Originally published as JCO Early Release 10.1200/JCO.2006.08.4228 on May 7 2007

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Prospective Multicentric Randomized Study Comparing Periareolar and Peritumoral Injection of Radiotracer and Blue Dye for the Detection of Sentinel Lymph Node in Breast Sparing Procedures: FRANSENODE Trial

Jean-François Rodier, Michel Velten, Marc Wilt, Pierre Martel, Gwanaël Ferron, Véronique Vaini-Elies, Hervé Mignotte, Alain Brémond, Jean-Marc Classe, François Dravet, Thierry Routiot, Christine Tunon de Lara, Antoine Avril, Gérard Lorimier, Eric Fondrinier, Gilles Houvenaeghel, Sandrine Avigdor

From the French Comprehensive Cancer Centers of Strasbourg, Toulouse, Lyon, Nantes, Bordeaux, Angers, and Marseille; Axium Clinic of Aix en Provence; Community Hospital of Le Mans; and the Community Hospital of Orléans, Orléans, France

Address reprint requests to Jean-François Rodier, MD, FACS, Department of Surgical Oncology, Paul Strauss Cancer Center, 3 rue de la Porte de l'Hôpital, BP 42 F-67065 Strasbourg Cedex, France; e-mail: jrodier{at}strasbourg.fnclcc.fr

Purpose To determine the optimal injection path for blue dye and radiocolloid for sentinel lymph node (SLN) biopsy in early breast cancer.

Patients and Methods A prospective randomized multicentric study was initiated to compare the peritumoral (PT) injection site to the periareolar (PA) site in 449 patients.

Results The detection rate of axillary SLN by lymphoscintigraphy was significantly higher (P = .03) in the PA group (85.2%) than in the PT group (73.2%). Intraoperative detection rate by blue dye and/or gamma probe was similar (99.11%) in both groups. The rate of SLN detection was somewhat higher in the PA group than in the PT group: 95.6% versus 93.8% with blue dye (P = .24) and 98.2% versus 96.0% by probe (P = .16), respectively. The number of SLNs detected by lymphoscintigraphy and by probe was significantly higher in the PA group than in the PT group, 1.5 versus 1.2 (P = .001) and 1.9 versus 1.7 (P = .02). The blue and hot concordance was 95.6% in the PA group and 91.5% in the PT group (P = .08). The mean ex vivo count of the SLN was significantly higher in the PA group than in the PT group (P < .0001).

Conclusion This study strongly validates the PA injection technique given the high detection rate (99.1%) of SLN and the high concordance (95.6%) between blue dye and the radiotracer, as well as higher significant ex and in vivo counts, improving SLN probe detection.

published online ahead of print at www.jco.org on July 23, 2007.

Supported by grants from the Ligue Nationale Contre le Cancer and the Féderation Nationale des Centres de Lutte Contre le Cancer.

Presented at the 4th Annual International Sentinel Node Congress, December 3-6, 2004, Los Angeles, CA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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