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S. Guadagni, MD; G. Fiorentini, MD; G. Palumbo, PhD; M. Valenti, MD; F. Russo, MD; M. Cantore, MD; M. Deraco, MD; M. Vaglini, MD; G. Amicucci, MD

Arch Surg. 2001;136:105-112.

Hypothesis  To evaluate the role of hypoxic pelvic perfusion in providing therapeutic options for palliation without relevant complications in a homogeneous group of patients with unresectable locally recurrent rectal cancer who are nonresponders or have disease progression after the standard treatments.

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 rectal cancer. The mean ± SD product of the 2 maximum perpendicular diameters of the recurrent cancer was 24.2 ± 11.0 cm² (range, 10-48 cm²). Tumor fixation to the pelvic side walls or proximal sacrum were the main criteria for unresectability. All patients were free from extrapelvic disease and had a life expectancy longer than 3 months.

Intervention  Patients were submitted to one course of pelvic perfusion with mitomycin C (MMC) (25 mg/m²) by means of a simplified balloon occlusion technique. A pharmacokinetic evaluation of the procedure was also performed.

Main Outcome Measures  Response rate and time to disease progression were the 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, hemodynamic, or vascular complications, and no deaths occurred during surgery or in the postoperative period. The response rate was 36.3% (95% confidence interval [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 survival was 9.1%.

Conclusions  Hypoxic pelvic perfusion with MMC is a safe and good palliative 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.

From the Departments of Surgery (Drs Guadagni, Fiorentini, Cantore, and Amicucci) and Internal Medicine (Drs Palumbo and Valenti), University of L'Aquila, L'Aquila, and the National Cancer Institute, Naples (Dr Russo) and Milan (Drs Deraco and Vaglini), Italy.

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