Frederick L Locke, Javier L Munoz, Michael T Tees, Lazaros J Lekakis, Sven de Vos, Rajneesh Nath, Don A Stevens, Shahbaz A Malik, Geoffrey P Shouse, Mehdi Hamadani, Olalekan O Oluwole, Miguel-Angel Perales, David B Miklos, Paul W Fisher, Amy Feng, Lynn Navale, John B Le Gall, Sattva S Neelapu
{"title":"Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies.","authors":"Frederick L Locke, Javier L Munoz, Michael T Tees, Lazaros J Lekakis, Sven de Vos, Rajneesh Nath, Don A Stevens, Shahbaz A Malik, Geoffrey P Shouse, Mehdi Hamadani, Olalekan O Oluwole, Miguel-Angel Perales, David B Miklos, Paul W Fisher, Amy Feng, Lynn Navale, John B Le Gall, Sattva S Neelapu","doi":"10.1200/JCO-24-01933","DOIUrl":"10.1200/JCO-24-01933","url":null,"abstract":"<p><strong>Purpose: </strong>Off-the-shelf, allogeneic CD19 chimeric antigen receptor (CAR) T-cell products may improve access to treatment versus autologous ones. We report the phase I experience of the allogeneic CD19 CAR T-cell product cemacabtagene ansegedleucel (cema-cel) and its predecessor, ALLO-501, in CD19 CAR T-naïve patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).</p><p><strong>Methods: </strong>In the ALPHA2/ALPHA studies, the safety and efficacy of allogeneic CD19 CAR T cells were evaluated in CD19 CAR T treatment-naïve patients with R/R LBCL. Patients received healthy donor-derived, human leukocyte antigen-unmatched cema-cel/ALLO-501 following a 3-day lymphodepletion regimen of fludarabine (30 mg/m<sup>2</sup> once daily), cyclophosphamide (300 or 500 mg/m<sup>2</sup> once daily), and escalating doses of the anti-CD52 monoclonal antibody, ALLO-647.</p><p><strong>Results: </strong>As of September 26, 2024, 33 CD19 CAR T-naïve patients with LBCL (median age, 66 years; median number of previous therapies, 3) received allogeneic CAR T cells. CAR T-cell expansion was observed following infusion, with persistence observed up to 4 months. The overall and complete response (CR) rates were 58% and 42%, respectively; the median duration of response in patients with a CR was 23.1 months. The most common treatment-emergent adverse events were hematologic toxicities. No cases of graft-versus-host disease, immune effector cell-associated neurotoxicity syndrome, or grade ≥3 cytokine release syndrome were reported.</p><p><strong>Conclusion: </strong>Allogeneic CD19 CAR T cells demonstrated promising overall and durable CR rates with a manageable safety profile in CD19 CAR T-naïve patients with R/R LBCL, supporting additional evaluation of cema-cel in patients with LBCL.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1695-1705"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12058369/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel P Petrylak, Raffaele Ratta, Nobuaki Matsubara, Ernesto Korbenfeld, Rustem Gafanov, Loic Mourey, Tilman Todenhöfer, Howard Gurney, Gero Kramer, Andries M Bergman, Pawel Zalewski, Maria De Santis, Andrew J Armstrong, Winald Gerritsen, Russell Pachynski, Seok Soo Byun, Margitta Retz, Eric Levesque, Ray McDermott, Sergio Bracarda, Ray Manneh, Meital Levartovsky, Xin Tong Li, Charles Schloss, Christian H Poehlein, Karim Fizazi
