Avoiding Cisplatin-Related Hearing Loss, Including Implementing Sodium Thiosulfate as Otoprotectant Into Daily Pediatric Clinical Practice: Proceedings Based on Evidence and Expert Opinion From the Ototoxicity Taskforce of the SIOP Supportive Care Ne
Nienke Streefkerk, James I. Geller, Kristin Knight, Marc Ansari, Vassilios Papadakis, Gabriele Calaminus, Amirhossein Masroor, Alwin D.R. Huitema, Claudia Pasqualini, Stefan Rutkowski, Eric Bouffet, Antoinette am Zehnhoff-Dinnesen, Miguela Caniza, Marianne D. van de Wetering, Pia Delano, Kaukab M. Rajput, Heather Weerdenburg, A. Lindsay Frazier, Alexander E. Hoetink, Martine van Grotel, Nathalie Gaspar, Furqan Shaikh, Brice Fresneau, Allison F. O’Neill, Gareth J. Veal, Michael Sullivan, Penelope R. Brock, Marry M. van den Heuvel-EibrinkObjectives:
Sodium thiosulfate (STS) has recently been approved as an otoprotectant for systemic use in pediatric cancer patients receiving cisplatin treatment for localized, nonmetastatic solid tumors by the Food and Drug Administration, European Medicines Agency, and Medicines and Healthcare Products Regulatory Agency. While incorporating STS into the current standard of care pediatric practice, questions about uniform, timely, and safe administration are raised that may benefit from additional guidance.
Design:
Recognizing that advancing clinical practice presents multiple challenges, an international onco-ototoxicity prevention task force, including experts in pediatric oncology, audiology, and pharmacology, was established to identify potential barriers to the implementation of otoprotection and to offer practical solutions for clinical services for children exposed to cisplatin, based on available evidence, as well as consensus where data are less robust. This task force held several online meetings and a working group session at the annual SIOPE meeting in Milan in May 2024, where the challenges for implementing STS were outlined and addressed.
Results:
Nine key challenges were identified, including, for example, the timing of both cisplatin infusion and STS administration, the optimal integration of STS into existing treatment protocols, potential drug interactions, and relevant economic considerations.
Conclusion:
In this article, we propose practical steps to address these challenges, informed by the existing literature and expert opinion, incorporating recommendation statements from the international onco-ototoxicity prevention task force on behalf of the SIOP Supportive Care Network, to facilitate the implementation of STS in children with localized, nonmetastatic disease.