Pharmacokinetic study and evaluation of the safety of taurolidine for dogs with osteosarcoma

Marley, Kevin; Helfand, Stuart C; Simpson, Jennifer; Mata, John E; Tracewell, William G; Brownlee, Lisa; Bracha, Shay; Séguin, Bernard

doi:10.1186/1756-9966-32-74

Journal of Experimental & Clinical Cancer Research

Table 2 Patient characteristics, treatment and side effects for dogs with osteosarcoma

From: Pharmacokinetic study and evaluation of the safety of taurolidine for dogs with osteosarcoma

Dog ID #	7	8	9	10	11	12	13
Weight (kg)	56	74	64	37	28	47	30
Breed	Great Pyrenees	Irish wolfhound	Great Pyrenees	Golden retriever	Shepherd mix	Labrador cross	Old English sheepdog
Age (yr)	6	4	6	7	11	7	5
Sex	Neutered male	Spayed female	Spayed female	Neutered male	Spayed female	Neutered male	Spayed female
Tumor location	Distal radius	Distal radius	Distal radius	Proximal tibia	Proximal humerus	Distal radius	Distal radius
Chemo drug	Doxorubicin	Doxorubicin	1 dose doxorubicin then carboplatin	Carboplatin	Carboplatin	Carboplatin	Carboplatin
Number of taurolidine treatments	4	10	4	5	3	5	2
Neutropenia	None	None	Grade 1 once^b	Grade 1 four times	None	Grade 1 once	Grade 1 once
Neutropenia	None	None	Grade 2 once	Grade 1 four times	None	Grade 2 once	Grade 1 once
Thrombocytopenia	None	Grade 1 twice	None	None	None	Grade 2 once	None
Thrombocytopenia	None	Grade 2 twice	None	None	None	Grade 2 once	None
Chemistry panel	Normal	Low albumin, high ALP which returned to normal in 2 weeks	Azotemia^b	Normal	Normal	ALT elevation^c	Normal
Constitutional adverse event	Lethargy grade 1 to 2^a	Grade 1 fever once	Lethargy grade 1 once	Lethargy grade 1 once	Grade 2 fever and lethargy grade 3 once, both associated with extravasation of carboplatin or taurolidine	Lethargy grade 1 twice and grade 2 twice	None
GI toxicity	Anorexia grade 2^a	Anorexia grade 1 twice	Diarrhea grade1^b	None	None	Anorexia grade 1 once and grade 2 twice	Anorexia grade 1 once
GI toxicity	Anorexia grade 2^a	Diarrhea grade 1 once	Diarrhea grade1^b	None	None	Anorexia grade 1 once and grade 2 twice	Diarrhea grade 1 once
Other adverse event or complication	Edema in limb which was used for IV infusion, vasculopathy at injection sites	Phlebitis and limb edema	Renal insufficiency^b	None	Hearing loss	None	None
		Congestive heart failure
		Proteinuria (urine protein/creatinine = 7.9) nephropathy
Outcome	Euthanized due to progressive disease ^a,e	Died of heart failure^e	Bone metastasis documented 1071 days postoperatively^e	Died 897 days postoperatively with pulmonary metastasis^d,e	Euthanized 174 days postoperatively due to pulmonary metastasis^e	Euthanized 165 days postoperatively due to metastasis to scapula^e	Euthanized 116 days postoperatively due to metastasis to lungs, liver, and spine ^{d, e}
Outcome	Necropsy performed	Necropsy performed	Still alive 1186 days postoperatively	Necropsy performed			Necropsy performed

^aThis dog had stage III osteosarcoma when the taurolidine/doxorubicin treatments were given. It was difficult to assess the number of events for the anorexia and lethargy as these adverse events were pervasive during the treatment period.
^bGrade 1 neutropenia, diarrhea, and azotemia occurred after the doxorubicin/taurolidine combination treatment: Blood Urea Nitrogen and creatinine were as high as 60 mg/dL (normal 7–27 mg/dL) and 3.1 mg/dL (normal 0.4-1.8 mg/dL), respectively. The renal function recovered before starting the carboplatin and taurolidine treatments.
^cALT (alanine transaminase) with up to 371 IU/L (normal 0–113 IU/L) after the 4th taurolidine treatment and 6th carboplatin treatment. Two weeks later it was down to 129 IU/L.
^dDog #10 was entered in another clinical trial 270 days postoperatively where it received dasatinib and dog #13 also received bortezomib 102 days after amputation once metastatic disease was detected on chest radiographs.
^eConfirmed with histology.

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ISSN: 1756-9966

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