Marco Ferrari, Francesca Mularoni, Davide Smussi, Piergiorgio Gaudioso, Pierluigi Bonomo, Jeppe Friborg, Maria Grazia Ghi, Vincent Gregoire, Kevin Harrington, Keith Hunter, Roberto Maroldi, Rosemary Martino, Ricard Mesia, Giorgio Peretti, Amanda Psyrri, Antonio Schindler, Giovanni Succo, Petr Szturz, Isabel Vilaseca, Piero Nicolai, David Viros Porcuna
{"title":"International consensus on laryngeal preservation strategies in laryngeal and hypopharyngeal cancer","authors":"Marco Ferrari, Francesca Mularoni, Davide Smussi, Piergiorgio Gaudioso, Pierluigi Bonomo, Jeppe Friborg, Maria Grazia Ghi, Vincent Gregoire, Kevin Harrington, Keith Hunter, Roberto Maroldi, Rosemary Martino, Ricard Mesia, Giorgio Peretti, Amanda Psyrri, Antonio Schindler, Giovanni Succo, Petr Szturz, Isabel Vilaseca, Piero Nicolai, David Viros Porcuna","doi":"10.1016/s1470-2045(25)00020-8","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00020-8","url":null,"abstract":"This Policy Review summarises an expert Delphi consensus process on larynx-preservation treatments in patients affected by intermediate-to-advanced laryngeal or hypopharyngeal squamous cell carcinoma. The experts, who represented all perspectives involved in multidisciplinary management of these patients and included patient representatives, approved 137 consensus statements that cover several relevant areas in the field of larynx-preserving treatments. Statements are grouped in the following topics: granular indications for T2–T3 cancer, indications for T4a cancer, indications for salvage organ-preservation surgery after chemoradiation failure, laryngeal function at baseline, which comorbidities are contraindications and to what extent, organ preservation in older patients: selection criteria, post-treatment surveillance, prognostic and predictive factors, listening to the patient's preferences: tools and implementation, prehabilitation and rehabilitation protocols, and cost-effectiveness of different laryngeal preservation approaches. We present a high-level summary of the results of the consensus process, with detailed reference to the full list of statements and supporting literature.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"47 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Myung-Ju Ahn: battling sexism in medicine and supporting the next generation","authors":"Emma Wilkinson","doi":"10.1016/s1470-2045(25)00063-4","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00063-4","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ya Haddy Sallah, Vanessa F Bratti, Bahar Rafinejad-Farahani, Shalini Jayasekar Zurn, Sonali Johnson, André S Crestani, Maria I Dacoregio, Haris Majeed, Rouhi Fazelzad, Aliyah Pabani, Brooke E Wilson, Fernanda M Favorito, Fabio Ynoe de Moraes, Lillian Sung, Yehoda M Martei, Danielle Rodin
{"title":"Antimicrobial resistance in patients with haematological malignancies: a scoping review","authors":"Ya Haddy Sallah, Vanessa F Bratti, Bahar Rafinejad-Farahani, Shalini Jayasekar Zurn, Sonali Johnson, André S Crestani, Maria I Dacoregio, Haris Majeed, Rouhi Fazelzad, Aliyah Pabani, Brooke E Wilson, Fernanda M Favorito, Fabio Ynoe de Moraes, Lillian Sung, Yehoda M Martei, Danielle Rodin","doi":"10.1016/s1470-2045(25)00079-8","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00079-8","url":null,"abstract":"Antimicrobial resistance (AMR) is a substantial global health threat. Patients with haematological malignancies have an increased risk of AMR infection due to disease-related and treatment-related immunosuppression. This scoping review searched four bibliographic databases from Jan 1, 2000, to Dec 7, 2023, for publications on AMR bacterial infections in patients with haematological malignancies and identified 274 eligible articles. AMR prevalence data extraction focused on WHO bacterial priority pathogens. The prevalence of AMR bacterial infections from seven WHO priority pathogens in patients with haematological malignancies was 35% (95% CI 30–40; <em>I</em><sup>2</sup> 99·4%). The most frequent AMR infections reported were bloodstream infections, with the highest reported AMR pathogens in third-generation cephalosporin-resistant Enterobacterales (pooled prevalence rate 44% [95% CI 23–64; <em>I</em><sup>2</sup> 99·8%]), meticillin-resistant <em>Staphylococcus aureus</em> (43% [31–54; <em>I</em><sup>2</sup> 95·9%]), and vancomycin-resistant enterococci (41% [26–56; <em>I</em><sup>2</sup> 96·2%]). 53 (65%) of the 81 studies that reported mortality showed higher mortality rates associated with AMR infections. 168 (61%) studies were conducted in high-income countries, with no studies published from the WHO Africa region, revealing a substantial data gap from low-income and middle-income regions. Future efforts should prioritise standardised reporting measures, robust surveillance, antimicrobial stewardship, and well designed clinical trials, particularly in under-represented regions, to mitigate the effect of AMR on cancer care.