ESMO Open最新文献

{"title":"Response to letter re: The prognostic and predictive value of the luminal-like subtype in hormone receptor-positive breast cancer: an analysis of the DATA trial","authors":"S.W.M. Lammers, V.C.G. Tjan-Heijnen, S.M.E. Geurts, I.J.H. Vriens","doi":"10.1016/j.esmoop.2025.105068","DOIUrl":"10.1016/j.esmoop.2025.105068","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105068"},"PeriodicalIF":7.1,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143839353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to letter re: Ethnic origin in cancer clinical trials: overrated or understated? A comprehensive analysis of cancer clinical trials leading to FDA and EMA approvals between 2020 and 2022","authors":"H.C. Puhr , E.C. Winkler , M. Preusser","doi":"10.1016/j.esmoop.2025.105063","DOIUrl":"10.1016/j.esmoop.2025.105063","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105063"},"PeriodicalIF":7.1,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143828707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to letter: a critical appraisal of the DATA trial analysis on the prognostic and predictive value of the luminal-like subtype","authors":"S.W.M. Lammers, V.C.G. Tjan-Heijnen, S.M.E. Geurts, I.J.H. Vriens","doi":"10.1016/j.esmoop.2025.105070","DOIUrl":"10.1016/j.esmoop.2025.105070","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105070"},"PeriodicalIF":7.1,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143828706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Differential benefit of adjuvant everolimus according to endocrine therapy backbone in the randomized UNIRAD trial","authors":"M. Saint-Ghislain ,&nbsp;S. Chabaud ,&nbsp;F. Dalenc ,&nbsp;D. Allouache ,&nbsp;D. Cameron ,&nbsp;M. Martinez ,&nbsp;J. Grenier ,&nbsp;P. Barthelemy ,&nbsp;M. Brunt ,&nbsp;L. Kaluzinski ,&nbsp;A. Mailliez ,&nbsp;E. Legouffe ,&nbsp;A.-C. Hardy-Bessard ,&nbsp;S. Giacchetti ,&nbsp;M.-A. Mouret-Reynier ,&nbsp;J.-L. Canon ,&nbsp;J. Bliss ,&nbsp;J. Lemonnier ,&nbsp;F. Andre ,&nbsp;T. Bachelot ,&nbsp;P. Cottu","doi":"10.1016/j.esmoop.2025.105050","DOIUrl":"10.1016/j.esmoop.2025.105050","url":null,"abstract":"<div><h3>Background</h3><div>The randomized, double-blind UNIRAD trial evaluating the addition of 2 years of everolimus to endocrine therapy in patients with high-risk, early luminal breast cancer failed to demonstrate a benefit. We report the subgroup analyses.</div></div><div><h3>Patients and methods</h3><div>We randomly assigned 1278 patients in a 1 : 1 ratio to receive 2 years of placebo or everolimus, added to endocrine therapy for up to 4 years after initiation. Randomization was stratified by endocrine therapy agent, prior adjuvant versus neoadjuvant therapy, progesterone receptor expression, and lymph node involvement. Subgroup analyses by each stratification factor were pre-specified. <em>Post hoc</em> analyses were carried out according to menopausal status and age. Treatment adherence was also analyzed.</div></div><div><h3>Results</h3><div>We observed a limited trend toward more favorable prognostic features in tamoxifen-treated patients, with more frequent estrogen receptor-positive/progesterone receptor-positive tumors (88.5% versus 84.1%, <em>P</em> = 0.026) and less frequent pN2-positive status (39.8% versus 46.0%, <em>P</em> = 0.032). In premenopausal women, we observed a numerical benefit of everolimus: 3-year disease-free survival was 86% in the placebo group and 90% in the everolimus group (hazard ratio 0.76, 95% confidence interval 0.43-1.34). In premenopausal patients treated with tamoxifen (<em>n</em> = 153; 12.3%), we observed an even stronger trend in favor of everolimus as 3-year DFS was 84% in the placebo group and 91% in the everolimus group (hazard ratio 0.54, 95% confidence interval 0.28-1.02). Early discontinuation of either everolimus or placebo was less frequent in the tamoxifen group than in the aromatase inhibitor group: 48.0% versus 56.9% (<em>P</em> = 0.028).</div></div><div><h3>Conclusions</h3><div>The present <em>post hoc</em> analyses generate hypotheses regarding the interaction between menopausal status, tamoxifen, and everolimus in patients with high-risk, ER-positive, human epidermal growth factor receptor type 2-negative early breast cancer. They suggest that tamoxifen alone is an underpowered endocrine treatment in high-risk premenopausal patients.