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Published on: March 16, 2018
Avoiding Cisplatin-Related Hearing Loss, Including Implementing Sodium Thiosulfate as Otoprotectant Into Daily
Nienke Streefkerk1, James I Geller2, Kristin Knight3
1Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
Insights
Sodium thiosulfate (STS) is now approved for otoprotection in pediatric cancer patients receiving cisplatin. This guidance addresses challenges in its administration to ensure safe and effective use in clinical practice.
Area of Science:
- Oncology
- Pharmacology
- Audiology
Background:
- Sodium thiosulfate (STS) is a newly approved otoprotectant for pediatric cancer patients undergoing cisplatin chemotherapy.
- Cisplatin treatment for localized, nonmetastatic solid tumors necessitates otoprotection strategies.
- Regulatory bodies like the FDA and EMA have approved STS for this indication.
Purpose of the Study:
- To identify and address challenges in the clinical implementation of sodium thiosulfate (STS) as an otoprotectant.
- To provide practical guidance for the uniform, timely, and safe administration of STS in pediatric oncology.
- To support the integration of STS into standard care for children receiving cisplatin.
Main Methods:
- An international task force of pediatric oncology, audiology, and pharmacology experts was convened.
- The task force reviewed existing evidence and reached expert consensus on implementation strategies.
- Challenges were identified through online meetings and a working group session at the SIOPE meeting.
Main Results:
- Nine key challenges were identified regarding STS administration.
- These challenges include optimal timing of cisplatin and STS, integration into treatment protocols, drug interactions, and economic factors.
- Practical solutions were developed to overcome these implementation barriers.
Conclusions:
- This article proposes actionable steps to facilitate STS implementation in pediatric oncology.
- Recommendations are based on expert opinion and existing literature.
- The goal is to ensure effective otoprotection for children with localized, nonmetastatic solid tumors receiving cisplatin.
Objectives:
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.
