Surgical versus percutaneous isolated pelvic perfusion (IPP) for advanced melanoma: comparison in terms of melphalan pharmacokinetic pelvic bio-availability

• Published in: BMC research notes 2017-08, Vol.10 (1), p.411-411, Article 411
• Main Authors: Guadagni, Stefano, Palumbo, Giancarlo, Fiorentini, Giammaria, Clementi, Marco, Marsili, Luca, Giordano, Aldo Victor, Masedu, Francesco, Valenti, Marco
• Format: Article
• Language: English
• Subjects: Aged; Analysis; Antineoplastic Agents, Alkylating - blood; Antineoplastic Agents, Alkylating - pharmacokinetics; Antineoplastic Agents, Alkylating - pharmacology; Area Under Curve; Balloon catheters; Balloon treatment; Blood flow; Cancer therapies; Catheters; Chemotherapy; Chemotherapy, Cancer, Regional Perfusion - methods; Clinical trials; Complications and side effects; Coronary vessels; Cytotoxicity; Dosage and administration; Drug therapy; Female; Humans; Hypoxia; Isolated pelvic perfusion; Male; Melanoma; Melanoma - blood supply; Melanoma - drug therapy; Melanoma - pathology; Melanoma - surgery; Melphalan; Melphalan - blood; Melphalan - pharmacokinetics; Melphalan - pharmacology; Metastases; Metastasis; Middle Aged; Pelvic Neoplasms - blood supply; Pelvic Neoplasms - drug therapy; Pelvic Neoplasms - pathology; Pelvic Neoplasms - surgery; Pelvic tumors; Pelvis; Pelvis - blood supply; Pelvis - pathology; Pelvis - surgery; Perfusion; Pharmacokinetics; Pilot Projects; Short Report; Statistical analysis; Statistics, Nonparametric; Surgical Procedures, Operative - methods; TNF inhibitors; Veins & arteries
• ISSN: 1756-0500; 1756-0500
• DOI: 10.1186/s13104-017-2738-y

Isolated pelvic perfusion (IPP) can be used to treat unresectable melanoma metastases of the pelvis. IPP can be performed either by surgical or percutaneous approaches, using different balloon catheters. The aim of this study was to examine whether the surgical and percutaneous approaches were comparable with respect to tumor drug exposure in the pelvis. A pharmacokinetic study was performed in 5 melanoma patients treated with surgical IPP and five with percutaneous IPP. Both groups received melphalan at the dose of 30 mg/m . Melphalan pharmacokinetic analyses were performed and the main parameter used to evaluate pelvic tumor drug-exposure was the ratio of areas under the melphalan plasma concentration curves in the pelvis and the systemic compartment, during the perfusion time (AUC ). Non-parametric Mann-Whitney tests were employed for statistical comparisons. The median and interquartile range (IQR) values of the ratios between melphalan AUC in pelvic and systemic compartments were 7.9 (IQR 7.2 to 9.9) and 5 (IQR 4 to 7.9) for surgical and percutaneous IPPs, respectively (p = 0.209). Tumor exposure to drug using these two methods did not statistically differ and both methods, therefore, can be adopted interchangeably, utilizing a perfusion blood flow rate of approximately 120 ml/min. The small sample size is a limitation of this study but our preliminary results can be used to calculate the effect size of a larger trial. Trial Registration Clinical Trials.gov Identifier NCT01920516; date of trial registration: August 6, 2013.