BMJ oncologyPub Date : 2024-07-01DOI: 10.1136/bmjonc-2024-000369
Medhavi Gupta, O. Akhtar, B. Bahl, Angel Mier-Hicks, Kristopher Attwood, Kayla Catalfamo, B. Gyawali, P. Torka
{"title":"Health-related quality of life outcomes reporting associated with FDA approvals in haematology and oncology","authors":"Medhavi Gupta, O. Akhtar, B. Bahl, Angel Mier-Hicks, Kristopher Attwood, Kayla Catalfamo, B. Gyawali, P. Torka","doi":"10.1136/bmjonc-2024-000369","DOIUrl":"https://doi.org/10.1136/bmjonc-2024-000369","url":null,"abstract":"Health-related quality of life (HRQoL) outcomes are important in making clinical and policy decisions. This study aimed to examine the HRQoL reporting in cancer drug trials leading to Food and Drug Administration (FDA) approvals.This retrospective cohort study analysed HRQoL data for trials leading to FDA approvals between July 2015 and May 2020. Proportion of included trials that reported HRQoL, latency between FDA approval and first report of HRQoL data, HRQoL outcomes, and their correlation with OS (overall survival) and PFS (progression-free survival) were analysed.Of the 233 trials associated with 207 FDA approvals, HRQoL was reported in 50% of trials, of which only 42% had the data reported by the time of FDA approval. There were no changes in frequency of HRQoL reporting between 2015 and 2020. HRQoL data were first reported in the primary publication in only 30% trials. Of the 115 trials with HRQoL data available, HRQoL improved in 43%, remained stable in 53% and worsened in 4% of trials. Among the trials that led to FDA approvals based on surrogate endpoints (79%), HRQoL was reported in 45% and improved only in 18% trials. There was no association between OS and PFS benefit and HRQoL outcomes.Rates of HRQoL reporting were suboptimal in trials that led to FDA approvals with no improvements seen between 2015 and 2020. HRQoL reporting was often delayed and not presented in the primary publication. HRQoL reporting was further sparse in trials with approvals based on surrogate endpoints and HRQoL improved in only a minority of them.","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141696332","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}
BMJ oncologyPub Date : 2024-07-01DOI: 10.1136/bmjonc-2024-000395
Maarten Cuypers, Deborah Cairns, Kathryn A. Robb
{"title":"Research priorities to improve cancer care for people with intellectual disabilities across the cancer continuum","authors":"Maarten Cuypers, Deborah Cairns, Kathryn A. Robb","doi":"10.1136/bmjonc-2024-000395","DOIUrl":"https://doi.org/10.1136/bmjonc-2024-000395","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141706110","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}
BMJ oncologyPub Date : 2024-07-01DOI: 10.1136/bmjonc-2023-000264
Z. Kaplan, Nikki van Leeuwen, David van Klaveren, Otto Visser, E. Posthuma, D. van Lammeren-Venema, T. Snijders, C. Van Elssen, A. van Rhenen, Peter A von dem Borne, N. Blijlevens, Jan J Cornelissen, M. H. Raaijmakers, A. A. van de Loosdrecht, G. Huls, V. E. Lemmens, H. Lingsma, A. Dinmohamed
{"title":"Regional disparities in the use of intensive chemotherapy for AML in the Netherlands: does it influence survival?","authors":"Z. Kaplan, Nikki van Leeuwen, David van Klaveren, Otto Visser, E. Posthuma, D. van Lammeren-Venema, T. Snijders, C. Van Elssen, A. van Rhenen, Peter A von dem Borne, N. Blijlevens, Jan J Cornelissen, M. H. Raaijmakers, A. A. van de Loosdrecht, G. Huls, V. E. Lemmens, H. Lingsma, A. Dinmohamed","doi":"10.1136/bmjonc-2023-000264","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000264","url":null,"abstract":"Acute myeloid leukaemia (AML) prognosis is enhanced with intensive remission induction chemotherapy (ICT) in eligible patients. However, ICT eligibility perceptions may differ among healthcare professionals. This nationwide, population-based study aimed to explore regional variation in ICT application and its relation with overall survival (OS).We compared nine Dutch regional networks using data from the Netherlands Cancer Registry. Regional variance was assessed for the entire population and age subgroups (ie, ≤60 years and >60 years) using multivariable mixed effects logistic and Cox proportional