European Journal of Cancer最新文献

{"title":"Impact of concomitant medication on recurrence, survival and tolerability of chemotherapy in early colon cancer patients – A post-hoc analysis of the PETACC 8 trial","authors":"Elisabeth Sophie Bergen ,&nbsp;Clémence Canton ,&nbsp;Mathieu Boulin ,&nbsp;Karine Le Malicot ,&nbsp;Jaafar Bennouna ,&nbsp;Daniel Gonzalez ,&nbsp;Laurent Mineur ,&nbsp;Olivier Bouche ,&nbsp;Côme Lepage ,&nbsp;Julien Taieb","doi":"10.1016/j.ejca.2025.115643","DOIUrl":"10.1016/j.ejca.2025.115643","url":null,"abstract":"<div><h3>Background</h3><div>Only few information is available about the impact of concomitant medication (CM) and comorbidities on the outcome of cancer patients and the tolerability of chemotherapy.</div></div><div><h3>Methods</h3><div>Patients of the phase III randomized trial PETACC8 had resection with curative intent of a stage III colon cancer (CC) and were treated with standard adjuvant fluoropyrimidine and oxaliplatin + /- cetuximab over 6 months. Information on CM intake has been gathered by study visits at inclusion as well as during chemotherapy. We investigated the association between number of CM as well as the 5 most frequently applied CM categories according to the WHO ATC classification system (gastro-esophageal reflux disease (GERD) treatment, anticoagulants, platelet aggregation inhibitors, cardiovascular and antidiabetic drugs) with outcome and tolerability.</div></div><div><h3>Results</h3><div>Among 2559 patients, median number of CM intake was 8 (range 0–25), with only 22 patients (0.9 %) without any CM intake. Anticoagulation treatment was the only CM category being significantly and independently associated with a shorter disease-free survival (DFS) (HR 1.29, 95 %CI 1.06–1.56, <em>p = 0.010</em>) as well as overall survival (OS) (HR 1.28, 95 %CI 1.02–1.59, <em>p = 0.032</em>). No association of number of CM (&lt;5,5–10,&gt;10) has been observed neither with DFS (ref.;HR 0.98;HR 1.17) nor OS (ref.;HR 0.98;HR 1.15) (<em>p &gt; 0.05</em>). Patients with anticoagulants experienced significantly more grade 3/4 adverse events (AEs) (75.9 % vs 64.8 %, <em>p = 0.002</em>) and treatment discontinuations due to toxicity (17.7 % vs 10.8 %, <em>p = 0.005</em>) compared to patients without anticoagulants.</div></div><div><h3>Discussion</h3><div>Early CC patients with polypharmacy do not generally exhibit an impaired outcome. Anticoagulation was the only CM category associated with a shorter DFS and OS which might be a consequence of enhanced toxicities necessitating treatment adaptations in these patients.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"227 ","pages":"Article 115643"},"PeriodicalIF":7.6,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144655912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter Re: Patient-reported outcomes with adjuvant nivolumab versus placebo after complete resection of stage IIB/C melanoma in the randomized phase 3 CheckMate 76 K trial","authors":"Brigit van Dijk,&nbsp;Joséphine C. Janssen,&nbsp;Evalyn E.A.P. Mulder,&nbsp;Karlijn de Joode,&nbsp;Astrid A.M. van der Veldt","doi":"10.1016/j.ejca.2025.115635","DOIUrl":"10.1016/j.ejca.2025.115635","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"227 ","pages":"Article 115635"},"PeriodicalIF":7.6,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144655914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Successful full-dose rechallenge after fruquintinib-associated posterior reversible encephalopathy syndrome","authors":"Georgios Ioannidis,&nbsp;Maria Pittaka,&nbsp;Maro Kleridou,&nbsp;Athena G. Skoulariki,&nbsp;George D. Vavougios","doi":"10.1016/j.ejca.2025.115646","DOIUrl":"10.1016/j.ejca.2025.115646","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"226 ","pages":"Article 115646"},"PeriodicalIF":7.6,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144631891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of trifluridine/tipiracil plus bevacizumab on tumor shrinkage and depth of response in refractory metastatic colorectal cancer: analysis of the SUNLIGHT trial","authors":"Julien Taieb ,&nbsp;Dominik P. Modest ,&nbsp;Marwan Fakih ,&nbsp;Fortunato Ciardiello ,&nbsp;Eric Van Cutsem ,&nbsp;Elena Elez ,&nbsp;Cristina Gravalos ,&nbsp;Arinilda Campos Bragagnoli ,&nbsp;Valentine Barboux ,&nbsp;Lucas Roby ,&nbsp;Nadia Amellal ,&nbsp;Gerald W. Prager","doi":"10.1016/j.ejca.2025.115644","DOIUrl":"10.1016/j.ejca.2025.115644","url":null,"abstract":"<div><h3>Objectives</h3><div>This <em>post hoc</em> analysis of the SUNLIGHT trial sought to assess the response to treatment with trifluridine/tipiracil (FTD/TPI) + bevacizumab and FTD/TPI in patients with refractory metastatic colorectal cancer using tumor shrinkage (TS), early TS (ETS), duration of TS (DTS) and depth of response (DpR) as response-related parameters.