Background: The purpose of this prospective Phase II study was to analyze morbidity and mortality of cytoreductive surgery (CRS) and intraperitoneal hyperthermic perfusion (IPHP) in the treatment of peritoneal surface malignancies.
Methods: A total of 205 patients (50 with peritoneal mesothelioma, 49 with pseudomyxoma peritonei, 41 with ovarian cancer, 32 with abdominal sarcomatosis, 13 with colon cancer, 12 with gastric cancer, and 8 with carcinomatosis from other origins) underwent 209 consecutive procedures. Four patients underwent the intervention twice because of disease relapse. There were 70 men and 135 women. Mean age was 52 years (range, 22-76 yrs). CRS was performed by using peritonectomy procedures. IPHP through the closed abdomen technique was conducted with a preheated (42.5 degrees C) perfusate containing cisplatin + mitomycin C or cisplatin + doxorubicin.
Results: Major morbidity rate was 12%. The most significant complications were 23 anastomotic leaks or bowel perforations, 4 abdominal bleeds, and 4 sepses. Operative mortality rate was 0.9%. On logistic regression model multivariate analysis, extent of cytoreduction (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.29-6.40) and dose of cisplatin for IPHP > or = 240 mg (OR, 3.13; 95% CI, 1.24-7.90) were independent risk factors for major morbidity. Ten patients presented with Grade 3 to 4 toxicity.
Conclusions: CRS + IPHP presented acceptable morbidity, toxicity, and mortality rates, all of which support prospective Phase III clinical trials.