Table 1 Characteristics and outcomes of patients with aggressive B-cell lymphoma treated with axicabtagene ciloleucel as stratified by obesity status.

From: The impact of obesity and body weight on the outcome of patients with relapsed/refractory large B-cell lymphoma treated with axicabtagene ciloleucel

Parameters

All Cohort

N = 78

Non-Obese

N = 59

Obese

N = 19

P-Valuea

Median age at the time of CAR T-cell infusion (years, range)

58.8 (26.8–76.5)

59.7 (26.8–76.5)

54.7 (30.1–70.1)

0.16

Age 60 years or older (%)

32 (41.0)

27 (45.8)

5 (26.3)

0.13

Male gender (%)

51 (65.4)

37 (62.7)

14 (73.7)

0.38

Advanced stage (3–4) (%)

74 (94.9)

57 (96.6)

17 (89.5)

0.25

Elevated lactate dehydrogenase (%)

53 (67.9)

41 (69.5)

12 (63.2)

0.61

ECOG performance status 2 or higher (%)

3 (3.8)

2 (3.4)

1 (5.3)

0.71

Median prior line of therapy before CAR T cells

3 (1–7)

3 (1–5)

3 (2–7)

0.21

Previous history of autologous stem cell transplant (%)

31 (39.7)

21 (35.6)

10 (52.6)

0.19

Patients with weight 100 kg or higher (%)

15 (19.2)

3 (5.1)

12 (63.2)

<0.001

Indication for CAR T-cell therapy (%):

   

0.29

 Diffuse Large B Cell Lymphoma

51 (65.4)

38 (64.4)

13 (68.4)

 

 Transformed Follicular Lymphoma

18 (23.1)

12 (20.3)

6 (31.6)

 

 High Grade B Cell Lymphoma

8 (10.3)

8 (13.6)

0 (0)

 

Prior history of central nervous system involvement (%)

10 (12.8)

9 (15.3)

1 (5.3)

0.44

Serum creatinine (mg/dL, range)

0.81 (0.54–2.64)

0.80 (0.56–2.1)

0.93 (0.54–2.64)

0.07

Creatinine clearance by MDRD equation (mL/min, range)

89.0 (222.9–140.6)

90.6 (22.9–130.5)

82.2 (26.0–140.6)

0.15

Creatinine clearance by CKG equation (mL/min, range)

103.4 (19.1–241.9)

97.8 (19.1–165.0)

135.8 (83.0–241.9)

0.001

Median duration from leukapheresis to CAR T infusion (day, range)

27 (20–356)

26 (20–356)

27 (24–33)

0.94

Median total delivered dose per body surface area of fludarabine (mg/m2, range)

89.1 (0–104.8)

89.2 (0–104.8)

88.7 (55.5–93.7)

0.36

Fludarabine dose reduction < 80% (%)

8 (11.0)

2 (3.7)

6 (31.6)

<0.001

Median total delivered dose per body surface area of cyclophosphamide (mg/m2, range)

1507 (1021–1660)

1512 (1021–1660)

1501 (1077–1525)

0.008

Cyclophosphamide dose reduction < 80% (%)

2 (2.7)

1 (1.9)

1 (5.3)

0.46

Median absolute lymphocyte count on the day of CAR-T infusion (× 109/L, range)

0.02 (0.0–1.4)

0.02 (0.0–1.4)

0.02 (0.02–0.07)

1.00

CRS grade 2 or more severe (%)

35 (55.6)

26 (55.3)

9 (56.2)

0.95

Median time from CAR T infusion to onset of CRS (days, range)

3 (0–8)

4 (0–8)

3 (0–7)

0.11

Median duration of CRS (days, range)

5 (1–19)

5 (1–19)

7 (2–18)

0.10

ICANS grade 2 or more severe (%)

26 (65.0)

18 (64.3)

8 (66.7)

0.88

Median time from CAR T infusion to onset of ICANS (days, range)

5 (0–13)

5 (0–13)

6 (4–7)

0.96

Median duration of ICANS (days, range)

5 (1–20)

5 (1–20)

6 (2–17)

0.26

Receipt of tocilizumab for CRS treatment (%)

16 (20.5)

11 (18.6)

5 (26.3)

0.47

Receipt of systemic corticosteroid for CRS and ICANS treatment (%)

24 (30.8)

16 (27.1)

8 (42.1)

0.22

Median dose of systemic corticosteroid for CRS and ICANS treatment (mg/m2/day prednisone equivalent, range)

1.8 (0.6–21.2)

1.9 (0.7–21.2)

1.0 (0.6–10.2)

0.08

Median duration of systemic corticosteroid for CRS and ICANS treatment (days, range)

4 (1–15)

5 (1–15)

3 (1–11)

0.21

Median absolute lymphocyte count at 1-month post-CAR T-cell therapy (109 cells/L, range)

0.46 (0–2.25)

0.48 (0–2.1)

0.38 (0.12–2.25)

0.43

Median absolute lymphocyte count at 3-months post-CAR T-cell therapy

0.44 (0.14–3.73)

0.49 (0.14–3.73)

0.31 (0.20–0.95)

0.10

Outcomes

 Best overall response rate (%)

56 (71.8)

43 (72.9)

13 (68.4)

0.71

 1-year event free survival

34.6 (25.2–47.6)

35.8 (25.0–51.4)

30.7 (15.4–61.1)

0.60

 1-year overall survival

65.5 (55.0–78.0)

59.4 (47.1–74.9)

83.9 (68.7–100.0)

0.18

 1-year cumulative incidence of relapse

62.8 (51.5–74.2)

60.8 (47.4–74.2)

69.3 (46.8–91.8)

0.40

 1-year cumulative incidence of non-relapse mortality

2.6 (0–6.1)

3.4 (0–8.0)

0 (0–0)

0.42

 30-days cumulative incidence of CRS

83.3 (74.9–91.7)

83.1 (73.2–92.9)

84.2 (66.7–100)

0.36

 30-days cumulative incidence of ICANS

51.3 (40.1–62.5)

47.5 (34–6–60.3)

63.2 (40.5–85.8)

0.23

  1. CAR chimeric antigen receptor, ECOG Eastern Cooperative Oncology Group, kg kilogram, CRS cytokine release syndrome, ICANS immune effector cell-associated neurotoxicity syndrome, MDRD the modification of diet in renal disease.
  2. aComparison between groups for continuous variables by Wilcoxon rank-sum test, Comparison between groups for categorical variables by Chi-square test or Fisher Exact test, Comparison between groups for survival outcomes (survival, cumulative incidence) by Log-rank analysis.
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