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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.