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Protocols and safety profile of convection enhanced delivery in pediatric patients: a systematic review
Nathan S Fredricks1,2, Mary Harkins3,4, Anthony Price5
1John Sealy School of Medicine, The University of Texas Medical Branch at Galveston, Galveston, TX, USA. nsfredri@utmb.edu.
Insights
Convection-enhanced delivery (CED) is a safe method for delivering drugs directly into the brain for pediatric patients, with mild side effects being common but severe events rare. This review benchmarks safety for expanding CED protocols in treating brain tumors and genetic disorders.
Area of Science:
- Neuroscience
- Oncology
- Pharmacology
Background:
- Convection-enhanced delivery (CED) facilitates direct intraparenchymal drug delivery, bypassing the blood-brain barrier for targeted therapeutic interventions.
- Pediatric applications of CED are expanding, necessitating a comprehensive understanding of its safety profile and adverse events.
- Current data on pediatric CED is fragmented, requiring aggregation to establish safety benchmarks for evolving treatment protocols.
Purpose of the Study:
- To systematically review and analyze the existing data on the applications and adverse events associated with pediatric convection-enhanced delivery (CED).
- To benchmark the safety of CED in pediatric patients as treatment protocols continue to expand.
- To evaluate the efficacy and safety of CED for conditions such as unresectable high-grade glioma and genetic enzyme deficiencies.
Main Methods:
- A systematic literature search was conducted across CINAHL, Cochrane, OVID Medline, and Scopus databases.
- Modified PRISMA analysis was employed for article selection and data extraction, including patient demographics, indications, procedural details, and adverse events.
- 12 studies involving 162 pediatric patients met the inclusion criteria for analysis.
Main Results:
- The primary indication for CED was unresectable high-grade glioma (92%), particularly diffuse intrinsic pontine glioma (83%).
- Common adverse events included headache (20%) and limb weakness (18.2%), with most events being low-grade (94.7% Grade 1 or 2).
- No severe adverse events (Grade 4 or 5) were reported, indicating a favorable safety profile for pediatric CED.
Conclusions:
- Pediatric CED demonstrates a generally safe profile, characterized by common mild adverse events but rare severe complications.
- CED is a viable platform for investigational therapies in pediatric patients with treatment-resistant pathologies.
- Further multi-institutional and longitudinal studies are required to fully elucidate the role and long-term outcomes of CED in pediatric neuro-oncology and genetic disorders.
Abstract:
Convection-enhanced delivery (CED) is a developmental drug delivery system enabling direct, intraparenchymal placement of therapeutics that bypass the blood-brain barrier. This systematic review aggregates and outlines the available data surrounding current applications and adverse events of pediatric CED to benchmark safety as protocols expand. A comprehensive search through CINAHL, Cochrane, OVID Medline, and Scopus databases was conducted using a modified PRISMA analysis. After deduplication and screening, final articles were selected for data extraction. Of 108 unique articles, 12 studies met the inclusion criteria, including 162 patients (51% males, 44% females, and 5% not reported). The average age was 8.64 years (range 5-14.1 years). The most common indication for CED was for unresectable high-grade glioma (92%), predominantly diffuse intrinsic pontine glioma (83%). CED also addressed genetic enzyme deficiency (8%). The trans-frontal approach was most common (58%), with single catheter systems employed in 50% of studies. A total of 285 adverse events were reported. The most common included headache (20%), limb weakness (18.2%), Grade 1 cranial nerve deficits (6.3%), and general pain (4.9%). Of 132 CTCAE-graded events, 125 were Grade 1 or Grade 2 (94.7%) and 7 were Grade 3 (5.3%). No Grade 4 or Grade 5 adverse events occurred. This first systematic review of CED of pediatric patients demonstrates that while mild side effects are common, severe adverse events are rare. Multi-institutional and longitudinal data are needed to further define CED's role in pediatric applications. These findings support CED as a viable platform for investigational therapies in treatment-resistant pediatric pathologies.
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