The therapeutic index is a quantitative measurement of the relative safety of a drug. It was calculated per treatment, as the ratio of the highest exposure dose that produces the desired antitumor response for a maximum tolerated toxicity (i.e., the MTD) to the lowest dose that produces an effective antitumor response.
To evaluate therapeutic index, mice were assessed for BWL, TV, DNA damage within tumor cells, tumor regression, plasma and tumor CPT-11 and SN-38 levels (tumor CPT-11 data not shown), and toxicity within the jejunum and bone marrow.