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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