Sodium Thiosulfate Seems to Protect Against Cisplatin-Related Hearing Loss in Children With Cancer
The antioxidant sodium thiosulfate provided protection against cisplatin-related hearing loss in children with cancer, according to a phase III trial reported by Freyer et al in The Lancet Oncology.
The open-label trial included 104 assessable patients (aged 1 to 18 years) from 38 Children’s Oncology Group hospitals in the United States and Canada who were randomized between June 2008 and September 2012 to sodium thiosulfate (n = 49) or observation (n = 55) along with planned cisplatin-containing chemotherapy. Patients had newly diagnosed cancer and normal audiometry at baseline. Sodium thiosulfate was given intravenously at 16 g/m² 6 hours after each cisplatin dose. The primary endpoint was hearing loss 4 weeks after the final cisplatin dose.
Hearing Loss
Hearing loss was identified in 28.6% (95% confidence interval [CI] = 16.6%–43.3%) of the sodium thiosulfate group vs 56.4% (95% CI = 42.3%–69.7%) of the control group (P = .00022). In an analysis adjusting for the stratification factors of age, duration of cisplatin infusion, and previous cranial irradiation, risk of hearing loss was significantly reduced with sodium thiosulfate (odds ratio [OR] = 0.31, P = .0036). The unadjusted odds ratio was 0.32 (P = .010) when 8 patients with previous cranial irradiation were excluded from the analysis. Benefit of sodium thiosulfate appeared to be greater in children aged < 5 years; hearing loss occurred in 3 of 14 patients (21.4%) vs 11 of 15 patients (73.3%) in this age group.
Adverse Events
The most common grade 3 or 4 hematologic adverse event was neutropenia (66% of cycles in the sodium thiosulfate group vs65% of cycles in the control group). The most common nonhematologic adverse event was hypokalemia (17% of cycles vs 12% of cycles).
The investigators concluded: “Sodium thiosulfate protects against cisplatin-induced hearing loss in children and is not associated with serious adverse events attributed to its use. Further research is needed to define the appropriate role for sodium thiosulfate among emerging otoprotection strategies.”
The study was funded by the National Cancer Institute.
David R. Freyer, MD, of Children’s Hospital Los Angeles, is the corresponding author of The Lancet Oncology article.
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