Dana Narvaez, Gerneiva T Parkinson, Stephanie L Graff
{"title":"Metronomic capecitabine plus aromatase inhibitor as initial therapy in HR-positive HER2-negative metastatic breast cancer: a low-cost and easily implementable option.","authors":"Dana Narvaez, Gerneiva T Parkinson, Stephanie L Graff","doi":"10.21037/cco-25-82","DOIUrl":"https://doi.org/10.21037/cco-25-82","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 6","pages":"79"},"PeriodicalIF":2.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-12-20DOI: 10.21037/cco-25-101
Cody Eslinger, Daniel Walden, Mohamad Bassam Sonbol, Daniel Ahn, Christina Wu, Mitesh Borad, Tanios Bekaii-Saab
Background: The ataxia-telangiectasia mutated (ATM) gene is central to homologous recombination (HR) repair and cell-cycle checkpoint control. Pathogenic ATM mutations are increasingly recognized in metastatic colorectal cancer (mCRC) and are associated with improved prognosis, with survival nearly twice that of ATM wild-type disease. DNA-damaging chemotherapy combined with poly (ADP-ribose) polymerase (PARP) inhibition is effective in other HR-deficient cancers, but data in mCRC are limited.
Case description: We describe four patients with mCRC harboring germline or somatic ATM mutations with high variant allele frequency (VAF). All demonstrated clinical and radiographic benefit from DNA-damaging chemotherapy, including platinum- and topoisomerase-based regimens, exceeding historical controls. In two patients, the addition of PARP inhibitors (PARPi) therapy was associated with sustained disease control. These cases illustrate the potential therapeutic relevance of targeting HR deficiency in ATM-mutated colorectal cancer (CRC).
Conclusions: This series underscores the sensitivity of ATM-mutated mCRC to DNA-damaging chemotherapy and highlights the potential role of PARPi. The therapeutic benefit of PARPi in these patients cannot be fully separated from concurrent chemotherapy, and the observed responses are likely to reflect combined effects. Nonetheless, these findings suggest potential synergy and warrant further investigation of PARP inhibition, alone or in combination, in biomarker-selected mCRC populations.
{"title":"Response to DNA-damaging agents and PARP inhibitors in ATM mutated metastatic colorectal cancer: case series.","authors":"Cody Eslinger, Daniel Walden, Mohamad Bassam Sonbol, Daniel Ahn, Christina Wu, Mitesh Borad, Tanios Bekaii-Saab","doi":"10.21037/cco-25-101","DOIUrl":"10.21037/cco-25-101","url":null,"abstract":"<p><strong>Background: </strong>The ataxia-telangiectasia mutated (ATM) gene is central to homologous recombination (HR) repair and cell-cycle checkpoint control. Pathogenic ATM mutations are increasingly recognized in metastatic colorectal cancer (mCRC) and are associated with improved prognosis, with survival nearly twice that of ATM wild-type disease. DNA-damaging chemotherapy combined with poly (ADP-ribose) polymerase (PARP) inhibition is effective in other HR-deficient cancers, but data in mCRC are limited.</p><p><strong>Case description: </strong>We describe four patients with mCRC harboring germline or somatic ATM mutations with high variant allele frequency (VAF). All demonstrated clinical and radiographic benefit from DNA-damaging chemotherapy, including platinum- and topoisomerase-based regimens, exceeding historical controls. In two patients, the addition of PARP inhibitors (PARPi) therapy was associated with sustained disease control. These cases illustrate the potential therapeutic relevance of targeting HR deficiency in ATM-mutated colorectal cancer (CRC).</p><p><strong>Conclusions: </strong>This series underscores the sensitivity of ATM-mutated mCRC to DNA-damaging chemotherapy and highlights the potential role of PARPi. The therapeutic benefit of PARPi in these patients cannot be fully separated from concurrent chemotherapy, and the observed responses are likely to reflect combined effects. Nonetheless, these findings suggest potential synergy and warrant further investigation of PARP inhibition, alone or in combination, in biomarker-selected mCRC populations.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":" ","pages":"74"},"PeriodicalIF":2.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhancing audiometric surveillance in head and neck cancer patients undergoing cisplatin-based chemoradiation.","authors":"Aurora Mirabile, Raffaele Addeo","doi":"10.21037/cco-25-89","DOIUrl":"https://doi.org/10.21037/cco-25-89","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 6","pages":"65"},"PeriodicalIF":2.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Siqin Liang, Ming Li, Zhiliang Xu, MingMing Luo, Xiaoxiang You, Tinghao Yuan, Xingwen Zhou, Bo Yi, Qiang Tu, Bin Xu
Background: In recent years, the tumor immune microenvironment (TIME) has been gradually emphasized in liver cancer interventional therapy. The present study aimed to evaluate the current research hotspots and developmental trends of TIME from the perspective of bibliometrics.