</div></div><div><h3>Methods</h3><div>TS was defined as any decrease from baseline of the sum of the longest diameter of target lesions. TS at first assessment was specified as ETS. DpR was defined as the maximum percentage change from baseline of the sum of the longest diameters of target lesions. DTS was defined as the time from first TS to first increase in tumor size, progressive disease, or death.</div></div><div><h3>Results</h3><div>In the FTD/TPI + bevacizumab group, 48 % had TS and 39 % had ETS. In the FTD/TPI group, 21 % had TS and 17 % had ETS. In patients achieving ETS, median DTS was prolonged with FTD/TPI + bevacizumab compared to FTD/TPI (3.8 versus 2.1 months; HR: 0.34 [95 % CI: 0.22, 0.53]; P &lt; 0.0001). Magnitude of DpR was greater with FTD/TPI + bevacizumab than with FTD/TPI.</div></div><div><h3>Conclusion</h3><div>The survival benefit of treatment with FTD/TPI + bevacizumab versus FTD/TPI is likely associated with the improvement of ETS and DpR.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"227 ","pages":"Article 115644"},"PeriodicalIF":7.6,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144672541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Paediatric strategy forum for medicinal product development of cyclin-dependent kinase inhibitors in children and adolescents ACCELERATE in collaboration with the European Medicines Agency With participation of the Food and Drug Administration","authors":"Andrew DJ Pearson ,&nbsp;Susan Chi ,&nbsp;Theodore W. Laetscht ,&nbsp;Lynley Marshall ,&nbsp;Elizabeth Raetz ,&nbsp;Rani E. George ,&nbsp;Louis Chesler ,&nbsp;Dominik Karres ,&nbsp;Nicole Scobie ,&nbsp;Holly Knoderer ,&nbsp;Brenda Weigel ,&nbsp;David Teachey ,&nbsp;Gabe S. Sonke ,&nbsp;Nita Seibel ,&nbsp;Alberto Pappo ,&nbsp;Karsten Nysom ,&nbsp;Jodi Muscal ,&nbsp;Jan Molenaar ,&nbsp;Joe McDonough ,&nbsp;Margaret E. Macy ,&nbsp;Gilles Vassal","doi":"10.1016/j.ejca.2025.115629","DOIUrl":"10.1016/j.ejca.2025.115629","url":null,"abstract":"<div><div>The twelfth multi-stakeholder Paediatric Strategy focused on cyclin-dependent kinase (CDK) inhibitors. Genetic aberrations in paediatric tumours increase CDK4/6 activity, thus the pathway is a therapeutic target. As a result, CDK4/6 inhibitors have been evaluated in clinical trials for children and young adults with different malignancies, both as single agents and in combination, including molecular enrichment in ESMART. In some instances, trials of different agents within this same class are very similar in design or target population, leading to duplication. Consistent with preclinical data with CDK4/6 inhibitors which mostly demonstrate cytostasis, but not tumour regression, objective responses are rare, although there may be slowing of tumour growth. Similar to adults, no predictive biomarkers have been identified and an integrated comprehensive clinical development strategy of this class of agents is lacking. Patient advocates believe that the many trials of CDK4/6 inhibitors, which have enrolled many children and young people, have not been matched by sufficient gains in knowledge. CDK9, CDK12 and CDK13 inhibitors, based on exploitation of transcriptional vulnerabilities, have shown promise in preclinical models of <em>MYCN-</em>driven neuroblastoma, osteosarcoma and translocation fusion-driven malignancies. The development of these inhibitors should be sequential, iterative and coordinated, including early engagement with regulators. In conclusion, there needs to be prioritisation and coordination of any further development of CDK4/6 inhibitors in paediatric malignancies. Definite tumour regression in preclinical models, not just cytostasis, should be taken as the go/no go decision point to progress such agents to clinical studies. Based on limited single agent activity in preclinical models, trials of new inhibitors should avoid unnecessary exposure of patients to monotherapy and rapidly progress to combination strategies, while retaining designs that allow early evaluation of activity. A framework to support integrated development strategies of new products across sponsors would be very beneficial.