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A Practical Approach to Understanding Real-World Study Methodology in Cancer Research: A Vodcast. 理解癌症研究中真实世界研究方法的实用方法:一个视频。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-11 DOI: 10.1007/s40487-025-00366-y
Adam Brufsky, Winson Cheung, Joanne C Ryan
{"title":"A Practical Approach to Understanding Real-World Study Methodology in Cancer Research: A Vodcast.","authors":"Adam Brufsky, Winson Cheung, Joanne C Ryan","doi":"10.1007/s40487-025-00366-y","DOIUrl":"https://doi.org/10.1007/s40487-025-00366-y","url":null,"abstract":"<p><p>Real-world studies have become more common in clinical literature in recent years, but many clinicians remain unfamiliar with real-world study design and statistical approaches. This vodcast intends to be a practical guide for clinicians by clarifying aspects of real-world study methodology. As both practicing oncologists and researchers with extensive real-world data experience, the hosts discuss types of study designs and real-world data source considerations. An overview of statistical techniques for mitigating treatment-selection bias is also provided, including propensity score matching, inverse probability of treatment weighting, and multivariable analysis. By combining high-quality data sources, careful sample size considerations, and rigorous statistical techniques, real-world studies can offer valuable insights into therapeutic effectiveness in routine clinical practice that supplement learnings from randomized clinical trials. This vodcast is designed to equip clinicians with the knowledge to critically evaluate real-world evidence and potentially apply it to their practice.Vodcast and infographic available for this article. Vodcast (MP4 1207725 KB) INFOGRAPHIC.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145041778","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}
引用次数: 0
Pembrolizumab-Induced High Inflammatory Panmyelitis: Contribution of Neurochemical Markers Predicting Severity of Central Nervous Affection. 派姆单抗诱导的高炎性panmyeltis:神经化学标志物预测中枢神经影响严重程度的贡献。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-05 DOI: 10.1007/s40487-025-00374-y
Beate Hagenkötter, Jérôme De Sèze, Faten Hammami, Timothée Klopfenstein, Souheil Zayet
{"title":"Pembrolizumab-Induced High Inflammatory Panmyelitis: Contribution of Neurochemical Markers Predicting Severity of Central Nervous Affection.","authors":"Beate Hagenkötter, Jérôme De Sèze, Faten Hammami, Timothée Klopfenstein, Souheil Zayet","doi":"10.1007/s40487-025-00374-y","DOIUrl":"https://doi.org/10.1007/s40487-025-00374-y","url":null,"abstract":"<p><p>This is the first documented case of recurrent, severe, and highly inflammatory panmyelitis induced by pembrolizumab. A 41-year-old woman with nodular melanoma developed tetraparesis after three cycles of pembrolizumab treatment. Spinal magnetic resonance imaging (MRI) revealed extensive longitudinal panmyelitis, and cerebrospinal fluid analysis showed markedly elevated cell counts (3900/mm<sup>3</sup>). Follow-up measurements of neurofilament light chain (NfL) levels correlated with the severity of central nervous system involvement and reflected clinical, radiological, and biochemical progression. The clinical outcome was surprisingly favorable following treatment with intravenous immunoglobulins (IVIG) and corticosteroids.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001675","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}
引用次数: 0
Correction: Clinical Burden of Recurrent Disease in High-Risk Endometrial Cancer. 修正:高危子宫内膜癌复发疾病的临床负担。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-04 DOI: 10.1007/s40487-025-00373-z
Kalé Kponee-Shovein, Vimalanand S Prabhu, Yan Song, Lei Chen, Mu Cheng, Yeran Li, Yezhou Sun, Annalise Hilts, Qi Hua, Jasmine Lichfield, Linda Duska
{"title":"Correction: Clinical Burden of Recurrent Disease in High-Risk Endometrial Cancer.","authors":"Kalé Kponee-Shovein, Vimalanand S Prabhu, Yan Song, Lei Chen, Mu Cheng, Yeran Li, Yezhou Sun, Annalise Hilts, Qi Hua, Jasmine Lichfield, Linda Duska","doi":"10.1007/s40487-025-00373-z","DOIUrl":"https://doi.org/10.1007/s40487-025-00373-z","url":null,"abstract":"","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144993831","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}
