The Lancet Oncology最新文献

{"title":"WHO reports health service disruptions due to suspensions of aid","authors":"Sharmila Devi","doi":"10.1016/s1470-2045(25)00235-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00235-9","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"75 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143846503","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":"Experts aim to boost gynaecological cancer research in Australia and beyond","authors":"Tony Kirby","doi":"10.1016/s1470-2045(24)00714-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00714-9","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"136 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143846564","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":"US National Firefighter Registry for Cancer shuts down amid layoffs","authors":"Karl Gruber","doi":"10.1016/s1470-2045(25)00234-7","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00234-7","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143846499","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":"Circulating tumour DNA and melanoma: time to take the leap?","authors":"Saskia M Wilting, Astrid AM van der Veldt","doi":"10.1016/s1470-2045(25)00195-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00195-0","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"114 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836917","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":"Clinical validation of droplet digital PCR assays in detecting BRAFV600-mutant circulating tumour DNA as a prognostic biomarker in patients with resected stage III melanoma receiving adjuvant therapy (COMBI-AD): a biomarker analysis from a double-blind, randomised phase 3 trial","authors":"Mahrukh M Syeda, Georgina V Long, James Garrett, Victoria Atkinson, Mario Santinami, Dirk Schadendorf, Axel Hauschild, Michael Millward, Mario Mandala, Vanna Chiarion-Sileni, Michael Smylie, Georgy M Manikhas, Reinhard Dummer, Jennifer M Wiggins, Saim Ali, Sachin Bajirao Adnaik, Monique Tan, Maya Dajee, David Polsky","doi":"10.1016/s1470-2045(25)00139-1","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00139-1","url":null,"abstract":"<h3>Background</h3>Cell-free, circulating tumour DNA (ctDNA) is an established measure of minimal residual disease; however, it is not utilised in melanoma management. We investigated whether ctDNA measurements could predict survival outcomes during adjuvant targeted therapy or placebo treatment in stage III melanoma, thereby identifying patients at high risk and low risk of recurrence.<h3>Methods</h3>Analytically validated mutation-specific droplet digital PCR assays were used to measure <em>BRAF</em><sup>V600E</sup> or <em>BRAF</em><sup>V600K</sup> ctDNA in patients aged 18 years or older who were enrolled in the COMBI-AD trial, which was a double-blind, randomised, phase 3 study of oral dabrafenib (150 mg twice daily) plus oral trametinib (2 mg once daily) combination therapy versus two matched placebos in resected <em>BRAF</em><sup>V600</sup>-mutant stage III melanoma. Patients were screened for enrolment between Jan 31, 2013, and Dec 11, 2014, had an Eastern Cooperative Oncology Group performance status of 0 or 1, and were randomly assigned (1:1) to the two treatment groups. The primary endpoint was recurrence-free survival, and the results from final analysis have been previously published and will not be described here. Biomarker analysis was a prespecified exploratory endpoint and performed in the intention-to-treat population. We compared associations between survival outcomes and baseline (post-resection) ctDNA copies per mL, tumour mutational burden and interferon gamma (<em>IFNG</em>) gene expression. In a subset of patients, ctDNA quantities during follow-up or at recurrence were measured. The trial 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>NCT01682083</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>Baseline plasma samples were available for 597 of 870 patients (331 male patients and 266 female patients) and samples for assessing the ctDNA positivity rate at landmark follow-up timepoints of 3 months, 6 months, 9 months, and 12 months after treatment initiation were available for 94 of 870 patients. Additionally, samples were available from 118 of 870 patients within a 2-month timeframe before or after clinical or radiographic recurrence. Median follow-up for the biomarker analyses was 60 months (IQR 39–66) in the combination therapy group and 58 months (21–66) for the placebo group. ctDNA was detectable in 79 (13%) of 597 baseline samples. ctDNA positivity rate and mutant copies per mL plasma were significantly higher in patients with higher disease substages. As a binary variable, ctDNA detection was as","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"50 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836912","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":"Using patient-reported outcomes and health-related quality of life data in regulatory decisions on cancer treatment: highlights from an EMA-EORTC workshop","authors":"Madeline Pe, Caroline Voltz-Girolt, Jill Bell, Vishal Bhatnagar, Jan Bogaerts, Christopher Booth, Juan Garcia Burgos, Joseph C Cappelleri, Corneel Coens, Pierre Demolis, Harald Enzmann, Johannes M Giesinger, Alexandra Gilbert, Mogens Groenvold, Paul Kluetz, Claire Piccinin, Douwe Postmus, Chantal Quinten, Bettina Ryll, Maxime Sasseville, Peter Mol","doi":"10.1016/s1470-2045(25)00150-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00150-0","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Well-defined PRO research objectives</h2>A commonly shared view across various international stakeholders was that PROs intended to provide quantitative assessment of clinical outcomes should be treated like any other endpoint that is included in the evaluation of a cancer treatment. Thus, an important first step is to clearly describe the research questions that PROs can address to support the evaluation of cancer treatments. PROs are not an outcome but a way to measure an outcome; therefore, it is important to identify in the</section></section><section><section><h2>Role of submitted PRO data for decision making</h2>Further optimisation in the use of PROs is necessary to fully leverage the insights patient-generated data can provide.4, 5</section></section><section><section><h2>Support overall benefit–risk evaluation</h2>PROs can quantify symptoms and functional aspects of how patients experience and respond to their treatment and can complement traditional clinical endpoints such as overall survival, progression-free survival, and tumour response measures. PRO data can reflect treatment efficacy (ie, improvement in disease-related symptoms) or harms (ie, emergence of symptomatic adverse events and their impact on functioning). By incorporating these additional outcomes into clinical trials, a more holistic</section></section><section><section><h2>Further characterise tolerability</h2>One research objective that is relevant across early phase and late phase clinical cancer trials is to characterise safety and tolerability. It has been proposed that a complete understanding of tolerability should include direct measurement from the patient on how they are feeling and functioning when on treatment.