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Table 2 Comparison of %T/C data of SPIL and reference DXR HCl liposome injectionsa

From: Lipodox® (generic doxorubicin hydrochloride liposome injection): in vivo efficacy and bioequivalence versus Caelyx® (doxorubicin hydrochloride liposome injection) in human mammary carcinoma (MX-1) xenograft and syngeneic fibrosarcoma (WEHI 164) mouse models

  Syngeneic fibrosarcoma mouse model Human mammary carcinoma xenograft mouse model
Days SPIL DXR HCl liposome injection
9 mg/kg
Reference DXR HCl liposome injection
9 mg/kg
SPIL DXR HCl liposome injection
1.5 mg/kg
Reference DXR HCl liposome injection
1.5 mg/kg
SPIL DXR HCl liposome injection
3 mg/kg
Reference DXR HCl liposome injection
3 mg/kg
SPIL DXR HCl liposome injection
6 mg/kg
Reference DXR HCl liposome injection
6 mg/kg
%T/C (n) %T/C (n) %T/C (n) %T/C (n) %T/C (n) %T/C (n) %T/C (n) %T/C (n)
0 98.26 (11) 96.59 (15)
ns
109.73 (10) 104.01 (10)
ns
121.01 (10) 110.15 (10)
ns
106.77 (10) 119.41 (10)
ns
3   95.85 (10) 99.43 (10)
ns
105.52 (10) 100.33 (10)
ns
90.24 (10) 105.11 (10)
ns
7 41.83 (11) 41.81 (15)
ns
99.89 (10) 96.20 (10)
ns
92.40 (10) 84.05 (10)
ns
73.89 (10) 86.59 (10)
ns
10   101.32 (10) 113.86 (10)
ns
80.23 (10) 90.67 (10)
ns
57.70 (10) 67.29 (10)
ns
14 11.07 (11) 8.46 (15)
ns
96.73 (10) 82.17 (10)
ns
56.76 (10) 56.82 (10)
ns
27.63 (10) 39.29 (10)
ns
17   82.60 (10) 70.85 (10)
ns
50.36 (10) 50.02 (10)
ns
18.47 (10) 30.75 (10)
ns
21 2.56 (11) 2.00 (15)
ns
77.17 (10) 61.13 (10)
ns
33.51 (10) 42.06 (10)
ns
13.80 (10) 20.37 (10)
ns
24   77.12 (10) 69.97 (10)
ns
33.53 (10) 36.99 (10)
ns
14.29 (10) 16.82 (10)
ns
28 0.48 (11) 0.40 (14)
ns
71.72 (10) 67.15 (10)
ns
35.25 (10) 37.60 (10)
ns
12.90 (9) 13.92 (9)
ns
31   70.05 (10) 64.51 (10)
ns
27.48 (10) 39.35 (10)
ns
10.64 (9) 11.29 (9)
ns
35 67.03 (10) 61.12 (10)
ns
28.80 (10) 31.64 (10)
ns
10.65 (8) 11.19 (9)
ns
38 68.52 (10) 63.41 (10)
ns
28.22 (10) 31.29 (10)
ns
10.44 (8) 11.75 (8)
ns
42 70.10 (10) 61.24 (10)
ns
24.61 (10) 25.86 (10)
ns
10.73 (8) 11.65 (8)
ns
  1. Abbreviations: DXR doxorubicin, HCl hydrochloride, ns non-significant as compared to SPIL DXR HCl liposome injection, SPIL Sun Pharmaceutical Industries Ltd., %T/C percentage test/control
  2. aPercentage test/control (%T/C) data were calculated from tumour volume data. %T/C ≤ 42% indicates acceptable antitumour activity; %T/C ≤ 20% indicates moderate antitumour activity; %T/C ≤ 10% indicates high antitumour activity. Differences were analysed by two-way analysis of variance followed by Bonferroni post tests. P values <0.05 were considered significant.