{"title":"Pembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial.","authors":"Daniel P Petrylak, Raffaele Ratta, Nobuaki Matsubara, Ernesto Korbenfeld, Rustem Gafanov, Loic Mourey, Tilman Todenhöfer, Howard Gurney, Gero Kramer, Andries M Bergman, Pawel Zalewski, Maria De Santis, Andrew J Armstrong, Winald Gerritsen, Russell Pachynski, Seok Soo Byun, Margitta Retz, Eric Levesque, Ray McDermott, Sergio Bracarda, Ray Manneh, Meital Levartovsky, Xin Tong Li, Charles Schloss, Christian H Poehlein, Karim Fizazi","doi":"10.1200/JCO-24-01283","DOIUrl":"10.1200/JCO-24-01283","url":null,"abstract":"<p><strong>Purpose: </strong>The standard of care for metastatic castration-resistant prostate cancer (mCRPC) after second-generation androgen receptor pathway inhibitor (ARPI) therapy is still docetaxel. The randomized, double-blind, phase III KEYNOTE-921 trial (Clinicaltrials.gov identifier: NCT03834506) evaluated the efficacy and safety of pembrolizumab or placebo plus docetaxel for previously treated mCRPC.</p><p><strong>Methods: </strong>Adults with mCRPC who progressed after androgen-deprivation therapy and one ARPI were randomly assigned 1:1 to pembrolizumab or placebo plus docetaxel with concomitant prednisone. Dual primary end points were radiographic progression-free survival (rPFS) by blinded independent central review per Prostate Cancer Working Group 3-modified RECIST 1.1 and overall survival (OS). Safety was a secondary end point.</p><p><strong>Results: </strong>Between May 30, 2019, and June 17, 2021, 515 participants were randomly assigned to pembrolizumab plus docetaxel and 515 to placebo plus docetaxel. Median time from random assignment to data cutoff date (June 20, 2022) at final analysis (FA) was 22.7 months (range, 12.1-36.7). At first interim analysis (data cutoff date: September 27, 2021), median rPFS was 8.6 months (95% CI, 8.3 to 10.2) with pembrolizumab plus docetaxel versus 8.3 months (95% CI, 8.2 to 8.5) with placebo plus docetaxel (hazard ratio [HR], 0.85 [95% CI, 0.71 to 1.01]; <i>P</i> = .03). At FA, median OS was 19.6 months (95% CI, 18.2 to 20.9) versus 19.0 months (95% CI, 17.9 to 20.9), respectively (HR, 0.92 [95% CI, 0.78 to 1.09]; <i>P</i> = .17). Grade ≥3 treatment-related adverse events occurred in 43.2% of participants who received pembrolizumab plus docetaxel and 36.6% of participants who received placebo plus docetaxel. Two and seven participants, respectively, died due to a treatment-related adverse event. Pneumonitis was the most common immune-mediated adverse event (7.0% <i>v</i> 3.1%).</p><p><strong>Conclusion: </strong>The addition of pembrolizumab to docetaxel did not significantly improve efficacy outcomes for participants with previously treated mCRPC. The current standard of care remains unchanged.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1638-1649"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12058370/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Where Is the Future of Adjuvant Therapy for Hepatocellular Carcinoma?","authors":"Yizhen Fu, Yaojun Zhang, Dandan Hu, Zhongguo Zhou, Li Xu, Minshan Chen","doi":"10.1200/JCO-24-02615","DOIUrl":"10.1200/JCO-24-02615","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1625-1630"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143501537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"They Not Like Us: Evaluating the Diverse Strategies in Locally Advanced Rectal Cancer Treatment.","authors":"Pratik Shah, Tony Philip","doi":"10.1200/JCO-24-02178","DOIUrl":"10.1200/JCO-24-02178","url":null,"abstract":"<p><p><i>The Oncology Grand Rounds series is designed to place original reports published in the</i> Journal <i>into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in</i> Journal of Clinical Oncology<i>, to patients seen in their own clinical practice</i>.