Skip to main content

Table 3 Comparison of SGD and other parameters 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

Treatment (dose) Median tumour volume (days) SGD CR/total (n/n) PR/total (n/n) DCR (days) TFS/TR (n/n)
Syngeneic fibrosarcoma mouse model
 Placebo 14 - 0/15 - - 0/0
 SPIL DXR HCl liposome injection 9 mg/kg >28b >1 3/11 8/11 21 3/0
 Reference DXR HCl liposome injection 9 mg/kg >28b >1 7/15 7/15 28 7/0
Human mammary carcinoma xenograft mouse model
 Placebo 19.00 - - - - -
 SPIL DXR HCl liposome injection 1.5 mg/kg 28.00 0.5 0/10 0/10 NA NA
 Reference DXR HCl liposome injection 1.5 mg/kg 28.00 0.5 0/10 0/10 NA NA
 SPIL DXR HCl liposome injection 3 mg/kg 35.00 0.8 1/10 0/10 38 1/0
 Reference DXR HCl liposome injection 3 mg/kg 28.00 0.5 0/10 0/10 NA NA
 SPIL DXR HCl liposome injection 6 mg/kg 42.00 1.2 1/10 2/10 28 1/0
 Reference DXR HCl liposome injection 6 mg/kg >42c >1.2 0/10 2/10 NA NA
  1. Abbreviations: CR/total (n/n) animals with complete tumour regression/total no. of animals, DCR median duration of complete tumour regression in days, DXR doxorubicin, HCl hydrochloride, PR/total (n/n) animals with partial tumour regression/total no. of animals, SGD specific tumour growth delay, SPIL Sun Pharmaceutical Industries Ltd., TFS/TR no. of tumour free survivors/no. of tumour recurrences
  2. aSGD and other parameters were calculated from tumour volume data. The efficacy criteria for SGD parameter was >1. Tumour regression was recorded as partial (PR) if the tumour volume decreased to less than 50% of the tumour volume at the start of the treatment without dropping below measurable size, or as complete (CR) if the tumour burden had become impalpable.
  3. bNone of the animals reached two volume doublings from initial tumour volume at the start of treatment. Hence median time to reach two tumour volume doublings was considered as >28 days.
  4. cNone of the animals reached two volume doublings from initial tumour volume at the start of treatment. Hence median time to reach two tumour volume doublings was considered as >42 days.