{"title":"Rise and Fall of Neoadjuvant Carboplatin for Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.","authors":"Paolo Tarantino","doi":"10.1200/jco-25-02855","DOIUrl":"https://doi.org/10.1200/jco-25-02855","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"39 1","pages":"JCO2502855"},"PeriodicalIF":45.3,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146033566","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":"Windows of Opportunity in Breast Cancer: Learning More From Fewer Patients in a Shorter Time.","authors":"Susan G Hilsenbeck,Alastair M Thompson","doi":"10.1200/jco-25-02714","DOIUrl":"https://doi.org/10.1200/jco-25-02714","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"75 1","pages":"JCO2502714"},"PeriodicalIF":45.3,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146034049","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":"BR.31 Trial: Adjuvant Durvalumab as the Third Contender in Resected Non-Small Cell Lung Cancer.","authors":"Jordi Remon,Tina Cascone,Solange Peters","doi":"10.1200/jco-25-02696","DOIUrl":"https://doi.org/10.1200/jco-25-02696","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"8 1","pages":"JCO2502696"},"PeriodicalIF":45.3,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146021565","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}
Martin Wermke,Valentina Gambardella,Yasutoshi Kuboki,Enriqueta Felip,Miguel F Sanmamed,Olatunji B Alese,Cyrus M Sayehli,Edurne Arriola,Jürgen Wolf,Liza C Villaruz,Julia Bertulis,Matus Studeny,Mohamed Bouzaggou,Xiaoyan Fang,Daniel Morgensztern
{"title":"Reply to: Delta-Like Ligand 3 Expression Across Lung Neuroendocrine Subtypes: Interpreting Response in Small Cell Lung Cancer and Beyond.","authors":"Martin Wermke,Valentina Gambardella,Yasutoshi Kuboki,Enriqueta Felip,Miguel F Sanmamed,Olatunji B Alese,Cyrus M Sayehli,Edurne Arriola,Jürgen Wolf,Liza C Villaruz,Julia Bertulis,Matus Studeny,Mohamed Bouzaggou,Xiaoyan Fang,Daniel Morgensztern","doi":"10.1200/jco-25-02654","DOIUrl":"https://doi.org/10.1200/jco-25-02654","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"69 1","pages":"JCO2502654"},"PeriodicalIF":45.3,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146021567","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}
PURPOSEPatients with human papillomavirus (HPV)-positive oropharyngeal cancer (OPC) and advanced stage and/or significant smoking history are at higher risk of relapse. Induction immunotherapy before chemoradiation (CRT) may improve outcomes. This randomized phase II trial assessed the feasibility and safety of induction nivolumab before CRT in this high-risk population.METHODSEligible patients had HPV-positive OPC with either T4 and/or N2/N3 disease or a smoking history >10 pack-years. Patients were randomly assigned 1:2 to receive either standard CRT (70 Gy with cisplatin, control arm [CA], n = 20) or two infusions of nivolumab followed by CRT (experimental arm [EA], n = 41). The primary end point was the rate of patients who received full treatment in due time (FTDT), defined as (1) two nivolumab infusions on days 1 and 13-17, (2) CRT started between days 27-37 after the first nivolumab infusion, (3) no radiotherapy break ≥7 days, (4) >95% of theoretical/prescribed RT dose, and (5) cisplatin dose received ≥200 mg/m2. If two patients or less in the EA failed FTDT, the strategy would be considered feasible. Secondary end points included oncologic outcomes and toxicity.RESULTSBetween July 2019 and September 2021, 62 patients were randomly assigned. Median follow-up was 37.5 months. The primary end point was not met: four of 41 patients in EA received <200 mg/m2 cisplatin. Grade 4 to 5 acute adverse events occurred only in EA, in seven patients. The 2-year cumulative incidence (95% CI) of relapse was 7.3% (1.9 to 18.0) in EA versus 15.0% (3.6 to 34.0) in CA.CONCLUSIONInduction nivolumab before CRT did not meet the predefined feasibility threshold because of reduced cisplatin dosing after toxicity in 10% of patients. The relapse incidence was numerically lower in the EA but this finding is exploratory and requires confirmation.