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1620-1624"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Immune Checkpoint Combos in Metastatic Castration-Resistant Prostate Cancer: Where Are We Going, What Are We Doing, and Why?","authors":"Susan F Slovin","doi":"10.1200/JCO-24-02402","DOIUrl":"10.1200/JCO-24-02402","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1617-1619"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matteo Lambertini, Eva Blondeaux, Loredana M Tomasello, Elisa Agostinetto, Anne-Sophie Hamy, Hee Jeong Kim, Maria Alice Franzoi, Rinat Bernstein-Molho, Florentine Hilbers, Katarzyna Pogoda, Hans Wildiers, Jyoti Bajpai, Michail Ignatiadis, Halle C F Moore, Ann H Partridge, Kelly-Anne Phillips, Angela Toss, Christine Rousset-Jablonski, Carmen Criscitiello, Tiphaine Renaud, Alberta Ferrari, Shani Paluch-Shimon, Robert Fruscio, Wanda Cui, Stephanie M Wong, Claudio Vernieri, Kathryn J Ruddy, Maria Vittoria Dieci, Alexios Matikas, Mariya Rozenblit, Cynthia Villarreal-Garza, Laura De Marchis, Fabio Puglisi, Kenny A Rodriguez-Wallberg, Francois P Duhoux, Luca Livraghi, Marco Bruzzone, Luca Boni, Judith Balmaña
{"title":"Clinical Behavior of Breast Cancer in Young <i>BRCA</i> Carriers and Prediagnostic Awareness of Germline <i>BRCA</i> Status.","authors":"Matteo Lambertini, Eva Blondeaux, Loredana M Tomasello, Elisa Agostinetto, Anne-Sophie Hamy, Hee Jeong Kim, Maria Alice Franzoi, Rinat Bernstein-Molho, Florentine Hilbers, Katarzyna Pogoda, Hans Wildiers, Jyoti Bajpai, Michail Ignatiadis, Halle C F Moore, Ann H Partridge, Kelly-Anne Phillips, Angela Toss, Christine Rousset-Jablonski, Carmen Criscitiello, Tiphaine Renaud, Alberta Ferrari, Shani Paluch-Shimon, Robert Fruscio, Wanda Cui, Stephanie M Wong, Claudio Vernieri, Kathryn J Ruddy, Maria Vittoria Dieci, Alexios Matikas, Mariya Rozenblit, Cynthia Villarreal-Garza, Laura De Marchis, Fabio Puglisi, Kenny A Rodriguez-Wallberg, Francois P Duhoux, Luca Livraghi, Marco Bruzzone, Luca Boni, Judith Balmaña","doi":"10.1200/JCO-24-01334","DOIUrl":"10.1200/JCO-24-01334","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the clinical behavior of breast cancer in young <i>BRCA</i> carriers according to the specific <i>BRCA</i> gene (<i>BRCA1 v BRCA2</i>) and the association of the timing of genetic testing (before <i>v</i> at diagnosis) with prognosis.</p><p><strong>Methods: </strong>This was an international, multicenter, hospital-based, retrospective cohort study that included 4,752 patients harboring germline pathogenic/likely pathogenic variants (PVs) in <i>BRCA1</i> or <i>BRCA2</i>, who were diagnosed with stage I-III invasive breast cancer at 40 years or younger between January 2000 and December 2020 in 78 centers worldwide (ClinicalTrials.gov identifier: NCT03673306).</p><p><strong>Results: </strong>Compared with <i>BRCA2</i> carriers (n = 1,683), <i>BRCA1</i> carriers (n = 3,069) had more frequently hormone receptor-negative (74.4% <i>v</i> 15.5%) and high-grade (77.5% <i>v</i> 49.1%) tumors. Similar outcomes were observed in <i>BRCA1</i> and <i>BRCA2</i> carriers but with a different pattern and risk of disease-free survival events over time. Compared with patients tested for <i>BRCA</i> at diagnosis (ie, between 2 months before and up to 6 months after diagnosis; n = 1,671), those tested before diagnosis (ie, any time up to 2 months before diagnosis; n = 411) had smaller tumors (T1: 61.3% <i>v</i> 32.4%), less nodal involvement (N0: 65.9% <i>v</i> 50.8%), less frequently received chemotherapy (84.4% <i>v</i> 92.9%), and axillary dissection (37.5% <i>v</i> 47.4%). Patients tested before diagnosis had better overall survival (OS; unadjusted hazard ratio [HR], 0.61 [95% CI, 0.40 to 0.92]); however, this result lost statistical significance after adjustment for potential confounders including tumor stage (adjusted HR, 0.74 [95% CI, 0.47 to 1.15]).</p><p><strong>Conclusion: </strong>This global study provides evidence on the different clinical behavior of breast cancer in young <i>BRCA1</i> and <i>BRCA2</i> carriers. Identifying a <i>BRCA</i> PV in healthy individuals was associated with earlier-stage breast cancer diagnosis and lower treatment burden, as well as better unadjusted OS.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1706-1719"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12058366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura M Fernandez, Guilherme P São Julião, Carlos Cerdan-Santacruz, Andrew G Renehan, Geerard L Beets, Amjad Parvaiz, Jose Azevedo, Bruna B Vailati, Rodrigo O Perez