hazard regression analyses, expressed via median OR (MOR) and median HR (MHR).Including all adult AML patients from 2014 to 2018 (N=4060 patients; 58% males; median age, 70 years), 1761 (43%) received ICT. ICT application varied from 36% to 57% (MOR 1.36 (95% CI 1.11 to 1.58)) across regions, with minor variations for patients aged ≤60 years (MOR 1.16 (95% CI 1.00 to 1.40)) and more extensive differences for those aged >60 years (MOR 1.43 (95% CI 1.16 to 1.63)). Median OS spanned 4.9–8.4 months across regions (MHR 1.11 (95% CI 1.00 to 1.15)), with pronounced differences in older patients (MHR 1.12 (95% CI 1.08 to 1.20)) but negligible differences in the younger group (MHR 1.02 (95% CI 1.00 to 1.14)). Survival differences for the total population and the older patients decreased to respectively, MHR 1.09 (95% CI 1.00 to 1.13) and 1.10 (95% CI 1.04 to 1.18), after additional adjustment for the probability of receiving ICT within a region, indicating approximately 10% unexplained differences.Regional disparities in ICT application and survival exist, especially in older AML patients. However, ICT application differences partially explain survival disparities, indicating the need for more standardised ICT eligibility criteria and a better understanding of underlying causes of outcome disparities.","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141706001","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}
BMJ oncologyPub Date : 2024-07-01DOI: 10.1136/bmjonc-2024-000480
C. Orvain
{"title":"Does the regional use of intensive chemotherapy impact the outcome of adults with AML?","authors":"C. Orvain","doi":"10.1136/bmjonc-2024-000480","DOIUrl":"https://doi.org/10.1136/bmjonc-2024-000480","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141703920","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}
BMJ oncologyPub Date : 2024-07-01DOI: 10.1136/bmjonc-2024-000481
Kosuke Takemura, Daniel Y C Heng
{"title":"Potential of neutrophil-to-eosinophil ratio as a new prognostic tool for patients with advanced renal cell carcinoma receiving first-line immuno-oncology combinations","authors":"Kosuke Takemura, Daniel Y C Heng","doi":"10.1136/bmjonc-2024-000481","DOIUrl":"https://doi.org/10.1136/bmjonc-2024-000481","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141700368","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}
BMJ oncologyPub Date : 2024-07-01DOI: 10.1136/bmjonc-2024-000406
M. Di Maio
{"title":"Availability of quality-of-life results for clinical decisions: an evolving scenario","authors":"M. Di Maio","doi":"10.1136/bmjonc-2024-000406","DOIUrl":"https://doi.org/10.1136/bmjonc-2024-000406","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141710159","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}
BMJ oncologyPub Date : 2024-05-01DOI: 10.1136/bmjonc-2023-000172
D. Lombe, M. Mwamba, M. Simwinga, Virginia Bond, A. Ssemata, R. Muhumuza, Janet Seeley, K. Lishimpi, Victor Mapulanga, John Kachimba, Ajay Aggarwal, S. Msadabwe
{"title":"Defining national research priorities for prostate cancer in Zambia: using the Delphi process for comprehensive cancer policy setting in sub-Saharan Africa","authors":"D. Lombe, M. Mwamba, M. Simwinga, Virginia Bond, A. Ssemata, R. Muhumuza, Janet Seeley, K. Lishimpi, Victor Mapulanga, John Kachimba, Ajay Aggarwal, S. Msadabwe","doi":"10.1136/bmjonc-2023-000172","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000172","url":null,"abstract":"Locally led research on cancer is needed in sub-Saharan Africa to set feasible research priorities that inform national policy. The aim of this project was to develop a research agenda for national cancer control planning, using a nationally driven approach, focused on barriers to diagnosis and high-quality treatment for prostate cancer in Zambia.This was a Delphi process. 29 stakeholders were scored barriers on feasibility, the proportion of patients affected, the impact on patient outcomes and if there was a potential to address health systems barriers meaningfully. There were three rounds (R) to the process: (R1 and R2) by electronic survey and (R3) in-person meeting. In R1 statements scoring above 15 from over 70% of participants were prioritised immediately for R3 discussion. Those scoring below 30% were dropped and those in between were re-surveyed in R2.22 and 17 of the 29 stakeholders responded to R1 and R2. 