目的人乳头瘤病毒（HPV）阳性口咽癌（OPC）晚期和/或有明显吸烟史的患者复发风险较高。放化疗前诱导免疫治疗（CRT）可能改善预后。这项随机II期试验评估了高危人群在CRT前使用诱导纳武单抗的可行性和安全性。方法hpv阳性OPC患者合并T4和/或N2/N3疾病或吸烟史≥10包年。患者按1:2随机分配，接受标准CRT （70 Gy顺铂，对照组[CA]， n = 20）或两次输注纳沃单抗后再接受CRT（实验组[EA]， n = 41）。主要终点是按时接受充分治疗的患者比率（FTDT），定义为(1)第1天和第13-17天两次纳武单抗输注，(2)第一次纳武单抗输注后27-37天开始CRT，(3)放疗无中断≥7天，(4)理论/处方RT剂量的95%，(5)顺铂剂量≥200mg /m2。如果EA中有两个或更少的患者FTDT失败，则认为该策略是可行的。次要终点包括肿瘤预后和毒性。结果在2019年7月至2021年9月期间，随机分配了62例患者。中位随访时间为37.5个月。主要终点未达到：41例EA患者中有4例接受了< 200mg /m2的顺铂治疗。4 - 5级急性不良事件仅发生在EA患者中，7例。EA组的2年累积复发发生率（95% CI）为7.3%(1.9 ~ 18.0)，而ca组为15.0%（3.6 ~ 34.0）。结论在CRT前诱导纳沃单抗未达到预先设定的可行性阈值，因为10%的患者毒性后顺铂剂量减少。EA的复发率在数字上较低，但这一发现是探索性的，需要证实。
{"title":"Induction Nivolumab Before Chemoradiation in High-Risk Human Papillomavirus-Driven Oropharynx Cancers: IMMUNEBOOST-HPV, a Multicenter Randomized Phase II Trial.","authors":"Haitham Mirghani,Anne Aupérin,Caroline Even,Alicia Larive,Jerome Fayette,Lionnel Geoffrois,Florian Clatot,Benoit Calderon,Yungan Tao,France Nguyen,Emmanuelle Fabiano,Sarah Kreps,Anne-Laure Gaultier,Francois Bidault,Julien Puech,Benjamin Morin,Lea Picavet,Eric Tartour,Aicha Ben Hariz,Michael Chevrot,Laure Monard,David Veyer,Cecile Badoual,Helene Péré,Pierre Blanchard","doi":"10.1200/jco-25-00835","DOIUrl":"https://doi.org/10.1200/jco-25-00835","url":null,"abstract":"PURPOSEPatients with human papillomavirus (HPV)-positive oropharyngeal cancer (OPC) and advanced stage and/or significant smoking history are at higher risk of relapse. Induction immunotherapy before chemoradiation (CRT) may improve outcomes. This randomized phase II trial assessed the feasibility and safety of induction nivolumab before CRT in this high-risk population.METHODSEligible patients had HPV-positive OPC with either T4 and/or N2/N3 disease or a smoking history >10 pack-years. Patients were randomly assigned 1:2 to receive either standard CRT (70 Gy with cisplatin, control arm [CA], n = 20) or two infusions of nivolumab followed by CRT (experimental arm [EA], n = 41). The primary end point was the rate of patients who received full treatment in due time (FTDT), defined as (1) two nivolumab infusions on days 1 and 13-17, (2) CRT started between days 27-37 after the first nivolumab infusion, (3) no radiotherapy break ≥7 days, (4) >95% of theoretical/prescribed RT dose, and (5) cisplatin dose received ≥200 mg/m2. If two patients or less in the EA failed FTDT, the strategy would be considered feasible. Secondary end points included oncologic outcomes and toxicity.RESULTSBetween July 2019 and September 2021, 62 patients were randomly assigned. Median follow-up was 37.5 months. The primary end point was not met: four of 41 patients in EA received <200 mg/m2 cisplatin. Grade 4 to 5 acute adverse events occurred only in EA, in seven patients. The 2-year cumulative incidence (95% CI) of relapse was 7.3% (1.9 to 18.0) in EA versus 15.0% (3.6 to 34.0) in CA.CONCLUSIONInduction nivolumab before CRT did not meet the predefined feasibility threshold because of reduced cisplatin dosing after toxicity in 10% of patients. The relapse incidence was numerically lower in the EA but this finding is exploratory and requires confirmation.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"57 1","pages":"JCO2500835"},"PeriodicalIF":45.3,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146021564","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":"Delta-Like Ligand 3 Expression Across Lung Neuroendocrine Subtypes: Interpreting Response in Small Cell Lung Cancer and Beyond.","authors":"Yitian Chen,Li Liu,Yang Ming,Ligang Chen","doi":"10.1200/jco-25-01894","DOIUrl":"https://doi.org/10.1200/jco-25-01894","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"31 1","pages":"JCO2501894"},"PeriodicalIF":45.3,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146021569","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}