引用次数: 0
Asian Subgroup Analysis of Patients in the Phase 2 DeLLphi-301 Study of Tarlatamab for Previously Treated Small Cell Lung Cancer. Tarlatamab治疗小细胞肺癌的2期delphi -301研究的亚洲亚组分析
IF 3.2
Oncology and Therapy Pub Date : 2025-09-04 DOI: 10.1007/s40487-025-00372-0
Myung-Ju Ahn, Byoung Chul Cho, Kadoaki Ohashi, Hiroki Izumi, Jong-Seok Lee, Ji-Youn Han, Chi-Lu Chiang, Shuang Huang, Ali Hamidi, Sujoy Mukherjee, Krista Lin Xu, Hiraoki Akamatsu
{"title":"Asian Subgroup Analysis of Patients in the Phase 2 DeLLphi-301 Study of Tarlatamab for Previously Treated Small Cell Lung Cancer.","authors":"Myung-Ju Ahn, Byoung Chul Cho, Kadoaki Ohashi, Hiroki Izumi, Jong-Seok Lee, Ji-Youn Han, Chi-Lu Chiang, Shuang Huang, Ali Hamidi, Sujoy Mukherjee, Krista Lin Xu, Hiraoki Akamatsu","doi":"10.1007/s40487-025-00372-0","DOIUrl":"https://doi.org/10.1007/s40487-025-00372-0","url":null,"abstract":"<p><strong>Introduction: </strong>Tarlatamab is a bispecific T-cell engager (BiTE<sup>®</sup>) immunotherapy that binds delta-like ligand 3 on the surface of small cell lung cancer (SCLC) cells and CD3 on T cells, facilitating T cell-mediated cancer cell lysis. In the primary analysis of the phase 2 DeLLphi-301 study (NCT05060016), tarlatamab showed a favourable benefit-to-risk profile with durable objective responses and promising survival outcomes in patients with previously treated SCLC. Here, phase 2 data for the Asia region subgroup are presented.</p><p><strong>Methods: </strong>Patients with previously treated, advanced SCLC received 10 mg tarlatamab every 2 weeks. The primary endpoint was objective response rate (ORR) by blinded independent central review (RECIST version 1.1). Key secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety. The present analysis includes patients enrolled at sites in Asia.</p><p><strong>Results: </strong>A total of 43 patients were enrolled at sites in Asia. ORR was 46.3% (95% confidence interval [CI], 30.7-62.6) and median DOR was 7.2 months (95% CI 3.9 to not estimable). The median follow-up was 16.6 months for PFS and 21.2 months for OS. Median PFS was 5.4 months (95% CI 3.0-8.1) and median OS was 19.0 months (95% CI 11.4 to not estimable). The most common treatment-emergent adverse event (AE) was cytokine release syndrome (48.8%), and all such events were grade 1 or 2. There were no discontinuations due to treatment-related AEs.</p><p><strong>Conclusions: </strong>Tarlatamab demonstrated durable responses and promising survival outcomes with a manageable safety profile in this post hoc analysis of patients from Asia with previously treated SCLC.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05060016.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001595","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}
引用次数: 0
Advances in the Optimization of CAR-T-Cell-Based Therapeutic Approaches to Enhance Antitumor Efficacy in Glioblastoma Treatment. 基于car - t细胞的治疗方法优化提高胶质母细胞瘤抗肿瘤疗效的研究进展。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-01 Epub Date: 2025-06-21 DOI: 10.1007/s40487-025-00355-1
Lidia Gatto, Vincenzo Di Nunno, Alicia Tosoni, Marta Aprile, Chiara Maria Argento, Marzia Margotti, Stefania Bartolini, Enrico Franceschi
{"title":"Advances in the Optimization of CAR-T-Cell-Based Therapeutic Approaches to Enhance Antitumor Efficacy in Glioblastoma Treatment.","authors":"Lidia Gatto, Vincenzo Di Nunno, Alicia Tosoni, Marta Aprile, Chiara Maria Argento, Marzia Margotti, Stefania Bartolini, Enrico Franceschi","doi":"10.1007/s40487-025-00355-1","DOIUrl":"10.1007/s40487-025-00355-1","url":null,"abstract":"<p><p>Chimeric antigen receptor (CAR)-T cell therapy is emerging as a promising immunotherapeutic modality for improving clinical outcomes in high-grade gliomas. Three recent studies have demonstrated the safety and feasibility of intracranial CAR-T cell administration in patients with glioblastoma (GBM), along with preliminary evidence of rapid but transient objective responses. These findings provide a rationale for further clinical investigation of this approach.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"535-539"},"PeriodicalIF":3.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12378241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340419","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}