{"title":"Reply to: \"Risks of Organ Preservation in Rectal Cancer: Beyond Distant Metastases, Ultimate Local Failure Can Also Be a Problem,\" \"Organ Preservation in Rectal Cancer: Fear of Risks Versus the Risks of Fear,\" and \"Distant Metastases With Nonoperative Management in Rectal Cancer: Challenges in Defining Risk\".","authors":"Laura M Fernandez, Guilherme P São Julião, Carlos Cerdan-Santacruz, Andrew G Renehan, Geerard L Beets, Amjad Parvaiz, Jose Azevedo, Bruna B Vailati, Rodrigo O Perez","doi":"10.1200/JCO-25-00132","DOIUrl":"10.1200/JCO-25-00132","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1746-1748"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura M Fernandez, Guilherme P São Julião, Carlos Cerdan Santacruz, Andrew G Renehan, Oscar Cano-Valderrama, Geerard L Beets, Jose Azevedo, Blas F Lorente, Rocío S Rancaño, Sebastiano Biondo, Eloy Espin-Basany, Bruna B Vailati, Per J Nilsson, Anna Martling, Cornelis J H Van De Velde, Amjad Parvaiz, Angelita Habr-Gama, Rodrigo O Perez
{"title":"Risks of Organ Preservation in Rectal Cancer: Data From Two International Registries on Rectal Cancer.","authors":"Laura M Fernandez, Guilherme P São Julião, Carlos Cerdan Santacruz, Andrew G Renehan, Oscar Cano-Valderrama, Geerard L Beets, Jose Azevedo, Blas F Lorente, Rocío S Rancaño, Sebastiano Biondo, Eloy Espin-Basany, Bruna B Vailati, Per J Nilsson, Anna Martling, Cornelis J H Van De Velde, Amjad Parvaiz, Angelita Habr-Gama, Rodrigo O Perez","doi":"10.1200/JCO.24.00405","DOIUrl":"10.1200/JCO.24.00405","url":null,"abstract":"<p><strong>Purpose: </strong>Organ preservation has become an attractive alternative to surgery (total mesorectal excision [TME]) among patients with rectal cancer after neoadjuvant therapy who achieve a clinical complete response (cCR). Nearly 30% of these patients will develop local regrowth (LR). Although salvage resection is frequently feasible, there may be an increased risk for development of subsequent distant metastases (DM). The aim of this study is to compare the risk of DM between patients with LR after Watch and Wait (WW) and patients with near-complete pathologic response (nPCR) managed by TME at the time of reassessment of response.</p><p><strong>Methods: </strong>Data from patients enrolled in the International Watch & Wait Database (IWWD) with cCR managed by WW and subsequent LR were compared with patients managed by TME (with ≤10% cancer cells-nPCR) from the Spanish Rectal Cancer Project (VIKINGO project). The primary end point was DM-free survival at 3 years from decision to WW or TME. The secondary end point was possible risk factors associated with DM.</p><p><strong>Results: </strong>Five hundred and eight patients with LR were compared with 893 patients with near-complete response after TME. Overall, DM rate was significantly higher among LRs (22.8% <i>v</i> 10.2%; <i>P</i> ≤ .001). Independent risk factors for DM included LR (<i>v</i> TME at reassessment; <i>P</i> = .001), ypT3-4 status (<i>P</i> = .016), and ypN+ status (<i>P</i> = .001) at the time of surgery. 3-year DM-free survival was significantly worse for patients with LR (75% <i>v</i> 87%; <i>P</i> = .001). When stratified for pathologic stage, patients with LR did significantly worse through all stages (<i>P</i> ≤ .009).