Methods: Publications related to interventional therapy, liver cancer, and TIME were searched on the Web of Science (WOS) Core Collection database for the years 2000-2024, and bibliometric analyses were performed using VOSviewer, CiteSpace, and R "Bibliometrix".
Results: A bibliometric analysis was conducted on the TIME in liver cancer interventional therapy using data from 2000-2024. The study included 277 articles from 21 regions/countries, with China and the USA leading. The number of articles is increasing annually. Fudan University and Huazhong University of Science and Technology are major research institutions. The Journal of Hepatocellular Carcinoma is the most popular journal, while Hepatology is the most cited. Zheng Chuansheng published the most papers, and Llovet was the most co-cited. Research topics include the mechanism of the TIME in interventional therapy and novel therapies. Emerging hotspots are "Immunotargeted inhibition", "tumor microenvironment", and "immunotherapy".
Conclusions: This is the first comprehensive bibliometric study in this field, providing insights into research trends and new directions.
背景:近年来,肿瘤免疫微环境(tumor immune microenvironment, TIME)在肝癌介入治疗中逐渐受到重视。本研究旨在从文献计量学的角度评价《时代》杂志当前的研究热点和发展趋势。方法:检索Web of Science (WOS) Core Collection数据库2000-2024年有关介入治疗、肝癌和《时代》杂志的出版物,使用VOSviewer、CiteSpace和R“Bibliometrix”进行文献计量学分析。结果:采用文献计量学方法对2000-2024年肝癌介入治疗的TIME进行分析。该研究包括来自21个地区/国家的277篇文章,以中国和美国为首。文章的数量每年都在增加。复旦大学和华中科技大学是主要的研究机构。《肝细胞癌杂志》是最受欢迎的杂志,而《肝病学》是被引用最多的杂志。发表论文最多的是郑传胜,被共同引用最多的是洛维特。研究课题包括TIME在介入治疗中的作用机制和新疗法。新兴的热点是“免疫靶向抑制”、“肿瘤微环境”和“免疫治疗”。结论:这是该领域第一次全面的文献计量学研究,为研究趋势和新方向提供了见解。
{"title":"A bibliometric analysis of 2000-2024 on interventional therapy for liver cancer and tumor immune microenvironment.","authors":"Siqin Liang, Ming Li, Zhiliang Xu, MingMing Luo, Xiaoxiang You, Tinghao Yuan, Xingwen Zhou, Bo Yi, Qiang Tu, Bin Xu","doi":"10.21037/cco-25-83","DOIUrl":"https://doi.org/10.21037/cco-25-83","url":null,"abstract":"<p><strong>Background: </strong>In recent years, the tumor immune microenvironment (TIME) has been gradually emphasized in liver cancer interventional therapy. The present study aimed to evaluate the current research hotspots and developmental trends of TIME from the perspective of bibliometrics.</p><p><strong>Methods: </strong>Publications related to interventional therapy, liver cancer, and TIME were searched on the Web of Science (WOS) Core Collection database for the years 2000-2024, and bibliometric analyses were performed using VOSviewer, CiteSpace, and R \"Bibliometrix\".</p><p><strong>Results: </strong>A bibliometric analysis was conducted on the TIME in liver cancer interventional therapy using data from 2000-2024. The study included 277 articles from 21 regions/countries, with China and the USA leading. The number of articles is increasing annually. Fudan University and Huazhong University of Science and Technology are major research institutions. The Journal of Hepatocellular Carcinoma is the most popular journal, while Hepatology is the most cited. Zheng Chuansheng published the most papers, and Llovet was the most co-cited. Research topics include the mechanism of the TIME in interventional therapy and novel therapies. Emerging hotspots are \"Immunotargeted inhibition\", \"tumor microenvironment\", and \"immunotherapy\".</p><p><strong>Conclusions: </strong>This is the first comprehensive bibliometric study in this field, providing insights into research trends and new directions.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 6","pages":"72"},"PeriodicalIF":2.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tao Luo, Senxin Wang, Shangru Yang, Ade Su, Xuean Zhao, Jianqi Qin, Wence Zhou
