Figure 1.

CONSORT diagram. ^aSample drawn after pump finished infusing, sample not analyzed secondary to labeling issues; patient given hydration via peripheral line and sample drawn without wasting, thus diluted; omission of stabilizing agent and/or blood sample hemolyzed. In addition, three of these patients had protocol violations such as per-protocol dose adjustment not made. ^bAll four patients completed two cycles of PK-guided 5-FU prior to being removed.

Abbreviations: 5-FU, 5-fluorouracil; mFOLFOX6, modified FOLFOX regimen (5-FU, leucovorin, oxaliplatin); PK, pharmacokinetic.