Phase I trial of sodium salicylate in patients with myelodysplastic syndromes and acute myelogenous leukemia.

Virginia M Klimek, Emily K Dolezal, Larry Smith, Gerald Soff, Stephen D Nimer

Journal: Leukemia research 2012;36(5):570-4

PMID: 22154022

Full Text on Elsevier Science View on PubMed

Abstract

Sodium salicylate is an inexpensive, readily available anti-inflammatory agent which inhibits NF-κB in in vitro models. We examined whether it was possible to safely achieve and maintain salicylate levels known to inhibit NF-κB in vitro in 11 patients with MDS or AML taking sodium salicylate. Most patients achieved the target blood salicylate level (20-30mg/dL) with acceptable toxicity, including reversible grade 1/2 elevations of hepatic transaminases (n=4) and ototoxicity (n=4). One patient had grade 3/4 elevations in AST/ALT. This study suggests that sodium salicylate may be safely combined with conventional chemotherapy regimens which are not associated with significant ototoxicity or hepatotoxicity.

Address: Department of Medicine, Leukemia Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA. [email protected]

DOI: 10.1016/j.leukres.2011.10.023

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MeSH Terms: Aged, Aged, 80 and over, Anti-Inflammatory Agents, Non-Steroidal, Female, Humans, Leukemia, Myeloid, Acute, Liver, Male, Middle Aged, Myelodysplastic Syndromes, NF-kappa B, Platelet Aggregation, Sodium Salicylate