Randomized trial of cytoreduction followed by intraperitoneal chemotherapy versus cytoreduction alone in patients with peritoneal sarcomatosis

Purpose: In order to decrease loco-regional relapse after complete resection of peritoneal sarcomatosis (PS), the rote of intraperitoneal chemotherapy (IPEC) was prospectively evatuated. Methods: Patients (pts) with completely resected PS were randomized between adjunction of IPEC or not. IPEC consisted of doxorubicin, 0.1 mg/kg and cisplatin, 15 mg/m' per day for 5 consecutive days. Primary endpoint was survival, measured as time from randomization to death. The scheduled number of patients needed was 40 in order to detect a minimal increase of 40% overall survival with the adjunction of IPEC with a power of 80%. Results: Thirty-eight consecutive pts have been randomized, 19 in each group. Ratio of retroperitoneal (RPS) and visceral (VS) sarcomatosis were 9/10 and 6/13 in IPEC and IPEC+ group, respectivety. Histoprognostic grade, Sugarbaker's score and mean number of resected organs were similar in both groups. There were no toxic deaths and morbidity was similar in both groups (four pts in each group). The median follow-up is 60 months. The median local, relapse-free, metastatic relapse-free survival and overall survival were identical in both groups (12.5, 18 and 29 months, respectivety), with no difference between RPS and VS sarcomatorsis. Conclusion: Administration of IPEC after a macroscopically complete surgery did not allow to increase greatly the outcome of pts. Complete surgery remains the cornerstone of the treatment of patients with sarcomatosis with best results for low grade sarcomatosis. (c) 2005 Elsevier Ltd. All rights reserved.