Background: Primary liver cancer constitutes a significant public health issue in China. The hepatitis B virus (HBV) remains the primary etiological agent of liver cancer, whereas the role of metabolic liver diseases, particularly non-alcoholic steatohepatitis (NASH), is escalating. It is imperative to examine the temporal progression of liver cancer etiology to establish a scientifically grounded framework for developing targeted prevention and control strategies tailored to China's national context. This study aims to utilize the Global Burden of Disease (GBD) 2021 database to systematically evaluate the temporal trends in the liver cancer disease burden in China from 1990 to 2021, analyze the changing contributions of different etiologies [including HBV, hepatitis C virus (HCV), and NASH], assess the impact of sociodemographic factors, and predict future trends, thereby providing a scientific basis for formulating targeted prevention and control strategies tailored to China's national context.
Methods: This study performed long-term, large-scale time-series trend comparisons of liver cancer burden in China from 1990 to 2021, focusing on five primary etiologies (HBV, HCV, alcohol consumption, NASH, and other causes) using the GBD 2021 database. The Joinpoint regression model identified trend inflection points, while the age-period-cohort (APC) model elucidated the determinants of disease burden. The Slope Index of Inequality (SII) and Concentration Index (CI) assessed the correlation between various disease burden indicators and the Socio-Demographic Index (SDI), and the Autoregressive Integrated Moving Average (ARIMA) and Bayesian Age-Period-Cohort (BAPC) models were employed for future burden projections.
Results: Between 1990 and 2021, the age-standardized incidence rate (ASIR) of liver cancer in China experienced a modest decline [estimated annual percentage change (EAPC) =-0.31], while the total number of cases escalated significantly (+103.91%), with aging contributing to a 141.91% rise in disability-adjusted life years (DALYs). The incidence of HBV-associated liver cancer diminished dramatically (ASIR EAPC =-0.55), whereas NASH-associated liver cancer escalated rapidly (ASIR EAPC =0.73). China, categorized as a medium-to-high SDI region, exhibits a greater incidence of liver cancer and various etiologies of the disease compared to other regions with equivalent SDI levels. Future forecasts indicate that liver cancer connected with alcohol consumption and NASH may persist in increasing.
Conclusions: The prevention and management of HBV infection in China have been efficient; however, the prevalence of metabolic illnesses in the etiology of liver cancer has escalated, and aging alongside population expansion has positively contributed to the increasing burden of liver cancer.
