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Controlled Clinical Trial With Pirfenidone in the Treatment of Breast Capsular Contracture: Association of TGF-β Polymorphisms

Veras-Castillo, Evelin Rosaira MD*; Cardenas-Camarena, Lazaro MD*; Lyra-Gonzalez, Ivan MD; Muñoz-Valle, Jose Francisco PhD; Lucano-Landeros, Silvia MD; Guerrerosantos, Jose MD*; Gonzalez-Ulloa, Beatriz MD§; Mercado-Barajas, Jose Luis MD; Sanchez-Parada, Maria Guadalupe MD; Azabache-Wennceslao, Ronney MD*; Armendariz-Borunda, Juan PhD†∥

doi: 10.1097/SAP.0b013e31822284f4
Breast Surgery

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.

From the *Instituto Jalisciense de Cirugía Reconstructiva ‘‘Dr. José Guerrerosantos’’, Guadalajara, Jalisco, Mexico; †Instituto de Biología Molecular en Medicina y Terapia Génica, CUCS, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico; ‡IIRSME, CUCS, Universidad de Guadalajara, Guadalajara Jalisco, Mexico; §Diagnóstico Especializado por Imagen DEI, Zapopan, Jalisco, Mexico; ¶Departamento de Ciencias Sociales, CUCS, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico; and ∥OPD Hospital Civil de Guadalajara, Guadalajara, Jalisco, Mexico.

Received March 11, 2011, and accepted for publication, after revision May 2, 2011.

Conflicts of interest and sources of funding: none declared.

Reprints: Juan Armendariz-Borunda, Department of Molecular Biology and Genomics, CUCS, University of Guadalajara, Sierra Mojada # 950, Guadalajara, Jalisco 44281, Mexico. E-mail:

© 2013 Lippincott Williams & Wilkins, Inc.