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Successful administration of mitotane (O, p'-DDD) in pediatric oncology
Geoffrey Strobbe1, Félicie Fraipont1, Sandra Raimbault2
1Pharmacy Department, 56105Oscar Lambret Center, Lille, France.
Introduction:
Mitotane (o, p'-DDD) is a molecule that was developed many years ago for adrenal cortical carcinoma, but no suitable pediatric dosage form is available for administration to young children. Mitotane requires therapeutic drug monitoring because of its long half-life and difficulty in stabilizing plasma concentrations. Furthermore, Mitotane is a highly lipophilic drug that requires concurrent lipid administration.
Case Report:
We present the case of a 3-year-old girl who was diagnosed with metastatic adrenal cortical carcinoma. Due to the difficulty in administering the tablets and the non-stabilized mitotane dosages, a nasogastric tube was inserted. An administration protocol based on dispersing the tablets in whole milk was established by the pharmacy team. This led to the stabilization of the disease for at least 1.5 years.
Management And Outcome:
Mitotanemia is difficult to stabilize even when treatment is administered orally. To maintain biological efficacy, we propose an easily reproducible protocol. The efficacy was stabilized at a dosage of 1500 mg per day. Mitotanemia fluctuated between 14 mg/mL, and 20 mg/mL. The implementation of this protocol prevented treatment discontinuation.
Discussion:
The administration of narrow therapeutic range drugs via a nasogastric tube is a challenge for healthcare teams, particularly in pediatric patients. Based on the findings of this clinical case, clinicians should consider future use of this protocol. The use of whole milk as a vehicle for mitotane is a simple, effective, and reproducible method to administer the drug to pediatric patients and can be used for other similar cases.
Insights
A new protocol using whole milk to administer mitotane (o, p'-DDD) via nasogastric tube stabilized treatment in a pediatric patient with adrenal cortical carcinoma, overcoming challenges with oral dosing and drug concentration. This method offers a simple, effective approach for similar cases.
Area of Science:
- Pediatric Oncology
- Pharmacology
- Drug Delivery Systems
Background:
- Mitotane (o, p '-DDD) is a critical treatment for adrenal cortical carcinoma but lacks a suitable pediatric dosage form.
- Its lipophilic nature and long half-life complicate oral administration and therapeutic drug monitoring.
- Stabilizing plasma concentrations of mitotane is challenging, especially in young children.
Observation:
- A 3-year-old girl with metastatic adrenal cortical carcinoma experienced difficulties with oral mitotane tablet administration and dosage stabilization.
- A nasogastric tube was inserted to manage administration challenges.
- A protocol involving dispersing mitotane tablets in whole milk was developed by the pharmacy team.
Findings:
- The whole milk-based nasogastric tube administration protocol successfully stabilized the patient's mitotane dosage.
- Disease stabilization was maintained for at least 1.5 years.
- Mitotane levels fluctuated within the target range of 14–20 mg/mL with a daily dose of 1500 mg, preventing treatment discontinuation.
Implications:
- This case highlights the challenges of administering narrow therapeutic range drugs to pediatric patients.
- The whole milk vehicle offers a simple, effective, and reproducible method for mitotane administration via nasogastric tube in pediatric oncology.
- Clinicians should consider this protocol for future pediatric cases requiring mitotane therapy, improving drug delivery and treatment adherence.
