Table 5.
Univariate analysis of clinical factors on ribociclib AUC
| Level | n | Statistics | p-valuea | |
|---|---|---|---|---|
| Correlationa | ||||
| Age (years) | – | 14 | 0.43 | 0.1258 |
| Weight (kg) | – | 14 | −0.28 | 0.3253 |
| Body surface area | – | 14 | −0.34 | 0.2360 |
| Creatinine clearance (mL/min) | – | 14 | −0.25 | 0.3825 |
| Days of ribociclib therapy | – | 14 | −0.03 | 0.9153 |
| median | ||||
| ECOG performance statusb | 0 | 8 | 39200 | 0.5728c |
| 1 | 6 | 43430 | ||
| Smoking | Never | 6 | 41155 | 0.4867d |
| Former | 5 | 32798 | ||
| Current | 3 | 46647 | ||
| Never/former | 11 | 39230 | 0.0879c | |
| Current | 3 | 46647 | ||
| Concomitant unrecommended medicatione | 0 | 11 | 43081 | 0.6612d |
| 1 | 2 | 35679 | ||
| 2 | 1 | 57566 |
aSpearman’s correlation and the corresponding p-value
b0: fully functional, 1: limited functional
cAn exact Wilcoxon rank sum test-based p-value
dAn exact Jonckheere-Terpstra trend test-based p-value
eThe number of unrecommended medications taken by each participant. The two participants taking one unrecommended medication were prescribed a medication that may prolong QT interval (mirtazapine, ondansetron). The participant with two unrecommended medications was prescribed metformin (ribociclib may increase metformin levels) throughout the study and atorvastatin (CYP3A substrate) was paused the day before ribociclib initiation until D13 after completion of sample collection for PK analysis.
AUC area under the curve