FDA approves Pedmark to prevent cisplatin-related ototoxicity among children with cancer
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The FDA approved sodium thiosulfate to reduce risk for cisplatin-associated ototoxicity among certain children with cancer.
The indication allows use of the agent by patients aged 1 month or older with localized, nonmetastatic solid tumors.
Sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) is a cisplatin-neutralizing agent.
Two randomized controlled trials assessed the agent for children receiving cisplatin-based chemotherapy for cancer.
The SIOPEL 6 trial included 114 patients with standard-risk hepatoblastoma who underwent six cycles of perioperative cisplatin-based chemotherapy. Researchers randomly assigned patients to chemotherapy with or without sodium thiosulfate administered at one of three dose levels — 10 g/m2, 15 g/m2 or 20 g/m2 — based on body weight.
The percentage of patients with Brock grade 1 hearing loss after treatment or at the age of at least 3.5 years — whichever was later — served as the primary outcome. A lower percentage of patients treated with sodium thiosulfate reached the designated hearing loss threshold (39% vs. 68%; RR = 0.58; 95% CI, 0.4-0.83).
The COG ACCL0431 trial included 125 children with solid tumors who underwent chemotherapy that included cumulative cisplatin doses of 200 mg/m2 or higher.
Researchers randomly assigned patients 1:1 to chemotherapy with or without sodium thiosulfate. The efficacy analysis included 77 patients with localized, nonmetastatic solid tumors.
Hearing loss per American Speech-Language-Hearing Association criteria — assessed at baseline and 4 weeks after the final cisplatin course — served as the primary outcome.
A lower percentage of patients assigned sodium thiosulfate experienced hearing loss (44% vs. 58%; RR = 0.75; 95% CI, 0.48-1.18).
Adverse events that occurred more frequently among sodium thiosulfate-treated patients in both trials included vomiting, nausea, decreased hemoglobin, hypernatremia and hypokalemia.
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