BMJ oncologyPub Date : 2024-08-22eCollection Date: 2024-01-01DOI: 10.1136/bmjonc-2024-000559
Janet Helen Roberts
{"title":"Determining fracture risk in patients exposed to immune checkpoint inhibitors: the time is now.","authors":"Janet Helen Roberts","doi":"10.1136/bmjonc-2024-000559","DOIUrl":"10.1136/bmjonc-2024-000559","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000559"},"PeriodicalIF":0.0,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347677/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2024-08-22eCollection Date: 2024-01-01DOI: 10.1136/bmjonc-2024-000398
Carrie Ye, Bo Zhao, William D Leslie, Juan Ignacio Ruiz, Hui Zhao, Noha Abdel-Wahab, Maria E Suarez-Almazor
{"title":"Increase in major osteoporotic fractures after therapy with immune checkpoint inhibitors.","authors":"Carrie Ye, Bo Zhao, William D Leslie, Juan Ignacio Ruiz, Hui Zhao, Noha Abdel-Wahab, Maria E Suarez-Almazor","doi":"10.1136/bmjonc-2024-000398","DOIUrl":"10.1136/bmjonc-2024-000398","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) can cause severe and sometimes long-standing immune-related adverse events (irAEs). Enhanced immune activation from ICI can theoretically result in osteoclast activation, bone loss and fracture. The objective of this study was to evaluate the incidence rates of major osteoporotic fractures (MOFs) in patients with melanoma treated with ICI.</p><p><strong>Methods: </strong>We conducted a before-after cohort study using a commercial healthcare claims dataset of adult patients with melanoma from the USA who received ICI therapy between 2011 and 2022. Incidence rates of MOF before and after ICI initiation were ascertained using International Classification of Diseases 9/10 diagnostic codes.</p><p><strong>Results: </strong>The study cohort included 3137 patients, mean age was 68 years, of which 2010 (64%) were men. 40 (1.3%) patients had an MOF in the year before ICI initiation and 57 (1.8%) and 34 (1.8%) had an MOF in the first and second years after ICI initiation, respectively. The HR for MOF over the first year after versus the year before the first ICI dose was 1.82 (95% CI 1.24 to 2.66), and it was 1.85 (95% CI 1.12 to 2.90) over the second year. Prior fracture, older age, female sex and combination ICI therapy were associated with greater risk of MOF after ICI initiation.</p><p><strong>Conclusion: </strong>Patients who receive ICI are at increased risk of MOF after receiving therapy. Given the plausible biological pathway, osteoporosis and osteoporotic fractures may represent a novel irAE of ICI therapy.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000398"},"PeriodicalIF":0.0,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347678/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2024-08-21eCollection Date: 2024-01-01DOI: 10.1136/bmjonc-2024-000539
Suraiya Dubash, Yat Tsang
{"title":"Unlocking the predictive power of imaging biomarkers: predicting immune checkpoint therapy response in non-small cell lung cancer through baseline tumour vessel perfusions.","authors":"Suraiya Dubash, Yat Tsang","doi":"10.1136/bmjonc-2024-000539","DOIUrl":"10.1136/bmjonc-2024-000539","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000539"},"PeriodicalIF":0.0,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347694/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2024-08-21eCollection Date: 2024-01-01DOI: 10.1136/bmjonc-2024-000473
Zhenhua Liu, Ke Ma, Qingzhu Jia, Yunpeng Yang, Peng Fan, Ying Wang, Junhui Wang, Jiya Sun, Liansai Sun, Hongtai Shi, Liang Sun, Bo Zhu, Wei Xu, Li Zhang, Rakesh K Jain, Songbing Qin, Yuhui Huang
