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Table 4 Simulation results for TITE-PK, CRM, and BLRM in Scenarios 1-6

From: Phase I dose-escalation oncology trials with sequential multiple schedules

 

Scenario

 

1

2

3

4

5

6

Probability of selecting MTD in the targeted toxicity interval

TITE-PK

0.78

0.52

0.75

0.36

0.71

n/a

CRM

0.73

0.61

0.24

0.22

0.79

n/a

BLRM

0.75

0.49

0.64

0.14

0.78

n/a

Probability of selecting MTD in the overdosing interval

TITE-PK

0.11

0.03

n/a

0.06

0.17

0.11

CRM

0.09

0.04

n/a

0.04

0.10

0.14

BLRM

0.06

0.02

n/a

0.04

0.10

0.07

Probability of selecting no combination as MTD

TITE-PK

0.01

0.42

0.00

0.01

0.04

0.87

CRM

0.01

0.36

0.01

0.01

0.03

0.86

BLRM

0.01

0.48

0.01

0.01

0.04

0.92

Mean number of patients enrolled

TITE-PK

24.7

15.4

23.3

27.0

22.8

8.1

CRM

20.9

15.7

20.9

20.8

20.5

8.9

BLRM

23.6

14.9

24.2

24.8

21.9

7.3

Proportion of patients enrolled in the overdosing interval

TITE-PK

0.28

0.15

n/a

0.13

0.27

1.00

CRM

0.05

0.05

n/a

0.01

0.06

1.00

BLRM

0.10

0.08

n/a

0.11

0.11

1.00

Proportion of DLT observed

TITE-PK

0.28

0.38

0.21

0.25

0.30

0.52

CRM

0.18

0.33

0.11

0.15

0.22

0.51

BLRM

0.21

0.35

0.15

0.20

0.24

0.50