引用次数: 0
Management and Clinical Outcomes of Patients with Advanced Ovarian Cancer in Routine Clinical Practice in Spain: The OVOC Study. 晚期卵巢癌患者在西班牙常规临床实践中的管理和临床结果:OVOC研究
IF 3.2
Oncology and Therapy Pub Date : 2025-09-01 Epub Date: 2025-05-20 DOI: 10.1007/s40487-025-00347-1
Maria Quindós-Varela, Diego Soto de Prado-Otero, Alejandro Gallego, Yolanda García, Eva Guerra, Purificación Estévez-García, Maria Pilar Barretina-Ginesta, Pilar Borraz, Antonio González-Martín, María Jesús Rubio
{"title":"Management and Clinical Outcomes of Patients with Advanced Ovarian Cancer in Routine Clinical Practice in Spain: The OVOC Study.","authors":"Maria Quindós-Varela, Diego Soto de Prado-Otero, Alejandro Gallego, Yolanda García, Eva Guerra, Purificación Estévez-García, Maria Pilar Barretina-Ginesta, Pilar Borraz, Antonio González-Martín, María Jesús Rubio","doi":"10.1007/s40487-025-00347-1","DOIUrl":"10.1007/s40487-025-00347-1","url":null,"abstract":"<p><strong>Introduction: </strong>The OVOC study was carried out to evaluate the management and clinical evolution of patients with advanced ovarian cancer (AOC) in routine clinical practice in Spain.</p><p><strong>Methods: </strong>A retrospective study was made in women diagnosed with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO IIIB-IV) who had received at least one line of treatment between 2013 and 2016, before the establishment of poly ADP ribose polymerase (PARP) inhibitors as first-line treatment.</p><p><strong>Results: </strong>A total of 400 patients (median age: 61.7 years; FIGO IIIC: 60.0%; high-grade serous carcinoma: 75.0%) received a median of two therapy lines. Primary and interval debulking surgery was performed in 37.0% and 54.3% of the patients. Germline BRCA1 and BRCA2 mutations were found in 16.2% and 12.0% of the patients. The median progression-free survival (PFS) from the start of the first-/second-/third-line of treatment was 14.2/8.7/4.5 months. The median treatment-free interval (TFI) to the start of the second line was 9.9 months. The median overall survival (OS) was 42.6 months. At first relapse, 65.9% of the patients were platinum-sensitive and 34.1% platinum-resistant. Biologic therapies were administered in 25.2% of the platinum-sensitive and 16.2% of the platinum-resistant patients. Patients harboring BRCA mutations had a lower risk of progression/relapse after the first (BRCA1 and BRCA2 mutation versus native: p < 0.0001) and second line (BRCA1 and BRCA2 mutation versus native: p = 0.021 and p = 0.037, respectively). Patients with BRCA2 mutations had a lower mortality risk than those without (p = 0.015). The median PFS was significantly higher in patients receiving targeted therapy in the first (17.4 versus 11.6 months; p = 0.039) and second line (11.1 versus 7.8 months; p < 0.001).</p><p><strong>Conclusion: </strong>This study provides real-world data on therapeutic management and outcomes in AOC patients in Spain. A longer PFS was achieved in patients receiving targeted therapies. BRCA1/2 mutations were a favorable prognostic factor for PFS and BRCA2 mutation for OS.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"631-648"},"PeriodicalIF":3.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12378247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112277","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}
引用次数: 0
Impact of Tumor Response and Response Duration on Survival Among Participants Receiving Pembrolizumab Plus Chemotherapy as First-Line Therapy for Non-Small-Cell Lung Cancer. 在接受派姆单抗联合化疗作为非小细胞肺癌一线治疗的参与者中,肿瘤反应和反应持续时间对生存的影响
IF 3.2
