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Table 2 Detailed results of surrogacy assessment on different endpoints

From: Surrogacy of one-year survival for overall survival in advanced hepatocellular carcinoma

 

Subgroups

Included trials

Included patients

R2

95% confidence interval

ORR ratio – OS HR

All trials

24

11,924

0.27

0.03–0.56

mORR ratio – OS HR

All trials

9

2,960

0.55

0.07–0.90

PFS

 Median PFS—median OS

All trials

32

13,808

0.32

0.08–0.55

ICIs relevant

3

1,657

0.70

0.01–1.00

ICIs irrelevant

29

12,151

0.41

0.16–0.67

LT relevant

4

714

0.80

0.56–0.98

LT irrelevant

28

13,094

0.31

0.08–0.56

Phase II

7

983

0.44

0.09–0.86

Phase III

25

12,825

0.31

0.05–0.54

First-line setting

18

8,415

0.30

0.04–0.64

secondary or later-line setting

14

5,393

0.13

0.02–0.42

2008–2015

9

4,915

0.21

0.02–0.62

2016–2022

23

8,893

0.39

0.13–0.65

PFS HR ≤ 0.6

11

3,928

0.48

0.16–0.80

PFS HR > 0.6

21

9,880

0.30

0.03–0.63

 PFS HR – OS HR

All trials

32

13,808

0.58

0.40–0.79

ICIs relevant

3

1,657

0.86

0.00–1.00

ICIs irrelevant

29

12,151

0.61

0.42–0.82

LT relevant

4

714

0.68

0.15–1.00

LT irrelevant

28

13,094

0.58

0.39–0.82

Phase II

7

983

0.78

0.38–0.99

Phase III

25

12,825

0.55

0.33–0.81

First-line setting

18

8,415

0.57

0.29–0.96

secondary or later-line setting

14

5,393

0.73

0.45–0.89

2008–2015

9

4,915

0.54

0.08–0.95

2016–2022

23

8,893

0.62

0.45–0.82

PFS HR ≤ 0.6

11

3,928

0.40

0.01–0.82

PFS HR > 0.6

21

9,880

0.37

0.05–0.70

1-yr survival

 1-yr survival rate – median OS

All trials

32

13,808

0.74

0.63–0.88

ICIs relevant

3

1,657

0.51

0.02–0.99

ICIs irrelevant

29

12,151

0.70

0.57–0.88

LT relevant

4

714

0.46

0.01–0.99

LT irrelevant

28

13,094

0.75

0.64–0.88

Phase II

7

983

0.55

0.19–0.98

Phase III

25

12,825

0.76

0.05–0.89

First-line setting

18

8,415

0.69

0.55–0.88

secondary or later-line setting

14

5,393

0.84

0.64–0.94

2008–2015

9

4,915

0.65

0.39–0.96

2016–2022

23

8,893

0.77

0.68–0.86

PFS HR ≤ 0.6

11

3,928

0.77

0.61–0.98

PFS HR > 0.6

21

9,880

0.75

0.62–0.92

 1-yr survival ratio – OS HR

All trials

32

13,808

0.65

0.47–0.99

ICIs relevant

3

1,657

0.49

0.00–1.00

ICIs irrelevant

29

12,151

0.72

0.41–0.87

LT relevant

4

714

0.90

0.57–1.00

LT irrelevant

28

13,094

0.64

0.44–0.98

Phase II

7

983

0.76

0.45–1.00

Phase III

25

12,825

0.63

0.19–0.84

First-line setting

18

8,415

0.64

0.24–0.87

secondary or later-line setting

14

5,393

0.66

0.20–0.86

2008–2015

9

4,915

0.74

0.12–0.95

2016–2022

23

8,893

0.66

0.33–0.86

PFS HR ≤ 0.6

11

3,928

0.75

0.42–0.95

PFS HR > 0.6

21

9,880

0.42

0.12–0.84

  1. Abbreviations: ORR Objective response rate, OS Overall survival, HR Hazard ratio, mORR ORR Evaluated by mRECIST, PFS Progression-free survival, ICIs Immune checkpoint inhibitors, LT Locoregional treatment