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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

VariableCarbohydrate group
(n = 26)
Missing data (Intervention group)Fasting group
(n = 35)
Missing data
(Control group)
P
n (%) n (%)  
Age
 < 5512 (46)016 (46)00.973
 > 5514 (54)019 (54)0
BMI (kg/m2)25.0 (3.9)425.1 (3.0)30.868
BMI <  25a14 (64)417 (53)30.443
BMI ≥ 258 (36)15 (47) 
BMI < 75 percentileb18 (82)423 (76)3 
BMI ≥ 75 percentile4 (18)13 (24)0.401
Menopausal status
 Premenopausal4 (17)17 (22)10.627
 Postmenopausal20 (83)125 (78)2
HRT - yes8 (35)310 (32)40.937
HRT – no14 (61)19 (61)
HRT- not relevant1 (4)2 (7)
HRT use (years)4.7 (4.3)167.9 (5.8)250.176
Tumor size (mm)19.4015.000.094
Tumor category
 T116 (62)029 (83)0 
 T210 (38)06 (17)00.061
Histological Gradec    0.157
 14 (15)07 (20)0 
 210 (39)020 (57)0 
 312 (46)08 (23)0 
pN negative18 (69)025 (71)00.852
pN positive8 (31)010 (29)0 
Number LNs removed5.525.800.843
Number positive LNs0.3820.8600.191
Estrogen receptor
 Positive (≥1%)21 (81)029 (83)00.834
 Negative (< 1%)5 (19)06 (17)0 
Progesterone receptor
 Positive (≥ 10%)13 (50)028 (80)00.014
 Negative (< 10%)13 (50)07 (20)0 
HER2
 Positive3 (12)01 (3)00.176
 Negative23 (88)034 (97)0
MAI (median, IQR)7 (2–9)15 (2–9)00.647
MAI <  1014 (56)127 (77)0 
MAI ≥ 1011 (44) 8 (23)00.083
Ki67 (mean, SD)30.4 (28.2)028.0 (26.5)10.747
Ki67 < 15%9 (35)017 (50)1 
Ki67 ≥ 15%17 (65)017 (50)00.233
Ki67 < 30%14 (54)024 (71)10.182
Ki67 ≥ 30%12 (46)010 (29)0 
PPH3 (mean, SD)20.2 (24.7)020.5 (26.9)00.966
PPH3 < 1314 (54)021 (60)00.631
PPH3 ≥ 1312 (46)014 (40)0 
TILs (mean %, SD)4.7 (10.7)04.3 (7.3)10.137
TILs
 Positive (> 10%)2 (8)04 (11)00.663
 Negative (< 10%)24 (92)031 (89)0 
Luminal typed
 Luminal A16 (62)023 (66)0 
 Luminal B10 (38)012 (34)00.737
Glucose
 Admissione|5.4 (1.1)05.3 (0.6)00.864
 Pre-operativef5.2 (1.8)05.1 (0.6)00.739
S-Insulin
 Admissione9.4 (8.5)09.1 (6.6)00.886
 Pre-operativef33.7 (20.2)09.1 (5.9)0< 0.0001
S-insulin-c-peptide
 Admissione0.69 (0.32)00.75 (0.32)00.517
 Pre-operativef2.10 (1.05)00.75 (0.27)0< 0.0001
Surgery
 BCT15 (58)023 (66)0 
 Mastectomy11 (42)012 (34)00.523
Axillary staging
 SN21 (81)028 (80)0 
 ALND5 (19)07 (20)00.940
Reoperation - 1
 -Breast1 (20)01 (50)0 
 -Axilla4 (80)01 (50)00.427
Chemo therapy
 Yes12 (46)017 (47)0 
 No14 (53)018 (51)00.852
Radiation therapy
 Yes17 (68)026 (74)0 
 No8 (32)19 (26)00.594
Endocrine therapy
 Yes17 (65)022 (63)0 
 No9 (35)013 (37)00.839
Smoking status 5 4 
 -Never smoked5 (24) 10 (32) 0.650
 -Former smoker9 (43) 14 (45)  
 -Ongoing smoking7 (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