title: Prospective randomised trial on adjuvant hepatic-artery infusion chemotherapy after R0 resection of colorectal liver metastases.
abstract: OBJECTIVE
  The liver represents the predominant site of cancer relapse after curative resection of hepatic metastases from colorectal carcinoma. Adjuvant intra-arterial chemotherapy was therefore considered a promising therapeutic approach in high-risk patients.
  
  
  METHODS
  From July 1984 to December 1985, a total of 42 consecutive patients underwent R0 resection of colorectal liver metastases. Thirty patients with mesenteric lymph-node metastases (Dukes C) were randomised into two groups. In 14 group-A patients, a hepatic artery port catheter was placed during liver resection. Four courses of adjuvant chemotherapy were administered at 4-week intervals, consisting of mitomycin C (8 mg/m2, day 1) and 5-fluorouracil (800 mg/m2, days 1-5). Sixteen group-B patients served as controls. The 12 patients with no mesenteric lymph-node metastases (Dukes A/B) were included in the follow-up program.
  
  
  RESULTS
  After 5 years, 64% of Dukes A/B patients and 29% of Dukes C patients were alive (P<0.01). The probability of remaining free of recurrent disease after 5 years and 10 years was 55% and 18%, respectively (P<0.01). No significant difference in either 5-year survival (25% vs 31%) or long-term disease-free status (15% vs 23%) was detected between groups A and B. The initial tumour relapse was shifted towards extrahepatic sites in group-A patients, but no difference was obtained regarding the definite distribution of recurrent disease.
  
  
  CONCLUSIONS
  Routine application of adjuvant regional chemotherapy after R0 liver resection is not warranted.
authors.affiliation: Department of Surgery, Friedrich-Schiller-University, Jena, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Rudroff
authors.forename: A
authors.initials: A
authors.lastname: Altendorf-Hoffmann
authors.forename: R
authors.initials: R
authors.lastname: Stangl
authors.forename: J
authors.initials: J
authors.lastname: Scheele
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006498:Hepatectomy; D006801:Humans; D007261:Infusions, Intra-Arterial; D008113:Liver Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000556:secondary* / Q000601:surgery; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009367:Neoplasm Staging; D015996:Survival Rate
chemical_list: D016685:Mitomycin; D005472:Fluorouracil