Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study
Abstract
PURPOSE The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i+) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i+ treated with and without ALND. METHODS The Oncoplastic Breast Consortium-05/ICARO cohort study (ClinicalTrials.gov identifier: NCT06464341 ) retrospectively analyzed data from patients with stage I to III breast cancer with ITCs in SLNs after NAC from 62 centers in 18 countries. The primary end point was the 3-year rate of any axillary recurrence. The rate of any invasive recurrence was the secondary end point. RESULTS In total, 583 patients were included, of whom 182 (31%) had completion ALND and 401 (69%) did not. The median age was 48 years. Most patients (74%) were clinically node-positive at diagnosis and 41% had hormone receptor–positive/human epidermal growth factor receptor 2–negative tumors. The mean number of SLNs with ITCs was 1.2. Patients treated with ALND were more likely to present with cN2/3 disease (17% v 7%, P < .001), have ITCs detected on frozen section (62% v 8%, P < .001), have lymphovascular invasion (38% v 24%, P < .001), and receive adjuvant chest wall (89% v 78%, P = .024) and nodal radiation (82% v 75%, P = .038). Additional positive nodes were found at ALND in 30% of patients, but only 5% had macrometastases. The 3-year rates of any axillary and any invasive recurrence were 2% (95% CI, 0.95 to 3.6) and 11% (95% CI, 8 to 14), respectively, with no statistical difference by type of axillary surgery. CONCLUSION The nodal burden in patients with ypN0(i+) was low, and axillary recurrence after ALND omission was rare in patients selected for this approach. These results do not support routine ALND in all patients with ypN0(i+).
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (105)
Giacomo Montagna
Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY
Alison Laws
Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA
Massimo Ferrucci
Breast Surgical Unit, Veneto Institute of Oncology IRCCS, Padova, Veneto, Italy
Mary M. Mrdutt
Division of Breast and Melanoma Surgical Oncology, Department of Surgery, Mayo Clinic, Rochester, MN
Susie X. Sun
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX
Suleyman Bademler
Institute of Oncology, Istanbul University, Istanbul, Turkey
Hakan Balbaloglu
Department of General Surgery, School of Medicine, Zonguldak Bulent Ecevit University, Zonguldak, Turkey
Nora Balint-Lahat
Sheba Medical Center, Ramat Gan, Israel
Maggie Banys-Paluchowski
Andrea V. Barrio
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY
John Benson
Mayo Clinic, Rochester, Minnesota, United States
Nuran Bese
Research Institute of Senology Acibadem, Istanbul, Turkey
Judy C. Boughey
Matthew P. Goetz, MD and Grace M. Choong, MD, Department of Oncology, Mayo Clinic, Rochester, MN; Tanya L. Hoskin, MS, Division of Clinical Trials and Biostatistics, Mayo Clinic, Rochester, MN; Judy C. Boughey, MD, Division of Breast and Melanoma Surgical Oncology, Mayo Clinic, Rochester, MN; Sameera R. Wijayawardana, PhD, Eli Lilly and Company, Indianapolis, IN; and James N. Ingle, MD, Department of Oncology, Mayo Clinic, Rochester, MN
Marissa K. Boyle
Cedars-Sinai Medical Center, Los Angeles, CA
Emilia J. Diego
University of Pittsburgh Medical Center, Pittsburgh, PA
Claire Eden
Department of Surgery, New York-Presbyterian/Weill Cornell Medical Center, New York, NY
Ruth Eller
University of Basel, Basel, Switzerland
Maite Goldschmidt
University of Basel, Basel, Switzerland
Callie Hlavin
University of Pittsburgh Medical Center, Pittsburgh, PA
Martin Heidinger
University Hospital Basel and Faculty of Medicine University of Basel, Basel, Switzerland
Justyna Jelinska
General Surgery and Surgical Oncology Clinic, Collegium Medicum, University Zielona Gora, Zielona Góra, Poland
Guldeniz Karadeniz Cakmak
Zonguldak BEUN The School of Medicine, Breast and Endocrine Unit, General Surgery Department, Kozlu/Zonguldak, Turkey
Susan B. Kesmodel
DeWitt Daughtry Department of Surgery, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL
Tari A. King
Winship Cancer Institute, Atlanta, GA
Henry M. Kuerer
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX
