 (13%) | 12 (13%) | |||||
| 3 | 5 (5%) | 5 (5%) | |||||
| 4 | 10 (10%) | 10 (10%) | |||||
| ypN stage | 0 | 64 (66%) | 64 (66%) | NA | NA | NA | NA |
| 1 | 11 (11%) | 11 (11%) | |||||
| 2 | 13 (14%) | 13 (14%) | |||||
| 3 | 8 (8%) | 8 (8%) | |||||
| Unknown | 1 (1%) | 1(1%) | |||||
| M stage | 0 | 316 (95%) | 93 (96%) | 168 (100%) | 55 (81%) | < 0.001 | 0.008 |
| 1 | 17 (5%) | 4 (4%) | 0 | 13 (19%) | |||
| Chemotherapy | Anthra., Taxane | 124 (47%) | 64 (66%) | 60 (36%) | NA | NA | NA |
| Agentsc | Taxane | 64 (24%) | 0 | 64 (38%) | |||
| Anthra., Taxane, carboplatin | 31 (12%) | 31 (32%) | 0 | ||||
| Anthra | 30 (11%) | 0 | 30 (18%) | ||||
| Other | 6 (2%) | 0 | 6 (3%) | ||||
| Unknown regimen | 10 (4%) | 2 (2%) | 8 (5%) | ||||
| Outcome | All new adverse eventsd,e | 88 (28%) | 21 (23%) | 46 (27%) | 21 (38%) | 0.121 | 0.395 |
| Ipsilateral recurrence (TNBC) | 13 (4%) | 1 (1%) | 8 (5%) | 4 (7%) | |||
| Ipsilateral recurrence (non-TNBC) | 2 (0.6%) | 0 | 1 (0.6%) | 1 (2%) | |||
| Contralateral IBC (TNBC) | 3 (1%) | 0 | 3 (2%) | 0 | |||
| Contralateral IBC (non-TNBC) | 1 (0.3%) | 1 (1%) | 0 | 0 | |||
| Distant event | 59 (19%) | 19 (20%) | 26 (15%) | 14 (25%) | |||
| Other cancer (non-breast) | 10 (3%) | 0 | 8 (5%) | 2 (4%) | |||
| Death from diseasef | 68 (22%) | 18 (19%) | 25 (16%) | 25 (39%) | |||
| Follow-up time (months) | Median | 43 | 30 | 64 | 24 | < 0.001 | < 0.001 |
| Range | 0–199 | 5–126 | 2–186 | 0–199 |
Anthra Anthracycline, CT chemotherapy, n number of patients, IBC invasive breast cancer, NACT neoadjuvant chemotherapy, NA not applicable, TNBC triple negative breast cancer
aOther tumor types include micropapillary (n = 1); mixed ductal-lobular (n = 1), mixed ductal-micropapillary (n = 1) and papillary carcinoma (n = 1); ILC comprised pleomorphic ILC (n = 13) and classic ILC (n = 3)
bBasal status: any positivity for either cytokeratin 5/6 or EGFR by immunohistochemistry
cChemotherapeutic agents listed for patients known to have received either adjuvant chemotherapy or NACT
dAll new adverse events were classified according to Maastricht Delphi consensus criteria [35]. All distant events of breast cancer were TNBC. There were no adverse events that were either regional axillary or in situ disease. Non-melanoma skin cancer was excluded from other cancer that was non-breast. Metastatic disease at diagnosis was not regarded as a new event
eNumber of patients evaluable for new adverse events excluding death from disease (DFS, MFS) = 316: NACT (n = 93), adjuvant chemotherapy (n = 168), no CT (n = 55)
fNumber of patients evaluable for death (BCSS) = 321: NACT (n = 96), adjuvant therapy (n = 161), no chemotherapy (n = 64)