Table 6.
Univariable analysis of breast cancer-specific survival
| Variable | Whole study cohort (n = 61) | ER-positive patients (n = 50) | ||||||
|---|---|---|---|---|---|---|---|---|
| Event/at risk (% survival) | Log rank P | HRa | 95% CI | Event/at risk (% survival) | Log rank P | HRa | 95% CI | |
| Pre-operative randomization | ||||||||
| Fasting | 1/35 (97) | 1 | 0/29 (100) | 1 | ||||
| Carbohydrates | 4/26 (85) | 0.086 | 4.4 | 0.88 to 21.7 | 4/21 (81) | 0.015 | a | a |
| Nodal status | ||||||||
| N0 | 1/43 (98) | 1/33 (82) | 1 | |||||
| N+ | 4/18 (78) | 0.012 | 4.4 | 1.05 to 18.5 | 3/17 (82) | 0.080 | 2.80 | 0.63 to 12.6 |
| Tumor size | – | – | ||||||
| T1 | 0/45 (100) | 1 | 0/40 (100) | 1 | ||||
| T2 | 5/16 (69) | < 0.0001 | 5.5 | 1.32 to 23.1 | 4/10 (60) | < 0.0001 | a | a |
| Nottingham grade b | 0.556 | 0.352 | ||||||
| Grade 1 | 0/11 (100) | 1 | 0/11 (100) | 1 | ||||
| Grade 2 | 3/30 (90) | a | a | 3/30 (90) | a | a | ||
| Grade 3 | 2/20 (90) | a | a | 1/9 (89) | a | a | ||
| Estrogen receptor | – | – | – | – | ||||
| Positive (≥ 1%) | 4/50 (92) | 1 | – | – | – | – | ||
| Negative (< 1%) | 1/11 (91) | 0.852 | 0.64 | 0.079 to 5.21 | – | – | – | – |
| Progesterone receptor | ||||||||
| Positive (≥10%) | 4/41 (90) | 1 | 3/37 (92) | 1 | ||||
| Negative (< 10%) | 1/20 (95) | 0.543 | 0.51 | 0.057 to 4.59 | 1/13 (92) | 0.94 | 0.93 | 0.1 to 8.9 |
| HER2 | ||||||||
| Negative (0 to 1+) | 4/57 (93) | 1 | 3/49 (94) | 1 | ||||
| Positive (2+ to 3+) | 1/4 (75) | 0.248 | 3.37 | 0.38 to 30.2 | 1/1 (0) | 0.001 | 11.7 | 1.31 to 105.1 |
| MAI | ||||||||
| < 10 | 3/41 (93) | 1 | 3/39 (92) | 1 | ||||
| ≥ 10 | 2/19 (90) | 0.645 | 1.5 | 0.25 to 9.1 | 2/10 (80) | 0.23 | 4.1 | 0.6 to 29.3 |
| MAI | ||||||||
| < 3 | 1/16 (94) | 1 | 1/16 (88) | 1 | ||||
| ≥ 3 | 4/44 (91) | 0.735 | 1.46 | 0.16 to 13.0 | 3/33 (85) | 0.76 | 1.4 | 0.15 to 13.8 |
| PPH3 | ||||||||
| < 13 | 2/35 (94) | 1 | 2/35 (94) | 1 | ||||
| > 13 | 3/26 (89) | 0.426 | 2.0 | 0.34 to 12.2 | 2/15 (87) | 0.40 | 2.3 | 0.32 to 16.1 |
| Ki67 | ||||||||
| < 15 | 0/26 (100) | 1 | 0/25 (100) | 1 | ||||
| ≥ 15 | 5/34 (82) | 0.040 | – | – | 4/24 (83) | 0.014 | a | a |
| Ki67 | ||||||||
| < 30 | 1/38 (97) | 1 | 1/37 (95) | 1 | ||||
| ≥ 30 | 4/22 (82) | 0.033 | 7.5 | 0.84 to 67.5 | 3/12 (75) | 0.023 | 9.9 | 1.03 to 95.3 |
| TILs | ||||||||
| Negative | 4/55 (93) | 1 | 3/45 (93) | 1 | ||||
| Positive | 1/6 (83) | 0.479 | 2.16 | 0.24 to 19.4 | 1/4 (75) | 0.24 | 3.6 | 0.37 to 34.6 |
| Luminal statusc | ||||||||
| Luminal A | 3/39 (92) | 1 | 2/28 (93) | 1 | ||||
| Luminal B | 2/22 (91) | 0.847 | 1.2 | 0.20 to 7.41 | 2/22 (91) | 0.777 | 1.33 | 0.19 to 9.42 |
| Chemo therapy | ||||||||
| Yes | 5/39 (87) | 1 | 3/20 (85) | 1 | ||||
| No | 0/22 (100) | 0.089 | 0.22 | 0.024 to 1.95 | 1/30 (97) | 0.15 | 0.22 | 0.023 to 2.10 |
| Radiation therapy | ||||||||
| Yes | 3/43 (93) | 1 | 2/38 (95) | 1 | ||||
| No | 2/17 (88) | 0.499 | 1.84 | 0.33 to 11.0 | 2/12 (83) | 0.19 | 3.9 | 0.48 to 24.1 |
| Endocrine therapy | ||||||||
| Yes | 5/39 (87) | 1 | 4/36 (89) | 1 | ||||
| No | 0/22 (100) | 0.089 | 0.024 | 0 to 46.4 | 0/14 (100) | 0.20 | 0.03 | 0 to 262 |
| BMI-25d | ||||||||
| < 25 | 1/31 (97) | 1 | 1/26 (96) | 1 | ||||
| ≥ 25 | 3/23 (87) | 0.177 | 4.19 | 0.44 to 40.3 | 2/20 (90) | 0.398 | 2.70 | 0.25 to 29.8 |
| BMI-75pe | ||||||||
| < 75p | 2/41 (95) | 1 | 2/36 (94) | 1 | ||||
| ≥ 75p | 2/13 (85) | 0.218 | 3.20 | 0.45 to 22.8 | 1/10 (90) | 0.622 | 1.81 | 0.16 to 20.0 |
| Smoking | ||||||||
| -Never smoked | 3/15 (80) | 1 | 2/12 (83) | 1 | ||||
| -Former smoker | 0/23 (100) | 0.003 | Inf. | 0/20 (100) | 0.003 | Inf. | ||
| -Ongoing smoking | 0/14 (100) | 0.020 | 0.003 | Inf | 0/12 (100) | 0.052 | 0.003 | Inf. |
BMI Body mass index, HRT Hormonal replacement therapy, T Pathological tumor size in mm or category, LN Lymph node, N0 Node negative, N+ Node positive (assessed by pathologists), HER-2 Human epidermal growth factor receptor 2, MAI Mitotic activity index, TILs Tumor infiltrating leucocytes, PPH3 Phosphorylated phospho-histone 3
aHR (95% CI) was not computed, as the equation did not converge and no events occurred in one or more categories
bHistological grading was performed according to the Nottingham algorithm
cLuminal A = ER+/HER2−/Ki67 < 15% and Luminal B = ER+/HER2−/Ki67 ≥ 15%
dBMI-25 represents a dichotomized BMI < 25 or ≥ 25 on the BMI scale
eBMI-75p represents a dichotomized BMI with cut off < /≥ 75 percentile, i.e., </≥ 26.8 on the BMI scale