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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