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 |