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Correlation Between Pathologic Complete Response in the Breast and Absence of Axillary Lymph Node Metastases After Neoadjuvant Systemic Therapy

Samiei, Sanaz, MD*,†,‡; van Nijnatten, Thiemo J. A., MD, PhD†,‡; de Munck, Linda, MSc§; Keymeulen, Kristien B. M. I., MD*; Simons, Janine M., MD; Kooreman, Loes F. S., MD‡,||; Siesling, Sabine, MD, PhD§,**; Lobbes, Marc B. I., MD, PhD†,‡; Smidt, Marjolein L., MD, PhD*,‡

doi: 10.1097/SLA.0000000000003126
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Objective: The aim was to investigate whether pathologic complete response (pCR) in the breast is correlated with absence of axillary lymph node metastases at final pathology (ypN0) in patients treated with neoadjuvant systemic therapy (NST) for different breast cancer subtypes.

Background: Pathologic complete response rates have improved on account of more effective systemic treatment regimens. Promising results in feasibility trials with percutaneous image-guided tissue sampling for the identification of breast pCR after NST raise the question whether breast surgery is a redundant procedure. Thereby, the need for axillary surgery should be reconsidered as well.

Methods: Patients diagnosed with cT1-3N0-1 breast cancer and treated with NST, followed by surgery between 2010 and 2016, were selected from the Netherlands Cancer Registry. Patients were compared according to the pathologic response of the primary tumor with associated pathologic axillary outcome. Multivariable analysis was performed to determine clinicopathological variables correlated with ypN0.

Results: A total of 4084 patients were included for analyses, of whom 986 (24.1%) achieved breast pCR. In clinically node negative patients (cN0), 97.7% (432/442) with breast pCR had ypN0 compared with 71.6% (882/1232) without breast pCR (P < 0.001). In clinically node positive patients (cN1), 45.0% (245/544) with breast pCR had ypN0 compared with 9.4% (176/1866) without breast pCR (P < 0.001). The odds of ypN0 was decreased in case of clinical T3 stage (OR 0.59, 95% CI 0.40–0.87), cN1 (OR 0.03, 95% CI 0.02–0.04) and ER+HER2- subtype (OR 0.30, 95% CI 0.20–0.44), and increased in case of breast pCR (OR 4.53, 95% CI 3.27–6.28).

Conclusions: Breast pCR achieved after NST is strongly correlated with ypN0 in cN0 patients, especially in ER+HER2+, ER-HER2+, and triple negative subtypes. These results provide data to proceed with future clinical trials to investigate if axillary surgery can be safely omitted in these selected patients when image-guided tissue sampling identifies a breast pCR.

This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

*Department of Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands

Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, Maastricht, The Netherlands

GROW – School for Oncology and Developmental Biology, Maastricht University Medical Center+, Maastricht, The Netherlands

§Department of Research, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands

Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands

||Department of Pathology, Maastricht University Medical Center+, Maastricht, The Netherlands

**Department of Health Technology and Services Research, Technical Medical Center, University of Twente, Enschede, The Netherlands.

Reprints: Sanaz Samiei, MD, Department of Surgery, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands. E-mail: sanaz.samiei@mumc.nl.

S.S. received a salary from the Alpe d’Huzes Foundation (Dutch Cancer Society).

The authors report no conflicts of interest.

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