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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