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105050"},"PeriodicalIF":7.1,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143829830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter re: A critical appraisal of the DATA trial analysis on the prognostic and predictive value of the luminal-like subtype","authors":"M. Rizk,&nbsp;K. Mokbel","doi":"10.1016/j.esmoop.2025.105067","DOIUrl":"10.1016/j.esmoop.2025.105067","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105067"},"PeriodicalIF":7.1,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143829832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systemic anticancer therapy near the end of life: an analysis of factors influencing treatment in advanced cancer patients","authors":"G. Fornas ,&nbsp;J. Montón-Bueno ,&nbsp;T. Tortajada ,&nbsp;P. Pérez ,&nbsp;A. Guimerá ,&nbsp;D. González ,&nbsp;B. Iglesias ,&nbsp;A. García ,&nbsp;N. Grimalt ,&nbsp;M. García ,&nbsp;I. González-Barrallo ,&nbsp;A.V. Monleón ,&nbsp;M.J. Molina-Garrido ,&nbsp;I. Chirivella ,&nbsp;A. Cervantes","doi":"10.1016/j.esmoop.2025.105064","DOIUrl":"10.1016/j.esmoop.2025.105064","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105064"},"PeriodicalIF":7.1,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143829831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Representation of geriatric oncology in cancer care guidelines in Europe: a scoping review by the International Society of Geriatric Oncology (SIOG)","authors":"I. Pinker ,&nbsp;C. Lafont ,&nbsp;G. Liposits ,&nbsp;R. Vidra ,&nbsp;A.J. Cunquero-Tomás ,&nbsp;E. Korobeinikova ,&nbsp;N.R. Neuendorff ,&nbsp;V. Slavova-Boneva ,&nbsp;J. Baltussen ,&nbsp;M. Chovanec ,&nbsp;F. Coutinho ,&nbsp;R. Dubianski ,&nbsp;U. Janzic ,&nbsp;C. Kenis ,&nbsp;I. Kukec ,&nbsp;Z. Küronya ,&nbsp;K. Lehtomäki ,&nbsp;C.M. Eochagain ,&nbsp;E. Osterlund ,&nbsp;P. Osterlund ,&nbsp;S. Pilleron","doi":"10.1016/j.esmoop.2025.105052","DOIUrl":"10.1016/j.esmoop.2025.105052","url":null,"abstract":"<div><h3>Introduction</h3><div>Implementation of national cancer policy is frequently shaped by medical guidelines. These guidelines often lack detail addressing the intricate care needs of vulnerable groups such as older adults, hindering the potential impact of these policies.</div></div><div><h3>Objective</h3><div>To provide an overview of the representation of older adults in European cancer guidelines to identify areas for improvement.</div></div><div><h3>Methods</h3><div>A scoping review was conducted using the Arksey and O’Malley framework and Levac et al. extension. The search strategy was developed for grey literature (i.e. guidelines) for the five most prevalent primary malignancies (prostate, breast, colorectal, lung, and urinary bladder) in 29 countries (member states of the European Union, Switzerland, and the UK). Data were extracted by a national expert and at least one other reviewer.</div></div><div><h3>Results</h3><div>A total of 187 guideline reports from 31 jurisdictions were analysed, encompassing general cancer care and selected primary malignancies. The representation of older adults varied by cancer type and region. Dedicated guidelines for older adults were uncommon, with only a few jurisdictions, such as France and Spain, providing age-specific recommendations for certain malignancies. Although some national guidelines addressed older patients, this focus was inconsistent both across different cancers and within the guidelines of the same country.</div></div><div><h3>Conclusions</h3><div>There is limited representation of geriatric oncology across European cancer guidelines. To enhance representative guideline development, there is a call for greater consideration of older adults’ unique needs. Suggestions include further guidance on the implementation of the comprehensive geriatric assessment and consequent treatment across neoadjuvant, adjuvant, and metastatic settings.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105052"},"PeriodicalIF":7.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter re: Ethnic origin in cancer clinical trials: overrated or understated?