Carmine Valenza,Nancy A Nixon,Winson Y Cheung,Sara M Tolaney
{"title":"Bridging the Gap: Advancing First-Line Therapy for Patients With Metastatic Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.","authors":"Carmine Valenza,Nancy A Nixon,Winson Y Cheung,Sara M Tolaney","doi":"10.1200/jco-25-02942","DOIUrl":"https://doi.org/10.1200/jco-25-02942","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"66 1","pages":"JCO2502942"},"PeriodicalIF":45.3,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146021563","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}
Maggie Banys-Paluchowski,Steffi Hartmann,Jana de Boniface,Oreste D Gentilini,Nina Ditsch,Elmar Stickeler,Guldeniz Karadeniz Cakmak,Michael Hauptmann,Jennifer Schroth,Marc Thill,Rosa di Micco,Markus Hahn,Dawid Murawa,Isabel T Rubio,David Pinto,Michalis Kontos,Laura Niinikoski,Maria Luisa Gasparri,Helidon Nina,Lia P Rebaza,Sarah Fröhlich,Esther Schmidt,Kristina Wihlfahrt,Tomasz Berger,Timo Basali,Franziska Ruf,Angelika Rief,Eduard-Alexandru Bonci,Florentia Peintinger,Ellen Schlichting,Hagigat Valiyeva Qanimat,Marian Vanhoeij,Geeta Kadayaprath,Lukas Dostalek,Ashutosh Kothari,Andraz Perhavec,Tsvetomir Ivanov,Douglas Zippel,Beata Adamczyk,Mauro Porpiglia,Günay M Gürleyik,Michael Untch,Michael P Lux,Katharina Jursik,Hans-Christian Kolberg,Toralf Reimer,Nikolas Tauber,Achim Rody,Zoltan Matrai,Natalia Krawczyk,Sarun Thongvitokomarn,Thorsten Kühn
PURPOSESurgical axillary staging in patients with node-positive breast cancer (BC) who converted to clinical node negativity through neoadjuvant chemotherapy (NACT) has changed significantly in recent years. Targeted axillary dissection (TAD) and target lymph node (TLN) biopsy (TLNB) became increasingly popular. However, data comparing marking techniques for the TLN are limited. Here, we evaluate marking techniques in the largest prospective cohort worldwide.MATERIALS AND METHODSAmong patients from the ongoing prospective multicenter AXSANA (EUBREAST-03) study who received TLN marking and TAD/TLNB, we evaluated different marking methods with respect to detection and removal rates and clinical performance.RESULTSUntil January 6, 2025, 6,129 patients from 26 countries were enrolled. Of these patients, 2,596 had ≥1 TLN marked before NACT and completed surgery; 13.3% of the patients had ≥4 suspicious nodes at diagnosis. Pre-NACT TLN marking used a clip in 2,003 patients (77.2%), magnetic seed in 287 (11.1%), carbon ink in 192 (7.4%), radar marker in 119 (4.6%), radioactive seed in 18 (0.7%), radiofrequency identification device (RFID) in 12 (0.5%), or other methods in two (0.1%). One TLN was marked in 2,427 patients (93.5%), two TLNs in 138 (5.3%), and ≥3 in 27 patients (1%). Targeted removal of the TLN was planned in 2,100 patients (80.9%; TAD in 2,076 [80.0%] and TLNB in 24 [0.9%]). The TLN was detected and removed by TAD/TLNB in 1,915 patients (91.2%). TLN detection rate was the highest in patients whose TLNs were marked pre-NACT with markers suitable for probe-guided detection (96.6%; radioactive seed: 100%, magnetic seed: 96.9%, radar marker: 96.1%, RFID: 90%), followed by carbon ink (94.9%) and clip (89.6%; P < .001).CONCLUSIONThis large prospective analysis of patients with initially clinically node-positive BC receiving NACT demonstrates that probe-guided detection markers used to mark metastatic nodes before NACT provide superior detection rates.
