medwireNews: The administration of sodium thiosulfate after cisplatin reduces the incidence of hearing loss in children with standard-risk hepatoblastoma, according to an international, randomized trial.
The incidence of hearing loss was 48% lower in children who were given cisplatin plus sodium thiosulfate versus cisplatin alone, according to findings published in The New England Journal of Medicine. Hearing loss of Brock grade 1 or worse occurred in 33% of 55 children in the sodium thiosulfate group, compared with 63% of 46 who received cisplatin alone.
The children received 80 mg/m2 cisplatin in a continuous 6-hour infusion in four preoperative and two postoperative courses. Six hours after the end of the cisplatin infusion, those in the sodium thiosulfate group were given the drug at a dose of 20 g/m2 over 15 minutes.
Although cisplatin monotherapy and surgery is the standard of care for children with standard-risk hepatoblastoma, cisplatin chemotherapy can be associated with permanent hearing loss, say Penelope Brock (Great Ormond Street Hospital, London, UK) and colleagues. And “even mild hearing loss may severely affect learning, development, and quality of life in young children,” they write.
Although the children in this study were given prophylactic antiemetics, sodium thiosulfate was emetogenic, and nausea and vomiting were common. In addition, one child developed grade 3 hypernatremia. The high sodium load associated with the otoprotective dose of sodium thiosulfate is, say the researchers, “a factor to consider in planning treatment.”
The addition of sodium thiosulfate had no effect on the secondary endpoints of event-free and overall survival, with 3-year event-free survival rates of 82% in the cisplatin plus sodium thiosulfate group and 79% in the cisplatin-alone group, and overall survival rates of 98% and 92%, respectively.
These results indicate that “[t]he initiation of sodium thiosulfate after a 6-hour delay from the completion of cisplatin administration caused no tumor protection and did not adversely affect disease outcome”, the researchers conclude.
By Catherine Booth
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