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Table 1 Baseline characteristics of patients in the two study groups

From: Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ─ a randomized trial

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)   
  1. Tumor size category analyzed as T1 vs. T2
  2. aBMI-25 represents a dichotomized BMI <  25 or ≥ 25 on the BMI scale
  3. bBMI-75p represents a dichotomized BMI with cut off < /≥ 75 percentile, i.e., </≥ 26.8 on the BMI scale
  4. cHistological grading was performed according to the Nottingham algorithm
  5. dLuminal A = ER+/HER2−/Ki67 < 15% and Luminal B = ER+/HER2−/Ki67 ≥ 15%
  6. eBlood samples taken in the fasting state at the time patients were admitted in the hospital approx. 24–30 h before surgery
  7. fPre-operative blood samples taken 1–2 h before the surgical procedure commenced
  8. 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