{"title":"Temporal evolution of liver cancer etiology in China, 1990-2021: insights from the Global Burden of Disease Study 2021.","authors":"Tao Luo, Senxin Wang, Shangru Yang, Ade Su, Xuean Zhao, Jianqi Qin, Wence Zhou","doi":"10.21037/cco-25-80","DOIUrl":"https://doi.org/10.21037/cco-25-80","url":null,"abstract":"<p><strong>Background: </strong>Primary liver cancer constitutes a significant public health issue in China. The hepatitis B virus (HBV) remains the primary etiological agent of liver cancer, whereas the role of metabolic liver diseases, particularly non-alcoholic steatohepatitis (NASH), is escalating. It is imperative to examine the temporal progression of liver cancer etiology to establish a scientifically grounded framework for developing targeted prevention and control strategies tailored to China's national context. This study aims to utilize the Global Burden of Disease (GBD) 2021 database to systematically evaluate the temporal trends in the liver cancer disease burden in China from 1990 to 2021, analyze the changing contributions of different etiologies [including HBV, hepatitis C virus (HCV), and NASH], assess the impact of sociodemographic factors, and predict future trends, thereby providing a scientific basis for formulating targeted prevention and control strategies tailored to China's national context.</p><p><strong>Methods: </strong>This study performed long-term, large-scale time-series trend comparisons of liver cancer burden in China from 1990 to 2021, focusing on five primary etiologies (HBV, HCV, alcohol consumption, NASH, and other causes) using the GBD 2021 database. The Joinpoint regression model identified trend inflection points, while the age-period-cohort (APC) model elucidated the determinants of disease burden. The Slope Index of Inequality (SII) and Concentration Index (CI) assessed the correlation between various disease burden indicators and the Socio-Demographic Index (SDI), and the Autoregressive Integrated Moving Average (ARIMA) and Bayesian Age-Period-Cohort (BAPC) models were employed for future burden projections.</p><p><strong>Results: </strong>Between 1990 and 2021, the age-standardized incidence rate (ASIR) of liver cancer in China experienced a modest decline [estimated annual percentage change (EAPC) =-0.31], while the total number of cases escalated significantly (+103.91%), with aging contributing to a 141.91% rise in disability-adjusted life years (DALYs). The incidence of HBV-associated liver cancer diminished dramatically (ASIR EAPC =-0.55), whereas NASH-associated liver cancer escalated rapidly (ASIR EAPC =0.73). China, categorized as a medium-to-high SDI region, exhibits a greater incidence of liver cancer and various etiologies of the disease compared to other regions with equivalent SDI levels. Future forecasts indicate that liver cancer connected with alcohol consumption and NASH may persist in increasing.</p><p><strong>Conclusions: </strong>The prevention and management of HBV infection in China have been efficient; however, the prevalence of metabolic illnesses in the etiology of liver cancer has escalated, and aging alongside population expansion has positively contributed to the increasing burden of liver cancer.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 6","pages":"73"},"PeriodicalIF":2.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tiago Nunes da Silva Soares, Thaís Moura Gascón, Fernando Luiz Affonso Fonseca, Neif Murad, Samantha Sanches de Carvalho, Glaucia Luciano da Veiga, Beatriz da Costa Aguiar Alves, Edimar Cristiano Pereira
Background: Cardiac markers are important in the diagnosis of heart and coronary insufficiency, it is through them that they can measure the damage to cardiac fibers resulting from these diseases. Recent research has shown that the levels of biomarkers are altered who have neoplasms under chemotherapy treatment without these patients having any clinical manifestations. The research was to conduct a systematic review of the main cardiac biomolecular markers in scientific publications bases and to verify how their levels present in individuals with breast cancer, as well as to analyze the influence of antineoplastic treatment in the circular levels of these markers resulting from the effects of cardiac damage on patient therapy and which are good predictors of cardiovascular diseases related to chemotherapy treatment.
Methods: Medline, Lilacs and Cochrane and in these databases, systematic searches of publications were carried out between the years 2010 and 2020 using the descriptors "Mesh" or the equivalent in the chosen database. Studies that evaluated the following cardiac biomarkers: troponin, pro-type B natriuretic peptide (proBNP)/N-terminal pro-BNP (NT-proBNP), myoglobin, creatine kinase-MB fraction, fibrinogen, and D-dimer.
Results: At the end, 31 published articles were obtained for analysis in which cardiac markers ultra-sensitive troponin I and T, myoglobin, and NT-proBNP showed to be the best predictors of cardiotoxicity for breast cancer patient under chemotherapy.
Conclusions: The ultra-sensitive cardiac markers troponin I and T, NT-proBNP and myoglobin, were the ones that provided the best biomarkers in detecting cardiotoxicity, requiring continuous research and research for cardiotoxic biomarkers.
