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Fine-Needle Aspiration Biopsy of Nonpalpable Breast Lesions in a Multicenter Clinical Trial: Results from the Radiologic Diagnostic Oncology Group V¹

¹ From the Dept of Radiology, Univ of North Carolina, 101 Manning Dr, 515 Old Infirmary, Chapel Hill, NC 27599-7510 (E.D.P.); Dept of Radiology, Johns Hopkins Univ, Baltimore, Md (L.L.F.); Dept of Pathology, M.D. Anderson Comprehensive Cancer Ctr, Houston, Tex (N.S.); Dept of Pathology, Medical College of Virginia of Virginia Commonwealth Univ, Richmond (W.J.F.); Ctr for Statistical Sciences, Brown Univ, Providence, RI (C.A.G.); Dept of Radiology, Univ of Maryland, Baltimore (W.A.B.); Dept of Radiology, Yale Univ, New Haven, Conn (I.T.); Depts of Pathology (S.J.S., J.L.C.) and Health Care Policy (D.J.C., B.J.M.), Harvard Medical School, Boston, Mass; and Dept of Radiology, Brigham and Women’s Hosp and Harvard Medical School, Boston, Mass (B.J.M.). The radiologist investigators of the Radiologic Diagnostic Oncology Group V (RDOGV) and their affiliations are listed at the end of this article. From the 1999 RSNA scientific assembly. Received Aug 15, 2000; revision requested Sep 26; revision received Nov 8; accepted Dec 12. Supported by NIH grants UO1 CA62476, UO1 CA62514, UO1 CA62462. Address correspondence to E.D.P. (e-mail: etpisano@med.unc.edu).

PURPOSE: To determine the diagnostic accuracy of ultrasonographically (US) and stereotactically guided fine-needle aspiration biopsy (FNAB) in the diagnosis of nonpalpable breast lesions.

MATERIALS AND 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).

CONCLUSION: 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.

Index terms: Breast, biopsy, 00.126 • Breast neoplasms, 00.31. 00.32 • Breast neoplasms, US, 00.12985 • Stereotaxis, 00.1267

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