14 stakeholders attended R3. National priority research areas for prostate cancer in Zambia were identified as prostate cancer awareness; building affordable high-quality diagnostic capacity; affordability of specialist cancer treatments; supporting better access to medicines; delivery and coordination of services across the pathway and staff training.The suggested seven priority areas allow for the development of the prostate cancer control programme to be conducted in a holistic manner. The expectation is with this guidance international partners can contribute within the frameworks of the local agenda for sustainable development to be realised.","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141032699","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}
BMJ oncologyPub Date : 2024-05-01DOI: 10.1136/bmjonc-2024-000448
Keith Langmack
{"title":"Does the evidence exist for the deployment of AI in cancer therapies?","authors":"Keith Langmack","doi":"10.1136/bmjonc-2024-000448","DOIUrl":"https://doi.org/10.1136/bmjonc-2024-000448","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141030144","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}
BMJ oncologyPub Date : 2024-05-01DOI: 10.1136/bmjonc-2024-000405
Kurt G Tournoy
{"title":"Careful take-off by the EQ-5D-5L tool in lung cancer: fly little one, fly!","authors":"Kurt G Tournoy","doi":"10.1136/bmjonc-2024-000405","DOIUrl":"https://doi.org/10.1136/bmjonc-2024-000405","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141039157","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}
BMJ oncologyPub Date : 2024-05-01DOI: 10.1136/bmjonc-2023-000255
Sheba Macheka, Peng Yun Ng, Ophira Ginsburg, Andrew Hope, Richard Sullivan, Ajay Aggarwal
{"title":"Prospective evaluation of artificial intelligence (AI) applications for use in cancer pathways following diagnosis: a systematic review","authors":"Sheba Macheka, Peng Yun Ng, Ophira Ginsburg, Andrew Hope, Richard Sullivan, Ajay Aggarwal","doi":"10.1136/bmjonc-2023-000255","DOIUrl":"https://doi.org/10.1136/bmjonc-2023-000255","url":null,"abstract":"The role of artificial intelligence (AI) in cancer care has evolved in the face of ageing population, workforce shortages and technological advancement. Despite recent uptake in AI research and adoption, the extent to which it improves quality, efficiency and equity of care beyond cancer diagnostics is uncertain to date. Henceforth, the objective of our systematic review is to assess the clinical readiness and deployability of AI through evaluation of prospective studies of AI in cancer care following diagnosis.We undertook a systematic review to determine the types of AI involved and their respective outcomes. A PubMed and Web of Science search between 1 January 2013 and 1 May 2023 identified 15 articles detailing prospective evaluation of AI in postdiagnostic cancer pathway. We appraised all studies using Risk of Bias Assessment of Randomised Controlled Trials and Risk of Bias In Non-randomised Studies-of Interventions quality assessment tools, as well as implementational analysis concerning time, cost and resource, to ascertain the quality of clinical evidence and real-world feasibility of AI.The results revealed that the majority of AI oncological research remained experimental without prospective clinical validation or deployment. Most studies failed to establish clinical validity and to translate measured AI efficacy into beneficial clinical outcomes. AI research are limited by lack of research standardisation and health system interoperability. Furthermore, implementational analysis and equity considerations of AI were largely missing.To overcome the triad of low-level clinical evidence, efficacy-outcome gap and incompatible research ecosystem for AI, future work should focus on multicollaborative AI implementation research designed and conducted in accordance with up-to-date research standards and local health systems.","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141026059","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}