</p><p><strong>Conclusion: </strong>Patients with LR appear to have a higher risk for subsequent DM development than patients with nPCR managed by TME at restaging irrespective of final pathology. Leaving the primary undetectable tumor in situ until development of LR may result in worse oncologic outcomes.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1663-1672"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12058371/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142522041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ko Un Park, Mark R Somerfield, Nirupama Anne, Muriel Brackstone, Alison K Conlin, Henrique Lima Couto, Lynn T Dengel, Andrea Eisen, Brittany E Harvey, Jeffrey Hawley, Janice N Kim, Nwamaka Lasebikan, Elizabeth S McDonald, Deepti Pradhan, Samantha Shams, Raymond Mailhot Vega, Alastair M Thompson, Mylin A Torres
{"title":"Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer: ASCO Guideline Update.","authors":"Ko Un Park, Mark R Somerfield, Nirupama Anne, Muriel Brackstone, Alison K Conlin, Henrique Lima Couto, Lynn T Dengel, Andrea Eisen, Brittany E Harvey, Jeffrey Hawley, Janice N Kim, Nwamaka Lasebikan, Elizabeth S McDonald, Deepti Pradhan, Samantha Shams, Raymond Mailhot Vega, Alastair M Thompson, Mylin A Torres","doi":"10.1200/JCO-25-00099","DOIUrl":"https://doi.org/10.1200/JCO-25-00099","url":null,"abstract":"<p><strong>Purpose: </strong>To update the ASCO evidence-based recommendations on the use of sentinel lymph node biopsy (SLNB) in patients with early-stage breast cancer treated with initial surgery.</p><p><strong>Methods: </strong>ASCO convened an Expert Panel to develop updated recommendations based on a systematic literature review (January 2016-May 2024).</p><p><strong>Results: </strong>Eleven randomized clinical trials (14 publications), eight meta-analyses and/or systematic reviews, and one prospective cohort study met the inclusion criteria for this systematic review. Expert Panel members used available evidence and informal consensus to develop practice recommendations.</p><p><strong>Recommendations: </strong>Clinicians should not recommend routine SLNB in select patients who are postmenopausal and ≥50 years of age and with negative findings on preoperative axillary ultrasound for grade 1-2, small (≤2 cm), hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer and who undergo breast-conserving therapy. Clinicians may offer postmastectomy radiation (RT) with regional nodal irradiation (RNI) and omit axillary lymph node dissection (ALND) in patients with clinically node-negative invasive breast cancer ≤5 cm who receive mastectomy and have one to two positive sentinel nodes. Clinicians may offer SLNB in patients who have cT3-T4c or multicentric tumors (clinically node-negative) or ductal carcinoma in situ treated with mastectomy, and in patients who are obese, male, or pregnant, or who have had prior breast or axillary surgery. Clinicians should not recommend ALND for patients with early-stage breast cancer who do not have nodal metastases, and clinicians should not recommend ALND for patients with early-stage breast cancer who have one or two sentinel lymph node metastases and will receive breast-conserving surgery and whole-breast RT with or without RNI.Additional information is available at www.asco.org/breast-cancer-guidelines.This guideline has been endorsed by the American Society for Radiation Oncology (ASTRO).</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"43 14","pages":"1720-1741"},"PeriodicalIF":42.1,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}