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Table 3 Clinical outcomes data

From: Phase 1/2 study of topical submicron particle paclitaxel for cutaneous metastases of breast cancer

Lesion response by subject (RECIST 1.1) Individual lesion response (All subjects)
  28-day (n = 19) 56-day (n = 8) BOR (n = 19) BOR (Longest Dimension) (n = 36) BOR (Area)
(n = 41)
Count Percent Count Percent Count Percent Count Percent Count Percent
CR 0 0% 0 0% 0 0% 4 11% 4 10%
PR 3 16% 2 25% 4 21% 8 22% 10 24%
SD 12 63% 4 50% 13 68% 18 50% 17 41%
PD 4 21% 2 25% 2 11% 6 17% 10 24%
ORR 3 16% 2 25% 4 21% 12 33% 14 34%
PFS 15 79% 6 75% 17 89% 30 83% 31 76%
  1. Abbreviations/Definitions: 28-DAY = 2 subjects treated with 0.15% SOR007 for 28 days, 3 subjects treated with 1.0% SOR007 for 28 days, 14 subjects treated with 2.0% SOR007 for 28 days; 56-DAY = response at 56 days for the 8 subjects treated with 2.0% SOR007 for a total of 56 days; CR = complete response meaning absence of any detectable residual disease in eligible lesion(s) in the treatment area; ORR = overall response rate (CR + partial response [PR]); Progression Free Survival (PFS) [CR + PR + stable disease (SD)]; BOR best overall response from day 15 measurement to end of treatment. Lesion Response by Subject sum of longest dimension of each target lesion per subject analyzed via site dimensions; Individual Lesion Response BOR of all lesions treated with SOR007 by longest dimension and by Area (measured in two dimensions via ImageJ, an image processing program in the public domain developed at the National Institutes of Health