title: Pilot study of adjuvant hyperthermic intraperitoneal chemotherapy in patients with colorectal cancer at high risk for the development of peritoneal metastases.
abstract: OBJECTIVE
  The prognosis of peritoneal metastases from colorectal cancer has recently improved with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Although outcomes are further improved when early stage peritoneal metastases are treated, adjuvant hyperthermic intraperitoneal chemotherapy has never been thoroughly addressed. This prospective pilot study assessed feasibility, safety and efficacy of hyperthermic intraperitoneal chemotherapy combined with primary curative surgery in colorectal cancer at high risk for peritoneal metastases.
  
  
  METHODS
  Twelve patients were prospectively selected according to predetermined risk factors for the development of peritoneal metastases. Patients underwent conventional colon surgery, closed-abdomen mitomycin-C plus cisplatin-based hyperthermic intraperitoneal chemotherapy, and cytoreductive surgical procedures, as needed.
  
  
  RESULTS
  Preoperative tumor-related risk factors were confirmed by intraoperative findings and pathological examination in all patients: minimal synchronous peritoneal metastases (n = 2), synchronous ovarian metastases (n = 1), positive peritoneal washing cytology (n = 2), primary tumor directly invading other organs (n = 6), or penetrating visceral peritoneum (n = 1). Major morbidity occurred in 2 patients and operative death in none. Median follow-up was 49 months (range, 22-72). Peritoneal metastases occurred in 1 patient and distant metastases in 2. Five-year overall survival was 83.3%.
  
  
  CONCLUSIONS
  Preoperative/early intraoperative assessment can reliably identify colorectal cancer patients at high risk for peritoneal metastases. Adjuvant hyperthermic intraperitoneal chemotherapy is well tolerated and safe. These preliminary results would support the design of future phase-III trials of adjuvant hyperthermic intraperitoneal chemotherapy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Virzì
authors.forename: Domenico
authors.initials: D
authors.lastname: Iusco
authors.forename: Dario
authors.initials: D
authors.lastname: Baratti
authors.forename: Serena
authors.initials: S
authors.lastname: Bonomi
authors.forename: Antonio
authors.initials: A
authors.lastname: Grassi
authors.forename: Shigeki
authors.initials: S
authors.lastname: Kusamura
authors.forename: Marcello
authors.initials: M
authors.lastname: Deraco
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009378:Neoplasms, Multiple Primary / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000517:prevention & control / Q000556:secondary; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000517:prevention & control / Q000556:secondary; D010865:Pilot Projects; D011379:Prognosis; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D016685:Mitomycin; D002945:Cisplatin