title: Hepatic chemoembolization combined with systemic infusion of 5-fluorouracil and bolus leucovorin for patients with metastatic colorectal carcinoma: A Southwest Oncology Group pilot trial.
abstract: BACKGROUND
  Rates of response to systemic chemotherapy among patients with advanced colorectal carcinoma rarely exceed 25- 30%, and complete responses are rare. The liver is the most common site of metastasis; however, regional therapies have not improved survival rates. The Southwest Oncology Group designed a clinical trial combining hepatic arterial chemoembolization with systemic infusion of 5-fluorouracil chemotherapy in an attempt to increase the complete response rate and prolong the time to disease progression.
  
  
  METHODS
  Patients with documented liver metastasis from colorectal carcinoma were treated with two or three cycles of chemoembolization using a collagen suspension with doxorubicin, mitomycin C, and cisplatin. Subsequently, systemic chemotherapy with continuous infusion of 5-fluorouracil and weekly leucovorin was initiated. Patients were assessed for response at 12-week intervals, with treatment continuing until disease progression.
  
  
  RESULTS
  Thirty-one eligible, evaluable patients were treated. One complete and 8 partial responses were observed, for an overall response rate of 29%. Fifty-eight percent of patients survived 1 year, and the median survival for the whole cohort was 14 months. The median time to progression was 8 months. Seven patients (23%) experienced Grade 4 toxicity and 21 patients (67%) had Grade 3 toxicity.
  
  
  CONCLUSIONS
  The response rate in this trial was comparable to that achieved with systemic chemotherapy consisting of a fluorinated pyrimidine-based regimen for patients with this disease. No improvement in complete response rate or time to progression was observed compared with the Southwest Oncology Group's experience with systemic therapy. The authors are not planning to study this regimen further as a treatment for patients with metastatic colorectal carcinoma.
authors.affiliation: Roswell Park Cancer Institute, Buffalo, New York, USA.
authors.forename: C G
authors.initials: CG
authors.lastname: Leichman
authors.forename: J R
authors.initials: JR
authors.lastname: Jacobson
authors.forename: M
authors.initials: M
authors.lastname: Modiano
authors.forename: J R
authors.initials: JR
authors.lastname: Daniels
authors.forename: M M
authors.initials: MM
authors.lastname: Zalupski
authors.forename: J H
authors.initials: JH
authors.lastname: Doroshow
authors.forename: W S
authors.initials: WS
authors.lastname: Fletcher
authors.forename: J S
authors.initials: JS
authors.lastname: Macdonald
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D016461:Chemoembolization, Therapeutic; D002945:Cisplatin / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000473:pathology* / Q000628:therapy*; D003131:Combined Modality Therapy; D004317:Doxorubicin / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D006499:Hepatic Artery; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008113:Liver Neoplasms / Q000098:blood supply / Q000556:secondary* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D010865:Pilot Projects; D016019:Survival Analysis
chemical_list: D016685:Mitomycin; D004317:Doxorubicin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil