Table 4.
Simulation results: log-logistic dose-toxicity: Loge(DLT rate/(1−DLT rate)) = −16.8485 + 2.66078*loge(dose).
| Design | % of times that dose level 3 is selected as the MTD | % of times that doses below the MTD (dose levels 1 and 2) are selected as the MTD | % of times that doses above the MTD (dose levels 4 and above) are selected as the MTD | Average number of dose levels examined | Std of dose levels examined | Max dose levels examined | Median dose levels examined | Average number of patients per trial | Median number of patients per trial | Median number of DLTs per trial | Average sample size at MTD | Average % of pts dosed at MTD | Average % of pts under- dosed | Average % of pts over- dosed |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 + 3a | 49.45 (50.55) | 31.66 (35.95) | 18.72 (13.38) | 3.8 | 0.8 | 7 | 4 | 14.2 (16.73) | 15 (15) | 3 (3) | 4.00 (5.18) | 28.72 (31.16) | 48.61 (47.44) | 22.67 (21.4) |
| 2 + 4a | 45.8 (50.89) | 24.48 (33.94) | 29.6 (15.05) | 4.1 | 0.87 | 8 | 4 | 11.89 (16.29) | 12 (16) | 3 (3) | 3.16 (5.19) | 27.49 (32.71) | 40.05 (37.8) | 32.46 (29.49) |
| 4 + 4 aa | 56.73 (57.76) | 20.26 (20.69) | 23.01 (21.54) | 4 | 0.7 | 6 | 4 | 21.96 (24.23) | 20 (24) | 5 (5) | 6.18 (7.4) | 29.09 (31.3) | 42.78 (41.49) | 28.13 (27.21) |
| 5 + 5 aa | 58.07 (58.09) | 31.38 (33.18) | 10.54 (8.71) | 3.8 | 0.65 | 6 | 4 | 25.54 (28.43) | 25 (30) | 4 (5) | 7.96 (9.37) | 31.95 (33.38) | 46.85 (46.63) | 21.21 (19.99) |
| 3 + 3+3 | 53.96 | 22.43 | 23.56 | 4 | 0.74 | 7 | 4 | 15.89 | 15 | 3 | 4.55 | 28.9 | 44.54 | 26.56 |
| Simple accelerated titration | 36.32 | 15.67 | 47.95 | 4.5 | 1.05 | 9 | 4 | 8.11 | 7 | 2 | 1.87 | 22.93 | 29.81 | 47.25 |
| mTPI | 63.15 | 22.45 | 14.35 | 7 | 7 | 7 | 24 (max) | 24 (max) | 10.0 | 41.67 | 40.49 | 17.85 | ||
| TEQR | 57 | 32 | 8 | 7 | 7 | 7 | 22.71 | 24 | 8.6 | 37.78 | 46.98 | 15.24 | ||
| BOIN | 59.2 | 28 | 12.7 | 7 | 7 | 7 | 24 (max) | 24 (max) | 3.7 (mean) | 8.9 | 37.08 | 50 | 12.92 | |
| CRM | 74 | 18 | 8 | 7 | 7 | 7 | 24 (max) | 24 (max) | 4.0 (mean) | 10.1 | 41.92 | 43.42 | 14.67 | |
| EWOC | 57.1 | 9.7 | 33.2 | 7 | 7 | 7 | 24 (max) | 24 (max) | 11.4 | 47.32 | 22.92 | 29.76 |
The bold highlighting shows the designs predicted by simulations to pick the MTD most accurately, to enroll the largest and smallest number of patients, to dose the maximum percentage of patients at the MTD, to under-dose the maximum percentage of patients, and to over-dose the maximum percentage of patients. Note also that the sum of columns 2 to 4 may add up to <100% because the remaining small percentage of times, no dose level is selected as the MTD.
a
The numbers shown in brackets are for a corresponding design that also allows dose de-escalation.