Table 1 Baseline patient characteristics.

From: Clinical and biomarker analyses of sintilimab versus chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma: a randomized, open-label phase 2 study (ORIENT-2)

Characteristic

Sintilimab (N = 95)

Chemo (N = 95)

Age, years

   Median (IQR)

60 (54–64)

60 (54–64)

   <65

74 (77.9%)

75 (78.9%)

   ≥65

21 (22.1%)

20 (21.1%)

Sex

   Male

88 (92.6%)

84 (88.4%)

   Female

7 (7.4%)

11 (11.6%)

ECOG PS

   0

23 (24.2%)

23 (24.2%)

   1

72 (75.8%)

72 (75.8%)

Pathological diagnosis

   Squamous cell carcinoma

95 (100%)

95 (100%)

Disease stagea

   IIIA

2 (2.1%)

3 (3.2%)

   IIIB

1 (1.1%)

0

   IIIC

4 (4.2%)

3 (3.2%)

   IV

86 (90.5%)

89 (93.7%)

Site of metastases

   Lymph node

67 (70.5%)

64 (67.4%)

   Liver

27 (28.4%)

33 (34.7%)

   Lung

37 (38.9%)

46 (48.4%)

   Bone

6 (6.3%)

6 (6.3%)

   Other

31 (32.6%)

32 (33.7%)

PD-L1 expression

   Combined Positive Score <1

11 (11.6%)

17 (17.9%)

   Combined Positive Score ≥1

63 (66.3%)

50 (52.6%)

   Combined Positive Score <10

34 (35.8%)

47 (49.5%)

   Combined Positive Score ≥10

40 (42.1%)

20 (21.1%)

   Tumor Proportion Score <1%

44 (46.3%)

43 (45.3%)

   Tumor Proportion Score ≥1%

30 (31.6%)

24 (25.3%)

   Tumor Proportion Score <10%

60 (63.2%)

53 (55.8%)

   Tumor Proportion Score ≥10%

14 (14.7%)

14 (14.7%)

   Not evaluable

21 (32.6%)

28 (33.7%)

Previous treatment

   First-line chemotherapy

84 (88.4%)

85 (89.5%)

   Prior to adjuvant chemotherpy (Disease progression within 6 months)

11 (11.6%)

10 (10.5%)

   Radiotherapy

50 (52.6%)

58 (61.1%)

   Surgery

58 (61.1%)

47 (49.5%)

  1. Data are n (%), unless otherwise specified.
  2. ECOG PS Eastern Cooperative Oncology Group performance status.
  3. aThe disease stage is the stage of clinical TNM at the screening time accroding to AJCC 7th.