title: Hypoxic pelvic perfusion with mitomycin C using a simplified balloon-occlusion technique in the treatment of patients with unresectable locally recurrent rectal cancer.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Nonrandomized and noncontrolled phase II experimental study.
  
  
  METHODS
  University hospital, L'Aquila, and the National Cancer Institute, Naples and Milan, Italy.
  
  
  METHODS
  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 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 had a life expectancy longer than 3 months.
  
  
  METHODS
  Patients were submitted to one course of pelvic perfusion with mitomycin C (MMC) (25 mg/m(2)) by means of a simplified balloon occlusion technique. A pharmacokinetic evaluation of the procedure was also performed.
  
  
  METHODS
  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.
authors.affiliation: Department of Surgery, University of L'Aquila, L'Aquila, Italy. guadagni@rdn.it
authors.forename: S
authors.initials: S
authors.lastname: Guadagni
authors.forename: G
authors.initials: G
authors.lastname: Fiorentini
authors.forename: G
authors.initials: G
authors.lastname: Palumbo
authors.forename: M
authors.initials: M
authors.lastname: Valenti
authors.forename: F
authors.initials: F
authors.lastname: Russo
authors.forename: M
authors.initials: M
authors.lastname: Cantore
authors.forename: M
authors.initials: M
authors.lastname: Deraco
authors.forename: M
authors.initials: M
authors.lastname: Vaglini
authors.forename: G
authors.initials: G
authors.lastname: Amicucci
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D002404:Catheterization; D010478:Chemotherapy, Cancer, Regional Perfusion; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D010166:Palliative Care; D010388:Pelvis; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000903:Antibiotics, Antineoplastic; D016685:Mitomycin