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"226 ","pages":"Article 115629"},"PeriodicalIF":7.6,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144656210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unlocking clinical quantum oncology through quantum control","authors":"Bruno F.E. Matarèse,&nbsp;Arnie Purushotham","doi":"10.1016/j.ejca.2025.115632","DOIUrl":"10.1016/j.ejca.2025.115632","url":null,"abstract":"<div><div>Quantum technologies present a transformative frontier for oncology, promising significant advancements in diagnostics, treatment precision, and drug discovery. The clinical realization of this potential is fundamentally reliant on mastering quantum control—the precise manipulation of quantum systems. This perspective details how quantum control is integral across emerging quantum oncology applications, potentially enhancing quantum imaging and quantum sensing by boosting signal sensitivity, improving clarity (e.g., fivefold Signal to Noise Ratio increase), and enabling subcellular visualization. In quantum omics, it could facilitate precise single-cell analysis and drive quantum machine learning for advanced biomarker discovery and validation. For treatment, such precise manipulation could optimise radiation targeting in quantum radiotherapy, could enable real-time tracking for precise quantum surgery, guide targeted delivery in quantum chemotherapy via controlled nanoparticle release, and could enhance the design and precision of quantum immunotherapy and personalised therapies. Overcoming challenges such as coherence and scalability is necessary, but advancements in quantum control are paramount for translating these capabilities into clinical benefits, ultimately improving cancer diagnosis and patient outcomes.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"226 ","pages":"Article 115632"},"PeriodicalIF":7.6,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144604827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Baseline D-dimers as predictive marker of efficacy of cemiplimab treatment in cutaneous squamous cell carcinoma","authors":"Glenn Geidel ,&nbsp;Laura Adam ,&nbsp;Sabrina Bänsch ,&nbsp;Nathan Fekade ,&nbsp;Sarah Degenhardt ,&nbsp;Alessandra Rünger ,&nbsp;Julian Kött ,&nbsp;Tim Zell ,&nbsp;Isabel Heidrich ,&nbsp;Daniel J. Smit ,&nbsp;Rüdiger Greinert ,&nbsp;Beate Volkmer ,&nbsp;Klaus Pantel ,&nbsp;Peter Mohr ,&nbsp;Axel Hauschild ,&nbsp;Stefan W. Schneider ,&nbsp;Christoffer Gebhardt","doi":"10.1016/j.ejca.2025.115639","DOIUrl":"10.1016/j.ejca.2025.115639","url":null,"abstract":"<div><h3>Background</h3><div>Cutaneous squamous cell carcinoma (cSCC) is the second most frequent skin cancer. In locally advanced and metastatic cases, the PD-1 inhibitor cemiplimab has transformed treatment, with response rates around 50 %. Despite its success, predictive biomarkers remain an unmet clinical need. D-dimer levels have been associated with poor outcomes in various cancers but have not been studied in cSCC.</div></div><div><h3>Objectives</h3><div>To assess the potential of serum D-dimer levels as predictive and monitoring biomarkers for disease control in advanced cSCC patients receiving cemiplimab.</div></div><div><h3>Methods</h3><div>In this retrospective monocentric study, 45 advanced cSCC patients treated with cemiplimab were analyzed. D-dimer levels before and during treatment were correlated with clinical disease control data. Clinical characteristics, including cardiovascular disease and anticoagulatory medication, were monitored and mapped among groups.</div></div><div><h3>Results</h3><div>Elevated baseline D-dimer levels were significantly associated with reduced time to progression (TTP; HR 3.46, <em>p</em> = 0.007). Multivariable logistic regression showed that high baseline D-dimers independently predicted lower disease control rate (DCR; OR 0.13, <em>p</em> = 0.011) and overall response rate (ORR; OR 0.06, <em>p</em> = 0.0182). After treatment start, D-dimer levels did not significantly correlate with response metrics.