Table 4.
Comparison of phase I designs under dose-toxicity Scenario 3.
| Dose | DLT rate | Designs |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 + 3 | 3 + 3@9,2 | CS(40; 3,6,9) | CS(25; 5,11) | CS(35; 2,6) | CS(50; 1,3,5) | CS(50) | mTPI | mTPI2 | CRM | ||
| Proportion of recommended dose (MTD) levels (%) | |||||||||||
| 0 | 10 | 11 | 9 | 26 | 7 | 0 | 2 | 0 | 0 | 0 | |
| 1 | 0.10 | 9 | 9 | 8 | 17 | 7 | 2 | 2 | 6 | 3 | 2 |
| 2 | 0.10 | 8 | 9 | 7 | 15 | 7 | 2 | 2 | 7 | 10 | 5 |
| 3 | 0.10 | 7 | 12 | 6 | 12 | 8 | 1 | 1 | 14 | 15 | 6 |
| 4 | 0.10 | 30 | 39 | 31 | 23 | 32 | 13 | 13 | 26 | 20 | 21 |
| 5 | 0.25 | 36 | 20 | 39 | 6 | 38 | 76 | 80 | 45 | 46 | 58 |
| 6 | 0.80 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 6 | 8 |
| 7 | 0.90 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Proportion of patients treated (%) | |||||||||||
| 1 | 0.10 | 29 | 28 | 26 | 47 | 23 | 11 | 9 | 27 | 27 | 11 |
| 2 | 0.10 | 19 | 18 | 17 | 22 | 18 | 10 | 8 | 23 | 24 | 7 |
| 3 | 0.10 | 16 | 15 | 15 | 14 | 16 | 11 | 8 | 20 | 20 | 8 |
| 4 | 0.10 | 16 | 20 | 19 | 11 | 19 | 15 | 14 | 16 | 16 | 22 |
| 5 | 0.25 | 15 | 16 | 19 | 5 | 19 | 33 | 46 | 11 | 11 | 38 |
| 6 | 0.80 | 4 | 4 | 4 | 0 | 5 | 18 | 14 | 2 | 2 | 10 |
| 7 | 0.90 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 4 |
| Average number of patients | 18.2 | 22 | 23.5 | 24.0 | 17.2 | 13.3 | 19.0 | 18.0 | 18.0 | 18.0 | |
| Percent toxicity (%) | 20.0 | 19.4 | 18.7 | 17.5 | 19.2 | 30.1 | 29.1 | 13.2 | 13.2 | 26.2 | |