Mitomycin C hypoxic pelvic perfusion for unresectable recurrent rectal cancer: pharmacokinetic comparison of surgical and percutaneous techniques

ABSTRACT: Patients with unresectable recurrent rectal cancer that progresses after standard and multi-modular treatments are candidates for hypoxic pelvic perfusion. Hypoxic pelvic perfusion can be performed using a surgical or percutaneous approach. The aim of this study was to examine whether the surgical and percutaneous approaches are comparable with respect to tumor drug exposure in the pelvis. A pharmacokinetic study was performed in 18 patients. Both the surgical and percutaneous procedures were performed using mitomycin C (MMC) at a dose of 25 mg/m(2). The main parameter that was used to evaluate pelvic tumor drug exposure was the ratio of the areas under the MMC plasma concentration curves in the pelvis and the systemic compartment during the perfusion time (AUC(0–20)). The mean values ± SD for the ratios between the MMC AUC(0–20) in the pelvic and systemic compartments were 14.38 ± 4.31 and 13.15 ± 4.26 for the surgical and percutaneous techniques, respectively (p = 0.53). This pharmacokinetic study demonstrated that the percutaneous approach for hypoxic pelvic perfusion did not statistically differ from the surgical approach. When perfusion must be repeated several times in the same patient, the percutaneous and surgical methods may be adopted interchangeably. CLINICALTRIALS.GOV IDENTIFIER: NCT01891552.