Hypoxic pelvic perfusion with mitomycin C using a simplified balloon-occlusion technique in the treatment of patients with unresectable locally recurrent rectal cancer

Hypothesis: To evaluate the role of hypoxic pelvic perfusion in providing t herapeutic options for palliation without relevant complications in a homog eneous group of patients with unresectable locally recurrent rectal cancer who are nonresponders or have disease progression after the standard treatm ents. Design: Nonrandomized and noncontrolled phase II experimental study. Setting: University hospital, L'Aquila, and the National Cancer Institute, Naples and Milan, Italy. Patients: Eleven patients had symptomatic unresectable pelvic recurrent rec tal cancer. The mean +/-SD product of the 2 maximum perpendicular diameters of the recurrent cancer was 24.2+/-11.0 cm(2) (range, 10-48 cm(2)). Tumor fixation to the pelvic side walls or proximal sacrum were the main criteria for unresectability. All patients were free from extrapelvic disease and h ad a life expectancy longer than 3 months. Intervention: Patients were submitted to one course of pelvic perfusion wit h mitomycin C (MMC) (25 mg/m(2)) by means of a simplified balloon occlusion technique. A pharmacokinetic evaluation of the procedure was also performe d. Main Outcome Measures: Response rate and time to disease progression were t he primary endpoints; overall survival was the secondary endpoint. Results: Mean +/-SD value of the ratios of pelvic MMC area under the plasma concentration curve (0 to 20 minutes) (AUC(0.20)) to systemic MMC AUC(0-20 ) was 13.30 +/- 6.52. During the procedures there were no technical, hemody namic, or vascular complications, and no deaths occurred during surgery or in the postoperative period. The response rate was 36.3% (95% confidence in terval [CI], 6.5%-66.1%). Pain response rate was 45.4% (95% CI, 16.6%-76.2% ). Median survival was 12.2 months (range, 5.7-19.5 months). Median time to disease progression was 6 months (range, 3-8 months). Two-year overall sur vival was 9.1%. Conclusions: Hypoxic pelvic perfusion with MMC is a safe and good palliativ e treatment for patients with unresectable locally recurrent rectal cancer. Further studies are necessary to establish if a different sequence in the multimodular treatment of these patients could be more useful.