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Table 1 Patient baseline demographics and disease characteristics

From: Long-term outcomes with HLX01 (HanliKang®), a rituximab biosimilar, in previously untreated patients with diffuse large B-cell lymphoma: 5-year follow-up results of the phase 3 HLX01-NHL03 study

 

HLX01-NHL03 study

5-year follow-up study

Characteristic

H-CHOP

(N = 199)

R-CHOP

(N = 203)

Total

(N = 402)

H-CHOP

(N = 157)

R-CHOP

(N = 159)

Total

(N = 316)

Median age (range), year

54 (46–61)

55 (46–63)

NR

56.9 (23.9–76.2)

55.5 (24.4–76.6)

56.1 (23.9–76.6)

Sex

      

 Male

118 (59.3)

102 (50.2)

220 (54.7)

93 (59.2)

79 (49.7)

172 (54.4)

 Female

81 (40.7)

101 (49.8)

182 (45.3)

64 (40.8)

80 (50.3)

144 (45.6)

ECOG PS

      

 0

75 (37.7)

75 (36.9)

150 (37.3)

63 (40.1)

65 (40.9)

128 (40.5)

 1

94 (47.2)

96 (47.3)

190 (47.3)

70 (44.6)

70 (44.0)

140 (44.3)

 2

30 (15.1)

32 (15.8)

62 (15.4)

24 (15.3)

24 (15.1)

48 (15.2)

IPI

      

 0

8 (4.0)

7 (3.4)

15 (3.7)

5 (3.2)

5 (3.1)

10 (3.2)

 1

95 (47.7)

106 (52.2)

201 (50.0)

70 (44.6)

83 (52.2)

153 (48.4)

 2

96 (48.2)

90 (44.3)

186 (46.3)

82 (52.2)

70 (44.0)

152 (48.1)

 3

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.6)

1 (0.3)

Clinical stage

      

 I

20 (10.1)

28 (13.8)

48 (11.9)

16 (10.2)

27 (17.0)

43 (13.6)

 II

82 (41.2)

84 (41.4)

166 (41.3)

63 (40.1)

61 (38.4)

124 (39.2)

 III

62 (31.2)

62 (30.5)

124 (30.8)

48 (30.6)

52 (32.7)

100 (31.6)

 IV

35 (17.6)

29 (14.3)

64 (15.9)

30 (19.1)

19 (11.9)

49 (15.5)

Bone marrow involvement

      

 Yes

34 (17.1)

32 (15.8)

66 (16.4)

30 (19.1)

26 (16.4)

56 (17.7)

 No

165 (82.9)

171 (84.2)

336 (83.6)

127 (80.9)

133 (83.6)

260 (82.3)

  1. Note: Data are presented in median (interquartile range) or n (%), unless otherwise stated. Percentages may not add up to 100% because of rounding.
  2. Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; IPI, International Prognostic Index; NR, not reported.