{"title":"Evaluation of cardiac markers in patients with breast cancer receiving antineoplastic treatment: a systematic review.","authors":"Tiago Nunes da Silva Soares, Thaís Moura Gascón, Fernando Luiz Affonso Fonseca, Neif Murad, Samantha Sanches de Carvalho, Glaucia Luciano da Veiga, Beatriz da Costa Aguiar Alves, Edimar Cristiano Pereira","doi":"10.21037/cco-24-136","DOIUrl":"https://doi.org/10.21037/cco-24-136","url":null,"abstract":"<p><strong>Background: </strong>Cardiac markers are important in the diagnosis of heart and coronary insufficiency, it is through them that they can measure the damage to cardiac fibers resulting from these diseases. Recent research has shown that the levels of biomarkers are altered who have neoplasms under chemotherapy treatment without these patients having any clinical manifestations. The research was to conduct a systematic review of the main cardiac biomolecular markers in scientific publications bases and to verify how their levels present in individuals with breast cancer, as well as to analyze the influence of antineoplastic treatment in the circular levels of these markers resulting from the effects of cardiac damage on patient therapy and which are good predictors of cardiovascular diseases related to chemotherapy treatment.</p><p><strong>Methods: </strong>Medline, Lilacs and Cochrane and in these databases, systematic searches of publications were carried out between the years 2010 and 2020 using the descriptors \"Mesh\" or the equivalent in the chosen database. Studies that evaluated the following cardiac biomarkers: troponin, pro-type B natriuretic peptide (proBNP)/N-terminal pro-BNP (NT-proBNP), myoglobin, creatine kinase-MB fraction, fibrinogen, and D-dimer.</p><p><strong>Results: </strong>At the end, 31 published articles were obtained for analysis in which cardiac markers ultra-sensitive troponin I and T, myoglobin, and NT-proBNP showed to be the best predictors of cardiotoxicity for breast cancer patient under chemotherapy.</p><p><strong>Conclusions: </strong>The ultra-sensitive cardiac markers troponin I and T, NT-proBNP and myoglobin, were the ones that provided the best biomarkers in detecting cardiotoxicity, requiring continuous research and research for cardiotoxic biomarkers.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 6","pages":"76"},"PeriodicalIF":2.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-12-19DOI: 10.21037/cco-25-79
Gilson Gabriel Viana Veloso, Nathalia Gimenes Afonso, Carlos Gil Ferreira
{"title":"ROS1 therapy among patients with advanced non-small cell lung cancer: an endless road to rediscover?","authors":"Gilson Gabriel Viana Veloso, Nathalia Gimenes Afonso, Carlos Gil Ferreira","doi":"10.21037/cco-25-79","DOIUrl":"10.21037/cco-25-79","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":" ","pages":"80"},"PeriodicalIF":2.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><p>Oncology clinical trial involves processing of vast amounts of personal health data, including medical history, treatment, biomarker, genetic information, etc., much of which qualifies as special category data under the General Data Protection Regulation (GDPR). While it sought to harmonize the data protection standards across the European Union (EU), its implementation has a profound impact on the operational and regulatory practice for oncology clinical trial sponsors. Its interaction with the Clinical Trials Regulation (CTR), diverse national health data laws, and emerging data localization mandates has made privacy compliance in multi-country clinical trials exceptionally complex for both EU and non-EU sponsors. This narrative review examines how core GDPR principles and requirements play out in the context of oncology clinical trials in the EU, and where tensions arise with CTR obligations and real-world operations. We highlight recurrent challenges in practice, including the need to distinguish ethical consent from GDPR legal bases, to honour data subject rights without unblinding, and to ensure proportionate data collection as study endpoints evolve. Additional difficulties arise from managing biospecimen storage and secondary use, addressing long retention horizons, navigating Member State and intra‑state variations in ethics committee and data protection officer expectations, and overcoming localization barriers that hinder cross-border pooling of rare molecular-marker data. With the evolving complex privacy compliance landscape in EU and beyond, full compliance with all privacy requirements becomes unrealistic for the oncology clinical trial sponsors. Instead of seeking perfection in compliance, which is not the main mission for oncology clinical trials, sponsors should adopt a risk-based approach to prioritize the mitigation of the most significant risks. Drawing on the recurrent