title: Controlled clinical trial with pirfenidone in the treatment of breast capsular contracture: association of TGF-β polymorphisms.
abstract: BACKGROUND
  Breast capsular contracture (BCC) is a commonly adverse event postmammoplastly characterized by an immune response mediated by cytokines and transforming growth factor (TGF)-β1 resulting in excessive synthesis and deposit of extracellular matrix around the breast implant. Presence of TGF-β1 polymorphisms has been associated as a risk factor to develop fibroproliferative diseases.
  
  
  METHODS
  This open, controlled, prospective, and pilot clinical trial with 6 months duration was carried out to evaluate the efficacy of 1800 mg a day, of oral Pirfenidone (PFD) in the treatment of BCC (Baker Score III/IV) postmammoplasty. Twenty BCC cases received PFD and 14 BCC control cases underwent capsulectomy after 6 months of enrollment. Both groups were followed up for 6 more months up to 12 months to determine the relapse in the absence of PFD. Determination of TGF-β1 polymorphisms was performed to establish a correlation with capsular contracture.
  
  
  RESULTS
  PFD group experienced BCC-reduction in all breasts 6 months after enrollment. Only 1 of 20 cases relapsed after follow-up. In capsulectomy group, 2 of 14 cases presented progression to grade IV during presurgical period. All capsulectomy cases relapsed at end of follow-up. Nearly hundred percent of all patients studied in this protocol had a profibrogenic homozygous TGF-β1 polymorphism (codon 25; genotype Arg25Arg).
  
  
  CONCLUSIONS
  PFD is useful to improve BCC (Baker Score III/IV) postmammoplasty with no relapse after drug administration. There is also an association between capsular contracture and the presence of homozygous G/G TGF-β1 genotype.
authors.affiliation: Instituto Jalisciense de Cirugía Reconstructiva Dr. José Guerrerosantos, Guadalajara, Jalisco, Mexico.
authors.forename: Evelin Rosaira
authors.initials: ER
authors.lastname: Veras-Castillo
authors.forename: Lazaro
authors.initials: L
authors.lastname: Cardenas-Camarena
authors.forename: Ivan
authors.initials: I
authors.lastname: Lyra-Gonzalez
authors.forename: Jose Francisco
authors.initials: JF
authors.lastname: Muñoz-Valle
authors.forename: Silvia
authors.initials: S
authors.lastname: Lucano-Landeros
authors.forename: Jose
authors.initials: J
authors.lastname: Guerrerosantos
authors.forename: Beatriz
authors.initials: B
authors.lastname: Gonzalez-Ulloa
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Mercado-Barajas
authors.forename: Maria Guadalupe
authors.initials: MG
authors.lastname: Sanchez-Parada
authors.forename: Ronney
authors.initials: R
authors.lastname: Azabache-Wennceslao
authors.forename: Juan
authors.initials: J
authors.lastname: Armendariz-Borunda
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D019928:Breast Implantation / Q000295:instrumentation*; D018427:Breast Implants; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005819:Genetic Markers; D006720:Homozygote; D006801:Humans; D057910:Implant Capsular Contracture / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000235:genetics / Q000601:surgery; D008875:Middle Aged; D010865:Pilot Projects; D016133:Polymerase Chain Reaction; D020641:Polymorphism, Single Nucleotide; D011446:Prospective Studies; D011728:Pyridones / Q000627:therapeutic use*; D053773:Transforming Growth Factor beta1 / Q000235:genetics*; D014463:Ultrasonography
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005819:Genetic Markers; D011728:Pyridones; D053773:Transforming Growth Factor beta1; C093844:pirfenidone