Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control

Table 1

EWOC with Covariate. Design operating characteristic with respect to safety and efficiency of the trial.

(𝛾0, 𝛾1)	0.2, 0.4	0.2, 0.6	0.2, 0.8	0.4, 0.6	0.4, 0.8	0.6, 0.8
Proportion of DLTs	0.3032	0.2735	0.2505	0.2442	0.2231	0.1954
Proportion of DLTs in group A	0.3058	0.2758	0.2495	0.2432	0.2230	0.1932
Proportion of DLTs in group B	0.3007	0.2713	0.2514	0.2451	0.2232	0.1975
Proportion overdosed in group A	0.5958	0.6236	0.6199	0.3174	0.3738	0.1029
Proportion overdosed in group B	0.0934	0.0448	0.0102	0.0373	0.0044	0.0019
Bias (𝛾1)	−0.0090	−0.0122	−0.0174	−0.0326	−0.0432	−0.0910
Bias of (𝛾2)	−0.0585	−0.1218	−0.2185	−0.1075	−0.2014	−0.2013
MSE (𝛾1)	0.0484	0.0501	0.0505	0.0916	0.0968	0.1476
MSE (𝛾2)	0.1068	0.1711	0.2622	0.1635	0.2451	0.2437