title: Cytoreductive surgery followed by intraperitoneal hyperthermic perfusion in the treatment of recurrent epithelial ovarian cancer: a phase II clinical study.
abstract: OBJECTIVE
  The optimal salvage therapy for recurrent ovarian carcinoma has not been clearly established. Response to second-line chemotherapy is low, with a short median survival (8.8-15 months). We investigated the effect of an aggressive approach consisting of surgery followed by intraperitoneal drug delivery and local hyperthermia.
  
  
  METHODS
  In a phase II clinical study, 27 patients with advanced/recurrent ovarian carcinoma were treated with cytoreductive surgery and intraperitoneal hyperthermic perfusion. Median patient age was 53 years (range, 30-67) and mean follow-up was 17.4 months (range, 0.3-36.0). Patients had been surgically staged and heavily pretreated with cisplatin-based, taxol-based or taxol/platinum-containing regimens. Nineteen (70%) patients were cytoreduced to minimal residual disease <2.5 mm. The intraperitoneal hyperthermic perfusion was performed with the closed abdomen technique, using a preheated polysaline perfusate containing cisplatin (25 mg/m2/L) + mitomycin C (3.3 mg/m2/L) through a heart-lung pump (mean flow of 700 mL/min) for 60 min in the hyperthermic phase (42.5 degrees C).
  
  
  RESULTS
  Two-year overall survival was 55%. Median times to overall progression and local progression were 16 months and 21.8 months, respectively. Variables that affected the overall survival or time to progression were as follows: residual disease (P = 0.00025), patient age (P = 0.04), and lag time between diagnosis and cytoreductive surgery + intraperitoneal hyperthermic perfusion (P = 0.04). Treatment-related morbidity, mortality and acute toxicity (grade II-III) rates were 11%, 4% and 11%, respectively. Eight (89%) of 9 patients had ascites resolution.
  
  
  CONCLUSIONS
  Our results suggest that cytoreductive surgery + intraperitoneal hyperthermic perfusion is a well-tolerated, feasible and promising alternative in the management of selected patients with recurrent ovarian cancer, but further randomized controlled studies are needed in order to confirm our findings.
authors.affiliation: Department of Surgery, National Cancer Institute, Milan, Italy. marcelloderaco@hotmail.com
authors.forename: M
authors.initials: M
authors.lastname: Deraco
authors.forename: C R
authors.initials: CR
authors.lastname: Rossi
authors.forename: E
authors.initials: E
authors.lastname: Pennacchioli
authors.forename: S
authors.initials: S
authors.lastname: Guadagni
authors.forename: D C
authors.initials: DC
authors.lastname: Somers
authors.forename: N
authors.initials: N
authors.lastname: Santoro
authors.forename: F
authors.initials: F
authors.lastname: Raspagliesi
authors.forename: S
authors.initials: S
authors.lastname: Kusamura
authors.forename: M
authors.initials: M
authors.lastname: Vaglini
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D002277:Carcinoma / Q000188:drug therapy* / Q000276:immunology / Q000601:surgery*; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006979:Hyperthermia, Induced; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000601:surgery*; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000601:surgery*; D010537:Peritoneum; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D016685:Mitomycin; D002945:Cisplatin