{"title":"Anticipating the future of cancer care in Trump's America","authors":"","doi":"10.1016/s1470-2045(24)00669-7","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00669-7","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759976","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}
M Saiful Huq, Sandhya C Acharya, Manish Gautam, Sudhir R Silwal, Simit Sapkota, Saugat Poudyal, Susmita Sharma, K Govind Babu, Taslima Nigar, Shahana Pervin, Seema Gulia, Sanjeeva Gunasekara, A F M Kamal Uddin, Ugyen Tshomo, Ahmad J Safi, Mohammad S Nadeem, Ahmed I Masood, Mostafa A Sumon, Shaila Purvin, Mohammad A Hai, Krishni Wijesooriya
{"title":"Cancer research in South Asian Association for Regional Cooperation (SAARC) countries","authors":"M Saiful Huq, Sandhya C Acharya, Manish Gautam, Sudhir R Silwal, Simit Sapkota, Saugat Poudyal, Susmita Sharma, K Govind Babu, Taslima Nigar, Shahana Pervin, Seema Gulia, Sanjeeva Gunasekara, A F M Kamal Uddin, Ugyen Tshomo, Ahmad J Safi, Mohammad S Nadeem, Ahmed I Masood, Mostafa A Sumon, Shaila Purvin, Mohammad A Hai, Krishni Wijesooriya","doi":"10.1016/s1470-2045(24)00518-7","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00518-7","url":null,"abstract":"Cancer is a major global health threat, with 35 million new cases projected by 2050, predominantly in low-income and middle-income-countries. Within South Asian Association for Regional Cooperation (SAARC) countries, a notable gap in cancer research investment and output compared with high-income countries highlights the need to strengthen research capacity. The rising cancer incidence across SAARC countries is not being matched by local research, particularly in clinical trials in molecular biology, targeted therapy, immunotherapy, and cancer vaccines. This paucity of research is problematic as guidelines and therapies developed in high-income countries might not be directly applicable to low-income and middle-income countries due to distinct regional sociocultural, genetic, and environmental factors and are often impractical in these countries due to cost and implementation challenges. This Series paper examines the cancer research landscape within SAARC countries, focusing on Bangladesh, Nepal, Sri Lanka, India, Pakistan, Afghanistan, Bhutan, and Maldives. We analyse PubMed publication rates and examine available infrastructure, current research (including clinical trials), and limitations and disparities among SAARC countries in terms of cancer research. Key challenges include disparities in health-care access, cultural and economic barriers, and little funding and infrastructure. Strengthening cancer research in SAARC countries requires building collaborative networks, improving research facilities and training, focusing on local epidemiological studies, and developing affordable technologies and treatments. Effective policy and stakeholder engagement could greatly advance cancer care in the region.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759977","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 the ESMO-Magnitude of Clinical Benefit Scale to guide HTA recommendations on coverage and reimbursement for cancer medicines: a retrospective analysis","authors":"Panos Kanavos, Erica Visintin, Aris Angelis","doi":"10.1016/s1470-2045(24)00505-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00505-9","url":null,"abstract":"<h3>Background</h3>Recommendations by countries’ health technology assessment (HTA) agencies are used to decide which new therapies warrant the allocation of limited health-care resources to make them available through publicly funded health systems. This process is of public health importance for balancing the dual aims of optimising patient outcomes while ensuring financial sustainability. We evaluated which factors affect HTA outcomes and the time to positive HTA outcome, focussing on the role of clinical benefit evaluated with the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).<h3>Methods</h3>In this retrospective analysis, data were extracted from publicly available HTA reports and related sources from six country settings and their respective HTA agencies (Australia, Canada, England, France, the Canadian province of Quebec, and Scotland). We evaluated new cancer medicines for treating solid tumours in a non-curative setting with published ESMO-MCBS scores and that had been assessed by at least three HTA agencies between Jan 1, 2011, and Dec 31, 2020. Using ESMO-MCBS score as an independent variable, we did descriptive and multivariable regression analyses to evaluate: (1) factors associated with the time between marketing authorisation and positive (unrestricted [List] and restricted [List with Constraints]) HTA outcome; and (2) factors associated with HTA outcomes.