Giacomo Montagna, Alison Laws, Massimo Ferrucci, Mary M Mrdutt, Susie X Sun, Suleyman Bademler, Hakan Balbaloglu, Nora Balint-Lahat, Maggie Banys-Paluchowski, Andrea V Barrio, John Benson, Nuran Bese, Judy C Boughey, Marissa K Boyle, Emilia J Diego, Claire Eden, Ruth Eller, Maite Goldschmidt, Callie Hlavin, Martin Heidinger, Justyna Jelinska, Güldeniz Karadeniz Cakmak, Susan B Kesmodel, Tari A King, Henry M Kuerer, Julie Loesch, Francesco Milardi, Dawid Murawa, Tracy-Ann Moo, Tehillah S Menes, Daniele Passeri, Jessica M Pastoriza, Andraz Perhavec, Nina Pislar, Natália Polidorio, Avina Rami, Jai Min Ryu, Alexandra Schulz, Varadan Sevilimedu, M Umit Ugurlu, Cihan Uras, Annemiek van Hemert, Stephanie M Wong, Tae-Kyung Robyn Yoo, Jennifer Q Zhang, Hasan Karanlik, Neslihan Cabioğlu, Marie-Jeanne Vrancken Peeters, Monica Morrow, Walter P Weber
{"title":"新辅助化疗后残留孤立肿瘤细胞（ypN0i+）患者的结节负荷和肿瘤学预后：OPBC-05/ICARO 研究。","authors":"Giacomo Montagna, Alison Laws, Massimo Ferrucci, Mary M Mrdutt, Susie X Sun, Suleyman Bademler, Hakan Balbaloglu, Nora Balint-Lahat, Maggie Banys-Paluchowski, Andrea V Barrio, John Benson, Nuran Bese, Judy C Boughey, Marissa K Boyle, Emilia J Diego, Claire Eden, Ruth Eller, Maite Goldschmidt, Callie Hlavin, Martin Heidinger, Justyna Jelinska, Güldeniz Karadeniz Cakmak, Susan B Kesmodel, Tari A King, Henry M Kuerer, Julie Loesch, Francesco Milardi, Dawid Murawa, Tracy-Ann Moo, Tehillah S Menes, Daniele Passeri, Jessica M Pastoriza, Andraz Perhavec, Nina Pislar, Natália Polidorio, Avina Rami, Jai Min Ryu, Alexandra Schulz, Varadan Sevilimedu, M Umit Ugurlu, Cihan Uras, Annemiek van Hemert, Stephanie M Wong, Tae-Kyung Robyn Yoo, Jennifer Q Zhang, Hasan Karanlik, Neslihan Cabioğlu, Marie-Jeanne Vrancken Peeters, Monica Morrow, Walter P Weber","doi":"10.1200/JCO.24.01052","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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% <i>v</i> 7%, <i>P</i> < .001), have ITCs detected on frozen section (62% <i>v</i> 8%, <i>P</i> < .001), have lymphovascular invasion (38% <i>v</i> 24%, <i>P</i> < .001), and receive adjuvant chest wall (89% <i>v</i> 78%, <i>P</i> = .024) and nodal radiation (82% <i>v</i> 75%, <i>P</i> = .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.</p><p><strong>Conclusion: </strong>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+).</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401052"},"PeriodicalIF":42.1000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study.\",\"authors\":\"Giacomo Montagna, Alison Laws, Massimo Ferrucci, Mary M Mrdutt, Susie X Sun, Suleyman Bademler, Hakan Balbaloglu, Nora Balint-Lahat, Maggie Banys-Paluchowski, Andrea V Barrio, John Benson, Nuran Bese, Judy C Boughey, Marissa K Boyle, Emilia J Diego, Claire Eden, Ruth Eller, Maite Goldschmidt, Callie Hlavin, Martin Heidinger, Justyna Jelinska, Güldeniz Karadeniz Cakmak, Susan B Kesmodel, Tari A King, Henry M Kuerer, Julie Loesch, Francesco Milardi, Dawid Murawa, Tracy-Ann Moo, Tehillah S Menes, Daniele Passeri, Jessica M Pastoriza, Andraz Perhavec, Nina Pislar, Natália Polidorio, Avina Rami, Jai Min Ryu, Alexandra Schulz, Varadan Sevilimedu, M Umit Ugurlu, Cihan Uras, Annemiek van Hemert, Stephanie M Wong, Tae-Kyung Robyn Yoo, Jennifer Q Zhang, Hasan Karanlik, Neslihan Cabioğlu, Marie-Jeanne Vrancken Peeters, Monica Morrow, Walter P Weber\",\"doi\":\"10.1200/JCO.24.01052\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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% <i>v</i> 7%, <i>P</i> < .001), have ITCs detected on frozen section (62% <i>v</i> 8%, <i>P</i> < .001), have lymphovascular invasion (38% <i>v</i> 24%, <i>P</i> < .001), and receive adjuvant chest wall (89% <i>v</i> 78%, <i>P</i> = .024) and nodal radiation (82% <i>v</i> 75%, <i>P</i> = .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.</p><p><strong>Conclusion: </strong>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+).</p>\",\"PeriodicalId\":15384,\"journal\":{\"name\":\"Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"JCO2401052\"},\"PeriodicalIF\":42.1000,\"publicationDate\":\"2024-11-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/JCO.24.01052\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/JCO.24.01052","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study.
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+).
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The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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