Article Figures & Data
Figures
- Fig. 1.
Pharmacokinetic profile of ABI-007 showing mean whole blood paclitaxel concentrations at increasing doses of ABI-007 versus time. All infusions were given over 30 min except for the first 3 patients who received 135 mg/m2 over 180 min.
- Fig. 2.
Correlation between the mean AUCinf and dose level. The data have been fit using a linear regression and an exponential regression function.
- Fig. 3.
Individual values of Cmax (a) and AUCinf (b) versus dose for patients receiving 30-min infusions of ABI-007.
- Fig. 4.
Individual values of Cmax (a) and AUCinf (b) for patients who experienced grade 3 nonhematological toxic effects (“yes”) and those who did not (“no”). In the “yes” category, the solid diamond symbols (♦) represent 2 patients with multiple grade 3 toxicities, whereas the open circle (○) represents the patient with only grade 3 neuropathy.
Tables
- Table 1
Dose levels
Level Dose (mg/m2) No. patients entered No. cycles 0 135 4 6 1 200 3 38 2 300 6 35 3 375 6 17 - Table 2
Patient characteristics
No. (%) Enrolled 20 Eligible 19 Age (yr) Median 50 Range 33–83 Performance status (Zubrod) 0 2 (10) 1 14 (74) 2 3 (16) Gender Female 16 (84) Male 3 (16) Malignancy Breast cancer 13 (68) Melanoma 6 (32) Prior treatment Chemotherapy 19 (100) Immunotherapy 6 (32) Radiotherapy 15 (79) - Table 3
Median absolute neutrophil and platelet nadirs by dose level
Dose level ANC nadir × 103/mm3 (range) Platelet nadir × 103/mm3 (range) 0 2.229 (1.850–5.040) 204 (174–292) 1 1.845 (0.586–3.729) 197 (118–270) 2 0.960 (0.264–3.680) 200 (105–609) 3 0.966 (0.018–1.804) 173 (25–251) - Table 4
Nonhematologic toxicity by dose levela
Toxicity Level 0 (n = 4) Level 1 (n = 3) Level 2 (n = 6) Level 3 (n = 6) Grade 1 or 2 Grade 3 Grade 1 or 2 Grade 3 Grade 1 or 2 Grade 3 Grade 1 or 2 Grade 3 Sensory neuropathy 0 0 0 0 4 1 3 3 Ocular 1 0 0 0 2 0 2 2 Stomatitis 0 0 1 0 4 0 3 2 Nausea 1 0 1 0 3 0 4 1 Vomiting 1 0 1 0 0 0 2 1 Diarrhea 1 0 2 0 3 0 1 1 Arthralgia/myalgia 3 0 3 0 4 0 4 1 Skin 0 0 0 0 5 0 2 0 Fever (non-neutropenic) 0 0 0 0 2 0 3 0 -
a Expressed as the number of patients experiencing the toxic effect during the first two cycles of treatment.
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- Table 5
Summary of noncompartmental pharmacokinetic parameters, mean (% coefficient of variation) values by dosea
Dose mg/m2 Infusion duration min n Cmax ng/ml AUCinf ng/h/ml Half-life h CL liter/h/m2 Vz liter/m2 135 180 3 1392 (30) 5654 (42) 12.9 (60) 27.4 (45) 418 (32) 135 30 1 6100 6427 14.6 21.1 442 200 30 3 7757 (35) 9613 (20) 13.4 (67) 21.4 (21) 384 (64) 300 30 5 13520 (7) 17610 (21) 14.6 (14) 17.7 (22) 370 (23) 375 30 4 19350 (15) 35805 (40) 13.2 (12) 11.9 (42) 236 (54) -
a n, number of patients; Cmax, maximum or peak concentration; AUCinf, area under the whole blood/plasma concentration-time curve from time 0 to time infinity; CL, total body clearance; Vz, volume of distribution.
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Volume 8, Issue 5
