Morbidity and mortality analysis of 200 treatments with cytoreductive surgery and hyperthermic intraoperative intraperitoneal chemotherapy using the Coliseum technique

Background: Peritoneal carcinomatosis from gastrointestinal cancers is a fa tal diagnosis without special combined surgical and chemotherapy interventi ons. Guidelines for cytoreductive surgery and hyperthermic intraoperative i ntraperitoneal chemotherapy (HIIC) by using the Coliseum technique have bee n developed to treat patients with peritoneal carcinomatosis and other peri toneal surface malignancies. The purpose of this study was to analyze the m orbidity and mortality of patients undergoing cytoreductive surgery and HII C by using mitomycin C. Methods: Data were prospectively recorded on 183 patients who underwent 200 cytoreductive surgeries with HIIC between November 1994 and June 1998. Sev enteen of the 183 patients returned for a second-look surgery plus HIIC. Al l HIIC administrations occurred after cytoreduction and used continuous man ual separation of intra-abdominal structures to optimize drug and heat dist ribution. Origins of the tumors were as follows: appendix (150 patients), c olon (20 patients), stomach (7 patients), pancreas (2 patients), small bowe l (1 patient), rectum (1 patient), gallbladder (1 patient), and peritoneal papillary serous carcinoma (1 patient). Morbidity was organized into 20 cat egories that were graded 0 to IV by the National Cancer Institute's Common Toxicity Criteria. In an attempt to identify patient characteristics that m ay predispose to complications, each morbidity variable was analyzed for an association with the 25 clinical variables recorded. Results: Combined grade III/IV morbidity was 27.0%. Complications observed included the following: peripancreatitis (6.0%), fistula (4.5%), postoperat ive bleeding (4.5%), and hematological toxicity (4.0%). Morbidity was stati stically linked with the following clinical variables: duration of surgery (P < .0001), the number of peritonectomy procedures and resections (P < .00 01), and the number of suture lines (P = .0078). No HIIC variables were sta tistically associated with the presence of grade III or grade IV morbidity. Treatment-related mortality was 1.5%. Conclusions: HIIC may be applied to select patients with peritoneal carcino matosis from gastrointestinal malignancies with 27.0% major morbidity and 1 .5% treatment-related mortality. The frequency of complications was associa ted with the extent of the surgical procedure and not with variables associ ated with the delivery of heated intraoperative intraperitoneal chemotherap y. The technique has shown an acceptable frequency of adverse events to be tested in phase IH adjuvant trials.