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Table 1 Characteristics of the included studies

From: Safety, efficacy, and cost-effectiveness evaluation of systemic treatments for refractory colorectal cancer: a systematic review and modeling study

Trial

Study arms

Number of patients

Age (mean, range)

Sex (Male,%)

Region

Median duration/month (mean, 95%CI or SD)

Median PFS/month (mean, 95%CI)

I

C

I

C

I

C

I

C

I

C

I

C

CONCUR [20]

Regorafenib

BSC

136

68

57.5 (50.0–66.0)

55.5 (48.5–62.0)

63

49

Asian

2.4 (1.6–5.3)

1.6 (1.1–1.6)

3.2 (2-3.7)

1.7 (1.6–1.8)

Correct [11]

Regorafenib

BSC

505

255

61(54.0–67.0)

61(54.0–68.0)

62

60

global

2.8 (1.4–3.7)

1.8 (1.3–1.7)

1.9 (1.6–3.9)

1.7 (1.4–1.9)

FRESCO [15]

Fruquintinib

BSC

278

138

55.0 (23–75)

57.0 (24–74)

57

70

Asian

3.7 (0.1–21.9)

1.8(0.1–11.1)

3.7 (3.7–4.6)

1.8 (1.8–1.8)

FRESCO-2 [16]

Fruquintinib

BSC

461

230

64 (56–70)

64 (56–69)

53

61

global

3.1 (1.8–5.6)

1.8 (1.0-2.3)

3.7 (3.5–3.8)

1.8 (1.8–1.9)

RECOURSE [13]

Regorafenib

BSC

534

266

63(27–82)

63(27–82)

61

62

global

1.6 (0–18)

1.3 (0.1–14.7)

2.0 (1.9–2.1)

1.7 (1.7–1.8)

REDOS [12]

REDoS

Regorafenib

54

62

62 (53–68)

61 (53–68)

67

56

global

NA

NA

2.8 (2.0–5.0)

2.0 (1.8–2.8)

SUNLIGHT [14]

TAS-BEV

TAS-102

246

246

62 (20–84)

64 (24–90)

50

55

global

5.0 (0.1–18.5)

2.1 (0.6–14.3)

5.6 (4.5–5.9)

2.4 (2.1–3.2)

C-TASKFORCE [19]

TAS-BEV

TAS-102

46

47

64 (57–69)

67 (58–72)

52

64

Europe

4.9 (3.7–6.8)

2.4 (1.3–3.4)

4.6 (3.5–6.5)

2.6 (1.5–3.5)

TERRA [18]

TAS-102

BSC

271

135

58 (26–81)

56 (24–80)

63

62

Asian

3.2 (2.6)

2 (1)

2 (1.9–2.8)

1.8 (1.7–1.8)

Trial

Study arms

Median OS/month (mean, 95%CI)

HR PFS (Mean, 95%CI)

HR OS (Mean, 95%CI)

Any grade TRAE, N

grade 3 + TRAE, N

Any Serious TRAE, N

 

I

C

I

C

I

C

I

C

I

C

I

C

CONCUR [20]

Regorafenib

BSC

8.8 (7.3–9.8)

6.3 (4.3–7.6)

0.31 (0.22–0.44)

0.55 (0.40–0.77)

136

60

74

10

12

3

Correct [11]

Regorafenib

BSC

6.4 (3.6–11.8)

5.0 (2.8–10.4)

0.49 (0.42–0.58)

0.77 (0.64–0.94)

465

154

270

35

219

100

FRESCO [15]

Fruquintinib

BSC

9.3 (8.2–10.5)

6.6 (5.9–8.1)

0.26 (0.21–0.34)

0.65 (0.51–0.83)

266

97

128

10

17

2

FRESCO-2 [16]

Fruquintinib

BSC

7.4 (6.7–8.2)

4.8 (4.0-5.8)

0.32 (0.27–0.39)

0.66 (0.55–0.80)

395

130

164

26

NA

NA

RECOURSE [13]

Regorafenib

BSC

7.1 (6.5–7.8)

5.3 (4.6- 6.0)

0.48 (0.41–0.57)

0.68 (0.58–0.81)

524

247

370

137

158

89

REDOS [12]

REDoS

Regorafenib

9.8 (7.5–11.9)

6 (4.9–10.2)

0.84 (0.57–1.24)

0.72 (0.47–1.10)

NA

NA

NA

NA

6

8

SUNLIGHT [14]

TAS-BEV

TAS-102

10.8 (9.4–11.8)

7.5 (6.3–8.6)

0.44 (0.36 to 0.54)

0.61 (0.49–0.77)

NA

NA

NA

NA

NA

NA

C-TASKFORCE [19]

TAS-BEV

TAS-102

9.4 (7.6–10.7)

6.7 (4.9–7.6)

0.45 (0.29–0.72)

0.55 (0.32–0.94)

NA

NA

NA

NA

21

19

TERRA [18]

TAS-102

BSC

7.8 (7.1–8.8)

7.1 (5.9–8.2)

0.43 (0.34–0.54)

0.79 (0.62–0.99)

244

70

124

14

63

31

  1. BSC, Best Supportive Care; C, control group; I, intervention group; HR, hazards ratio; N, number of patients; NA, not available; PFS, progression-free survival; OS, overall surviva; RCT, Randomized Controlled Trial; REDo, regorafenib dose optimization; TAS-102, trifluridine/tipiracil; TAS-BEV, TAS-102 with bevacizumab; TRAE, treatment-related adverse event