</div></div><div><h3>Conclusions</h3><div>High pre-treatment D-dimer levels are an independent predictive biomarker for reduced DCR and ORR in advanced cSCC patients treated with cemiplimab. On-treatment D-dimer levels did not exhibit discriminatory value as a monitoring biomarker in this real-world cohort. Further studies are needed to confirm the role of D-dimer levels in response prediction in advanced cSCC.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"226 ","pages":"Article 115639"},"PeriodicalIF":7.6,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144613920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brain metastases from Merkel cell carcinoma: A nationwide retrospective study","authors":"Raphaëlle Caillot ,&nbsp;Astrid Blom ,&nbsp;Céleste Lebbé ,&nbsp;Laetitia Da Meda ,&nbsp;Marie Boileau ,&nbsp;Caroline Dutriaux ,&nbsp;Benoit Guillon ,&nbsp;Florence Granel-Brocard ,&nbsp;Manuelle Viguier ,&nbsp;Candice Lesage ,&nbsp;Charlée Nardin ,&nbsp;Sandrine Mansard ,&nbsp;Clément Charpentier ,&nbsp;Ouidad Zehou ,&nbsp;Caroline Gaudy-Marqueste ,&nbsp;Delphine Legoupil ,&nbsp;Benoit Minart ,&nbsp;Alice Kieny ,&nbsp;Henri Montaudié ,&nbsp;Jean-Matthieu L'orphelin ,&nbsp;Mahtab Samimi","doi":"10.1016/j.ejca.2025.115637","DOIUrl":"10.1016/j.ejca.2025.115637","url":null,"abstract":"<div><h3>Background</h3><div>Merkel cell carcinoma (MCC) is an aggressive skin cancer causing distant metastases in 30 % of cases but rarely involving the brain. PD-1/PD-L1 inhibitors constitute the standard treatment of advanced MCC but their impact on brain metastases is unknown.</div></div><div><h3>Methods</h3><div>This retrospective study included MCC patients with central nervous system (CNS) metastases from the French CARADERM registry and the Groupe de Cancérologie Cutanée network. Primary objective was to assess CNS metastases incidence. Secondary objectives included response and survival.</div></div><div><h3>Results</h3><div>Among 1056 MCC patients, CNS metastases incidence was 0.3 % at baseline and 2.6 % throughout the disease course, reaching 7.0 % in stage IV patients. In 37 patients with CNS metastases, median time from diagnosis to CNS metastases was 15.7 months. Extra-CNS metastases preceded CNS involvement (n = 23) with a median delay of 7.3 months. PD-1/PD-L1 inhibitors were administered before (n = 20) and/or after (n = 23) CNS metastases onset. Intra-cranial responses (n = 15) occurred regardless of prior treatment before CNS metastases. Most (9/15) occurred following stereotactic radiosurgery (SRS) plus immunotherapy, with longer median response duration (15.3 months) versus other treatments (5.1 months). Of prior PD-1/PD-L1 complete responders, 4/6 achieved intracranial response. Median OS and PFS after CNS metastases were 6.6 months and 4.7 months, respectively. PD-1/PD-L1 inhibitors and SRS were associated with improved survival in univariate analysis.</div></div><div><h3>Conclusion</h3><div>CNS metastases are rare, late, and often fatal. PD-1/PD-L1 inhibitors with SRS are likely to constitute the optimal treatment. The quality of response to PD-1/PD-L1 inhibitors prior to CNS metastases predicts intracranial disease control.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"227 ","pages":"Article 115637"},"PeriodicalIF":7.6,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144694849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Circulating tumour DNA to augment PET-CT in determining clinical outcome after head and neck cancer treatment","authors":"Sumrit Bola ,&nbsp;Anthony Cutts ,&nbsp;Dimitris Vavoulis ,&nbsp;Manu Shrivastava ,&nbsp;Shaheel Bhuva ,&nbsp;Anna Schuh ,&nbsp;Ketan Shah ,&nbsp;Stuart C. Winter ,&nbsp;Jenny C. Taylor","doi":"10.1016/j.ejca.2025.115626","DOIUrl":"10.1016/j.ejca.2025.115626","url":null,"abstract":"<div><h3>Aim</h3><div>PET-CT and MRI are used to assess disease response after head and neck cancer treatment. Equivocal findings can delay the potential for salvage curative treatment or result in over- treatment with further surgery. The aims of this study were to establish if liquid biopsy (LB) of circulating tumour DNA, could be used to aid decision-making after treatment.