The Incidence of Adjacent Synchronous Invasive Carcinoma and/or Ductal Carcinoma In Situ in Patients with Intraductal Pa
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ORIGINAL ARTICLE – BREAST ONCOLOGY
The Incidence of Adjacent Synchronous Invasive Carcinoma and/ or Ductal Carcinoma In Situ in Patients with Intraductal Papilloma without Atypia on Core Biopsy: Results from a Prospective Multi-Institutional Registry (TBCRC 034) Faina Nakhlis, MD1,2, Gabrielle M. Baker, MD3, Melissa Pilewskie, MD4, Rebecca Gelman, PhD5, Katherina Z. Calvillo, MD1,2, Kandice Ludwig, MD6, Priscilla F. McAuliffe, MD, PhD7, Shawna Willey, MD8, Laura H. Rosenberger, MD9, Catherine Parker, MD10, Kristalyn Gallagher, DO11, Lisa Jacobs, MD12, Sheldon Feldman, MD13, Paulina Lange, BS2, Stephen D. DeSantis, BS2, Stuart J. Schnitt, MD2, and Tari A. King, MD1,2 Division of Breast Surgery, Department of Surgery, Brigham and Women’s Hospital, Boston, MA; 2Breast Oncology Program, Dana-Farber/Brigham and Women’s Cancer Center, Boston, MA; 3Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; 4Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY; 5Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA; 6Indiana University Cancer Center, Indianapolis, IN; 7UPMC Hillman Cancer Center, Pittsburgh, PA; 8Georgetown University Cancer Center, Washington, DC; 9Duke University Medical Center, Durham, NC; 10University of Alabama, Birmingham, AL; 11 University of North Carolina, Chapel Hill, NC; 12Johns Hopkins University, Baltimore, MD; 13Montefiore Medical Center, New York, NY 1
ABSTRACT Background. Available retrospective data suggest the upgrade rate for intraductal papilloma (IP) without atypia on core biopsy (CB) ranges from 0 to 12%, leading to variation in recommendations. We conducted a prospective multi-institutional trial (TBCRC 034) to determine the upgrade rate to invasive cancer (IC) or ductal carcinoma in situ (DCIS) at excision for asymptomatic IP without atypia on CB. Methods. Prospectively identified patients with a CB diagnosis of IP who had consented to excision were included. Discordant cases, including BI-RADS [ 4, and
Electronic supplementary material The online version of this article (https://doi.org/10.1245/s10434-020-09215-w) contains supplementary material, which is available to authorized users. Ó Society of Surgical Oncology 2020 First Received: 22 July 2020 Accepted: 17 September 2020 F. Nakhlis, MD e-mail: [email protected]
those with additional lesions requiring excision were excluded. The primary endpoint was upgrade to IC or DCIS by local pathology review with a predefined rule that an upgrade rate of B 3% would not warrant routine excision. Sample size and confidence intervals were based on exact binomial calculations. Secondary endpoints included diagnostic concordance for IP between local and central pathology review and upgrade rates by central pathology review. Results. The trial included116 patients (median age 56 years, range 24–82) and the most common imaging abnormality was a mass (n = 91, 78%). Per local review, 2 (1.7%) cases were upgraded to DCIS. In both of these cases central pathology revie
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