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Multicenter Study
. 2024 Jun 1;10(6):793-798.
doi: 10.1001/jamaoncol.2024.0578.

Omission of Axillary Dissection Following Nodal Downstaging With Neoadjuvant Chemotherapy

Giacomo Montagna  1 , Mary M Mrdutt  2 , Susie X Sun  3 , Callie Hlavin  4 , Emilia J Diego  4 , Stephanie M Wong  5   6 , Andrea V Barrio  1 , Astrid Botty van den Bruele  7 , Neslihan Cabioglu  8 , Varadan Sevilimedu  9 , Laura H Rosenberger  7 , E Shelley Hwang  7 , Abigail Ingham  10 , Bärbel Papassotiropoulos  11 , Bich Doan Nguyen-Sträuli  12 , Christian Kurzeder  13   14 , Danilo Díaz Aybar  15 , Denise Vorburger  16 , Dieter Michael Matlac  17 , Edvin Ostapenko  18   19 , Fabian Riedel  20 , Florian Fitzal  18   21 , Francesco Meani  22   23 , Franziska Fick  17 , Jacqueline Sagasser  24 , Jörg Heil  20 , Hasan Karanlik  25 , Konstantin J Dedes  12 , Laszlo Romics  10 , Maggie Banys-Paluchowski  17 , Mahmut Muslumanoglu  8 , Maria Del Rosario Cueva Perez  15 , Marcelo Chávez Díaz  15 , Martin Heidinger  13   14 , Mathias K Fehr  26 , Mattea Reinisch  27   28 , Mustafa Tukenmez  8 , Nadia Maggi  13   14 , Nicola Rocco  29 , Nina Ditsch  24 , Oreste Davide Gentilini  30 , Regis R Paulinelli  31 , Sebastián Solé Zarhi  32 , Sherko Kuemmel  27   28 , Simona Bruzas  27 , Simona di Lascio  22   33 , Tamara K Parissenti  26 , Tanya L Hoskin  2 , Uwe Güth  11 , Valentina Ovalle  32 , Christoph Tausch  11   14 , Henry M Kuerer  3 , Abigail S Caudle  3 , Jean-Francois Boileau  5   6 , Judy C Boughey  2 , Thorsten Kühn  34 , Monica Morrow  1 , Walter P Weber  13   14
Affiliations
Multicenter Study

Omission of Axillary Dissection Following Nodal Downstaging With Neoadjuvant Chemotherapy

Giacomo Montagna et al. JAMA Oncol. .

Abstract

Importance: Data on oncological outcomes after omission of axillary lymph node dissection (ALND) in patients with breast cancer that downstages from node positive to negative with neoadjuvant chemotherapy are sparse. Additionally, the best axillary surgical staging technique in this scenario is unknown.

Objective: To investigate oncological outcomes after sentinel lymph node biopsy (SLNB) with dual-tracer mapping or targeted axillary dissection (TAD), which combines SLNB with localization and retrieval of the clipped lymph node.

Design, setting, and participants: In this multicenter retrospective cohort study that was conducted at 25 centers in 11 countries, 1144 patients with consecutive stage II to III biopsy-proven node-positive breast cancer were included between April 2013 and December 2020. The cumulative incidence rates of axillary, locoregional, and any invasive (locoregional or distant) recurrence were determined by competing risk analysis.

Exposure: Omission of ALND after SLNB or TAD.

Main outcomes and measures: The primary end points were the 3-year and 5-year rates of any axillary recurrence. Secondary end points included locoregional recurrence, any invasive (locoregional and distant) recurrence, and the number of lymph nodes removed.