</div></div><div><h3>Method</h3><div>Patients (n = 41) undergoing chemoradiotherapy (CRT) and surgical treatment had serial blood testing; pre-treatment and 10–12 weeks post-treatment, alongside imaging. PET-CT/MRIs were categorised as Cancer, Equivocal or Complete Response and true disease status was determined retrospectively. A bespoke 17-gene panel and probes targeting 5 HPV subtypes were used for next-generation sequencing in the ctDNA assay.</div></div><div><h3>Results</h3><div>PET-CT was equivocal in 13/27 CRT patients; sensitivity and specificity for determining true disease status was 67 % and 42 % respectively. LB performed better at determining true disease status than PET-CT post-treatment in CRT patients; sensitivity and specificity of 83 % and 95 % respectively. A combined LB/PET/MRI test performed better than imaging alone; sensitivity and specificity of 100 % and 90 % respectively. The improved specificity was statistically significant (Fisher’s exact test OR=7.1; 95 % CI:1.6–45.8, p = 0.0005), as was the balanced accuracy (Welch’s t-test, p &lt; 0.0001).</div></div><div><h3>Conclusion</h3><div>LB outperformed PET-CT at determining true disease status after CRT and could complement post-treatment imaging in CRT and surgical patients, playing a potential role in decision-making after treatment.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"227 ","pages":"Article 115626"},"PeriodicalIF":7.6,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144686922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness analysis of perioperative durvalumab plus platin-based chemotherapy in muscle invasive bladder cancer in Germany","authors":"Constantin Rieger ,&nbsp;Jörg Schlüchtermann ,&nbsp;Julian Heidenreich ,&nbsp;Olivia Steenbock ,&nbsp;Florian A. Schmid ,&nbsp;Richard Weiten ,&nbsp;Christian Bach ,&nbsp;David Pfister ,&nbsp;Axel Heidenreich","doi":"10.1016/j.ejca.2025.115621","DOIUrl":"10.1016/j.ejca.2025.115621","url":null,"abstract":"<div><h3>Background</h3><div>The NIAGARA trial evaluated the efficacy of adding perioperative immunotherapy with durvalumab to standard gemcitabine/cisplatin chemotherapy in muscle-invasive bladder cancer (MIBC). In light of the rising financial burden associated with the treatment of urothelial carcinoma and the favorable clinical outcomes reported in the NIAGARA trial, we conducted a cost-effectiveness analysis based on clinical data to determine whether the inclusion of durvalumab is also justified from a socioeconomic standpoint in Germany.</div></div><div><h3>Methods</h3><div>We constructed a Markov model from the payer’s perspective, incorporating clinical data derived from the NIAGARA trial. A Monte Carlo simulation was employed to determine the most cost-effective treatment strategy within the context of the German healthcare system. Lastly, we compared the incremental cost-effectiveness ratios (ICERs) of each treatment approach across varying willingness-to-pay (WTP) thresholds.</div></div><div><h3>Results</h3><div>The average cost associated with the standard of care (SoC) was €113,224, whereas the combination of durvalumab with gemcitabine/cisplatin resulted in an average cost of €126,386, leading to incremental costs of €13,162. The quality-adjusted life years (QALYs) gained were 3.16 for the SoC and 3.37 for the intervention, corresponding to an incremental effectiveness of 0.21 QALYs. The resulting ICER for the combination therapy was €61,006 per QALY. At a WTP threshold of €100,000, the addition of durvalumab to gemcitabine/cisplatin is the preferred treatment option, with a 76.5 % probability of being cost-effective. A significant proportion of the costs observed in the simulations was attributable to the expenses associated with subsequent therapies administered in the metastatic disease setting.</div></div><div><h3>Conclusion</h3><div>Based on our findings, the incorporation of durvalumab into the perioperative treatment regimen constitutes a cost-effective strategy, primarily due to its potential to reduce the need for high-cost subsequent therapies in a proportion of patients. Consequently, an intensified therapeutic approach for MIBC may confer not only oncological advantages but also notable socioeconomic benefits.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"227 ","pages":"Article 115621"},"PeriodicalIF":7.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144749714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}