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Title: Controlled clinical trial with pirfenidone in the treatment of breast capsular contracture: Association of TGF-? polymorphisms
Author: Veras-Castillo, E.R.
Cardenas-Camarena, L.
Lyra-Gonzalez, I.
Munoz-Valle, J.F.
Lucano-Landeros, S.
Guerrerosantos, J.
Gonzalez-Ulloa, B.
Mercado-Barajas, J.L.
Sanchez-Parada, M.G.
Azabache-Wennceslao, R.
Armendariz-Borunda, J.
Issue Date: 2013
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)-?1 resulting in excessive synthesis and deposit of extracellular matrix around the breast implant. Presence of TGF-?1 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-?1 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-?1 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-?1 genotype. Copyright � 2012 by Lippincott Williams & Wilkins.
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