challenges identified in this narrative review, we propose such an approach that begins with early scoping of the study type, distinguishing CTR-governed investigational medicinal product trials from other designs, and mapping member state legal bases alongside layered transparency materials. It also involves implementing site-mediated subject rights workflows, carefully justifying the inclusion of "buffer" variables or biospecimens, and planning differentiated retention strategies for samples and data. Sponsors should further incorporate privacy-by-design through country-specific mapping and, where cross-border transfers are constrained, consider federated or "data-visiting" analytics. At the system level, we recommend adopting modular consent language, clarifying controller and processor roles through guidance, maintaining public registers of national derogations, and investing in federated infrastructures and accredited biobanks. These insights aim to help oncology sponsors, as well as other clinical sponsors, ethics committees, privacy professionals,
{"title":"The global impact of the General Data Protection Regulation: implications, challenges, and future outlook in oncology clinical research sponsors.","authors":"Xiao Liu, Denis Lacombe, Stephane Lejeune","doi":"10.21037/cco-25-31","DOIUrl":"10.21037/cco-25-31","url":null,"abstract":"<p><p>Oncology clinical trial involves processing of vast amounts of personal health data, including medical history, treatment, biomarker, genetic information, etc., much of which qualifies as special category data under the General Data Protection Regulation (GDPR). While it sought to harmonize the data protection standards across the European Union (EU), its implementation has a profound impact on the operational and regulatory practice for oncology clinical trial sponsors. Its interaction with the Clinical Trials Regulation (CTR), diverse national health data laws, and emerging data localization mandates has made privacy compliance in multi-country clinical trials exceptionally complex for both EU and non-EU sponsors. This narrative review examines how core GDPR principles and requirements play out in the context of oncology clinical trials in the EU, and where tensions arise with CTR obligations and real-world operations. We highlight recurrent challenges in practice, including the need to distinguish ethical consent from GDPR legal bases, to honour data subject rights without unblinding, and to ensure proportionate data collection as study endpoints evolve. Additional difficulties arise from managing biospecimen storage and secondary use, addressing long retention horizons, navigating Member State and intra‑state variations in ethics committee and data protection officer expectations, and overcoming localization barriers that hinder cross-border pooling of rare molecular-marker data. With the evolving complex privacy compliance landscape in EU and beyond, full compliance with all privacy requirements becomes unrealistic for the oncology clinical trial sponsors. Instead of seeking perfection in compliance, which is not the main mission for oncology clinical trials, sponsors should adopt a risk-based approach to prioritize the mitigation of the most significant risks. Drawing on the recurrent challenges identified in this narrative review, we propose such an approach that begins with early scoping of the study type, distinguishing CTR-governed investigational medicinal product trials from other designs, and mapping member state legal bases alongside layered transparency materials. It also involves implementing site-mediated subject rights workflows, carefully justifying the inclusion of \"buffer\" variables or biospecimens, and planning differentiated retention strategies for samples and data. Sponsors should further incorporate privacy-by-design through country-specific mapping and, where cross-border transfers are constrained, consider federated or \"data-visiting\" analytics. At the system level, we recommend adopting modular consent language, clarifying controller and processor roles through guidance, maintaining public registers of national derogations, and investing in federated infrastructures and accredited biobanks. These insights aim to help oncology sponsors, as well as other clinical sponsors, ethics committees, privacy professionals,","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"54"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-01Epub Date: 2025-10-20DOI: 10.21037/cco-25-62
Edoardo Francini
{"title":"Patient-related reported outcomes (PROs) from TALAPRO-2: the PROs and cons.","authors":"Edoardo Francini","doi":"10.21037/cco-25-62","DOIUrl":"10.21037/cco-25-62","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":" ","pages":"62"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}