Table 1 Studies overview and pooled analysis.

From: Is CAR T a drug or a therapeutic pathway? Intention to treat versus per protocol analysis of real world studies of CAR-T cell therapy in relapsed refractory diffuse large B cell lymphoma

Study

Location

ITT Median follow up months (95%CI)

ITT Population N

Not infused patients %

PP population N

ORR_ITT (95%CI)

ORR_PP (95%CI)

CRR_ITT (95%CI)

CRR_PP (95%CI)

mPFS_ITT months (95%CI)

mPFS_PP months (95%CI)

mEFS_ITT months (95%CI)

mEFS_PP months (95%CI)

mOS_ITT months (95%CI)

mOS_PP months (95%CI)

mDoR months (95%CI)

BT %

Bachy et al. [6]

EU

13.1 (12.6–13.4)

809

9.9

729

67% (0.63–0.7)

74% (0.71–0.77)

47% (0.43–0.5)

52% (0.48–0.55)

NA

5.7 (4.1–7.5)

NA

NA

16.8 (13.3–21.6)

19 (NA)

11 (7.6–17.2)

78

Bastos-Oreiro et al. [7]

EU

11.0 (9–14)

198

3.0

192

34% (0.27–0.41)

35% (0.28–0.42)

28% (0.22–0.35)

29% (0.23–0.36)

5.1 (3.5–6.7)

5.6 (3.7–7.5)

5.1 (3.53–6.67)

3.3 (2.05–4.61)

14.5 (NA)

15 (NA)

6.4 (0.7–22)

82

Ghafouri et al. [8]a

USA

39.5 (36.6–49.9)

62

14.5

53

68% (0.55–0.79)

79% (0.66–0.89)

55% (0.42–0.68)

64% (0.50–0.77)

5.57 (4–18.5)

6.67 (3.6–22.7)

5.23 (4–14.3)

6.67 (3.6–22.7)

11.1 (7.87–27.2)

17.7 (7.9-NR)

20.2 (10–31.9)

NA

Iacoboni et al. [9]

EU

9.7 (0.1–24.5)

91

17.6

75

49% (0.39–0.60)

60% (0.48–0.71)

26% (0.18–0.37)

32% (0.22–0.44)

4.6 (4.1–6.9)

3 (2.6–4.7)

NA

2.75 (1.2–4.3)

11.1 (7.9-NR)

10.7 (7.4–NR)

8.9 (2.2-NR)

87

Kittai et al. [10]a

USA

35.6 (29.9–41.7)

215

10.2

193

68% (0.61–0.74)

76% (0.69–0.82)

42% (0.36–0.49)

47% (0.40–0.54)

5.43 (4.23–7.53)

5.7 (3.57–10)

4.97 (3.97–6.83)

5.2 (3.3–9.2)

19.7 (12.9–38.3)

26.1 (15.5-NR)

15.1 (11.8–19.8)

NA

Kwon et al. [11]

EU

9.2 (8–11.5)

307

15.0

261

48% (0.42–0.54)

57% (0.50–0.62)

32% (0.27–0.38)

38% (0.32–0.44)

4.8 (4.5–5.6)

3.5 (3–6)

4.8 (4.5–5.6)

3.5 (3–6)

11.7 (12.9–38.3)

11.8 (1.3–31.4)

14.1 (5.8-NR)

80

Mian et al. [12]

USA

5.9 (4.5–10.8)

38

28.9

27

58% (0.41–0.74)

81% (0.62–0.94)

32% (0.18–0.49)

44% (0.25–0.65)

5.59 (4.3-NR)

9.07 (3.65-NR)

5.59 (4.3-NR)

9.07 (3.65-NR)

10.9 (6.08-NR)

13 (7.7-NR)

7.69 (2.73-NR)

50

Nastoupil et al. [13]

USA

13.8 (11.8–16.2)

298

7.7

275

76% (0.70–0.80)

82% (0.77–0.86)

59% (0.53–0.65)

64% (0.58–0.70)

7.16 (5.65–12.4)

8.31 (6.01–15.1)

NA

NA

NR

NR

NR (6.2 -NR)

53

Pinnix et al. [14]

USA

11.1 (9.9–12.3)

148

16.2

124

64% (0.56–0.72)

77% (0.68–0.84)

40% (0.32–0.48)

48% (0.39–0.57)

4.8 (3.7–6.0)

6.2 (4.1–8.3)

NA

NA

16.7 (7.1–26.2)

21.9 (NA)

NA

50

Casadei et al. [15]a

EU

16 (13.8–21.8)

80

26.3

59

38% (0.27–0.49)

51% (0.37–0.64)

21% (0.13–0.32)

29% (0.18–0.42)

7.9 (6.23–14.9)

5.6 (3.07–16.5)

4.5 (3.77–7.47)

5.6 (3.07–16.5)

14.9 (13.4-NR)

17.2 (12.6-NR)

12.5 (5.1-NR)

80

Pooled analysisb

 

29.7 (25.3–32.8)

357

14.6

305

61% (0.56–0.66)

71% (0.66–0.76)

40% (0.35–0.45)

47% (0.41–0.53)

6.2 (4.9–7.9)

5.67 (4.1–8.33)

4.9 (4.1–6.2)

5.2 (3.97–7.07)

17.2 (13.4–26.6)

24.1 (16.2–33.1)

13.4 (10.9–18.9)

 
  1. Bold values: re-estimations by the principal investigator of the project (LA) or new information provided by authors after request. In the other cells, data already present in the original publication.
  2. BT bridging therapy, CRR complete response rate, ITT intention-to-treat, mDoR median duration of response, mEFS median event-free survival, mPFS median progression-free survival, mOS median overall survival, NA Not available, NR Not reached, ORR overall response rate, PP per protocol.
  3. aUpdated data.
  4. bGhafouri et al. [8], Kittai et al. [10] and Casadei et al. [15].
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