title: Advanced breast cancer: anti-progressive immunotherapy using a thermostable autologous hemoderivative.
abstract: BACKGROUND
  Advanced breast cancer patients, acquired-chemotherapy resistant and in progression, are therapeutically terminal. We tested a recently described medical procedure using a thermostable autohemoderivative purported to inhibit tumor growth possibly through an immunological mechanism of action.
  
  
  METHODS
  Metastatic breast cancer patients, chemotherapy-resistant, high CEA and CA 15-3 plasma levels of tumor markers, in progression, were 2-group randomized. Group 1 received the test procedure and Group 2 adequate measures to be comparable control. From 121 included patients, 108 could be evaluated. During 8-month follow-up period, tumor growth, number of cases attaining clinical non-progressive status and mortality were monthly assessed. Immunologic effect was assessed by delayed type hypersensitivity test and lymphocyte proliferation assay. Responding-tumors histopathologies were studied. The proteome of the autologous immunogen was characterized by 2-D electrophoresis.
  
  
  CONCLUSIONS
  In a significant number of cases, the test procedure promoted inhibition of tumor growth, non-progressive disease status, and lower cumulative mortality. These clinical results were associated with polyvalent immunization against several tested antigens: the hemoderivative used for treatment, the blood tumor markers and the derivative obtained from a regulatory lymphocyte population (CD4+CD25+). Interference with this regulatory activity could explain the selective autoimmunity suggested by the histopathology findings in responding tumors. The thermostability could be an essential property of the immunogen hemoderivative.
  
  
  CONCLUSIONS
  The thermostable autohemoderivative tested is antigenically polyvalent and promoted a polytargeted immune response associated to a tumor anti-progressive effect, consequently, acting as an autohemoderivative cancer vaccine.
authors.affiliation: PharmaBlood Inc, Research & Development Department, 2050 NE 163rd Street, # 202, North Miami Beach, Florida 33162, USA. research@pharmablood.com
authors.forename: Eduardo
authors.initials: E
authors.lastname: Lasalvia-Prisco
authors.forename: Emilio
authors.initials: E
authors.lastname: Garcia-Giralt
authors.forename: Silvia
authors.initials: S
authors.lastname: Cucchi
authors.forename: Jesús
authors.initials: J
authors.lastname: Vázquez
authors.forename: Eduardo
authors.initials: E
authors.lastname: Lasalvia-Galante
authors.forename: Wilson
authors.initials: W
authors.lastname: Golomar
authors.forename: Joshemaria
authors.initials: J
authors.lastname: Larrañaga
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000276:immunology / Q000628:therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies; D050378:T-Lymphocytes, Regulatory / Q000502:physiology