title: Randomized, dose-finding phase III study of lithium gamolenate in patients with advanced pancreatic adenocarcinoma.
abstract: BACKGROUND
  Chemotherapy for pancreatic cancer offers small survival benefits and considerable side-effects. Unsaturated fatty acids have an antitumour effect in experimental studies; in phase II studies few side-effects were seen.
  
  
  METHODS
  In this group-sequential, open-label, randomized study, 278 patients with a diagnosis of inoperable pancreatic cancer were treated with either oral (700 mg daily for 15 days), low-dose (0.28 g/kg) or high-dose (0.84 g/kg) intravenous lithium gamolenate (LiGLA). The primary endpoint was survival time from randomization using Kaplan-Meier estimates.
  
  
  RESULTS
  Median survival after oral and low-dose intravenous treatment was 129 and 121 days respectively. Median survival after high-dose intravenous treatment was 94 days. A good Karnofsky score and the absence of metastases were associated with increased survival. Haemolysis, a marker of rapid infusion, was associated with a median survival time of 249 days in the low-dose intravenous group.
  
  
  CONCLUSIONS
  Oral or low-dose intravenous LiGLA led to survival times similar to those of other treatments for pancreatic cancer although one subgroup (low-dose intravenous LiGLA with haemolysis) had longer survival. High-dose intravenous treatment appeared to have an adverse effect. Systemic treatment with LiGLA cannot be recommended for the treatment of pancreatic cancer.
authors.affiliation: University Surgical Unit, Southampton General Hospital, Southampton, UK. c.d.johnson@soton.ac.uk
authors.forename: C D
authors.initials: CD
authors.lastname: Johnson
authors.forename: M
authors.initials: M
authors.lastname: Puntis
authors.forename: N
authors.initials: N
authors.lastname: Davidson
authors.forename: S
authors.initials: S
authors.lastname: Todd
authors.forename: R
authors.initials: R
authors.lastname: Bryce
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005231:Fatty Acids, Unsaturated / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis; D005719:gamma-Globulins
chemical_list: D000970:Antineoplastic Agents; D005231:Fatty Acids, Unsaturated; D005719:gamma-Globulins; C426249:lithium gamolenate; C031151:pepsinated immunoglobulin G