Table 4.
Clinical Outcome | Nb | Pharmacokinetic Parameters | ||
---|---|---|---|---|
AUCCY | AUCHCY | AUCCEPM | ||
Non-relapse mortality | 10 | HR=1.15 (p=0.64) | HR=1.67 (p=0.11) | HR=1.40(p=0.25) |
Relapse | 9 | HR=1.05 (p=0. 84) | HR=1.2 (p=0.53) | HR=1.53 (p=0.10) |
Overall mortality | 20 | HR=1.28 (p=0.26) | HR=1.74 (p=0.03) | HR=1.67(p=0.02) |
AUC modeled as continuous linear variable, with hazard ratios for AUCCEPM and AUCHCY representing increase in hazard ratio (HR) associated with increase in AUC of 100 μM•h. Hazard ratios for AUCCY represent increase in hazard associated with increase in AUC of 1000 μM•h. Hazard ratios adjusted for age at time of HCT, type of donor, and relapse risk.
Number of events in cohort in 51 cases.
Abbreviations: CY, cyclophosphamide; TBU, targeted busulfan; HR, hazard ratio; AUC, area under the curve; HCY, 4-hydroxycyclophosphamide; CEPM, carboxyethylphosphoramide mustard.