{"title":"Baseline tumour vessel perfusion as a non-invasive predictive biomarker for immune checkpoint therapy in non-small-cell lung cancer.","authors":"Zhenhua Liu, Ke Ma, Qingzhu Jia, Yunpeng Yang, Peng Fan, Ying Wang, Junhui Wang, Jiya Sun, Liansai Sun, Hongtai Shi, Liang Sun, Bo Zhu, Wei Xu, Li Zhang, Rakesh K Jain, Songbing Qin, Yuhui Huang","doi":"10.1136/bmjonc-2024-000473","DOIUrl":"10.1136/bmjonc-2024-000473","url":null,"abstract":"<p><strong>Objective: </strong>Current biomarkers for predicting immunotherapy response in non-small-cell lung cancer (NSCLC) are derived from invasive procedures with limited predictive accuracy. Thus, identifying a non-invasive predictive biomarker would improve patient stratification and precision immunotherapy.</p><p><strong>Methods and analysis: </strong>In this retrospective multicohort study, the discovery cohort included 205 NSCLC patients screened from ORIENT-11 and an external validation (EV) cohort included 99 real-world NSCLC patients. The 'onion-mode segmentation' method was developed to extract 'onion-mode perfusion' (OMP) from contrast-enhanced CT images. The predictive performance of OMP or its combination with the PD-L1 Tumour Proportion Score (TPS) was evaluated by the area under the curve (AUC).</p><p><strong>Results: </strong>High baseline OMP was associated with significantly longer survival and predicted patient response to combination anti-PD-(L)1 therapy in the discovery and EV cohorts. OMP complemented the PD-L1 TPS with superior predictive sensitivity (p=0.02). In the PD-L1 TPS<50% subgroup, OMP achieved an AUC of 0.77 for the estimation of treatment response (95% CI 0.66 to 0.86, p<0.0001). A simple bivariate model of OMP/PD-L1 robustly predicted therapeutic response in both the discovery (AUC 0.82, 95% CI 0.74 to 0.88, p<0.0001) and EV (AUC 0.80, 95% CI 0.67 to 0.89, p<0.0001) cohorts.</p><p><strong>Conclusion: </strong>OMP, derived from routine CT examination, could serve as a non-invasive and cost-effective biomarker to predict NSCLC patient response to immune checkpoint inhibitor-based therapy. OMP could be used alone or in combination with other biomarkers to improve precision immunotherapy.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000473"},"PeriodicalIF":0.0,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347692/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2024-08-14eCollection Date: 2024-01-01DOI: 10.1136/bmjonc-2024-000410
Alexander David VanHelene, Matthew J Hadfield, Dario Trapani, Jeremy Lyle Warner, Mark P Lythgoe
{"title":"As bleak as it sounds? Analysing trends in oncology clinical trial initiation in the UK from 2010 to 2022.","authors":"Alexander David VanHelene, Matthew J Hadfield, Dario Trapani, Jeremy Lyle Warner, Mark P Lythgoe","doi":"10.1136/bmjonc-2024-000410","DOIUrl":"10.1136/bmjonc-2024-000410","url":null,"abstract":"<p><strong>Objectives: </strong>The UK's withdrawal from the European Union (a political movement known as 'Brexit') incited concern both in the public and private sector about the future of drug development and the clinical trial landscape in the UK. This study evaluates trends in the initiation of phase III clinical trials that evaluated systemic anticancer treatments from 2010 to 2022 both in the UK and worldwide.</p><p><strong>Methods and analysis: </strong>Relevant clinical trials were identified through ClinicalTrials.gov. Initiation date in each country was defined as the date that a study's record was updated to include a recruiting site in the country of interest. Concurrent clinical site counts were defined as the number of facilities that contemporaneously hosted trials. Temporal trends in trial initiation and site counts were evaluated.</p><p><strong>Results: </strong>Our analysis uncovered a worldwide increase in clinical trial initiation from 2013 to 2019. The UK experienced a decrease in clinical trial initiation immediately post-Brexit in 2020 but rebounded in 2021. The UK's resurgence in clinical trials in 2021 was driven predominately by industry-funded trials. Other countries saw a similar increase in clinical trial initiation from 2020 to 2021.</p><p><strong>Conclusions: </strong>The UK's trends in phase III oncology clinical trial initiation from 2010 to 2022 largely reflects global trends, suggesting that other factors (eg, COVID-19 pandemic) beyond Brexit, may have had a stronger influence on clinical trial initiation within the UK.