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

Stefano Guadagni, Giammaria Fiorentini, Marco Clementi, Paola Palumbo, Andrea Mambrini, Francesco Masedu, Stefano Guadagni, Giammaria Fiorentini, Marco Clementi, Paola Palumbo, Andrea Mambrini, Francesco Masedu

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/m2. 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 (AUC0-20). The mean values ± SD for the ratios between the MMC AUC0-20 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.

Keywords: Hypoxic pelvic perfusion; Mitomycin C; Stop-flow; Unresectable recurrent rectal cancer.

Conflict of interest statement

Conflict of interest

The authors declare that there is no conflict of interest regarding the publication of this paper.

Research involving human participants and/or animals

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1964 and later versions.

Informed consent

Informed consent or substitute for it was obtained from all patients for being included in the study.

Figures

Fig. 1
Fig. 1
Schema of the surgical and percutaneous (in cartouche) hypoxic pelvic perfusions with hemofiltration
Fig. 2
Fig. 2
Cross sections; a 3-lumen, 12-Fr. balloon catheter (the blood flows in the white area); b 2-lumen, 8-Fr. balloon catheter, and 11-Fr. cannula sheath introducer (the blood flows in the white area)
Fig. 3
Fig. 3
MMC concentrations in blood from inferior vena cava (0–20 min) and peripheral blood (0–20 min) for the surgical and percutaneous groups
Fig. 4
Fig. 4
MMC concentrations in peripheral blood (0–120 min) for the surgical and percutaneous groups
Fig. 5
Fig. 5
a Hypoxic pelvic perfusion: endovascular occlusion of the inferior vena cava and the aorta with blood flow blockade at the level of the thighs; b Hypoxic pelvic perfusion: after contrast injection, the pelvic compartment was defined, and leakage through the retroperitoneal vessels (arrow) was detected

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