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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)
CharacteristicsEvent/at risk (% survival)Log rank PHR95% CIEvent/at risk (% survival)Log rank PHR95% CI
Pre-operative randomization
 Fasting2/35 (94)0.0491 1/29 (97) 1 
 Carbohydrates6/26 (77) 4.40.9 to 21.76/21 (71)0.0129.31.1 to 77.7
Nodal status
 N03/43 (93) 1 3/33 (91) 1 
 N+5/18 (13)0.039.81.10 to 88.14/17 (77)0.162.80.63 to 12.6
Tumor size
 T13/45 (93) 1 3/39 (92) 1 
 T25/16 (69)0.0095.51.3 to 23.24/11 (64)0.0086.01.3 to 27.0
Nottingham gradeb 0.33   0.31  
 Grade 10/11 (100) 1 0/11 (100) 1 
 Grade 25/30 (83)Inf.Inf.5/30 (83) Inf.Inf.
 Grade 33/20 (85)inf.Inf.2/9 (78) inf.Inf.
Estrogen receptor    
 Positive (≥ 1%)7/50 (86) 1 
 Negative (< 1%)1/11 (91)0.671.60.2 to 12.7
Progesterone receptor
 Positive (≥10%)4/41 (37) 1 3/37 (92) 1 
 Negative (< 10%)4/20 (80)0.272.10.5 to 8.64/13 (69)0.0484.00.90 to 18.1
HER2        
 Negative (0 to 1+)7/57 (88) 1 6/49 (88) 1 
 Positive (2+ to 3+)1/4 (75)0.462.10.3 to 17.51/1 (0)0.00511.71.3 to 105.1
MAI
 < 105/41 (88) 1 4/39 (90) 1 
 ≥ 103/19 (66)0.661.40.3 to 5.83/10 (70)0.093.40.8 to15.2
MAI
 < 32/16 (88) 1 2/16 (88) 1 
 ≥ 36/44 (86)0.891.10.2 to 5.55/33 (85)0.801.20.2 to 6.4
PPH3
 < 133/35 (91) 1 3/35 (91) 1 
 ≥ 135/26 (81)0.262.20.5 to 9.44/15 (73)0.123.10.7 to 14.0
Ki67
 < 150/26 (100)   0/25 (100) 1 
 ≥ 158/34 (77)0.0087/24 (71)0.003aa
Ki67
 < 303/38 (92) 1 3/37 (92) 1 
 ≥ 305/22 (77)0.0933.20.8 to 13.44/12 (67)0.0234.81.1 to 21.8
TILs
 Negative (< 10%)2/13 (85)   7/55 (87) 1 
 Positive (≥10%)6/48 (88)0.771.40.2 to 3.91/6 (83)0.752.20.24
Luminal statusc
 Luminal A3/39 (92)   2/28 (93)   
 Luminal B5/22 (77)0.0913.20.77 to 13.55/22 (77)0.113.50.68 to 18.1
Chemotherapy
 Yes6/29 (79) 1 5/20 (75) 1 
 No2/32 (94)0.0960.280.06 to 1.42/30 (93)0.0690.250.05 to 1.3
Radiotherapy
 Yes6/43 (86) 1 5/38 (87) 1 
 No2/17 (88)0.900.910.18 to 4.52/12 (83)0.721.40.26 to 7.0
Endocrine Therapy
 Yes7/39 (82) 1 6/36 (83) 1 
 No1/22 (96)0.150.240.03 to 2.01/14 (93)0.380.400.05 to 3.3
BMI-25d
 < 253/31 (90) 1 3/26 (89) 1 
 ≥ 254/23 (83)0.401.90.42 to 8.43/20 (85)0.701.40.28 to 6.8
BMI-75pe
 < 75p4/41 (90) 1 4/36 (89) 1 
 ≥ 75p3/13 (77)0.2012.570.57 to 11.52/10 (80)0.4171.990.36 to 10.9
Smoking
 -Never smoked4/15 (73) 1 3/12 (87) 1 
 -Former smoker1/23 (96) 0.220.025 to 2.001/20 (95) 0.260.027 to 2.5
 -Ongoing smoking1/14 (93)0.0650.140.015 to 1.221/12 (92)0.150.170.017 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