title: Effect of talactoferrin alfa on the immune system in adults with non-small cell lung cancer.
abstract: BACKGROUND
  Talactoferrin alfa (talactoferrin), an agent with immune-stimulating properties, has demonstrated safety and preliminary efficacy in clinical trials.
  
  
  METHODS
  Ten patients (five males and five females) with stage IV non-small cell lung cancer (NSCLC) in a single-arm pilot study received orally administered talactoferrin (1.5 g, b.i.d.) for up to 24 weeks. Radiographic and immunologic studies were performed at baseline and at weeks 6 and 12. Circulating immune cells (natural killer cells [NKCs], CD4+, CD8+, and regulatory T cells) and systemic cytokine levels were measured to assess immune response.
  
  
  RESULTS
  Patients enrolled in the study had received a median of four prior chemotherapy regimens, and all patients were symptomatic. Talactoferrin was well tolerated, with no grade 3 or 4 toxicities. Median time to progression (TTP) and overall survival were 6 weeks and 14.5 weeks, respectively. The four patients with ≥9 weeks TTP had evidence of immunologic activity (three with increased NKC activity).
  
  
  CONCLUSIONS
  The median of four previous chemotherapy regimens, with elevated levels of interleukin (IL) 6 and tumor necrosis factor-alfa in most patients, suggests these patients were poor candidates for immunotherapy.
authors.affiliation: Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health,Bethesda, Maryland 20892, USA.
authors.forename: Ravi A
authors.initials: RA
authors.lastname: Madan
authors.forename: Kwong-Yok
authors.initials: KY
authors.lastname: Tsang
authors.forename: Marijo
authors.initials: M
authors.lastname: Bilusic
authors.forename: Matteo
authors.initials: M
authors.lastname: Vergati
authors.forename: Diane J
authors.initials: DJ
authors.lastname: Poole
authors.forename: Caroline
authors.initials: C
authors.lastname: Jochems
authors.forename: Jo A
authors.initials: JA
authors.lastname: Tucker
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Schlom
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giaccone
authors.forename: James L
authors.initials: JL
authors.lastname: Gulley
mesh_terms: D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007107:Immune System / Q000187:drug effects*; D015850:Interleukin-6 / Q000378:metabolism; D007694:Killer Cells, Natural / Q000187:drug effects; D007781:Lactoferrin / Q000008:administration & dosage* / Q000009:adverse effects; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D010865:Pilot Projects; D050378:T-Lymphocytes, Regulatory / Q000187:drug effects; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism
chemical_list: D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; C515276:talactoferrin alfa; D007781:Lactoferrin