Related Experiment Videos
Intraperitoneal mitoxantrone: a feasibility and pharmacokinetic study.
D Civalleri1, M O Vannozzi, F De Cian
1Università di Genova, Facoltà di Medicina e Chirurgia, Dipartimento di Chirurgia DICMI, Largo Rosanna Benzi 8, Genova, 16132, Italy. civa@unige.it
Summary
Fractionated intraperitoneal mitoxantrone is a safe and feasible treatment for peritoneal carcinomatosis, showing a high local advantage with no major complications. This approach allows for up to 5 days of treatment with a maximum tolerated dose of 20-25 mg/m(2).
Area of Science:
- Oncology
- Pharmacology
- Surgical Oncology
Background:
- Peritoneal carcinomatosis requires effective local treatment to improve patient outcomes.
- Intraperitoneal chemotherapy, specifically with mitoxantrone, is a strategy to achieve high drug concentrations at the tumor site.
- Fractionated dosing regimens are explored to optimize efficacy and minimize toxicity.
Purpose of the Study:
- To evaluate the safety and feasibility of fractionated early post-operative intraperitoneal mitoxantrone administration.
- To assess the pharmacokinetic profile and local drug advantage of this treatment approach.
- To determine the maximum tolerated dose and optimal duration for fractionated intraperitoneal mitoxantrone in patients with peritoneal carcinomatosis.
Main Methods:
- A total of 20 patients with peritoneal carcinomatosis underwent surgery followed by fractionated intraperitoneal mitoxantrone infusion.
- Dosing regimens varied, including 5 mg/m(2) for 3-5 days, 7.5 mg/m(2) for 3-4 days, and 10 mg/m(2) for 2-4 days.
- Pharmacokinetic analyses were performed on various days post-infusion to measure peritoneal concentrations and dialysate/plasma exposure ratios.
Main Results:
- No major complications or severe pain were reported in the 20 treated patients.
- The maximum tolerated total dose was determined to be 20-25 mg/m(2), with treatment feasible for up to 5 days.
- Mean peritoneal peak concentrations of mitoxantrone were observed, with a mean dialysate/plasma exposure (AUC) ratio of 115, indicating high local drug concentration.
Conclusions:
- Early post-operative fractionated intraperitoneal mitoxantrone is a feasible and safe treatment option for patients with peritoneal carcinomatosis.
- The treatment demonstrates a significant local advantage, with high peritoneal drug concentrations achieved.
- This regimen can be administered for up to 5 days, with a maximum tolerated total dose of 20-25 mg/m(2), even in patients with surgical sutures.