Table 1 Clinical characteristics of the study population

From: Sintilimab (anti-PD-1 antibody) plus chidamide (histone deacetylase inhibitor) in relapsed or refractory extranodal natural killer T-cell lymphoma (SCENT): a phase Ib/II study

Characteristic

Chidamide dosage

Total (n = 38)

No. (%)

20 mg (n = 3)

25 mg (n = 3)

30 mg (n = 32)

Age, years 

  Median (range)

37 (20–53)

37 (27–51)

48 (21–72)

43 (20–72)

  <60

3 (100)

3 (100)

27 (84.3)

33 (86.8)

  ≥60

0

0

5 (15.7)

5 (13.2)

Sex

  Male

2 (66.7)

2 (66.7)

24 (75.0)

28 (73.7)

  Female

1 (33.3)

1 (33.3)

8 (25.0)

10 (26.3)

ECOG performance status at study entry

  0

3 (100)

1 (33.3)

14 (43.8)

18 (47.4)

  1

0

2 (66.7)

14 (43.8)

16 (42.1)

  2

0

0

4 (12.4)

4 (10.5)

Ann Arbor stage

  I–II

1 (33.3)

1 (33.3)

11 (34.4)

13 (34.2)

  III–IV

2 (66.7)

2 (66.7)

21 (65.6)

25 (65.8)

Fever at study entry

  Yes

2 (66.7)

1 (33.3)

10 (31.3)

13 (34.2)

  No

1 (33.3)

2 (66.7)

22 (68.7)

25 (65.8)

Plasma lactate dehydrogenase level at study entry

  Normal

0

2 (66.7)

17 (53.1)

19 (50.0)

  Elevated

3 (100)

1 (33.3)

15 (46.9)

19 (50.0)

Lesion’s location

  Nasal

0

0

15 (46.9)

15 (40.0)

  Non-nasal

3 (100)

3 (100)

17 (53.1)

23 (60.0)

Bone marrow involvement

  Yes

0

1 (33.3)

4 (12.5)

5 (13.1)

  No

3 (100)

2 (66.7)

28 (87.5)

33 (86.9)

Distant lymph node involvement

  Yes

2 (66.7)

1 (33.3)

10 (31.3)

13 (34.2)

  No

1 (33.3)

2 (66.7)

22 (68.7)

25 (65.8)

Prior HLH

  Yes

2 (66.7)

0

1 (3.1)

3 (7.9)

  No

1 (33.3)

3 (100)

31 (96.9)

35 (92.1)

Plasma EBV-DNA level

  Non-detectable

0

0

9 (28.1)

9 (23.7)

  Detectable

3 (100)

3 (100)

23 (71.9)

29 (76.3)

PINK-E score4

  Low (0–1)

0

1 (33.3)

10 (31.3)

11 (29.0)

  Intermediate (2)

1 (33.3)

0

4 (12.5)

5 (13.1)

  High (≥3)

2 (66.7)

2 (66.7)

18 (56.2)

22 (57.9)

Disease status at study entry

  Relapsed

1 (33.3)

1 (33.3)

12 (37.5)

14 (36.8)

  Refractory

2 (66.7)

2 (66.7)

20 (62.5)

24 (63.2)

Relapse or disease progression within 3 months from last therapy

  Yes

1 (33.3)

0

13 (40.6)

14 (36.8)

  No

2 (66.7)

3 (100)

19 (59.4)

24 (63.2)

Previous systemic therapies

  Median (IQR)

NA

NA

1 (1–2)

1 (1–2)

  One line

2 (66.7)

2 (66.7)

17 (53.1)

21 (55.3)

  Two lines

1 (33.3)

1 (33.3)

8 (25.0)

10 (26.3)

  More than three lines

0

0

7 (21.9)

7 (18.4)

Prior anti-PD-1/L1 antibody therapya

  Yes

1 (33.3)

0

5 (15.7)

6 (15.8)

  No

2 (66.7)

3 (100)

27 (84.3)

32 (84.2)

Prior chidamide therapy

  Yes

0

0

4 (12.5)

4 (10.5)

  No

3 (100)

3 (100)

28 (87.5)

34 (89.5)

Prior ASCT therapy

  Yes

0

0

2 (6.3)

2 (5.3)

  No

3 (100)

3 (100)

30 (93.7)

36 (94.7)

Previous radiotherapy

  Yes

1 (33.3)

2 (66.7)

21 (65.6)

24 (63.2)

  No

2 (66.7)

1 (33.3)

11 (34.4)

14 (36.8)

  1. Data are n (%), unless otherwise indicated
  2. ASCT autologous stem cell transplantation, EBV Epstein-Barr virus, ECOG eastern cooperative oncology group, HLH hemophagocytic lymphohistiocytosis, LDH lactate dehydrogenase, NA not applicable, PINK-E prognostic index for natural killer cell lymphoma–Epstein-Barr virus
  3. aAnti-PD-1/L1 antibody including pembrolizumab, sintilimab, sugemalimab31
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