Table 4.
Univariate and multivariate analysis (first model)
| PFS | OS | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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| Univ | Multiv | Univ | Multiv | |||||||||||||
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| Factor | N | HR | 95% CI | p-value | HR | 95% CI | p-value | % selection | HR | 95% CI | p-value | HR | 95% CI | p-value | % selection | |
| p53 | wt | 825 | 1 | 0.0005 | – | – | 26.4 | 1 | <0.0001 | 1 | 0.036 | 62.0 | ||||
| mut | 644 | 1.37 | 1.16–1.62 | 1.80 | 1.43–2.27 | 1.32 | 1.02–1.73 | |||||||||
| missing | 387 | 1.04 | 0.84–1.28 | 1.10 | 0.81–1.50 | 0.93 | 0.67–1.30 | |||||||||
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| Stage | LO | 1429 | 1 | <0.0001 | – | – | 14.1 | 1 | <0.0001 | – | – | 7.9 | ||||
| LABC/T4d | 421 | 2.18 | 1.86–2.55 | 2.48 | 2.00–3.07 | |||||||||||
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| cT | T1–2 | 930 | 1 | <0.0001 | 1 | <0.0001 | 100 | 1 | <0.0001 | 1 | <0.0001 | 99.9 | ||||
| T3 | 573 | 1.89 | 1.58–2.27 | 1.97 | 1.63–2.39 | 1.96 | 1.51–2.55 | 1.97 | 1.49–2.60 | |||||||
| T4 | 352 | 3.03 | 2.50–3.66 | 2.78 | 2.25–3.43 | 3.42 | 2.63–4.44 | 2.99 | 2.24–4.00 | |||||||
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| cN | N0 | 792 | 1 | <0.0001 | 1 | <0.0001 | 100 | 1 | <0.0001 | 1 | <0.0001 | 100 | ||||
| N1 | 924 | 1.73 | 1.46–2,04 | 1.46 | 1.22–1.75 | 2.23 | 1.74–2.87 | 1.88 | 1.43–2.47 | |||||||
| N2 | 116 | 2.44 | 1.84–3.25 | 1.67 | 1.22–2.28 | 3.55 | 2.44–5.17 | 2.34 | 1.55–3.53 | |||||||
| N3 | 20 | 7.43 | 4.46–12.39 | 5.47 | 3.19–9.38 | 11.72 | 6.23–22.04 | 6.49 | 3.29–12.79 | |||||||
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| PS | 0 | 1748 | 1 | <0.0001 | 1 | 0.0008 | 90.7 | 1 | 0.0008 | 1 | 0.007 | 71.6 | ||||
| 1 (2 pts with 2) | 108 | 1.80 | 1.38–2.35 | 1.65 | 1.23–2.21 | 1.81 | 1.27–2.56 | 1.68 | 1.15–2.46 | |||||||
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| Age | 50 or more | 766 | 1 | 0.33 | – | – | 23.3 | 1 | 0.12 | – | – | 7.7 | ||||
| <50 | 1090 | 0.93 | 0.80–1.08 | 0.85 | 0.69–1.05 | |||||||||||
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| Menopausal status | Post | 752 | 1 | 0.14 | 10.7 | 1 | 0.08 | 8.7 | ||||||||
| Pre | 1099 | 0.89 | 0.77–1.04 | 0.83 | 0.67–1.03 | |||||||||||
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| Endocrine receptors | ER+ and/or PgR+ | 1154 | 1 | <0.0001 | – | – | – | 13.7 | 1 | <0.0001 | 16.3 | |||||
| ER− and PgR− | 506 | 1.94 | 1.65–2.28 | 2.39 | 1.92–2.98 | |||||||||||
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| Histological type | Lobular | 200 | 1 | 0.089 | 11.2 | 1 | 0.16 | |||||||||
| Ductal | 1546 | 1.27 | 0.98–1.65 | 1.38 | 0.94–2.02 | |||||||||||
| Other | 94 | 1.52 | 1.03–2.27 | 1.65 | 0.95–2.87 | |||||||||||
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| Grade | 1 | 121 | 1 | <0.0001 | 1 | 0.018 | 78.2 | 1 | <0.0001 | – | – | 28.7 | ||||
| 2 | 859 | 2.10 | 1.36–3.24 | 1.55 | 0.99–2.43 | 2.65 | 1.30–5.40 | |||||||||
| 3 | 615 | 3.15 | 2.04–4.87 | 1.74 | 1.10–2.75 | 4.34 | 2.13–8.84 | |||||||||
| Not assessed | 253 | 2.31 | 1.45–3.68 | 1.22 | 0.74–2.01 | 3.32 | 1.58–6.99 | |||||||||
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| Treatment arm (stratified, 98.3% CI) | FEC | 928 | 1 | 0.035 | – | – | 44.7 | 1 | 0.28 | – | – | 29.9 | ||||
| T-ET | 928 | 0.85 | 0.71–1.02 | 0.89 | 0.69–1.14 | |||||||||||
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| Endoc Ttt | Tam/AI | 1290 | 1 | <0.0001 | 1 | <0.0001 | 98.6 | 1 | <0.0001 | 1 | <0.0001 | 93.0 | ||||
| None | 566 | 2.11 | 1.81–2.46 | 1.95 | 1.62–2.33 | 2.59 | 2.10–3.19 | 2.27 | 1.78–2.89 | |||||||
Abbreviations: cT: clinical tumour size; cN: clinical nodal status; PS: performance status; Endoc Ttt: endocrine treatment; wt: wild type; mut: mutated; LO: large operable; LABC: locally advanced breast cancer; ER: estrogen receptor; PgR: progesterone receptor; FEC: 5-fluorouracil, epirubicin, and cyclophosphamide; T-ET: docetaxel followed by epirubicin and docetaxel; Tam: tamoxifen; AI: aromatase inhibitor; PFS: progression-free survival; OS: overall survival; Univ: univariate; Multiv: multivariate; HR: hazard ratio; CI: confidence interval; % selection: % of times the covariate remained (by backward selection) in the final model in bootstrapped (resampled) models.