title: Randomized trial of 5-fluorouracil, leucovorin and cisplatin in advanced pancreatic cancer.
abstract: OBJECTIVE
  Phase II trials of combined 5 fluorouracil, leucovorin and cisplatin have demonstrated an 18-28% response rate in advanced pancreatic carcinomas. We investigated the effect of this chemotherapy regime on patients' survival.
  
  
  METHODS
  Patients included gave informed consent. They had an advanced and proven pancreatic adenocarcinoma. The trial was multicentric, prospective and randomized. It compared a 5-day course of leucovorin (200 mg/m2/day), 5-fluorouracil (375 mg/m2/day) and cisplatin (15 mg/m2/day) repeated every 21 days (23 patients) with a control group (22 patients). The main end points were survival time (Kaplan-Meier and log-rank methods) a[not readable: see text]side effects of chemotherapy.
  
  
  RESULTS
  Association of leucovorin, 5-fluorouracil and cisplatin failed to demonstrate any advantage of this regimen compared with supported care alone. Median survival times were 8.6 months (SD +/- 1.8) and 7.0 months (SD +/- 0.6), respectively. The modulation of 5-fluorouracil by leucovorin and cisplatin was well tolerated with moderate toxic effects.
  
  
  CONCLUSIONS
  This multicentric trial failed to demonstrate any advantage of the evaluated chemotherapy regime in the palliative treatment of cancer of the exocrine pancreas. Other trials including gemcitabine and/or radiotherapy are needed in advanced pancreatic adenocarcinoma.
authors.affiliation: Department of Surgery, Hôpital Tenon, 4 rue de la Chine 75020, Paris, France. michel.huguier@tnn.ap-hop-paris.fr
authors.forename: M
authors.initials: M
authors.lastname: Huguier
authors.forename: A
authors.initials: A
authors.lastname: Barrier
authors.forename: R
authors.initials: R
authors.lastname: Valinas
authors.forename: A
authors.initials: A
authors.lastname: Flahault
authors.forename: M
authors.initials: M
authors.lastname: Adloff
authors.forename: D
authors.initials: D
authors.lastname: Pezet
authors.forename: D
authors.initials: D
authors.lastname: Jaeck
authors.forename: B
authors.initials: B
authors.lastname: Millat
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010166:Palliative Care; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies
chemical_list: D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil