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Table 2 Baseline demographic and clinical characteristics of the 501 patients before the start of treatment

From: CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial

Characteristica CMAB009 plus irinotecan
(n = 337)
Irinotecan-only
(n  = 164)
Entire study cohort
(n  = 501)
P
No. of patients % No. of patients % No. of patients %  
Age, years        0.652
 Median 55.0   55.0   55.0   
 Standard deviation 10.55   11.02   10.69   
 < 65 287 85.2 141 86.0 428 85.4  
 ≥ 65 50 14.8 23 14.0 73 14.6  
Sex        0.246
 Male 195 57.9 104 63.4 299 59.7  
 Female 142 42.1 60 36.6 202 40.3  
Ethnic minority        0.121
 Han 334 99.1 159 97.0 493 98.4  
 Other 3 0.9 5 3.0 8 1.6  
ECOG performance status        0.120
 0 136 40.4 56 34.1 192 38.3  
 1 201 59.6 107 65.2 308 61.5  
 2 0 0 1 0.6 1 0.2  
Previous therapy        
 Chemotherapy 337 100 163 99.4 500 99.8 0.327
 Radiation therapy 92 27.3 37 22.6 129 25.7 0.277
First-line therapy        0.667
 Median duration, months 6   7   7   
 Range, months 1–38   1–24   1–38   
Reason off therapy        0.552
 Disease progression 301 66.8 144 63.7 445 65.8  
 Adverse events 41 9.1 25 11.1 66 9.7  
 Other 108 24.0 57 25.2 165 24.4  
Site of metastasis        0.873
 Lung 142 42.1 73 44.5 215 42.9  
 Peritoneum 25 7.4 17 10.4 42 8.4  
 Liver 186 55.2 99 60.4 285 56.9  
 Lymph node 106 31.5 60 36.6 166 33.1  
 Other 105 31.2 50 30.5 155 30.9  
No. of disease sites        0.199
 1 98 29.1 38 23.2 136 27.1  
 ≥ 2 239 70.9 126 76.8 365 72.9  
  1. ECOG, Eastern Cooperative Oncology Group
  2. aThere was no significant difference in baseline patient characteristics between the 2 groups