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to Lancet Oncol 2025; 26: 609–19","authors":"","doi":"10.1016/s1470-2045(25)00204-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00204-9","url":null,"abstract":"<em>Bhamani A, Creamer A, Verghese P, et al. Low-dose CT for lung cancer screening in a high-risk population (SUMMIT): a prospective, longitudinal cohort study.</em> Lancet Oncol <em>2025; <strong>26:</strong> 609–19</em>—In this Article, Claire Levermore's affiliation should have been “University College London Hospitals NHS Foundation Trust, London, UK”. This correction has been made to the online version as of April 30, 2025, and the printed version is correct.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gauthier Bouche, Duncan Gilbert, Matteo Quartagno, Hakim-Moulay Dehbi, Sophie Merrick, Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, Richard Stephens, Mahesh Parmar, Ruth E Langley
{"title":"Determining the optimal use of approved drugs in oncology","authors":"Gauthier Bouche, Duncan Gilbert, Matteo Quartagno, Hakim-Moulay Dehbi, Sophie Merrick, Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, Richard Stephens, Mahesh Parmar, Ruth E Langley","doi":"10.1016/s1470-2045(25)00037-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00037-3","url":null,"abstract":"Optimising the use of approved drugs requires evidence from post-approval trials that investigate variations of their use. Determining optimal drug use goes beyond the dominant, academic effort to conduct trials to identify effective lower doses of new drugs. Other important therapeutic approaches that use either less, similar, or more drug than the standard dose need testing in clinical trials, to get the most out of these drugs. Trial objectives on survival outcomes vary greatly; some aim for superiority, others for equivalent exposure or non-inferiority. This Personal View aims to inform academic trialists in how to conceive and prioritise questions aimed at determining the optimal use of drugs, taking into account the perspectives of patients, clinicians, and trial funders, to maximise the chances of successful delivery and impact for patients globally.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Limitations in the meta-analysis of prostate radiotherapy-associated toxicity","authors":"Zongjian Liang, Kun Chen, Fa Sun","doi":"10.1016/s1470-2045(25)00092-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00092-0","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"42 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sherko Kuemmel, Monika Graeser, Peter Schmid, Mattea Reinisch, Friedrich Feuerhake, Valery Volk, Sorin Armeanu-Ebinger, Leon Schütz, Olga Kelemen, Christopher Schroeder, Stephan Ossowski, Katarzyna Jóźwiak, Athina Kostara, Iris Scheffen, Kerstin Lüdtke-Heckenkamp, Felix Hilpert, Angela Kentsch, Carsten Ziske, Reinhard Depenbusch, Michael Braun, Andreas Diel
{"title":"Chemotherapy-free neoadjuvant pembrolizumab combined with trastuzumab and pertuzumab in HER2-enriched early breast cancer (WSG-KEYRICHED-1): a single-arm, phase 2 trial","authors":"Sherko Kuemmel, Monika Graeser, Peter Schmid, Mattea Reinisch, Friedrich Feuerhake, Valery Volk, Sorin Armeanu-Ebinger, Leon Schütz, Olga Kelemen, Christopher Schroeder, Stephan Ossowski, Katarzyna Jóźwiak, Athina Kostara, Iris Scheffen, Kerstin Lüdtke-Heckenkamp, Felix Hilpert, Angela Kentsch, Carsten Ziske, Reinhard Depenbusch, Michael Braun, Andreas Diel","doi":"10.1016/s1470-2045(25)00097-x","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00097-x","url":null,"abstract":"<h3>Background</h3>Accumulating evidence indicates that about 30–40% of patients with HER2-positive early breast cancer might achieve excellent outcomes without chemotherapy. Therefore, we aimed to test the pathological complete response after the addition of pembrolizumab to dual anti-HER2 blockade and omission of chemotherapy in patients with HER2-enriched breast cancer.