—A comprehensive analysis of cancer clinical trials leading to FDA and EMA approvals between 2020 and 2022","authors":"M. von Lilienfeld-Toal ,&nbsp;S. Agkatsev ,&nbsp;A. Glasmacher ,&nbsp;P. Reiß ,&nbsp;S. Sen ,&nbsp;A. Seltmann ,&nbsp;S. Wolf","doi":"10.1016/j.esmoop.2025.105062","DOIUrl":"10.1016/j.esmoop.2025.105062","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105062"},"PeriodicalIF":7.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143816065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exposure–response relationship of niraparib in maintenance therapy for recurrent ovarian cancer: ancillary analysis of the French GINECO–NiQoLe study","authors":"S. Quesada ,&nbsp;A. Puszkiel ,&nbsp;A. Jouinot ,&nbsp;R. Thomas ,&nbsp;E. Kalbacher ,&nbsp;P. Follana ,&nbsp;A.-C. Hardy-Bessard ,&nbsp;P.-E. Brachet ,&nbsp;P. Combe ,&nbsp;F. Selle ,&nbsp;C. Lebreton ,&nbsp;P. Fournel ,&nbsp;D. Mille ,&nbsp;J. Alexandre ,&nbsp;T. Grellety ,&nbsp;S. Emambux ,&nbsp;D. Le Roux ,&nbsp;D. Spaeth ,&nbsp;M. Fabbro ,&nbsp;F. Joly ,&nbsp;B. Blanchet","doi":"10.1016/j.esmoop.2025.105054","DOIUrl":"10.1016/j.esmoop.2025.105054","url":null,"abstract":"<div><h3>Background</h3><div>Interindividual variability in pharmacokinetics may influence clinical outcomes of niraparib in patients with platinum-sensitive recurrent ovarian cancer (ROC). We aimed to investigate the pharmacokinetic–pharmacodynamic (PK–PD) relationship of niraparib in 49 patients with ROC from the multicenter phase IV NiQoLe study.</div></div><div><h3>Materials and methods</h3><div>Steady-state trough concentrations (C_min,ss) on days 8 (D8) and 90 (D90) after treatment initiation were analyzed in the PK–PD analysis in regard to early dose-limiting toxicity (DLT) during the first 3 months of treatment, self-reported adverse events [Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)], and progression-free survival (PFS). Logistic regression and Cox proportional hazards models were used to identify risk factors of toxicity and predictors of PFS, respectively.</div></div><div><h3>Results</h3><div>The starting dose was 200 mg/day in 39 patients (80%). Nineteen patients (39%) experienced early DLT. In multivariable analysis, the fourth quartile (Q4) of C_min,ss at D8 (≥686 ng/ml) was identified as an independent risk factor for early DLT [odds ratio (OR) 27.92, 95% confidence interval (CI) 1.99-392.53, <em>P</em> = 0.014] in contrast to the starting dose (OR 0.44, 95% CI 0.04-4.76, <em>P</em> = 0.50). High C_min,ss at D8 was also associated with grade ≥2 self-reported adverse events, including nausea (<em>P</em> = 0.03) and fatigue (<em>P</em> = 0.02). In univariate analysis, PFS was associated neither with the 200-mg starting dose [hazard ratio (HR) 1.25, 95% CI 0.59-2.62, <em>P</em> = 0.57] nor with C_min,ss at D8 (HR 1.03, 95% CI 0.90-1.19, <em>P</em> = 0.65). No difference in PFS was observed between Q4 and Q1-Q3 for C_min,ss at D8 [174 days (95% CI 120 days-not reached) versus 242 days (95% CI 183-490 days), respectively; HR 1.15, 95% CI 0.57-2.36, <em>P</em> = 0.69]. Median PFS in patients who had a dose reduction was consistent with that of patients who remained at the starting dose [197 days (95% CI 166 days-not reached) versus 207 days (95% CI 176-469 days), respectively; log-rank <em>P</em> value = 0.29].</div></div><div><h3>Conclusions</h3><div>Increased plasma exposure at D8 (C_min,ss ≥686 ng/ml) was associated with a higher risk of early DLT onset and patient-reported outcomes adverse events, without gain of efficacy in regard to PFS. Early plasma drug monitoring may be useful to prevent niraparib toxicity in patients with ROC treated in the maintenance phase.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 105054"},"PeriodicalIF":7.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143815946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “An open-label, phase IB/II study of abemaciclib with paclitaxel for tumors with CDK4/6 pathway genomic alterations”","authors":"K.H. Kim ,&nbsp;C. Park ,&nbsp;S.-H. Beom ,&nbsp;M.H. Kim ,&nbsp;C.G. Kim ,&nbsp;H.R. Kim ,&nbsp;M. Jung ,&nbsp;S.J. Shin ,&nbsp;S.Y. Rha ,&nbsp;H.S. Kim","doi":"10.1016/j.esmoop.2025.104542","DOIUrl":"10.1016/j.esmoop.2025.104542","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 5","pages":"Article 104542"},"PeriodicalIF":7.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143815948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}