Oncology and Therapy Pub Date : 2025-09-01 Epub Date: 2025-06-11 DOI: 10.1007/s40487-025-00350-6
Marina C Garassino, Ying Cheng, Delvys Rodriguez-Abreu, Silvia Novello, Julien Mazieres, Andrew G Robinson, Steven F Powell, Balazs Halmos, Jhanelle E Gray, Meihua Wang, Cong Chen, Jing Yang, Fabricio Souza, Paul Schwarzenberger, Luis Paz-Ares
{"title":"Impact of Tumor Response and Response Duration on Survival Among Participants Receiving Pembrolizumab Plus Chemotherapy as First-Line Therapy for Non-Small-Cell Lung Cancer.","authors":"Marina C Garassino, Ying Cheng, Delvys Rodriguez-Abreu, Silvia Novello, Julien Mazieres, Andrew G Robinson, Steven F Powell, Balazs Halmos, Jhanelle E Gray, Meihua Wang, Cong Chen, Jing Yang, Fabricio Souza, Paul Schwarzenberger, Luis Paz-Ares","doi":"10.1007/s40487-025-00350-6","DOIUrl":"10.1007/s40487-025-00350-6","url":null,"abstract":"<p><strong>Introduction: </strong>Response Evaluation Criteria in Solid Tumors (RECIST) is the primary tool for assessing tumor response in solid tumors. Immunotherapy elicits unique response patterns, and assessment of their contribution to overall survival (OS) is of interest. We evaluated tumor size changes (TSC) for association with OS, evaluated whether deeper response had greater association with OS than the 30% RECIST cutoff, and quantified the contribution of objective response rate (ORR) and duration of response (DOR) to OS benefit using data from KEYNOTE-189 and KEYNOTE-407 examining first-line pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer (NSCLC).</p><p><strong>Methods: </strong>Associations between early TSC (percentage change from baseline in sum of target lesion diameters) and OS were evaluated using recursive partitioning analyses, C-index, and time-varying receiver operating characteristic curve. Deeper response and OS associations were assessed in sensitivity analyses. Contribution of TSC, ORR, and DOR to the OS benefit of pembrolizumab plus chemotherapy (versus chemotherapy) was quantified with a proportion of treatment effect analysis. Data cutoff was May 2019.</p><p><strong>Results: </strong>In total, 1175 participants were included (KEYNOTE-189, n = 616; KEYNOTE-407, n = 559). At week 12, -30% TSC had a greater association with OS than other cutoffs, which was similar to week 12 ORR. Deeper response did not have greater association with OS than the 30% RECIST cutoff. For pembrolizumab plus chemotherapy versus chemotherapy in KEYNOTE-189, the proportion of treatment effect on OS benefit for DOR coupled with ORR was higher than ORR alone (0.57 versus 0.36) or an alternative TSC cutoff (0.57 versus 0.08 for -10%, 0.09 for -20%, and 0.20 for -30%), with similar results in KEYNOTE-407 for DOR and ORR versus ORR alone (0.92 versus 0.61) or an alternative TSC cutoff (0.92 versus 0.36, 0.43, and 0.40, respectively).</p><p><strong>Conclusions: </strong>These ad hoc exploratory analyses suggest that RECIST remains a valid assessment for metastatic NSCLC treated with immunotherapy plus chemotherapy. Early responses per RECIST criteria predicted improved OS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT02578680, NCT02775435.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"667-681"},"PeriodicalIF":3.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12378254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267570","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}
引用次数: 0
Progression-Free Survival Under Immune Checkpoint Inhibitors for Metastatic Non-Small-Cell Lung Cancer: A Retrospective Cohort Study. 免疫检查点抑制剂治疗转移性非小细胞肺癌的无进展生存期:一项回顾性队列研究
IF 3.2
Oncology and Therapy Pub Date : 2025-09-01 Epub Date: 2025-08-04 DOI: 10.1007/s40487-025-00362-2
Paul Boré, Margaux Geier, Loïc Campion, Jean-Luc Raoul, Ludovic Doucet, Sandrine Hiret, Frédéric Bigot, François Bocquet, Laura Mezquita, Teresa Gorria, Judith Raimbourg
