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Table 1 Baseline characteristics of the 123 treated patients with advanced esophageal squamous cell carcinoma (intention-to-treat population)

From: Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer (ESWN 01): a prospective randomized, multicenter, open-labeled phase 3 trial

Characteristic Treatment groups P value
Irinotecan plus S-1 [cases (%)] S-1 monotherapy [cases (%)]
Age 0.877
 Median years (range) 60 (39.1–70.0) 57 (42.0–70.0)  
 ≤ 65 years 46 (75.4) 46 (74.2)  
 > 65 years 15 (24.6) 16 (25.8)
Sex 0.774
 Male 56 (91.8) 56 (90.3)  
 Female 5 (8.2) 6 (9.7)
ECOG performance score 0.593
 0 23 (37.7) 18 (29.0)  
 1 33 (54.1) 38 (61.3)
 2 5 (8.2) 6 (9.7)
Tumor grade 0.792#
 Poorly differentiated 28 (45.9) 29 (46.8)  
 Moderately differentiated 29 (47.5) 31 (50.0)
 Well differentiated 4 (6.6) 2 (3.2)
Number of metastatic sites 0.409
 1 23 (37.7) 19 (30.6)  
 ≥ 2 38 (62.3) 43 (69.4)
Previous treatmenta
 Surgery 28 (45.9) 19 (30.6) 0.082
 Local radiation 32 (52.5) 32 (51.6) 0.925
Disease status 1.000#
 Local recurrence 3 (4.9) 4 (6.5)  
 Distant metastasis 58 (95.1) 58 (93.5)
Prior lines of chemotherapy 0.668
 First-line 51 (83.6) 50 (80.6)  
 Second-line 10 (16.4) 12 (19.4)
  1. ECOG Eastern Cooperative Oncology Group
  2. #Tested by Fisher’s exact test
  3. aSome of the patients presented with metastatic disease at their initial diagnosis, therefore they did not receive either surgery or radiation