Trial reportPediatric blood & cancer2019
Determining success rates of the current pharmacokinetically guided dosing approach of topotecan in pediatric oncology patients.
Trial report in Pediatric blood & cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Topotecan clearance based on a single sample and a population pharmacokinetic model: Application to a pediatric high-risk neuroblastoma clinical trial.Pediatric blood & cancer · 2023Trial
- Convection Enhanced Delivery of Topotecan for Gliomas: A Single-Center Experience.Pharmaceutics · 2020Review
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
backgroundTopotecan is a chemotherapeutic agent that is active against many pediatric tumors. Although its effect is related to systemic exposure, the interpatient variability in systemic clearance makes it challenging to achieve desired topotecan targets. This study aims to evaluate the success of the pharmacokinetically (PK) guided dosing process, which was used to achieve a target topotecan area under the concentration-time curve (AUC).
methodsPatients received an empiric topotecan dosage on the first day; the topotecan lactone AUC was determined, and based upon these values the topotecan dosage was adjusted. The success rates of both the empiric and PK-guided strategies were calculated. Patient-specific covariates were collected to explain variability observed in the empiric and PK-guided results. A simulation study was performed to assess the differences in cumulative topotecan dosage and systemic exposure between a PK-guided and standard dosing approach.
resultsData were collected from nine clinical trials open from 1996 to 2016 (n = 232 patients). The empiric dosing success rate was 35.5%, while the PK-guided rate was 64.4%. A difference in mean serum creatinine was observed between successful empiric studies and those above the AUC target. Compared to a standard dosing approach, the PK-guided group had a higher average cumulative dosage and systemic exposure.
conclusionThe low empiric dosing success rate indicates that additional studies are needed to refine the initial topotecan dosage. The role of renal function, measured as serum creatinine, remains to be elucidated. However, the PK-guided targeting success rate highlighted the need to account for variable topotecan systemic clearance.
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