BMJ oncology最新文献

{"title":"Predictive biomarkers and specific immune responses of COVID-19 mRNA vaccine in patients with cancer: prospective results from the CACOV-VAC trial","authors":"L. Spehner, E. Orillard, A. Falcoz, Quentin Lepiller, A. Bouard, H. Almotlak, Stefano Kim, E. Curtit, G. Meynard, M. Jary, Charlee Nardin, K. Asgarov, S. Abdeljaoued, Ugo Chartral, V. Mougey, Myriam Ben Khelil, Morgane Lopez, Romain Loyon, D. Vernerey, O. Adotévi, Christophe Borg, L. Mansi, M. Kroemer","doi":"10.1136/bmjonc-2023-000054","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000054","url":null,"abstract":"Vaccinated patients with cancer in follow-up studies showed a high seropositivity rate but impaired antibody titres and T cell responses following mRNA vaccine against COVID-19. Besides clinical characteristics and the type of anticancer treatment before vaccination, the identification of patients susceptible to non-response following vaccination using immunological markers is worth to be investigated.All patients (n=138, solid cancers) were included in the CACOV-VAC Study comprising three cohorts ((neo)-adjuvant, metastatic and surveillance). Immune responses were assessed using, respectively, anti-receptor-binding domain (RBD) SARS-CoV-S-IgG assay and interferon-γ ELISpot assay 3 months following the prime vaccination dose. Immunophenotyping of T cells and immunosuppressive cells from peripheral blood was performed before the prime dose. The serological threshold 3563 AU/mL was used to discriminate non-responders or suboptimal responders versus responders.Most patients achieved seroconversion after receiving the two doses of vaccine (97.6%). The median serological level of anti-RBD SARS-CoV-S-IgG was equal to 3029 for patients at the metastatic stage. The patient’s age was the main demographic characteristic that influenced vaccine efficacy. Among the immunological parameters measured at baseline, lower TIGIT (T cell immunoreceptor with Ig and ITIM domains) expression on CD8 T cells was associated with a better vaccine immunogenicity both in terms of humoral and cellular immune responses.Despite a high seroconversion rate, median serological levels of patients with cancer, particularly elderly patients, were below the threshold equal to 3563 AU/mL considered as a humoral correlate of protection against SARS-CoV-2. Our findings suggest that the inhibitory receptor TIGIT might be an interesting predictive biomarker of COVID-19 vaccine immunogenicity and beyond in an anticancer vaccine context.ClinicalTrials.gov Registry (NCT04836793).","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"85 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139024188","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":"Endpoints for trials of adjuvant anticancer therapies","authors":"A. Pastorino, Alberto Sobrero, Paolo Bruzzi","doi":"10.1136/bmjonc-2023-000179","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000179","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"139 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139012963","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":"‘Godrevy Project’: virtual reality for symptom control and well-being in oncology and palliative care – a non-randomised pre-post interventional trial","authors":"Niall O Moon, Jemima R Henstridge-Blows, Eva A Sprecher, Elizabeth Thomas, Amy Byfield, John McGrane","doi":"10.1136/bmjonc-2023-000160","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000160","url":null,"abstract":"The ‘Godrevy Project’ is an interventional trial designed to determine the effectiveness of immersive virtual reality (VR) on the holistic symptom control and well-being in oncology and palliative care patients. The primary objective of this study was to determine whether VR changed the revised Edmonton Symptom and Assessment System (ESAS-r) score representing an effective improvement in symptom control and well-being.This study reports on 60 participants recruited from hospital inpatient oncology and palliative care lists, to participate in an unblinded, VR intervention. Participants were included aged >18 years with a diagnosis of cancer, receiving inpatient treatment of systemic anticancer therapy. Impact evaluation on symptoms was measured using the ESAS-r pre-VR and post-VR intervention. For ethical reasons, participants were not randomised.From the 60 inpatients recruited, 58 participants were included for analysis. Participants recruited were aged 19–84 years with female (58%) and male (42%) participation. The primary outcome of the study demonstrated significant improvement in ESAS-r scores for symptoms and well-being. Total ESAS-r scores showed an improvement of 42% compared with baseline, with well-being ESAS-r scores improving 51%. The most common side effect was drowsiness. There were no adverse events related to study