<sup>6</sup> For example, patient-reported symptomatic adverse events can complement standard safety reporting by clinicians. Understanding treatment tolerability can help corroborate or refine</section></section><section><section><h2>Product information and label</h2>A common goal for commercial sponsors is to use PROs to support medicines' approval, labelling, or marketing claims of treatment benefit. However, methodological issues, PRO data quality (including high rates of missing data or asymmetric missing data), and the question of what makes a clinically relevant PRO result have often prevented their inclusion in the product label (eg, EU Summary of Product Characteristics).<sup>1</sup> Development of PRO standards to address these methodological issues is</section></section><section><section><h2>PROs, including HRQOL, are a crucial endpoint from the HTA's and payers' perspectives</h2>PROs can help assess the overall value of a new treatment by considering patient-reported experiences. A crucial consideration for HTA decisions is that the data can address questions on comparative effectiveness versus standard of care. In some health-care systems, PROs also inform cost–benefit considerations of alterna","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143832146","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":"Use of patient-reported outcomes to inform symptom and functional outcomes in cancer drug regulatory decisions: challenges and future directions","authors":"Francesco Pignatti, Peter Mol, Chantal Quinten, Douwe Postmus, Anja Schiel, Maxime Sasseville, Shun Tezuka, Vishal Bhatnagar, Paul Kluetz","doi":"10.1016/s1470-2045(25)00151-2","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00151-2","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143832277","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":"Living within our means: trouble ahead for England's cancer planning","authors":"Mark Lawler, Pat Price, Richard Sullivan","doi":"10.1016/s1470-2045(25)00202-5","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00202-5","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143832274","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":"Belzutifan for von Hippel-Lindau disease-associated renal cell carcinoma and other neoplasms (LITESPARK-004): 50 months follow-up from a single-arm, phase 2 study","authors":"Ramaprasad Srinivasan, Othon Iliopoulos, Kathryn E Beckermann, Vivek Narayan, Benjamin L Maughan, Stephane Oudard, Tobias Else, Jodi K Maranchie, Ane B Iversen, Jerry Cornell, Rodolfo F Perini, Yanfang Liu, W Marston Linehan, Eric Jonasch","doi":"10.1016/s1470-2045(25)00099-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00099-3","url":null,"abstract":"<h3>Background</h3>Hypoxia-inducible factor-2α inhibitor belzutifan is approved for von Hippel-Lindau disease-associated renal cell carcinoma, CNS haemangioblastomas, and pancreatic neuroendocrine tumours, based on previously published initial results from the LITESPARK-004 study. Updated results are presented here after a median follow-up of nearly 50 months.<h3>Methods</h3>In this single-arm, phase 2 study, participants were enrolled at 11 centres in Denmark, France, the UK, and the USA. Oral belzutifan 120 mg once daily was given to eligible adults aged 18 years or older with a diagnosis of von Hippel-Lindau disease (based on germline <em>VHL</em> alterations), at least one measurable renal cell carcinoma tumour, no tumour larger than 3 cm that necessitated immediate surgery, no metastatic disease, no previous systemic anticancer treatment, and an Eastern Cooperative Oncology Group performance status score of 0 or 1. The primary endpoint was the proportion of participants with an objective response in von Hippel-Lindau disease-associated renal cell carcinoma per Response Evaluation Criteria in Solid Tumours, version 1.1, determined by an independent review committee, and assessed in all participants who received at least one dose of belzutifan. This ongoing study is no longer recruiting and is registered at <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>NCT03401788</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>.<h3>Findings</h3>Between May 31, 2018, and Mar 29, 2019, 61 participants were enrolled; 36 (59%) were continuing treatment as of April 3, 2023. The median age of all enrolled participants was 41·0 years (IQR 29·0–51·0); 32 (52%) of 61 participants were male and 29 (48%) were female; most were White (n=55; 90%). Median study follow-up was 49·9 months (IQR 48·9–52·2). 41 (67%; 95% CI 54–79) of 61 participants with renal cell carcinoma had an objective response; seven (11%) had a complete response and 34 (56%) a partial response. 13 grade 3 treatment-related adverse events occurred in 11 (18%) participants (anaemia: seven [11%]; fatigue: three [5%]; urinary tract infection: one [2%]; hypoxia: one [2%]; and blister: one [2%]). None of the participants had a grade 4 or 5 treatment-related adverse event. Four (7%) participants had serious treatment-related adverse events (one participant each: anaemia, urinary tract infection, intracranial haemorrhage, and hypoxia).<h3>Interpretation</h3>Updated results support the use of belzutifan as systemic treatment for von Hippel-Lindau disease-associated renal cell carcinoma.<h3>Funding</h3>Merck Sharp & Dohme, a subsidiary of Merc","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"309 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822729","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":"Belzutifan in von Hippel-Lindau disease","authors":"Chiara Ciccarese, Roberto Iacovelli, Giampaolo Tortora","doi":"10.1016/s1470-2045(25)00153-6","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00153-6","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"75 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822733","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}