FDA Approves Sodium Thiosulfate to Decrease Cisplatin-Associated Ototoxicity in Pediatric Localized, Non-Metastatic Solid Malignancies


Sodium thiosulfate, which appears to be effective in decreasing the risk for hearing loss related to treatment with cisplatin, received FDA approval in pediatric patients with localized, non-metastatic solid tumors.

Sodium thiosulfate has been approved by the FDA as treatment to help decrease the risk of cisplatin-related ototoxicity in pediatric patients aged 1 month or older who have received a diagnosis of localized, non-metastatic solid malignancies, according to a press release issued by the agency.

The compound, with or without cisplatin, was evaluated as part of the phase 3 SIOPEL6 trial (NCT00652132) in pediatric patients with stage I to III childhood liver cancer, as well as in the phase 3 COG ACCL0431 study (NCT00716976) in pediatric patients with newly diagnosed germ cell tumors, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or another malignancy who were being treated with cisplatin.

The incidence of hearing loss in the SIOPEL trial among patients who received sodium thiosulfate was 39% compared with 68% in patients who received cisplatin alone (HR, 0.58; 95% CI, 0.40-0.83). In the COG ACCL0431 trial, 44% of patients experienced hearing loss in the sodium thiosulfate and cisplatin arm vs 58% in the cisplatin alone arm (HR, 0.75; 95% CI, 0.48-1.18).

In total, 114 patients with standard-risk hepatoblastoma who underwent 6 cycles of treatment with cisplatin were included in the SIOPEL6 trial. Patients were randomly assigned 1:1 to receive cisplatin-based chemotherapy with or without sodium thiosulfate at different dosing levels, including 10 g/m2, 15 g/m2, and 20 g/m2.

The COG ACCL0431 included 125 patients with solid malignancies who were treated with 200 mg/m2 of cisplatin or more. A total of 77 patients were included in the efficacy analysis.

Common adverse effects included nausea, vomiting, hemoglobin decrease, hypernatremia, and hypokalemia.


FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors. News release. FDA. September 20, 2022. Accessed September 21, 2022. https://bit.ly/3DLjVgC

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