Dr. Shah on the Significance of the Approval of Sodium Thiosulfate in Pediatric Solid Tumors

Nilay Shah, MD, physician scientist, the Center for Childhood Cancer and Blood Diseases, Nationwide Children’s Hospital, assistant professor, the Department of Pediatrics, the Ohio State University College of Medicine, discusses the significance of the approval of sodium thiosulfate (Pedmark) for pediatric patients with cisplatin-treated pediatric solid tumors.

In September 2022, the FDA approved sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors. The approval was based on data from the phase 3 SIOPEL6 (NCT00652132) and COG ACCL0431 (NCT00716976) trials.

The ability to use sodium thiosulfate to reduce ototoxicity can provide a positive effect on the quality of life for pediatric patients treated with cisplatin, Shah says, adding that reduced ototoxicity can help eliminate some of the stigma of pediatric cancer. With the FDA approval, sodium thiosulfate can now be integrated into the standard of care for pediatric patients with solid tumors, Shah continues.

Similar to how patients treated with anthracyclines also receive dexrazoxane to reduce morbidity, sodium thiosulfate can now be used in the same way with cisplatin, Shah concludes.