Abstract
8255 Background: Renal failure with accumulation of MTX after HD-MTX therapy is a potentially devastating complication. CPG2 cleaves MTX into non-toxic metabolites, whereas in this situation hemodialysis is ineffective. Little is known on the clinical efficacy of CPG2 in pts. with renal failure and excessive MTX accumulation. Methods: In a nationwide survey, we have evaluated pts. treated with CPG2 for very severe MTX-intoxication and renal failure. Results: Four pts. (age: 20–35 years; 2 male, 2 female; 2 osteosarcoma, 2 chondrosarcoma) with renal failure and a serum MTX (sMTX) level >100μmol/l at registration were identified. HD-MTX-therapy (5464 to 12005mg/m2) was given as a 4 hour infusion. Pts. were registered at 19, 40, 48 and 48 hours after start of HD-MTX when sMTX-levels were 567, 304, 158 and 292μmol/l, respectively. Serum creatinin levels at registration ranged from 308–362μmol/l. Risk factors contributing to renal failure were overweight (BMI >=25kg/m2; n=2), suboptimal hydration (n=2), low urine pH (n=2), preexisting renal insufficiency (n=2), comedication interfering with renal MTX-excretion (n=2) and urine flow obstruction (n=1). CPG2 (15–35units/kg/body weight) was given as a single intravenous injection 28–61hours after start of HD-MTX. In all pts., CPG2 was tolerated without side effects. Serum creatinin levels peaked (331–508μmol/l) days 0–5 and returned to normal in all pts. by days 23–43 after CPG2 treatment. Extrarenal grade III/IV MTX-toxicity were mucositis (n=1), liver (n=3), central nervous (n=2) and hematological toxicity (n=2). Conclusions: CPG2 is an effective, well tolerated antidote in patients with excessive MTX-intoxication and facilitates complete recovery from renal failure in these high-risk pts. More studies are needed to evaluate more precisely the efficacy of an early use of CPG2 and its potential role as a standard rescue agent. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Protherics PLC Protherics PLC Protherics PLC Protherics PLC
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