participation.The ‘Godrevy Project’ successfully demonstrates the feasible, effective use of VR on symptom control and well-being in oncology and palliative care patients. This study demonstrates VR as an effective, patient controlled, non-pharmacological intervention without significant side effects. This interventional trial is well placed to support future research and improve clinical practice.NCT04821466.","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139024653","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":"Closing the gaps in recruitment and retention in cancer trials: sufficient evidence but poor implementation","authors":"Giulia Pellizzari","doi":"10.1136/bmjonc-2023-000195","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000195","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"1999 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139297353","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":"Boosting and broadening recruitment to UK cancer trials: towards a blueprint for action","authors":"V. Nanton, R. Bryan, Anne M Pope, Ana Hughes, Kieran Jefferson, James W F Catto, Allen Knight, J. Gallagher, H. Mintz, S. Pirrie, Wenyu Liu, A. Young, Prashant Patel, Nicholas D. James","doi":"10.1136/bmjonc-2023-000092","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000092","url":null,"abstract":"Recruitment and retention in cancer trials are long-standing issues, exacerbated by the COVID-19 pandemic. The UK National Institute of Health Research and leading clinicians have emphasised the urgency to achieve and surpass prepandemic levels of participation.Data from a recent UK trial demonstrated the impact of COVID-19 and highlighted factors that limited recruitment. In response to this worldwide problem, studies have identified strategies for remediation at the levels of funding, the research environment, study design and trial team-related aspects, yet evidence of progress is lacking.Equality, diversity and inclusivity have become central to UK health and social policy during the 2000s. The need for greater inclusivity in trials has become a particular concern for cancer researchers and funders in the UK and in the USA, in recognition of potential bias in results. In the UK trials, the lack of standardised recording of ethnicity data renders interpretation difficult and caution is required in comparisons with the USA.Recently, the focus of concern has shifted away from the impact of deprivation and low socioeconomic status on trial participation. Barriers created by these factors and their frequent intersection with ethnicity should not be overlooked.The UK has adopted an advisory approach to broadening recruitment, publishing policy documents, guidance and toolkits. In the USA, by contrast, action on inclusion is increasingly mandated. Within the UK paradigm, the cancer research community is strongly encouraged to adopt a coordinated approach towards standardised digital data collection and embed and evaluate innovative, cocreated, locally relevant strategies.","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139299708","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":"The English National Lynch Syndrome transformation project: an NHS Genomic Medicine Service Alliance (GMSA) programme","authors":"Kevin J Monahan, Neil Ryan, Laura Monje-Garcia, Ruth Armstrong, David N Church, Jackie Cook, Alaa Elghobashy, Fiona Lalloo, Sally Lane, Frank D McDermott, Tracie Miles, Steven A Hardy, Adele Tyson, Valerie Ya Wen Wang, Anna Kim, Simone Gelinas, Francesca Faravelli, Frances Elmslie, Adam C Shaw","doi":"10.1136/bmjonc-2023-000124","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000124","url":null,"abstract":"Objective In England, through the Genomic Medicine Service Alliances (GMSAs), a national transformation project aims to embed robust pathways to deliver universal Lynch syndrome (LS) testing for patients with colorectal and endometrial cancers. Prior to commencement of the project, there was evidence of variation and low testing levels in eligible patients which is consistent with other health systems; however, we believe this is amenable to systematic improvement with responsibility for testing delivery by local cancer teams supported by regional infrastructure. Methods and analysis A project team and national oversight group was formed in May 2021 with membership including 21×cancer alliances, 7×GMSAs, charities and other stakeholders who agreed key performance indicators. ‘LS champions’ within each cancer team were identified and surveyed. Workforce training focused on effective identification of eligible patients, overcoming barriers and mainstreamed constitutional genetic testing. Comprehensive pathway data analysis was performed in conjunction with the National Disease Registration Service. Results Survey and baseline testing data