Table 6.
Simulation Results Using Data from Study A09712* with Different Values of β and wij=1 for all Toxicities.
| Dose Level | Treatment | Total Dosage | Percent of Trials Recommending Dose Level d as the MTD | |||
|---|---|---|---|---|---|---|
| EWOC (Binary) | EWOC-NETS | |||||
| β=0.1 | β=0.25 | β=0.5 | ||||
| 1 | 1.7mg/kg/dose M-F*3w | 25.5 | 0 | 0 | 0 | 0 |
| 2 | 1.7mg/kg/dose MWF*6w | 30.6 | 0 | 0 | 0 | 0 |
| 3 | 1.7mg/kg/dose M-F*6w | 51 | 0 | 0 | 0 | 0 |
| 4 | 1.9mg/kg/dose M-F*6w | 57 | 4 | 0 | 0 | 0 |
| 5 | 3.4mg/kg/dose M-F*6w | 102 | 0 | 0 | 0 | 0 |
| 6* | 4.4mg/kg/dose M-F*6w | 132 | 11 | 0 | 0 | 0 |
| 7 | 5.5mg/kg/dose M-F*6w | 165 | 50 | 2 | 6 | 10 |
| 8** | 7.1mg/kg/dose M-F*6w | 213 | 35 | 98 | 94 | 90 |
| 9 | 9.2mg/kg/dose M-F*6w | 276 | 0 | 0 | 3 | 0 |
| Mean (SD) | Sample size | 26.3 (7.9) | 20.2 (5.0) | 20.6 (6.6) | 20.7 (6.2) | |
For EWOC, and EWOC-NETS: Trial stops when a same dose has been recommended to 4 consecutive patient cohorts.
*
: The original trial with standard 3+3 design with dose de-escalation recommended the dose level 6 as MTD and used 13 patient cohorts and a total of 41 eligible patients.
**
: The true MTD suggested by the following Phase II trial.
#
: The maximum possible total dosage is 350 mg/kg.