Table 1 Patients’ characteristics from the confirmed diagnosis set.

From: Synthetic control arm from mixed clinical trials and real-world data from the LYSA group for untreated diffuse large B-cell lymphoma patients aged over 80 years: a bona fide strategy for innovative clinical trials

 

Population

SENIOR

experimental arm

N = 104

SENIOR

standard arm

N = 98

LNH09-7B

N = 73

REALYSA

N = 97

Sex

Male

45

(43.3%)

44

(44.9%)

34

(46.6%)

53

(54.6%)

Female

59

(56.7%)

54

(55.1%)

39

(53.4%)

44

(45.4%)

Age at randomization (years)

Mean (SD)

83.7 (3.48)

 

84.2 (3.72)

 

83.7 (3.06)

 

84.1 (3.02)

  

≤85

80

(76.9%)

70

(71.4%)

51

(69.9%)

70

(72.2%)

>85

24

(23.1%)

28

(28.6%)

22

(30.1%)

27

(27.8%)

Ann Arbor Stage

2

12

(11.5%)

15

(15.3%)

9

(12.3%)

9

(9.3%)

 

3

15

(14.4%)

12

(12.2%)

16

(21.9%)

15

(15.5%)

4

77

(74.0%)

71

(72.4%)

48

(65.8%)

73

(75.3%)

Performans status (ECOG)

0

28

(26.9%)

18

(18.4%)

23

(31.5%)

16

(16.7%)

1

53

(51.0%)

54

(55.1%)

35

(47.9%)

57

(59.4%)

2

23

(22.1%)

26

(26.5%)

15

(20.5%)

23

(24.0%)

Missing

0

 

0

 

0

 

1

  

Extra-nodal involvement ≥2

Yes

54

(51.9%)

50

(51.0%)

30

(41.1%)

55

(56.7%)

IPI in classes

1–2

27

(26.7%)

23

(23.5%)

15

(20.5%)

19

(20.0%)

3–5

74

(73.3%)

75

(76.5%)

58

(79.5%)

76

(80.0%)

Missing

3

 

0

 

0

 

2

  

B symptoms

Yes

22

(21.2%)

29

(29.6%)

13

(17.8%)

40

(41.2%)

LDH

>Upper limit

61

(60.4%)

66

(67.3%)

47

(64.4%)

64

(68.8%)

Missing

3

 

0

 

0

 

4

  

Mass > 10cm

Yes

17

(16.3%)

22

(22.4%)

5

(6.8%)

13

(15.7%)

Missing

0

 

0

 

0

 

14

  

Diagnosis (classification)

HGBL

3

(2.9%)

1

(1.0%)

0

(0.0%)

16

(16.5%)

DLBCL

101

(97.1%)

97

(99.0%)

73

(100.0%)

81

(83.5%)

Albumin (g/L)

Mean (SD)

35.8 (7.02)

 

35.9 (7.46)

 

35.9 (5.66)

 

34.7 (6.39)

  

Missing

4

 

1

 

5

 

27

  
  1. Characteristics of all patients included, from their cohort of origin, are shown before propensity score assessment and weighting procedures. Values are displayed as n (%) or mean (SD) when specified.
  2. SD standard deviation, IPI international prognostic index, LDH lactate dehydrogenase, HGBL high-grade B-cell lymphoma, DLBCL diffuse large B-cell lymphoma.