Fine-needle aspiration biopsy of nonpalpable breast lesions in a multicenter clinical trial: results from the radiologic diagnostic oncology group V.
OBJECTIVE
To determine the diagnostic accuracy of ultrasonographically (US) and stereotactically guided fine-needle aspiration biopsy (FNAB) in the diagnosis of nonpalpable breast lesions.


METHODS
At 18 institutions, 442 women who underwent 22-25-gauge imaging-guided FNAB were enrolled. Definitive surgical, core-needle biopsy, and/or follow-up information was available for 423 (95.7%) of these women. The reference standard was established from additional clinical and imaging information for an additional six (1.4%) women who did not undergo further histopathologic evaluation. The FNAB protocol was standardized at all institutions, and all specimens were reread by one of two expert cytopathologists.


RESULTS
When insufficient samples were included in the analysis and classified as positive, the sensitivity and specificity of FNAB were 85%-88% and 55.6%-90.5%, respectively; accuracy ranged from 62.2% to 89.2%. The diagnostic accuracy of FNAB was significantly better for detection of masses than for detection of calcifications (67.3% vs. 53.8%, P =.006) and with US guidance than with stereotactic guidance (77.2% vs. 58.9%; P =.002).


CONCLUSIONS
FNAB of nonpalpable breast lesions has limited value given the high insufficient sample rate and greater diagnostic accuracy of other interventions, including core-needle biopsy and needle-localized open surgical biopsy.
Pisano
E D
ED
Dept of Radiology, Univ. of North Carolina, 101 Manning Dr, 515 Old Infirmary, Chapel Hill, NC 27599-7510, USA. etpisano@med.unc.edu
Fajardo
L L
LL
Caudry
D J
DJ
Sneige
N
N
Frable
W J
WJ
Berg
W A
WA
Tocino
I
I
Schnitt
S J
SJ
Connolly
J L
JL
Gatsonis
C A
CA
McNeil
B J
BJ
D001707:Biopsy, Needle; D001940:Breast / Q000473:pathology*; D001943:Breast Neoplasms / Q000453:epidemiology / Q000473:pathology*; D005260:Female; D006801:Humans; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D016217:Ultrasonography, Mammary