<h3>Methods</h3>WSG-KEYRICHED-1 was a single-arm, multicentre, open-label, hypothesis-generating phase 2 trial done at 15 breast cancer centres in Germany. Women aged 18 years and older, with previously untreated clinical stage T1c–T3, N0–N2, M0, primary unilateral early invasive breast cancer, and locally confirmed HER2 immunohistochemistry score 2+ or 3+ status, and hormone receptor-positive or receptor-negative status, were enrolled. Women with centrally confirmed HER2-enriched subtype by prediction analysis of microarrays 50 gene set (PAM50) and an Eastern Cooperative Oncology Group performance status of 0–1 were allocated to four cycles of intravenous pembrolizumab (200 mg every 3 weeks for 12 weeks), intravenous trastuzumab biosimilar ABP 980 (8 mg/kg loading dose, then 6 mg/kg every 3 weeks for 12 weeks), and intravenous pertuzumab (840 mg loading dose, then 420 mg every 3 weeks for 12 weeks). The primary outcome was the proportion of patients with a pathological complete response (defined as ypN0 or ypT0/is), assessed in the full analysis set, which included all patients who had at least one dose of trial treatment and had central tumour assessment within 3 weeks after the end of trial treatment. For the primary endpoint to be met, at least 52·2% of patients had to have a pathological complete response to support the hypothesis that the proportion of patients with pathological complete response after trial treatment would be higher than 40% with statistical significance. Safety was analysed in all patients who had at least one dose of trial treatment. The study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT03988036</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and has been completed.<h3>Findings</h3>Between Sept 2, 2020, and May 5, 2021, 48 women were enrolled, of whom four did not have surgery, and one had only a local pathological complete response assessment. Therefore, 43 patients with central pathological complete response assessment were included in the full analysis set. Median follow-up was 8·6 months (IQR 8·3–9·0). 20 (47%) of 43 patients had a pathological complete response by central assessment (lower bound of the one-sided 95% CI 33%), thus the null hypothesis (40% pa","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"47 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fábio Cardoso Borges, Winette T A van der Graaf, Robbe Saesen, Stefan Aebi, Ana E Amariutei, Justin Bekelman, Thierry Gorlia, Frank Hulstaert, Isabelle Huys, Paul Kluetz, Michael J Morris, Vijay Patil, Sheila A Prindiville, Richard L Schilsky, Andrew Thomson, Shaun Treweek, Michael Weller, Mira Zuidgeest, Valesca Retel, Denis Lacombe
{"title":"Defining the role of pragmatic clinical trials in cancer clinical research: outcomes of a collaborative workshop hosted by the European Organisation for Research and Treatment of Cancer","authors":"Fábio Cardoso Borges, Winette T A van der Graaf, Robbe Saesen, Stefan Aebi, Ana E Amariutei, Justin Bekelman, Thierry Gorlia, Frank Hulstaert, Isabelle Huys, Paul Kluetz, Michael J Morris, Vijay Patil, Sheila A Prindiville, Richard L Schilsky, Andrew Thomson, Shaun Treweek, Michael Weller, Mira Zuidgeest, Valesca Retel, Denis Lacombe","doi":"10.1016/s1470-2045(24)00756-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00756-3","url":null,"abstract":"Explanatory clinical trials, which focus on evaluating therapeutic efficacy under ideal circumstances, are crucial for learning about new therapeutic interventions; however, they also exhibit shortcomings. These include non-representative populations and frequent use of intermediate endpoints, leading to uncertainty about the applicability of study results to patients in the real-world. Moreover, these trials often do not address all clinically meaningful questions, highlighting the need for optimisation within the oncology research framework. Refinements can be partly achieved by incorporating more pragmatic elements into cancer clinical trials. At a virtual European Organisation for Research and Treatment of Cancer workshop, key stakeholders convened to discuss the methodological characteristics and value of pragmatic trials, which focus on evaluating effectiveness in routine clinical practice, and their capacity to address the efficacy–effectiveness gap. This Policy Review outlines and discusses some of the views and perspectives expressed on the role of pragmatic trials in the current framework and their ability to inform decision making, and the recommended priorities for enhancing pragmatism in cancer clinical research.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to Lancet Oncol 2021; 22: 1530–40","authors":"","doi":"10.1016/s1470-2045(25)00221-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00221-9","url":null,"abstract":"<em>Fennell DA, Ewings S, Ottensmeier C, et al. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial.</em> Lancet Oncol <em>2021; <strong>22:</strong> 1530–40</em>—The appendix of this Article has been corrected as of April 30, 2025.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Antimicrobial resistance: a problem across the cancer care continuum","authors":"William C Shropshire, Samuel A Shelburne","doi":"10.1016/s1470-2045(25)00155-x","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00155-x","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143893839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}