{"title":"Marking Techniques for Target Lymph Nodes in Node-Positive Breast Cancer Treated With Neoadjuvant Therapy in the AXSANA/EUBREAST-03/AGO-B-053 Study.","authors":"Maggie Banys-Paluchowski,Steffi Hartmann,Jana de Boniface,Oreste D Gentilini,Nina Ditsch,Elmar Stickeler,Guldeniz Karadeniz Cakmak,Michael Hauptmann,Jennifer Schroth,Marc Thill,Rosa di Micco,Markus Hahn,Dawid Murawa,Isabel T Rubio,David Pinto,Michalis Kontos,Laura Niinikoski,Maria Luisa Gasparri,Helidon Nina,Lia P Rebaza,Sarah Fröhlich,Esther Schmidt,Kristina Wihlfahrt,Tomasz Berger,Timo Basali,Franziska Ruf,Angelika Rief,Eduard-Alexandru Bonci,Florentia Peintinger,Ellen Schlichting,Hagigat Valiyeva Qanimat,Marian Vanhoeij,Geeta Kadayaprath,Lukas Dostalek,Ashutosh Kothari,Andraz Perhavec,Tsvetomir Ivanov,Douglas Zippel,Beata Adamczyk,Mauro Porpiglia,Günay M Gürleyik,Michael Untch,Michael P Lux,Katharina Jursik,Hans-Christian Kolberg,Toralf Reimer,Nikolas Tauber,Achim Rody,Zoltan Matrai,Natalia Krawczyk,Sarun Thongvitokomarn,Thorsten Kühn","doi":"10.1200/jco-25-01921","DOIUrl":"https://doi.org/10.1200/jco-25-01921","url":null,"abstract":"PURPOSESurgical axillary staging in patients with node-positive breast cancer (BC) who converted to clinical node negativity through neoadjuvant chemotherapy (NACT) has changed significantly in recent years. Targeted axillary dissection (TAD) and target lymph node (TLN) biopsy (TLNB) became increasingly popular. However, data comparing marking techniques for the TLN are limited. Here, we evaluate marking techniques in the largest prospective cohort worldwide.MATERIALS AND METHODSAmong patients from the ongoing prospective multicenter AXSANA (EUBREAST-03) study who received TLN marking and TAD/TLNB, we evaluated different marking methods with respect to detection and removal rates and clinical performance.RESULTSUntil January 6, 2025, 6,129 patients from 26 countries were enrolled. Of these patients, 2,596 had ≥1 TLN marked before NACT and completed surgery; 13.3% of the patients had ≥4 suspicious nodes at diagnosis. Pre-NACT TLN marking used a clip in 2,003 patients (77.2%), magnetic seed in 287 (11.1%), carbon ink in 192 (7.4%), radar marker in 119 (4.6%), radioactive seed in 18 (0.7%), radiofrequency identification device (RFID) in 12 (0.5%), or other methods in two (0.1%). One TLN was marked in 2,427 patients (93.5%), two TLNs in 138 (5.3%), and ≥3 in 27 patients (1%). Targeted removal of the TLN was planned in 2,100 patients (80.9%; TAD in 2,076 [80.0%] and TLNB in 24 [0.9%]). The TLN was detected and removed by TAD/TLNB in 1,915 patients (91.2%). TLN detection rate was the highest in patients whose TLNs were marked pre-NACT with markers suitable for probe-guided detection (96.6%; radioactive seed: 100%, magnetic seed: 96.9%, radar marker: 96.1%, RFID: 90%), followed by carbon ink (94.9%) and clip (89.6%; P < .001).CONCLUSIONThis large prospective analysis of patients with initially clinically node-positive BC receiving NACT demonstrates that probe-guided detection markers used to mark metastatic nodes before NACT provide superior detection rates.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"101 1","pages":"JCO2501921"},"PeriodicalIF":45.3,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146015358","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}
Amar H Kelkar,Gregory A Abel,Corey S Cutler,Stephanie J Lee,Robert J Soiffer
{"title":"Is It Time to Move Beyond Graft-Versus-Host Disease-Free, Relapse-Free Survival as a Primary End Point in Clinical Trials for Hematopoietic Cell Transplantation?","authors":"Amar H Kelkar,Gregory A Abel,Corey S Cutler,Stephanie J Lee,Robert J Soiffer","doi":"10.1200/jco-25-02130","DOIUrl":"https://doi.org/10.1200/jco-25-02130","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"58 1","pages":"JCO2502130"},"PeriodicalIF":45.3,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146015356","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":"Is Unmutated IgG1 a Wrong Choice for Therapeutic Antibodies Targeting Immune Checkpoints? Lessons From the Clinical Failures of the First Anti-TIGIT Antibodies.","authors":"Pierre Boulard,Hervé Watier,Marion Ferreira","doi":"10.1200/jco-25-01930","DOIUrl":"https://doi.org/10.1200/jco-25-01930","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"95 1","pages":"JCO2501930"},"PeriodicalIF":45.3,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146015361","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}
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