<h3>Findings</h3>67 medicine–indication pairs used in non-curative settings were identified, totalling 360 HTA submissions (medicine–indication–country triplets) reviewed by the six HTA agencies. Factors significantly associated with a reduced interval between marketing authorisation and a positive (unrestricted or restricted) HTA outcome included a high ESMO-MCBS score (ie, 4 or 5, <em>vs</em> a low or average score of 1–3; hazard ratio [HR] per 1 month increment 1·42 [95% CI 1·11–1·81], p=0·0055), parallel review (<em>vs</em> standard marketing authorisation process; HR 1·69 [1·13–2·54], p=0·011), having a risk-sharing agreement or special funding arrangements (<em>vs</em> no funding agreement, HR 4·62 [95% CI 2·51–8·51], p<0·0001, and HR 4·16 [2·03–8·50], p=0·0001, respectively), and assessment by particular HTA agencies (pan-Canadian Oncology Drug Review <em>vs</em> National Institute for Health and Care Excellence [NICE], HR 2·82 [1·68–4·75], p=0·0001; and Haute Autorité de Santé <em>vs</em> NICE, HR 5·70 [2·87–11·33], p<0·0001). Accelerated marketing authorisation was significantly associated with a longer time to positive HTA outcome (<em>vs</em> standard authorisation process; HR 0·70 [95% CI 0·51–0·95], p=0·024). Positive HTA outcomes (both unrestricted and restricted) were significantly associated with a high ESMO-MCBS score (<em>vs</em> low or average ESMO-MCBS score; relative risk ratio [RRR] 14·10 [95% CI 3·54–56·20], p=0·0002, and RRR 4·52 [1·90–10·75], p=0·0006, respectively) and acknowledgment of unmet medical need (<em","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759988","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":"Decentralised clinical trials: a game changer for improved access to clinical trials","authors":"Craig Underhill, Sabe Sabesan, Elizabeth Wilson","doi":"10.1016/s1470-2045(24)00595-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00595-3","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142760046","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":"Capturing the true effect of anti-PD-1 therapy on patients’ health-related quality of life","authors":"Mees D Egeler, Lonneke V van de Poll-Franse","doi":"10.1016/s1470-2045(24)00601-6","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00601-6","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142760275","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}
M Saiful Huq, Sandhya C Acharya, Susmita Sharma, Saugat Poudyal, Simit Sapkota, Sunil Shrestha, Manish Gautam, Sudhir R Silwal, Mohammad M Haque, A F M Kamal Uddin, Sanjeeva Gunasekara, K Govind Babu, Ugyen Tshomo, Ahmad J Safi, Ahmed I Masood, Mostafa A Sumon, Mohammad A Hai, Altaf Hossain, Shaila Purvin, Heath Devin Skinner, Krishni Wijesooriya
{"title":"Cancer care and outreach in South Asian Association for Regional Cooperation (SAARC) countries: from epidemiology and the National Cancer Control Programme to screening, diagnosis, and treatment","authors":"M Saiful Huq, Sandhya C Acharya, Susmita Sharma, Saugat Poudyal, Simit Sapkota, Sunil Shrestha, Manish Gautam, Sudhir R Silwal, Mohammad M Haque, A F M Kamal Uddin, Sanjeeva Gunasekara, K Govind Babu, Ugyen Tshomo, Ahmad J Safi, Ahmed I Masood, Mostafa A Sumon, Mohammad A Hai, Altaf Hossain, Shaila Purvin, Heath Devin Skinner, Krishni Wijesooriya","doi":"10.1016/s1470-2045(24)00521-7","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00521-7","url":null,"abstract":"South Asian Association for Regional Collaboration (SAARC) countries, home to 24% of the world's population, are facing the double burden of disease (ie, where a population experiences both an increasing incidence of cancers typically associated with affluence and a sustained or rising burden of cancers linked to infections and poverty) with non-communicable diseases (NCDs) attributing to 47% of the global burden of disease and to about 60% of all deaths. In 2022, cancer in this region accounted for approximately 9·3% of incidence worldwide and 12% of global mortality. Cancer is one of the major NCDs affecting South Asia, accounting for a large proportion of disability-adjusted life-years lost in this region. The most common cancers are lung, head and neck, and gastrointestinal cancers in both