Eighteen months clinical experience with the GeneSearch breast lymph node assay.
BACKGROUND
The accuracy of a molecular reverse transcriptase-polymerase chain reaction (RT-PCR)-based assay for metastases detection in axillary sentinel lymph nodes (SLNs) has recently been validated in our institution and adopted as an intraoperative test for breast cancer patient management.


METHODS
Molecular assay performance was compared to standard postoperative histology in 253 consecutive patients with clinically node-negative T1 early breast cancer (<2 cm).


RESULTS
The molecular assay correctly identified 26/27 macrometastases and 11/15 micrometastases. Overall concordance with histopathology was 93%, with 87% sensitivity, 94% specificity, and 75% positive and 97% negative predictive values. The molecular assay was positive in 13/14 patients with SLNs and nonsentinel lymph node (axillary lymph node [ALN])-positive histology. Notably, 2/12 patients with assay-positive/histology-negative SLNs exhibited ALN positivity.


CONCLUSIONS
This molecular assay can raise the standard of care for patient management as its accuracy is similar to that of standard postoperative histology with the advantage of being standardized, objective, and fast enough for intraoperative use.
Veys
Isabelle
I
Department of Surgery, Jules Bordet Institute, Université Libre de Bruxelles, Belgium.
Durbecq
Virginie
V
Majjaj
Samira
S
Schobbens
Jean Christophe
JC
Noterman
Danielle
D
Sirtaine
Nicolas
N
Martinez
Maria Dolores Martin
MD
Hertens
Dina
D
Feoli
Francesco
F
Bourgeois
Pierre
P
Nogaret
Jean-Marie
JM
Larsimont
Denis
D
D001365:Axilla; D014408:Biomarkers, Tumor / Q000235:genetics; D001943:Breast Neoplasms / Q000235:genetics / Q000473:pathology*; D005260:Female; D006801:Humans; D053539:Keratin-19 / Q000235:genetics*; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000175:diagnosis*; D060785:Mammaglobin A; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000235:genetics*; D011237:Predictive Value of Tests; D012313:RNA / Q000032:analysis; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy; D014598:Uteroglobin / Q000235:genetics*
D014408:Biomarkers, Tumor; D053539:Keratin-19; D060785:Mammaglobin A; D009363:Neoplasm Proteins; C556448:SCGB2A2 protein, human; D012313:RNA; D014598:Uteroglobin