Table 1.
Baseline characteristics of patients in the two study groups
| Variable | Carbohydrate group (n = 26) |
Missing data (Intervention group) | Fasting group (n = 35) |
Missing data (Control group) |
P |
|---|---|---|---|---|---|
| n (%) | n (%) | ||||
| Age | |||||
| < 55 | 12 (46) | 0 | 16 (46) | 0 | 0.973 |
| > 55 | 14 (54) | 0 | 19 (54) | 0 | |
| BMI (kg/m2) | 25.0 (3.9) | 4 | 25.1 (3.0) | 3 | 0.868 |
| BMI < 25a | 14 (64) | 4 | 17 (53) | 3 | 0.443 |
| BMI ≥ 25 | 8 (36) | 15 (47) | |||
| BMI < 75 percentileb | 18 (82) | 4 | 23 (76) | 3 | |
| BMI ≥ 75 percentile | 4 (18) | 13 (24) | 0.401 | ||
| Menopausal status | |||||
| Premenopausal | 4 (17) | 1 | 7 (22) | 1 | 0.627 |
| Postmenopausal | 20 (83) | 1 | 25 (78) | 2 | |
| HRT - yes | 8 (35) | 3 | 10 (32) | 4 | 0.937 |
| HRT – no | 14 (61) | 19 (61) | |||
| HRT- not relevant | 1 (4) | 2 (7) | |||
| HRT use (years) | 4.7 (4.3) | 16 | 7.9 (5.8) | 25 | 0.176 |
| Tumor size (mm) | 19.4 | 0 | 15.0 | 0 | 0.094 |
| Tumor category | |||||
| T1 | 16 (62) | 0 | 29 (83) | 0 | |
| T2 | 10 (38) | 0 | 6 (17) | 0 | 0.061 |
| Histological Gradec | 0.157 | ||||
| 1 | 4 (15) | 0 | 7 (20) | 0 | |
| 2 | 10 (39) | 0 | 20 (57) | 0 | |
| 3 | 12 (46) | 0 | 8 (23) | 0 | |
| pN negative | 18 (69) | 0 | 25 (71) | 0 | 0.852 |
| pN positive | 8 (31) | 0 | 10 (29) | 0 | |
| Number LNs removed | 5.5 | 2 | 5.8 | 0 | 0.843 |
| Number positive LNs | 0.38 | 2 | 0.86 | 0 | 0.191 |
| Estrogen receptor | |||||
| Positive (≥1%) | 21 (81) | 0 | 29 (83) | 0 | 0.834 |
| Negative (< 1%) | 5 (19) | 0 | 6 (17) | 0 | |
| Progesterone receptor | |||||
| Positive (≥ 10%) | 13 (50) | 0 | 28 (80) | 0 | 0.014 |
| Negative (< 10%) | 13 (50) | 0 | 7 (20) | 0 | |
| HER2 | |||||
| Positive | 3 (12) | 0 | 1 (3) | 0 | 0.176 |
| Negative | 23 (88) | 0 | 34 (97) | 0 | |
| MAI (median, IQR) | 7 (2–9) | 1 | 5 (2–9) | 0 | 0.647 |
| MAI < 10 | 14 (56) | 1 | 27 (77) | 0 | |
| MAI ≥ 10 | 11 (44) | 8 (23) | 0 | 0.083 | |
| Ki67 (mean, SD) | 30.4 (28.2) | 0 | 28.0 (26.5) | 1 | 0.747 |
| Ki67 < 15% | 9 (35) | 0 | 17 (50) | 1 | |
| Ki67 ≥ 15% | 17 (65) | 0 | 17 (50) | 0 | 0.233 |
| Ki67 < 30% | 14 (54) | 0 | 24 (71) | 1 | 0.182 |
| Ki67 ≥ 30% | 12 (46) | 0 | 10 (29) | 0 | |
| PPH3 (mean, SD) | 20.2 (24.7) | 0 | 20.5 (26.9) | 0 | 0.966 |
| PPH3 < 13 | 14 (54) | 0 | 21 (60) | 0 | 0.631 |
| PPH3 ≥ 13 | 12 (46) | 0 | 14 (40) | 0 | |
| TILs (mean %, SD) | 4.7 (10.7) | 0 | 4.3 (7.3) | 1 | 0.137 |
