AIMS: The purpose of this phase II study was to analyze the morbidity and mortality of cytoreductive surgery (CRS) + intraperitoneal hyperthermic perfusion (IPHP) in the treatment of peritoneal surface malignancies. PATIENTS AND METHODS: One hundred and sixty four patients (36 ovarian cancer, 32 abdominal sarcomatosis, 34 peritoneal mesothelioma, 36 pseudomyxoma peritonei, 12 gastric cancer, 8 colon adenocarcinoma and 8 from other origins) underwent 166 procedures. Two patients underwent the intervention twice due to disease relapse. The mean follow-up was 20.6 months (range: 0.4 - 91.3). The mean age was 52 years (range: 24-76). CRS was performed with peritonectomy procedures. IPHP through Closed abdominal technique was conducted with preheated (42.5 degrees) perfusate containing cisplatin+mitomycin C or cisplatin+doxorubicin for 60/90 minutes. RESULTS: grade 3/4 morbidity rate was 12.0%. Some frequent post-operatory complications were intestinal fistulas (17), respiratory (5) and abdominal bleeding (4). Multivariate analysis with logistic regression model with the backward elimination method identified carcinomatosis extension (OR: 5.3, CI95%: 1.2-24.5) as the best predictor of morbidity grade 3/4. Four patients presented grade 3/4 toxicity. Operative mortality rate was 0.6%. CONCLUSIONS: CRS+ IPHP presented acceptable morbidity 3/4 toxicity and mortality rates what support the need to be tested in prospective phase III clinical trial.
AIMS: The purpose of this phase II study was to analyze the morbidity and mortality of cytoreductive surgery (CRS) + intraperitoneal hyperthermic perfusion (IPHP) in the treatment of peritoneal surface malignancies. PATIENTS AND METHODS: One hundred and sixty four patients (36 ovarian cancer, 32 abdominal sarcomatosis, 34 peritoneal mesothelioma, 36 pseudomyxoma peritonei, 12 gastric cancer, 8 colon adenocarcinoma and 8 from other origins) underwent 166 procedures. Two patients underwent the intervention twice due to disease relapse. The mean follow-up was 20.6 months (range: 0.4 - 91.3). The mean age was 52 years (range: 24-76). CRS was performed with peritonectomy procedures. IPHP through Closed abdominal technique was conducted with preheated (42.5 degrees) perfusate containing cisplatin+mitomycin C or cisplatin+doxorubicin for 60/90 minutes. RESULTS: grade 3/4 morbidity rate was 12.0%. Some frequent post-operatory complications were intestinal fistulas (17), respiratory (5) and abdominal bleeding (4). Multivariate analysis with logistic regression model with the backward elimination method identified carcinomatosis extension (OR: 5.3, CI95%: 1.2-24.5) as the best predictor of morbidity grade 3/4. Four patients presented grade 3/4 toxicity. Operative mortality rate was 0.6%. CONCLUSIONS: CRS+ IPHP presented acceptable morbidity 3/4 toxicity and mortality rates what support the need to be tested in prospective phase III clinical trial.