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Table 5 Univariable analysis of relapse-free survival

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

  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
  1. 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
  2. aHR (95% CI) was not computed, as the equation did not converge, and no events occurred in one or more categories
  3. bHistological grading was performed according to the Nottingham algorithm
  4. cLuminal A = ER+/HER2−/Ki67 < 15% and Luminal B = ER+/HER2−/Ki67 ≥ 15% or ER+/HER2 +
  5. dBMI-25 represents a dichotomized BMI < 25 or ≥ 25 on the BMI scale
  6. eBMI-75p represents a dichotomized BMI with cut off < /≥ 75 percentile, i.e., </≥ 26.8 on the BMI scale