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000410"},"PeriodicalIF":0.0,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347684/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prospective comparative study of quality of life in patients with bladder cancer undergoing cystectomy with ileal conduit or bladder preservation.","authors":"Vedang Murthy, Sheetal R Kashid, Mahendra Pal, Alvina Vadassery, Priyamvada Maitre, Amandeep Arora, Pallavi Singh, Amit Joshi, Ganesh Bakshi, Gagan Prakash","doi":"10.1136/bmjonc-2024-000435","DOIUrl":"10.1136/bmjonc-2024-000435","url":null,"abstract":"<p><strong>Objective: </strong>To compare health-related quality of life (HRQOL) in patients undergoing radical cystectomy with ileal conduit (RC) or bladder preservation (BP) with (chemo)radiotherapy for bladder cancer.</p><p><strong>Methods and analysis: </strong>Patients with bladder cancer, stage cT1-T4, cN0-N1, M0 with a minimum follow-up of 6 months from curative treatment (RC or BP) and without disease were eligible for inclusion. Two HRQOL instruments were administered: Bladder Cancer Index (BCI) for bladder cancer-specific HRQOL and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The mean QOL scores across various domains and specific questions were compared between the two treatment groups using an independent t-test.</p><p><strong>Results: </strong>Out of the 104 enrolled patients, 56 underwent RC and 48 opted for BP, with 95 (91.3%) being male. The median time from treatment completion to QOL assessment was 22 months (IQR 10-56). The median age for the entire cohort was 62 years (IQR 55-68), 65.5 years (IQR 55-71) in BP and 59.5 years (IQR 55-66) in RC. There was no significant difference in mean BCI urinary and bowel scores in function or bother subdomains between the two groups. Overall, BCI sexual scores were low in both groups but significantly better after BP (BPmean 56.9, RCmean 41.5, p=0.01). Mean scores for sexual function subdomain were BPmean 38.4 and RCmean 25 (p=0.07) and for sexual bother were BPmean 81 RCmean 62 (p=0.02). The EORTC QLQ-C30 outcomes did not show a significant difference in either group.</p><p><strong>Conclusion: </strong>The BP group showed significantly better results in the sexual domain compared with the RC group. Both groups had good QOL in terms of urinary and bowel functions.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000435"},"PeriodicalIF":0.0,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347679/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Geriatric oncology in LMICs: it is time to mature.","authors":"Amol Akhade, Haydee Verduzco-Aguirre, Bishal Gyawali","doi":"10.1136/bmjonc-2024-000537","DOIUrl":"10.1136/bmjonc-2024-000537","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000537"},"PeriodicalIF":0.0,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2024-08-12eCollection Date: 2024-01-01DOI: 10.1136/bmjonc-2024-000466
Urvish Jain, Faraan Rahim, Bhav Jain, Abhinav Komanduri, Aditya Arkalgud, Cameron John Sabet, Alessandro Hammond, Phub Tshering, Tej A Patel, Bhawna Sirohi, Pankaj Jain, Shah Zeb Khan, Sanjeeva Gunasekera, Ramila Shilpakar, Zabihullah Stanikzai, Arman Reza Chowdhury, Nishwant Swami, Edward Christopher Dee, Bishal Gyawali
{"title":"Cancer burden across the South Asian Association for Regional Cooperation in 2022.","authors":"Urvish Jain, Faraan Rahim, Bhav Jain, Abhinav Komanduri, Aditya Arkalgud, Cameron John Sabet, Alessandro Hammond, Phub Tshering, Tej A Patel, Bhawna Sirohi, Pankaj Jain, Shah Zeb Khan, Sanjeeva Gunasekera, Ramila Shilpakar, Zabihullah Stanikzai, Arman Reza Chowdhury, Nishwant Swami, Edward Christopher Dee, Bishal Gyawali","doi":"10.1136/bmjonc-2024-000466","DOIUrl":"10.1136/bmjonc-2024-000466","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study is to present a cross-sectional analysis of cancer burden in the South Asian Association for Regional Cooperation (SAARC) region and explain unique characteristics of its cancer burden as compared with the rest of the world.