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 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 ≤ 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 review did not confirm DCIS on excision. Additionally, central pathology review confirmed IP without atypia in core biopsies of 85/116 cases (73%), and both locally upgraded cases were among them.
Conclusion
In this prospective study of 116 IPs without atypia on CB, the upgrade rate was 1.7% by local review, suggesting that routine excision is not indicated for IP without atypia on CB with concordant imaging findings.
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Acknowledgments
We are grateful for the funding support to the TBCRC from The Breast Cancer Research Foundation and Susan G. Komen. This study was chosen as an oral presentation at the Society of Surgical Oncology 2020 International Conference on Surgical Cancer Care, Boston, MA, initially scheduled for March 25–28, 2020, rescheduled to August 17–19, 2020. The authors have no conflict of interest disclosures to report, and the findings presented in this manuscript have not been published elsewhere.
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The Breast Cancer Research Foundation and Susan G. Komen.
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Nakhlis, F., Baker, G.M., Pilewskie, M. et al. 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). Ann Surg Oncol 28, 2573–2578 (2021). https://doi.org/10.1245/s10434-020-09215-w
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DOI: https://doi.org/10.1245/s10434-020-09215-w