| TILs | |||||
| Positive (> 10%) | 2 (8) | 0 | 4 (11) | 0 | 0.663 |
| Negative (< 10%) | 24 (92) | 0 | 31 (89) | 0 | |
| Luminal typed | |||||
| Luminal A | 16 (62) | 0 | 23 (66) | 0 | |
| Luminal B | 10 (38) | 0 | 12 (34) | 0 | 0.737 |
| Glucose | |||||
| Admissione| | 5.4 (1.1) | 0 | 5.3 (0.6) | 0 | 0.864 |
| Pre-operativef | 5.2 (1.8) | 0 | 5.1 (0.6) | 0 | 0.739 |
| S-Insulin | |||||
| Admissione | 9.4 (8.5) | 0 | 9.1 (6.6) | 0 | 0.886 |
| Pre-operativef | 33.7 (20.2) | 0 | 9.1 (5.9) | 0 | < 0.0001 |
| S-insulin-c-peptide | |||||
| Admissione | 0.69 (0.32) | 0 | 0.75 (0.32) | 0 | 0.517 |
| Pre-operativef | 2.10 (1.05) | 0 | 0.75 (0.27) | 0 | < 0.0001 |
| Surgery | |||||
| BCT | 15 (58) | 0 | 23 (66) | 0 | |
| Mastectomy | 11 (42) | 0 | 12 (34) | 0 | 0.523 |
| Axillary staging | |||||
| SN | 21 (81) | 0 | 28 (80) | 0 | |
| ALND | 5 (19) | 0 | 7 (20) | 0 | 0.940 |
| Reoperation - 1 | |||||
| -Breast | 1 (20) | 0 | 1 (50) | 0 | |
| -Axilla | 4 (80) | 0 | 1 (50) | 0 | 0.427 |
| Chemo therapy | |||||
| Yes | 12 (46) | 0 | 17 (47) | 0 | |
| No | 14 (53) | 0 | 18 (51) | 0 | 0.852 |
| Radiation therapy | |||||
| Yes | 17 (68) | 0 | 26 (74) | 0 | |
| No | 8 (32) | 1 | 9 (26) | 0 | 0.594 |
| Endocrine therapy | |||||
| Yes | 17 (65) | 0 | 22 (63) | 0 | |
| No | 9 (35) | 0 | 13 (37) | 0 | 0.839 |
| Smoking status | 5 | 4 | |||
| -Never smoked | 5 (24) | 10 (32) | 0.650 | ||
| -Former smoker | 9 (43) | 14 (45) | |||
| -Ongoing smoking | 7 (33) | 7 (23) | |||
Tumor size category analyzed as T1 vs. T2
aBMI-25 represents a dichotomized BMI < 25 or ≥ 25 on the BMI scale
bBMI-75p represents a dichotomized BMI with cut off < /≥ 75 percentile, i.e., </≥ 26.8 on the BMI scale
cHistological grading was performed according to the Nottingham algorithm
dLuminal A = ER+/HER2−/Ki67 < 15% and Luminal B = ER+/HER2−/Ki67 ≥ 15%
eBlood samples taken in the fasting state at the time patients were admitted in the hospital approx. 24–30 h before surgery
fPre-operative blood samples taken 1–2 h before the surgical procedure commenced
BMI Body mass index, HRT Hormonal replacement therapy, pT Pathological tumor size in mm or category, pN Pathological lymph node status, LN Lymph node, HER-2 Human epidermal growth factor receptor 2, MAI Mitotic activity index, TILs Tumor infiltrating leucocytes, PPH3 Phosphorylated phospho-histone 3, SN Sentinel node, ALND Axillary lymph node dissection