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Table 1 Patient demographics, disease characteristics, and prior therapy

From: TIMP-1 and responsiveness to gemcitabine in advanced breast cancer; results from a randomized phase III trial from the Danish breast cancer cooperative group

   Included    Excluded   
Characteristics No.   (%) No.   (%) Pd
No. of patients 264    73    
Regimen        0.36
   Docetaxel and Gemcitabine 137   (51.9) 33   (45.2)  
   Docetaxel 127   (48.1) 40   (54.8)  
Median age at randomization, years   59    57   0.57e
   Range   30-75    36-73   
ECOG performance status        0.84
   0-1 223   (84.5) 65   (89.0)  
   2 32   (12.1) 8a   (11.0)  
   Unknown 9   (3.4) 0   (0.0)  
Stage of disease        0.049
   Locally advanced 22   (8.3) 12   (16.4)  
   Metastatic 242   (91.7) 61   (83.6)  
No. of metastatic sites        0.74
   1 78   (29.5) 18   (24.7)  
   2 93   (35.2) 27   (37.0)  
   ≥ 3 93   (35.2) 28   (38.4)  
Type of metastatic site        
   Visceral 150   (56.8) 43   (58.9) 0.79
   Lung 78   (29.5) 25   (34.2)  
   Liver 99   (37.5) 27   (37.0)  
   Non-visceral 114   (43.2) 30   (41.1)  
   Bone 175   (66.3) 41   (56.2)  
Hormone receptor status        0.76
   Positive 190   (72.0) 49   (67.1)  
   Negative 70   (26.5) 20   (27.4)  
   Unknown 4   (1.5) 4   (5.5)  
HER2 statusb        0.77
   Normal/deletion 212   (80.3) 20   (27.4)  
   Amplification 37   (14.0) 4   (5.5)  
   Unknown 15   (5.7) 49   (67.1)  
PAM50 subtype        0.18
   Luminal A 78   (29.5) 6   (8.2)  
   Luminal B 94   (35.6) 3   (4.1)  
   Basal-like 40   (15.2) 3   (4.1)  
   HER2-enriched 46   (17.4) 0   (0.0)  
   Unknown 6   (2.3) 61   (83.6)  
Prior chemotherapy        
   Total 188   (71.2) 45   (61.6) 0.15
   (Neo)adjuvant 127   (48.1) 17   (23.3) 0.0002
    Anthracycline 71   (26.9) 11   (15.1)  
    Non-anthracycline 56   (21.2) 6   (8.2)  
   Locally advanced/metastatic 102   (38.6) 31   (42.5) 0.20
    Anthracycline 86   (32.6) 30   (41.1)  
    Non-anthracycline 16   (6.1) 1   (1.4)  
Hormonal therapy        
   Total 173   (65.5) 41   (56.2) 0.17
   Adjuvant 119   (45.1) 19   (26.0) 0.006
   Locally advanced/metastatic 120   (45.5) 37   (50.7) 0.43
Radiation therapy 157   (59.5) 22   (30.1) <0.0001
Disease-free interval, monthsc        
   Median   31    22   0.12e
   Range   0-250    0-231   
  1. aIncluding one patient ECOG performance status 3.
  2. bRetrospective analysis, primary tumor only.
  3. cTime interval from diagnosis of primary cancer to recurrence.
  4. dFisher's exact test, unknown values excluded from tests.
  5. eWilcoxon test.
  6. Abbreviations: ECOG Eastern Cooperative Oncology Group, HER2 Human epidermal growth factor receptor 2.