Skip to main content
. 2019 Oct 12;16:100461. doi: 10.1016/j.conctc.2019.100461

Table 2.

Additional Dosing Decisions to Table 1 to be followed for the 2D TEQR design.

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.