</p><p><strong>Methods and analysis: </strong>Using publicly available data from the Global Cancer Observatory (GCO) and the World Bank, we collected cancer statistics and population statistics for Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, and Sri Lanka from 2017 to 2022.</p><p><strong>Results: </strong>The number of newly diagnosed cases in the region was 1 846 963, representing 9.3% of the incidence worldwide. As defined by the GCO, the crude incidence rate (CIR) (per 100 000) of cancer in SAARC was 97.3 compared with the worldwide rate of 235.5. The crude mortality rate (per 100 000) in SAARC was 63.4, compared with 123.6 globally. However, the mortality to incidence ratio (MIR) (per 100 000) was 0.65, compared with 0.49 globally.</p><p><strong>Conclusion: </strong>Our research highlights SAARC's unique cancer landscape with low incidence (CIR) and mortality (CMR) but elevated MIR compared with global figures. These findings underscore the need for a united, contextually relevant approach to addressing the burden of cancer in SAARC. In particular, investment in collaborative, tailored cancer care programmes will build the SAARC region's capacity to address the growing cancer challenge.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000466"},"PeriodicalIF":0.0,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Under-representation of older Indian persons with cancer in clinical trials.","authors":"Vanita Noronha, Vijay Patil, Nandini Menon, Manali Kolkur, Zoya Peelay, Minit Shah, Vijayalakshmi Mathrudev, Srushti Shah, Kavita Nawale, Nita S Nair, Anant Ramaswamy, Vikas Ostwal, Sarbani Ghosh-Laskar, Jai Prakash Agarwal, Pankaj Chaturvedi, Supriya Chopra, Vedang Murthy, Sheila N Myatra, Jigeeshu Divatia, Vikram Gota, Sudeep Gupta, Vikram Chaudhari, Sabita Jiwnani, Shailesh V Shrikhande, Richa Vaish, Devendra Chaukar, Shivakumar Thiagarajan, Sudhir Nair, Anil D'Cruz, Amey Oak, Rohini Hawaladar, Oindrila Roy Chowdhury, Shripad Banavali, Rajendra Badwe, Kumar Prabhash","doi":"10.1136/bmjonc-2024-000445","DOIUrl":"10.1136/bmjonc-2024-000445","url":null,"abstract":"<p><strong>Objective: </strong>Older patients with cancer have traditionally been under-represented in global clinical trials. There are no data from India regarding this issue.</p><p><strong>Methods and analysis: </strong>This was a retrospective analysis done at our institute on interventional studies conducted between 2003 and 2023 in adult patients with malignancies. We excluded studies done exclusively in the paediatric population and observational studies.</p><p><strong>Results: </strong>We included 21 894 patients enrolled in 150 interventional trials from the departments of surgical, medical, and radiation oncology, anaesthesia, and clinical pharmacology; 110 (73.3%) were investigator initiated. There were 38 trials (25.3%) in breast cancer (6141 patients, 28%), and 33 (22%) in head and neck cancer (6975 patients, 31.9%). Studies were predominantly phase III (97 trials (64.7%)). Multicentric studies comprised approximately one-third (48, 32%). The median age of enrolled patients was 51 years (IQR 43-59). There were 5132 (23.4%) participants aged ≥60 years, 2678 (12.2%) ≥65 years and 1045 (4.8%) ≥70 years. Data from the hospital registry revealed that 30% of adult registrations were ≥60 years. There was a significant increase in the proportion of older patients enrolled in clinical trials from 2003 (8%) to 2019 (22%) compared with their proportion in the hospital registry (stable at 28%-29%); p<0.001.</p><p><strong>Conclusion: </strong>There is a gap between the proportion of older Indian adults with cancer in the hospital registry and those enrolled in interventional clinical trials, however, this gap has shrunk over time. Various factors that limit the recruitment of this vulnerable cohort like age-specific eligibility criteria are immediately actionable to make clinical trials more inclusive.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000445"},"PeriodicalIF":0.0,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}