title: Cytoreductive surgery and intraperitoneal chemotherapy versus systemic chemotherapy for colorectal peritoneal metastases: A randomised trial.
abstract: BACKGROUND
  First-line treatment of isolated resectable colorectal peritoneal metastases remains unclear. This study (the Swedish peritoneal study) compares cytoreductive surgery and intraperitoneal chemotherapy (surgery arm) with systemic chemotherapy (chemotherapy arm).
  
  
  METHODS
  Patients deemed resectable preoperatively were randomised to surgery and intraperitoneal 5-fluorouracil 550 mg/m(2)/d for 6 d with repeated courses every month or to systemic oxaliplatin and 5-fluorouracil regimen every second week. Both treatments continued for 6 months. Primary end-point was overall survival (OS) and secondary end-points were progression-free survival (PFS), and morbidity.
  
  
  RESULTS
  The study terminated prematurely when 48 eligible patients (24/arm) were included due to recruitment difficulties. Two-year OS was 54% in the surgery arm and 38% in the chemotherapy arm (p = 0.04). After 5 years, 8 versus 1 patient were alive, respectively (p = 0.02). Median OS was 25 months versus 18 months, respectively, hazard ratio 0.51 (95% confidence interval: 0.27-0.96, p = 0.04). PFS in the surgery arm was 12 months versus 11 months in the chemotherapy arm (p = 0.16) with 17% versus 0% 5-year PFS. Grade III-IV morbidity was seen in 42% and 50% of the patients, respectively. No mortalities.
  
  
  CONCLUSIONS
  Cytoreductive surgery with intraperitoneal chemotherapy may be superior to systemic oxaliplatin-based treatment of colorectal cancer with resectable isolated peritoneal metastases.(ClinicalTrials.gov nr:NCT01524094).
authors.affiliation: Department of Surgical Sciences, Section of Surgery, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden. Electronic address: Peter.cashin@gmail.com.
authors.forename: P H
authors.initials: PH
authors.lastname: Cashin
authors.affiliation: Department of Surgical Sciences, Section of Surgery, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden; Uppsala Cancer Clinic, Uppsala, Sweden.
authors.forename: H
authors.initials: H
authors.lastname: Mahteme
authors.affiliation: Department of Surgical Sciences, Section of Surgery, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden.
authors.forename: N
authors.initials: N
authors.lastname: Spång
authors.affiliation: Department of Surgery, Skåne University Hospital, 21428 Malmö, Sweden.
authors.forename: I
authors.initials: I
authors.lastname: Syk
authors.affiliation: Department of Oncology and Pathology, Karolinska Institutet, 171 76 Stockholm, Sweden.
authors.forename: J E
authors.initials: JE
authors.lastname: Frödin
authors.affiliation: Department of Surgical Sciences, Section of Radiology, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Torkzad
authors.affiliation: Department of Oncology and Pathology, Karolinska Institutet, 171 76 Stockholm, Sweden; Department of Immunology, Genetics and Pathology, Section of Oncology, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden.
authors.forename: B
authors.initials: B
authors.lastname: Glimelius
authors.affiliation: Department of Surgical Sciences, Section of Surgery, Uppsala University, Akademiska Sjukhuset, 75185 Uppsala, Sweden.
authors.forename: W
authors.initials: W
authors.lastname: Graf
mesh_terms: D000230:Adenocarcinoma / Q000556:secondary / Q000628:therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000379:methods; D015179:Colorectal Neoplasms; D003131:Combined Modality Therapy; D065426:Cytoreduction Surgical Procedures / Q000379:methods*; D057239:Early Termination of Clinical Trials; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000556:secondary / Q000628:therapy*
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil
keywords: Colorectal cancer; Cytoreductive surgery; Intraperitoneal chemotherapy; Peritoneal carcinomatosis; Peritoneal metastases; Systemic chemotherapy