Table 5.
Univariable analysis of relapse-free survival
| Whole cohort (n = 61) | ER positive patients (n = 50) | |||||||
|---|---|---|---|---|---|---|---|---|
| Characteristics | Event/at risk (% survival) | Log rank P | HR | 95% CI | Event/at risk (% survival) | Log rank P | HR | 95% CI |
| Pre-operative randomization | ||||||||
| Fasting | 2/35 (94) | 0.049 | 1 | 1/29 (97) | 1 | |||
| Carbohydrates | 6/26 (77) | 4.4 | 0.9 to 21.7 | 6/21 (71) | 0.012 | 9.3 | 1.1 to 77.7 | |
| Nodal status | ||||||||
| N0 | 3/43 (93) | 1 | 3/33 (91) | 1 | ||||
| N+ | 5/18 (13) | 0.03 | 9.8 | 1.10 to 88.1 | 4/17 (77) | 0.16 | 2.8 | 0.63 to 12.6 |
| Tumor size | ||||||||
| T1 | 3/45 (93) | 1 | 3/39 (92) | 1 | ||||
| T2 | 5/16 (69) | 0.009 | 5.5 | 1.3 to 23.2 | 4/11 (64) | 0.008 | 6.0 | 1.3 to 27.0 |
| Nottingham gradeb | 0.33 | 0.31 | ||||||
| Grade 1 | 0/11 (100) | 1 | 0/11 (100) | 1 | ||||
| Grade 2 | 5/30 (83) | – | Inf. | Inf. | 5/30 (83) | Inf. | Inf. | |
| Grade 3 | 3/20 (85) | – | inf. | Inf. | 2/9 (78) | inf. | Inf. | |
| Estrogen receptor | – | – | – | – | ||||
| Positive (≥ 1%) | 7/50 (86) | 1 | – | – | – | – | ||
| Negative (< 1%) | 1/11 (91) | 0.67 | 1.6 | 0.2 to 12.7 | – | – | – | – |
| Progesterone receptor | ||||||||
| Positive (≥10%) | 4/41 (37) | 1 | 3/37 (92) | 1 | ||||
| Negative (< 10%) | 4/20 (80) | 0.27 | 2.1 | 0.5 to 8.6 | 4/13 (69) | 0.048 | 4.0 | 0.90 to 18.1 |
| HER2 | ||||||||
| Negative (0 to 1+) | 7/57 (88) | 1 | 6/49 (88) | 1 | ||||
| Positive (2+ to 3+) | 1/4 (75) | 0.46 | 2.1 | 0.3 to 17.5 | 1/1 (0) | 0.005 | 11.7 | 1.3 to 105.1 |
| MAI | ||||||||
| < 10 | 5/41 (88) | 1 | 4/39 (90) | 1 | ||||
| ≥ 10 | 3/19 (66) | 0.66 | 1.4 | 0.3 to 5.8 | 3/10 (70) | 0.09 | 3.4 | 0.8 to15.2 |
| MAI | ||||||||
| < 3 | 2/16 (88) | 1 | 2/16 (88) | 1 | ||||
| ≥ 3 | 6/44 (86) | 0.89 | 1.1 | 0.2 to 5.5 | 5/33 (85) | 0.80 | 1.2 | 0.2 to 6.4 |
| PPH3 | ||||||||
| < 13 | 3/35 (91) | 1 | 3/35 (91) | 1 | ||||
| ≥ 13 | 5/26 (81) | 0.26 | 2.2 | 0.5 to 9.4 | 4/15 (73) | 0.12 | 3.1 | 0.7 to 14.0 |
| Ki67 | ||||||||
| < 15 | 0/26 (100) | 0/25 (100) | 1 | |||||
| ≥ 15 | 8/34 (77) | 0.008 | – | – | 7/24 (71) | 0.003 | a | a |
| Ki67 | ||||||||
| < 30 | 3/38 (92) | 1 | 3/37 (92) | 1 | ||||
| ≥ 30 | 5/22 (77) | 0.093 | 3.2 | 0.8 to 13.4 | 4/12 (67) | 0.023 | 4.8 | 1.1 to 21.8 |
| TILs | ||||||||
| Negative (< 10%) | 2/13 (85) | 7/55 (87) | 1 | |||||
| Positive (≥10%) | 6/48 (88) | 0.77 | 1.4 | 0.2 to 3.9 | 1/6 (83) | 0.75 | 2.2 | 0.24 |
| Luminal statusc | ||||||||
| Luminal A | 3/39 (92) | 2/28 (93) | ||||||
| Luminal B | 5/22 (77) | 0.091 | 3.2 | 0.77 to 13.5 | 5/22 (77) | 0.11 | 3.5 | 0.68 to 18.1 |
| Chemotherapy | ||||||||
| Yes | 6/29 (79) | 1 | 5/20 (75) | 1 | ||||
| No | 2/32 (94) | 0.096 | 0.28 | 0.06 to 1.4 | 2/30 (93) | 0.069 | 0.25 | 0.05 to 1.3 |
| Radiotherapy | ||||||||
| Yes | 6/43 (86) | 1 | 5/38 (87) | 1 | ||||
| No | 2/17 (88) | 0.90 | 0.91 | 0.18 to 4.5 | 2/12 (83) | 0.72 | 1.4 | 0.26 to 7.0 |
| Endocrine Therapy | ||||||||
| Yes | 7/39 (82) | 1 | 6/36 (83) | 1 | ||||
| No | 1/22 (96) | 0.15 | 0.24 | 0.03 to 2.0 | 1/14 (93) | 0.38 | 0.40 | 0.05 to 3.3 |
| BMI-25d | ||||||||
| < 25 | 3/31 (90) | 1 | 3/26 (89) | 1 | ||||
| ≥ 25 | 4/23 (83) | 0.40 | 1.9 | 0.42 to 8.4 | 3/20 (85) | 0.70 | 1.4 | 0.28 to 6.8 |
| BMI-75pe | ||||||||
| < 75p | 4/41 (90) | 1 | 4/36 (89) | 1 | ||||
| ≥ 75p | 3/13 (77) | 0.201 | 2.57 | 0.57 to 11.5 | 2/10 (80) | 0.417 | 1.99 | 0.36 to 10.9 |
| Smoking | ||||||||
| -Never smoked | 4/15 (73) | 1 | 3/12 (87) | 1 | ||||
| -Former smoker | 1/23 (96) | 0.22 | 0.025 to 2.00 | 1/20 (95) | 0.26 | 0.027 to 2.5 | ||
| -Ongoing smoking | 1/14 (93) | 0.065 | 0.14 | 0.015 to 1.22 | 1/12 (92) | 0.15 | 0.17 | 0.017 to 1.6 |
BMI Body mass index, HRT Hormonal replacement therapy, T Tumor size in mm or category, N Pathological lymph node status, 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% or ER+/HER2 +
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