title: Intravenous ω-3 Fatty Acids Plus Gemcitabine.
abstract: Marine-derived ω-3 fatty acids (ω-3FAs) have proven antitumor activity in vivo and in vitro and improve quality of life (QOL) in clinical cancer studies. These changes may be mediated by reduction in circulating proangiogenic and proinflammatory factors. In this first study of intravenous ω-3FAs as a therapy in cancer patients, we aimed to assess if it could augment the antitumor activity of gemcitabine in patients with advanced pancreatic cancer and improve QOL.
  
  
  
  Patients were administered gemcitabine 1000 mg/m3weekly followed by up to 100 g (200 mg/mL) of ω-3 rich lipid emulsion for 3 weeks followed by a rest week. This was continued for up to 6 cycles, progression, unacceptable toxicity, patient request, or death. The primary outcome measure was objective response rate, with secondary outcome measures of overall and progression free survival, QOL scores, and adverse events.
  
  
  
  Fifty patients were recruited. Response rate was 14.3% and disease control rate was 85.7%. Overall and progression free survival were 5.9 and 4.8 months, respectively. Increase in global health of > 10% over baseline was seen in 47.2% of patients. More than 50% of patients had > 10% increase in QOL scores in generic symptom scores and both disease-specific domains. Grade 3/4 adverse events were thrombocytopenia (8%), neutropenia (12%), nausea or vomiting (4%), and chills (6%).
  
  
  
  Intravenous ω-3FAs in combination with gemcitabine shows evidence of improved activity and benefit to QOL in patients with advanced pancreas cancer and is worthy of investigation in a randomized phase III trial.
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: Ali
authors.initials: A
authors.lastname: Arshad
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: John
authors.initials: J
authors.lastname: Isherwood
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Mann
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: Jill
authors.initials: J
authors.lastname: Cooke
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: Cristina
authors.initials: C
authors.lastname: Pollard
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: Franscois
authors.initials: F
authors.lastname: Runau
authors.affiliation: 2 Department of Radiology, University Hospitals of Leicester, Leicester, UK.
authors.forename: Bruno
authors.initials: B
authors.lastname: Morgan
authors.affiliation: 3 Department of Medical Oncology, University Hospitals of Leicester, Leicester, UK.
authors.forename: William
authors.initials: W
authors.lastname: Steward
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Metcalfe
authors.affiliation: 1 Department of Hepatobiliary and Pancreatic Surgery, University Hospitals of Leicester, Leicester, UK.
authors.forename: Ashley
authors.initials: A
authors.lastname: Dennison
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D015525:Fatty Acids, Omega-3; D003841:Deoxycytidine; D000093542:Gemcitabine
keywords: gemcitabine; pancreatic cancer; quality of life; ω-3