illustrated variation, and a disparity between practice and perception, in levels of testing. The main reported barriers related to funding streams and systematic approaches. Multifaceted training programmes were produced to support workforce development. Champions responsible for testing delivery were appointed in >95% of cancer teams. We identified >9000 historically diagnosed LS patients to support ascertainment for a nationally coordinated screening programme. Conclusion This ongoing transformational project is strongly supported by stakeholders in England. Significant quality improvement has been implemented, facilitating systematic delivery of universal testing for LS nationally and reduction in variation in care.","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"68 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136128193","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":"Is post-ablation neo-squamous epithelium genomically predisposed to malignant progression?","authors":"Emily L Black, Rebecca C Fitzgerald","doi":"10.1136/bmjonc-2023-000183","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000183","url":null,"abstract":"Radiofrequency ablation (RFA) is a frequently used treatment for dysplastic Barrett’s oesophagus or early oesophageal intramucosal carcinomas.[1 2][1] As a treatment, it is widely considered to be safe and effective at removing these aberrant lesions. The treated areas are re-populated with","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"2011 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136127974","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":"Nivolumab in salivary gland cancers: confronting the challenges of unlocking the therapeutic benefits of immunotherapy for rare diseases","authors":"Antoine Desilets, Alan L Ho","doi":"10.1136/bmjonc-2023-000214","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000214","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136153045","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":"Transforming the care of people with Lynch syndrome: a system-wide approach","authors":"John Burn","doi":"10.1136/bmjonc-2023-000211","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000211","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136153036","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":"NISCAHN: a phase II trial of nivolumab in patients with salivary gland carcinoma (Unicancer ORL-08)","authors":"Jérôme Fayette, Caroline Even, Laurence Digue, Lionnel Geoffrois, Fréderic Rolland, Didier Cupissol, Joel Guigay, Christophe Le Tourneau, Anne Françoise Dillies, Sylvie Zanetta, Laurence Bozec, Christian Borel, Sophie Couchon-Thaunat, Valérie Costes-Martineau, Anne Sudaka-Bahadoran, Isabelle Jallut, Florence Garic, Audrey Lardy-Cleaud, Sylvie Chabaud","doi":"10.1136/bmjonc-2023-000065","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000065","url":null,"abstract":"Objective Salivary gland cancers (SGC) are rare cancers with currently no standard treatment for recurrent/metastatic disease. Based on checkpoint inhibitors benefit in a broad range of tumours, NIvolumab in Salivary gland CArcinoma of the Head and Neck (NISCAHN) evaluated nivolumab efficacy in SGC. Methods and analysis In this phase II single-stage Fleming design, patients with SGC with a progressive disease progression within 6 months prior to entering the study, were divided into ACC (adenoid cytic carcinoma) and non-ACC. All received nivolumab for a maximum of 12 months. The primary endpoint was the non-progression rate at 6 months (NPR 6m ) according to Response Evaluation Criteria in Solid Tumors V.1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), tumour growth rate, safety and quality of life (health-related quality of life). Results 46 patients with ACC and 52 patients without ACC were enrolled over 1 year. Median follow-up was respectively 29.2 months and 16.9 months for patients with ACC and non-ACC. In the ACC cohort, with 15/45 patients non-progressive at 6 months, the primary endpoint was met (33.3%; 95% CI 21.8 to NE). Nivolumab failed to demonstrate efficacy in the non-ACC cohort (NPR 6m : 14.0%; 7/50 patients). ORR, PFS and OS were 8.7% (95% CI 2.4 to 20.8), 5.3 (95% CI 3.2 to 5.6) and 17.2 months (95% CI 12.5-NE) in the ACC cohort, and 3.8% (95% CI 0.5 to 13.2), 1.8 (95% CI 1.7 to 3.5) and 11.5 months (95% CI 7.5 to 14.8) in the non-ACC cohort. Nivolumab safety profile was consistent with previous reports. Conclusion Nivolumab has limited efficacy in SGC. Differential results were observed in the two cohorts. The primary endpoint was met in the ACC cohort and no new safety signals were identified. Trial registration number EudraCT number: 2016-001794-32/ NCT03132038 .","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136153311","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}