Results: A total of 1144 patients (median [IQR] age, 50 [41-59] years; 78 [6.8%] Asian, 105 [9.2%] Black, 102 [8.9%] Hispanic, and 816 [71.0%] White individuals; 666 SLNB [58.2%] and 478 TAD [41.8%]) were included. A total of 1060 patients (93%) had N1 disease, 619 (54%) had ERBB2 (formerly HER2)-positive illness, and 758 (66%) had a breast pathologic complete response. TAD patients were more likely to receive nodal radiation therapy (85% vs 78%; P = .01). The clipped node was successfully retrieved in 97% of TAD cases and 86% of SLNB cases (without localization). The mean (SD) number of sentinel lymph nodes retrieved was 3 (2) vs 4 (2) (P < .001), and the mean (SD) number of total lymph nodes removed was 3.95 (1.97) vs 4.44 (2.04) (P < .001) in the TAD and SLNB groups, respectively. The 5-year rates of any axillary, locoregional, and any invasive recurrence in the entire cohort were 1.0% (95% CI, 0.49%-2.0%), 2.7% (95% CI, 1.6%-4.1%), and 10% (95% CI, 8.3%-13%), respectively. The 3-year cumulative incidence of axillary recurrence did not differ between TAD and SLNB (0.5% vs 0.8%; P = .55).

Conclusions and relevance: The results of this cohort study showed that axillary recurrence was rare in this setting and was not significantly lower after TAD vs SLNB. These results support omission of ALND in this population.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kurzeder reported personal fees from GSK, Astra Zeneca, Novartis, Roche, Eli Lilly, Pfizer, Genomic Health, Pharmamar, MSD, and Gilead as well as nonfinancial support from GSK, Astra Zeneca, and Roche outside the submitted work. Dr Fitzal reported personal fees from MSD and AstraZeneca outside the submitted work. Dr Banys-Paluchowski reported honoraria for lectures and participation in advisory boards from Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, Amgen, Samsung, Canon, MSD, GSK, Daiichi Sankyo, Gilead, Sirius Medical, Syantra, resitu, Pierre Fabre, and ExactSciences; study support from EndoMag, Mammotome, MeritMedical, Sirius Medical, Gilead, Hologic, and ExactSciences; and travel reimbursement from Eli Lilly, ExactSciences, Pierre Fabre, Pfizer, Daiichi, Sankyo, and Roche. Dr Fehr reported grants from Cancer League Canton Thurgau during the conduct of the study as well as grants from Cancer League Canton Thurgau outside the submitted work. Dr Reinisch reported personal fees from Roche, Novartis Travel Support, personal fees from Lilly, personal fees from Daiichi Sankyo, Gilead, Seagen, Somatex, and MSD as well as travel support from AstraZeneca outside the submitted work. Dr Ditsch reported consulting fees from AstraZeneca, Aurikamed, Daiichi-Sankyo, Elsevier Verlag, ESO, Exact Sciences, Gilead, GSK, if-Kongress, KelCon, Leopoldina Schweinfurt, Lilly, Lukon, Molekular Health, MSD, Novartis, Onkowissen, Pfizer, RG- Ärztefortbildungen, Roche, and Seagen outside the submitted work. Dr Gentilini reported honoraria for lectures and advisory roles for MSD, Astra-Zeneca, BD, Bayer, and Eli-Lilly. Dr Kuemmel reported a study patient fee from Taxis for their institution during the conduct of the study as well as personal fees from Novartis, Roche, Lilly, Pfizer, Seagen, Gilead, Exact Science, Agendia, Stryker, Somatex, Hologic, AstraZeneca, MSD, Daiichi Sankyo, Daiichi Sankyo, and Roche and nonfinancial support from WSG outside the submitted work. Dr Bruzas reported personal fees from AstraZeneca and Roche outside the submitted work. Dr Kuerer reported personal fees from NEJM Group, Inc, McGraw Hill Professional, Inc, and UpToDate, Inc as well as grants from Exact Sciences outside the submitted work. Dr Boileau reported advisory board service for Merck, AstraZeneca, Novartis, Lilly, Exact Sciences, and Pfizer outside the submitted work. Dr Boughey reported research support from Eli Lilly and SimBioSys and service on the data safety monitoring board of Cairns Surgical outside the submitted work. Dr Weber reported grants from Agendia and personal fees from MSD outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Flow Diagram
ALND indicates axillary lymph node dissection; SLNB, sentinel lymph node biopsy; TAD, targeted axillary dissection.
See this image and copyright information in PMC

References

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