{"title":"Progression-Free Survival Under Immune Checkpoint Inhibitors for Metastatic Non-Small-Cell Lung Cancer: A Retrospective Cohort Study.","authors":"Paul Boré, Margaux Geier, Loïc Campion, Jean-Luc Raoul, Ludovic Doucet, Sandrine Hiret, Frédéric Bigot, François Bocquet, Laura Mezquita, Teresa Gorria, Judith Raimbourg","doi":"10.1007/s40487-025-00362-2","DOIUrl":"10.1007/s40487-025-00362-2","url":null,"abstract":"<p><strong>Introduction: </strong>Immune checkpoint inhibitors (ICI) are the standard of care for non-small-cell lung cancer (NSCLC) regardless of program death ligand-1 (PDL1) expression. However, a majority of patients presented early progression, underlining the need for better patient selection. The aim of this study was to determine effective clinical and biological biomarkers of real-world progression-free survival (rwPFS) in addition to PDL1.</p><p><strong>Methods: </strong>From January 2015 to January 2020, 173 patients with metastatic NSCLC were treated with second line or further nivolumab at the Institut de Cancérologie de l'Ouest (ICO). Using univariate and multivariate analyses, we screened clinical and biological parameters associated with rwPFS. From the independent prognostic variables, a prediction model of 9 and 12 months of median PFS was calculated using a nomogram. This model was validated in a second retrospective cohort of 253 patients with NSCLC from eight centers.</p><p><strong>Results: </strong>In the first cohort, we found five independent prognostic biomarkers: bone and lung metastases, current smoking status, PFS in first line (PFS1), and neutrophil-to-lymphocyte ratio (NLR). The nomogram identified three distinct prognostic groups with respective median rwPFS values of 11.7, 3.9, and 1.6 months. This prediction model was confirmed in our second retrospective cohort.</p><p><strong>Conclusions: </strong>We created a predictive model on the basis of five simple biomarkers that may predict the efficacy of ICI regardless of PDL1 status. The presence of lung metastases, prolonged PFS1, low NLR, and smoking status are good prognostic factors, whereas the presence of bone metastases was associated with worse prognosis.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"783-796"},"PeriodicalIF":3.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12379673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144785591","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}
引用次数: 0
The Health Impact of Using Anti-PD-1 Agents to Treat Early-Stage Cancer in Belgium. 在比利时使用抗pd -1药物治疗早期癌症对健康的影响
IF 3.2
Oncology and Therapy Pub Date : 2025-09-01 Epub Date: 2025-07-24 DOI: 10.1007/s40487-025-00357-z
André Bento-Abreu, Saar Vandekeere, Demet Sönmez, Catarina Neves, Tyler Mantaian, Olivier Ethgen, Raquel Aguiar-Ibáñez
{"title":"The Health Impact of Using Anti-PD-1 Agents to Treat Early-Stage Cancer in Belgium.","authors":"André Bento-Abreu, Saar Vandekeere, Demet Sönmez, Catarina Neves, Tyler Mantaian, Olivier Ethgen, Raquel Aguiar-Ibáñez","doi":"10.1007/s40487-025-00357-z","DOIUrl":"10.1007/s40487-025-00357-z","url":null,"abstract":"<p><strong>Introduction: </strong>Anti-PD-1 agents, inhibitors of programmed cell death protein 1 (PD-1), significantly improve clinical outcomes and overall survival for individuals with several metastatic and early-stage cancers. This study evaluates the health impact of using anti-PD-1 agents for early-stage disease (ESD) treatment of melanoma (stage IIB-C and III), renal cell carcinoma (RCC), and triple-negative breast cancer (TNBC) in Belgium (2023-2032).</p><p><strong>Methods: </strong>Belgian individuals eligible for ESD treatment (target population) entered a Markov-based health outcomes model in a recurrence/event/disease-free state. The model compared anti-PD-1 agents only for metastatic disease treatment (reference scenario) versus anti-PD-1 agents for ESD treatment (ESD scenario) from 2023 to 2032. Clinical outcomes of the model included recurrence/event/disease-free life-years (LYs), total LYs, quality-adjusted LYs (QALYs), recurrences/events, active treatments for metastatic disease, and total deaths. The cumulative health impact of ESD anti-PD-1 treatment in Belgium was calculated as the difference in health outcomes between the ESD and reference scenarios for the time horizon.