Julie Loesch
University of Basel, Basel, Switzerland
Francesco Milardi
General Surgery, Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy
Dawid Murawa
General Surgery and Surgical Oncology Department, Collegium Medicum, University in Zielona Gora, Zielona Gora, Poland
Tracy-Ann Moo
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY
Tehillah S. Menes
Sheba Medical Center, Tel Hashomer, Israel
Daniele Passeri
Jessica M. Pastoriza
Breast Surgery Division, Department of Surgery, Montefiore Medical Center, Montefiore Einstein Center for Cancer Care, New York, NY
Andraz Perhavec
Institute of Oncology Ljubljana, Ljubljana, Slovenia
Nina Pislar
Department of Surgical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia
Natalia Polidorio
Avina Rami
Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA
Jai Min Ryu
Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
Alexandra Schulz
University Hospital Basel, Basel, Switzerland
Varadan Sevilimedu
Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY
M. Umit Ugurlu
Marmara University School of Medicine, Istanbul, Turkey
Cihan Uras
Research Institute of Senology Acibadem, Istanbul, Turkey
Annemiek van Hemert
Department of Surgery, Stichting HET Netherlands Kanker Instituut-Antoni van Leeuwenhoek, Amsterdam, the Netherlands
Stephanie M. Wong
Stroll Cancer Prevention Centre, Jewish General Hospital, and McGill University Medical School, Montreal, Canada
Tae-Kyung Robyn Yoo
Division of Breast Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
Jennifer Q. Zhang
Division of Breast Surgery, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Hasan Karanlik
Institute of Oncology, Istanbul University, Istanbul, Turkey
Neslihan Cabioglu
Istanbul University Faculty of Medicine, Department of Surgery, Istanbul, Turkey
Marie-Jeanne Vrancken Peeters
Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands
Monica Morrow
Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York
Walter P. Weber
Sung Gwe Ahn
Mariacarla Andreozzi
Daniel Meirelles Barbalho
Jean François Boileau
Edi Brogi
Flavia Vidal Cabero
CORA - Centro Avançado de Diagnóstico da Mama do Hospital das Clinicas da Universidade Federal de Goias, Goiania, Goias, Brazil
Daniela Cocco
Fabio Corsi
Angelena Crown
Eelco de Bree
Maria del Mar Vernet-Tomas
Christine Deutschmann
Nina Ditsch
Emanuela Esposito
Oluwadamilola M. Fayanju
Franziska Fick
Department of Gynecology and Obstetrics, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany
Florian Fitzal
Department of General Surgery and Breast Health Center, Hanusch Hospital, Vienna, Austria
Meghan R. Flanagan
Damiano Gentile
Humanitas University - IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
Oreste D. Gentilini
Breast Surgery Unit, IRCCS Ospedale San Raffaele, Milan, Italy
Anne Grabenstetter
Mehmet Ali Gulcelik
Jörg Heil
University Hospital Heidelberg, Heidelberg, Germany
Johannes Holtschmidt
German Breast Group, Neu-Isenburg, Germany
Natalia Krawczyk
Department of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany
Thorsten Kühn
Hospital Esslingen, Esslingen, Germany
Sherko Kümmel
Cornelia Leo
Mahmut Muslumanoglu
Valentina Nekljudova
German Breast Group, Neu-Isenburg, Germany
Lisa A. Newman
Melissa L. Pilewskie
Fiorita Poulakaki
Breast Surgery Department, Athens Medical Centre, Athens, Greece
Fabian Riedel
Department of Obstetrics and Gynecology, Heidelberg University Hospital, Heidelberg, Germany
Nicola Rocco
Freya R. Schnabel
Christopher Schwartz
Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY
Emily L. Siegel
Department of Surgery, University of Southern California, Los Angeles, CA
Colin Simonson
Christian Singer
Leonardo Ribeiro Soares
CORA - Advanced Center for Diagnosis of Breast Cancer, Federal University of Goias, Goiania, Goias, Brazil
Ekaterini Christina Tampaki
Athanasios Tampakis
Marios Konstantinos Tasoulis
Christoph Tausch
Cicero Urban
Nossa Senhora das Graças Hospital and Centro de Doenças da Mama Oncoplastic Academy, Curitiba, Brazil
Astrid Botty Van den Bruele
Glenn Vergauwen
Denise Vorburger
Fredrik Wärnberg
Anna Weiss
Austin D. Williams
Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA
Kerstin Wimmer
Steven G. Woodward
Firdos M. Ziauddin