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10.1245/s10434-008-0026-8
Annals of Surgical Oncology 15:3222-3226 (2008)
© 2008 Society of Surgical Oncology
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Original Article

Radiofrequency Thermal Ablation of Breast Cancer Local Recurrence: A Phase II Clinical Trial

Jean-Rémi Garbay, MD1, Marie-Christine Mathieu, MD1, Michele Lamuraglia, MD1, Nathalie Lassau, MD, PhD1, Corrine Balleyguier, MD1 and Roman Rouzier, MD, PhD2,3

1 Department of Surgery, Pathology and Radiology, and the Breast Unit, Institut Gustave Roussy, Villejuif, France
2 Department of Gynecology and Obstetrics, Hopitâl Tenon, 4 rue de la Chine, 75020 Paris, France
3 UnitéPropre de Recherche de l’Enseignement Supérieur, Equipe d’Accueil 4053 of the University Pierre et Marie Curie, Paris VI, France

Correspondence: Address correspondence and reprint requests to: Roman Rouzier, MD, PhD; E-mail: rouzierroman{at}yahoo.fr

Background: The role of radiofrequency (RF) ablation to treat local recurrence of breast cancer is unknown.

Methods: We conducted a two-stage phase II clinical trial. Eligible patients had a histologically confirmed noninflammatory and ≤3 cm ipsilateral breast tumor recurrence. The tumor site was identified by intraoperative sonography. A LeVeen needle electrode (RadioTherapeutics Corp, Mountain View, Calif) was inserted into a single site within the tumor and radiofrequency ablation was performed using a RF-2000 generator (RadioTherapeutics Corp). After completion of radiofrequency, a mastectomy was performed. Conventional staining and nicotinamide adenine dinucleotide-diaphorase (NADH-diaphorase) cell viability staining were performed.

Results: During the first stage, procedures were uneventful. Conventional, cytokeratin, and NADH-diaphorase staining identified persistent viable tumor cells in the RF-ablated region in three patients. This phase II trial was stopped after completion of the first stage because of insufficient efficacy.

Conclusion: We demonstrate in this study that RF ablation is a potential technique to destroy local recurrence of breast tumors but the technique we tested in this phase II clinical trial had insufficient efficacy to recommend its use in routine.

Key Words: Breast cancer • Local recurrence • Radiofrequency ablation • Breast conservation






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