</p><p><strong>Results: </strong>Of the 14,306 eligible individuals, 11,065 were predicted to initiate treatment with anti-PD-1 agents for ESD. Anti-PD-1 therapies for ESD increased recurrence/event/disease-free LYs (+13.4%), total LYs (+4.4%), and QALYs (+4.9%) after 10 years. Additionally, ESD treatment decreased recurrences/events (-24.6%), active treatments for metastatic disease (-28.6%), and total deaths (-23.8% decrease) over 10 years.</p><p><strong>Conclusions: </strong>The investment in and use of innovative anti-PD-1 agents for the treatment of early-stage cancers would have a positive health impact for Belgium and align with the high standards in cancer care called for in Europe's Beating Cancer Plan.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"735-753"},"PeriodicalIF":3.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12379667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144709414","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}
引用次数: 0
Practical Guidance on the Clinical Management of Ocular Adverse Events Associated with Belantamab Mafodotin for Patients with Relapsed/Refractory Multiple Myeloma: Latin American Expert Panel Recommendations. 针对复发/难治性多发性骨髓瘤患者使用贝兰他单-马福多汀相关眼部不良事件的临床管理实用指南:拉丁美洲专家小组建议。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-01 Epub Date: 2025-07-04 DOI: 10.1007/s40487-025-00354-2
Vânia Hungria, Virginia Abello Polo, Ariel Corzo, Edvan Q Crusoe, Michel E Farah, Natália A Iutaka, Gracia A Martinez, Aline G Ramírez Alvarado, Simón Romano-Bucay, Patricio G Schlottmann, Cristian M Seehaus, Jorge C Torres Flores, Angelo Maiolino
{"title":"Practical Guidance on the Clinical Management of Ocular Adverse Events Associated with Belantamab Mafodotin for Patients with Relapsed/Refractory Multiple Myeloma: Latin American Expert Panel Recommendations.","authors":"Vânia Hungria, Virginia Abello Polo, Ariel Corzo, Edvan Q Crusoe, Michel E Farah, Natália A Iutaka, Gracia A Martinez, Aline G Ramírez Alvarado, Simón Romano-Bucay, Patricio G Schlottmann, Cristian M Seehaus, Jorge C Torres Flores, Angelo Maiolino","doi":"10.1007/s40487-025-00354-2","DOIUrl":"10.1007/s40487-025-00354-2","url":null,"abstract":"<p><p>Multiple myeloma is a significant cause of mortality worldwide, and although changes in the treatment landscape have improved outcomes overall, many patients become refractory to standard therapies. In Latin America, outcomes are especially poor, further compounded by access and equality barriers. Belantamab mafodotin is a novel antibody-drug conjugate, targeting anti-B-cell maturation antigen. Two recent phase 3 trials, DREAMM-7 and DREAMM-8, have demonstrated notable efficacy with belantamab mafodotin combination regimens in patients with relapsed/refractory multiple myeloma. Ocular adverse events were also observed in these studies, as anticipated with antibody-drug conjugates containing monomethyl auristatin F. If belantamab mafodotin is approved for use in clinical practice, healthcare professionals will need clear, region-appropriate guidance on the management of ocular adverse events. A multidisciplinary panel of experts from Argentina, Brazil, Colombia, and Mexico was established, comprising 13 specialists in hematology/oncology and ophthalmology. The panel established a set of practical recommendations to address key clinical questions relating to identification of ocular events, management strategies, multidisciplinary collaboration, and patient-centric care. These recommendations were developed through detailed discussion, review of available evidence, and experience in clinical trials, and are intended to support healthcare professionals across Latin America in the treatment of patients with relapsed/refractory multiple myeloma.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"797-810"},"PeriodicalIF":3.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12378815/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561450","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}
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