Table 2.
Table 1says Escalate | |
If toxicity rate < toxlim and efficacy rate >= efflim at the next higher dose level, then | Escalate one dose level higher than the current one |
If toxicity rate >= toxlim at the next higher dose level, then irrespective of efficacy rate at the next higher dose level | Stay at the same dose level if efficacy rate >= efflim at the same dose level, or if efficacy rate < efflim at the same dose level and the number of patients dosed at this dose level is <= 2*cohort size (this would be 6 patients for cohort size of 3 and 10 patients for cohort size of 5). Otherwise de-escalate one dose level lower than the current one |
If toxicity rate < toxlim and efficacy rate < efflim at the next higher dose level, then | Escalate one dose level higher than the current one if the number of patients dosed at the next higher dose level is <= 2*cohort size Stay at the same dose level if the number of patients already dosed at the next higher dose level is >= 3*cohort size and efficacy rate >= efflim at the same dose level, or if efficacy rate < efflim at the same dose level and the number of patients dosed at the same dose level is <= 2*cohort size. Otherwise de-escalate one dose level lower than the current one |
| |
Table 1says De-Escalate | |
If efficacy rate >= efflim at the next lower dose level, then If efficacy rate < efflim at the next lower dose level, then |
De-escalate to the next lower dose level than the current one De-escalate to the next lower dose level than the current one if the number of patients at the lower dose is <= 2*cohort size De-escalate one more dose level (i.e. 2 dose levels lower than the current one) if the number of patients at the next lower dose (1 dose level lower than the current one) is >= 3*cohort size |
| |
Table 1says Stay | Stay at the same dose |
Toxlim and efflim, the upper limit for toxicity and lower limit for efficacy, are parameters chosen by the physician and are respectively 0.51 and 0.1 in this paper.