Sodium thiosulfate lowers risk for hearing loss among children with hepatoblastoma

Great news to reduce the ototoxicity of the chemotherapy

Children with standard-risk hepatoblastoma who received sodium thiosulfate 6 hours after cisplatin chemotherapy had a 48% lower incidence of cisplatin-induced hearing loss, according to phase 3 results from the SIOPEL 6 clinical trial published in The New England Journal of Medicine.

Cisplatin chemotherapy and surgery are standard treatments for children with standard-risk hepatoblastoma. However, hearing loss – a side effect of cisplatin chemotherapy - can affect learning, development and quality of life among young children.

Previous studies have shown that sodium thiosulfate may have an otoprotective effect, with maximum efficacy when administered 4 to 8 hours after cisplatin therapy.

Researchers randomly assigned children aged 1 month to 18 years to receive 80 mg/m² cisplatin alone over 6 hours (n = 52; median age, 13.4 months) or cisplatin plus 20 g/m² IV sodium thiosulfate (n = 57; median age, 12.8 months) over a 15-minute period, 6 hours after discontinuing cisplatin in four preoperative and two postoperative courses.

Investigators used the Brock grade scale to measure hearing loss.

Absolute hearing threshold at a minimum age of 3.5 years measured by pure-tone audiometry served as the primary endpoint. Secondary endpoints included OS and EFS at 3 years.

The intention-to-treat population comprised 109 children, of whom 101 could be evaluated for the primary endpoint.

Hearing loss of grade 1 or higher occurred among 18 of 55 children (33%; 95% CI, 21-47) evaluated in the cisplatin-sodium thiosulfate group compared with 29 of 46 children (63%; 95% CI, 48-77) in the cisplatin alone group.

The RR of any hearing loss with sodium thiosulfate was 0.52 (95% CI, 0.33-0.81), which indicated a 48% lower risk than with cisplatin alone.

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At median 52 months of follow-up, 3-year OS was 98% (95% CI, 88-100) in the cisplatin-sodium thiosulfate group and 92% (95% CI, 81-97) in the cisplatin-alone group.

https://www.healio.com/hematology-oncology/pediatric-oncology/news/in-the-journals/%7B632aedbb-a705-4b71-8790-7314b1677782%7D/sodium-thiosulfate-lowers-risk-for-hearing-loss-among-children-with-hepatoblastoma.