title: Phase I trial of sodium salicylate in patients with myelodysplastic syndromes and acute myelogenous leukemia.
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.
authors.affiliation: Department of Medicine, Leukemia Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA. Klimekv@mskcc.org
authors.forename: Virginia M
authors.initials: VM
authors.lastname: Klimek
authors.forename: Emily K
authors.initials: EK
authors.lastname: Dolezal
authors.forename: Larry
authors.initials: L
authors.lastname: Smith
authors.forename: Gerald
authors.initials: G
authors.lastname: Soff
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Nimer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008099:Liver / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D016328:NF-kappa B / Q000037:antagonists & inhibitors; D010974:Platelet Aggregation / Q000187:drug effects; D012980:Sodium Salicylate / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D016328:NF-kappa B; D012980:Sodium Salicylate