Real‐World Experience Using Sodium Thiosulfate Pentahydrate Off‐Label for Cisplatin Otoprotection in Children, Adolescents, and Young Adults
Bibliographic record
Abstract
ABSTRACT Background Cisplatin is used to treat solid tumors but causes irreversible hearing loss. Pedmark, a formulation of sodium thiosulfate (STS), is approved to prevent cisplatin‐induced hearing loss (CIHL). Prior to approval, non‐Pedmark formulations of STS pentahydrate (STS‐P) were prescribed off‐label for otoprotection and continue to be used in the absence of data. Procedure This multicenter retrospective study examined tolerability, toxicity, and hearing outcomes of STS‐P used off‐label for otoprotection. Exploratory analyses compared toxicity and hearing data in patients receiving STS‐P versus the pre‐Pedmark investigational formulation (STS‐inv) tested in trials. Results Fifty‐nine patients received STS‐P (16 or 20 g/m 2 ). Infusion‐related reactions (IRR) occurred in 14% (8/59), more commonly in patients receiving 20 g/m 2 . No severe adverse events occurred. One patient (2%) discontinued STS‐P for IRR. The prevalence of CIHL (International Society of Paediatric Oncology [SIOP] Grade ≥2) at the end of therapy and at the most recent hearing assessment was 30% at both timepoints (12/40 and 8/27, respectively). In exploratory analyses comparing STS‐P with STS‐inv ( n = 14), there was no difference in tolerance or toxicity. In multivariable analysis, a lower risk for CIHL at the end of therapy was found for age ≥5 years, higher dosing of 20 g/m 2 , and received STS‐inv (odds ratio 0.02, 95% confidence interval: 0.0003–0.691, p < 0.01). No difference was present at the most recent exam. Conclusions STS‐P off‐label for otoprotection following cisplatin was tolerable in a real‐world setting across age groups and cancer types. Formal testing in larger studies of different STS formulations is needed to explore possible differences in toxicity and CIHL prevention.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".