sexes, and cervix and breast cancers in females. The cancer burden is high in SAARC countries, although there are differences among countries and within urban and rural regions of each country, depending on the level of available resources, development, and epidemiological shift. Here we discuss various cancer care issues and challenges throughout the cancer care continuum in the SAARC region. We make an urgent call for regional collaboration to develop, modify, and implement a holistic cancer control plan and formulate a systematic approach directed to address the growing burden of cancer in this region. It is crucial to establish strong political will and commitment to take forward the recommended actions outlined in this Series to overcome and address the cancer crisis in the SAARC region, aligning with Sustainable Development Goal 2030 targets.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"261 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759969","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}
Hope S Rugo, Florence Lerebours, Eva Ciruelos, Pamela Drullinsky, Manuel Ruiz-Borrego, Patrick Neven, Yeon Hee Park, Aleix Prat, Thomas Bachelot, Dejan Juric, Nicholas Turner, Nickolas Sophos, Juan Pablo Zarate, Christina Arce, Yu-Ming Shen, Stuart Turner, Hemanth Kanakamedala, Wei-Chun Hsu, Stephen Chia
{"title":"Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study","authors":"Hope S Rugo, Florence Lerebours, Eva Ciruelos, Pamela Drullinsky, Manuel Ruiz-Borrego, Patrick Neven, Yeon Hee Park, Aleix Prat, Thomas Bachelot, Dejan Juric, Nicholas Turner, Nickolas Sophos, Juan Pablo Zarate, Christina Arce, Yu-Ming Shen, Stuart Turner, Hemanth Kanakamedala, Wei-Chun Hsu, Stephen Chia","doi":"10.1016/s1470-2045(24)00673-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00673-9","url":null,"abstract":"<h3>Background</h3>Alpelisib, a PI3Kα-selective inhibitor and degrader, plus fulvestrant showed efficacy in hormone receptor-positive, HER2-negative, <em>PIK3CA</em>-mutated advanced breast cancer in SOLAR-1; limited data are available in the post-cyclin-dependent kinase 4/6 inhibitor setting. BYLieve aimed to assess alpelisib plus endocrine therapy in this setting in three cohorts defined by immediate previous treatment; here, we report results from cohort A.<h3>Methods</h3>This ongoing, phase 2, multicentre, open-label, non-comparative study enrolled patients with hormone receptor-positive, HER2-negative, advanced breast cancer with tumour <em>PIK3CA</em> mutation, following progression on or after previous therapy, including CDK4/6 inhibitors, from 114 study locations (cancer centres, medical centres, university hospitals, and hospitals) in 18 countries worldwide. Participants aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 2 or less, with no more than two previous anticancer treatments and no more than one previous chemotherapy regimen, were enrolled in three cohorts. In cohort A, patients must have had progression on or after a CDK4/6 inhibitor plus an aromatase inhibitor as the immediate previous treatment. Patients received oral alpelisib 300 mg/day (continuously) plus fulvestrant 500 mg intramuscularly on day 1 of each 28-day cycle and on day 15 of cycle 1. The primary endpoint was the proportion of patients alive without disease progression at 6 months per local assessment using Response Evaluation Criteria in Solid Tumors, version 1.1, in patients with a centrally confirmed <em>PIK3CA</em> mutation. This 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>NCT03056755</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 Aug 14, 2017, and Jul 29, 2022 (data cutoff), 127 patients with at least 18 months’ follow-up were enrolled into cohort A. 119 patients had a centrally confirmed <em>PIK3CA</em> mutation. At data cutoff, median follow-up was 21·8 months (IQR 10·8–37·6). 64 (53·8%; 95% CI 44·4–63·0) of 119 patients were alive without disease progression at 6 months. The most frequent grade 3 or worse adverse events were hyperglycaemia (37 [29%] of 127 patients), rash (13 [10%]), and rash maculopapular (11 [9%]). Serious adverse events occurred in 37 (29%) of 127 patients. No treatment-related deaths were reported.<h3>Interpretation</h3>BYLieve showed activity of alpelisib plus fulvestrant with manageable toxicity in patients with <em>PIK3CA</em>-mutated, hormone receptor-positive, HER2-negative ","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142759975","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}