ESMO Real World Data and Digital Oncology最新文献

{"title":"Characterisation of oncology EHR-derived real-world data in the UK, Germany, and Japan","authors":"B. Adamson ,&nbsp;E. Horne ,&nbsp;C. Xu ,&nbsp;A. Samani ,&nbsp;C. Buhl ,&nbsp;P. Mpofu ,&nbsp;H. Pittell ,&nbsp;Q. Zhang ,&nbsp;D. Ng ,&nbsp;K. Seidl-Rathkopf ,&nbsp;N. Schinwald ,&nbsp;E. Tajima ,&nbsp;A. Sujenthiran","doi":"10.1016/j.esmorw.2025.100113","DOIUrl":"10.1016/j.esmorw.2025.100113","url":null,"abstract":"<div><div>Oncology real-world data (RWD) from electronic health records (EHRs) can generate real-world evidence crucial for clinical and policy decisions. However, challenges in accessing and harmonising data across countries limit its global applicability. Flatiron Health has developed oncology EHR-derived RWD datasets in the UK, Germany, and Japan, integrating these with its United States database to support multinational studies. This paper outlines the methods, aligned with the ISPOR EHR-derived data SUITABILITY checklist, to ensure the trustworthiness, reliability, and relevance of these datasets.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100113"},"PeriodicalIF":0.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143360558","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}

{"title":"Utility of automated data transfer for cancer clinical trials and considerations for implementation","authors":"M. Pfeffer ,&nbsp;M. Deneris ,&nbsp;A. Shelley ,&nbsp;P. Salcuni ,&nbsp;I. Altomare","doi":"10.1016/j.esmorw.2025.100112","DOIUrl":"10.1016/j.esmorw.2025.100112","url":null,"abstract":"<div><h3>Background</h3><div>The burden of data collection on site staff for cancer clinical trials is steadily increasing, and inefficiencies in data entry into electronic data capture (EDC) systems lead to poor data quality and delays in reporting. Software that facilitates automated transfer of mapped structured data from the electronic health record (EHR) to EDC can help to address these challenges.</div></div><div><h3>Materials and methods</h3><div>We examined the impact of multi-site usage of an embedded point and click EHR-to-EDC tool on study data capture across multiple phase I cancer clinical trials by conducting a retrospective analysis of volume of and time for data transfer across protocols.</div></div><div><h3>Results</h3><div>During a 15-month observation period, the EHR-to-EDC tool was used to transfer 11 342 individual data points (89% laboratory values, 8% vitals and 3% concomitant medications) representing 955 unique case report form (CRF) submissions. Use was consistent across protocols. The average time for a user to launch, complete and submit a CRF was 37 s (range 15-59 s).</div></div><div><h3>Conclusions</h3><div>This study demonstrates efficiencies in clinical trial conduct provided by EHR-to-EDC technology and supports growing adoption among sites and sponsors, while highlighting how variability in data standards and interoperability across EHR systems pose practical challenges to widespread implementation.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100112"},"PeriodicalIF":0.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143220018","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}

{"title":"Evolving treatment patterns and outcomes among patients with metastatic urothelial carcinoma post-avelumab maintenance approval: insights from The US Oncology Network","authors":"H. Li ,&nbsp;S. Sura ,&nbsp;A. Babcock ,&nbsp;L. Herms ,&nbsp;J. Guo ,&nbsp;P. Conkling ,&nbsp;S. Franco ,&nbsp;P. Singhal ,&nbsp;R. Mamtani ,&nbsp;M. Bupathi","doi":"10.1016/j.esmorw.2024.100110","DOIUrl":"10.1016/j.esmorw.2024.100110","url":null,"abstract":"<div><h3>Background</h3><div>The addition of immune checkpoint inhibitors (ICIs) and antibody–drug conjugates into the metastatic urothelial cancer (mUC) treatment landscape has advanced therapeutic strategies beyond platinum-based chemotherapy (PBT). We evaluated real-world treatment patterns and overall survival (OS) among mUC patients during the period between maintenance avelumab (maintA) and enfortumab vedotin plus pembrolizumab approvals in the United States.</div></div><div><h3>Materials and methods</h3><div>This retrospective cohort study utilized structured and chart review data from iKnowMed, a United States community oncology electronic health record database, to identify adult mUC patients initiating first-line (1L) anticancer treatment (index date) between April 2020 and September 2022. Patients were followed from the index date until March 2023, the last patient visit, or death, whichever occurred first. Descriptive statistics were used to report treatment patterns. Kaplan–Meier methods were used to assess OS.</div></div><div><h3>Results</h3><div>A total of 597 patients initiated 1L treatments (ICI monotherapy: 47.9%, PBT: 40.7%, other: 11.4%). The median age at diagnosis was 74 years, and 76.9% were male. Among patients receiving 1L PBT, 39.5% received maintA. Among those who were not on prior treatment at the end of the follow-up, 32.7% and 11.3% of 1L-treated patients received second-line and third-line treatment. The median OS from the index date for 1L-treated patients was 11.8 months (95% confidence interval 10.4-14.2 months).</div></div><div><h3>Conclusions</h3><div>Despite the approval of maintenance therapy, prognoses for mUC patients remained poor. ICI monotherapy continues to be a common option in 1L. Many 1L patients did not have an opportunity to receive subsequent treatment, highlighting the continuing unmet need for mUC patients.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100110"},"PeriodicalIF":0.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154397","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}

{"title":"Collaborating across sectors in service of open science, precision oncology, and patients: an overview of the AACR Project GENIE (Genomics Evidence Neoplasia Information Exchange) Biopharma Collaborative (BPC)","authors":"A. Acebedo ,&nbsp;P.L. Bedard ,&nbsp;S. Brown ,&nbsp;E. Ceca ,&nbsp;M. Fiandalo ,&nbsp;H. Fuchs ,&nbsp;X. Guo ,&nbsp;J.N. Hoppe ,&nbsp;K.L. Kehl ,&nbsp;R. Kundra ,&nbsp;J.A. Lavery ,&nbsp;M.L. LeNoue-Newton ,&nbsp;E. Lepisto ,&nbsp;B. Mastrogiacomo ,&nbsp;C.M. Micheel ,&nbsp;C. Nayan ,&nbsp;A. Newcomb ,&nbsp;C. Nichols ,&nbsp;K.S. Panageas ,&nbsp;B. Piening ,&nbsp;C. Yu","doi":"10.1016/j.esmorw.2024.100097","DOIUrl":"10.1016/j.esmorw.2024.100097","url":null,"abstract":"<div><div>The American Association for Cancer Research (AACR) Project GENIE (Genomics Evidence Neoplasia Information Exchange) Biopharma Collaborative (BPC) is a multi-phase, pre-competitive collaboration between 10 biopharmaceutical companies and select GENIE-participating academic institutions, focused on detailed clinical annotations of a subset of patients within the GENIE Registry. The cohorts focus on 10 solid tumors, and each integrates demographic, diagnosis, genomic, and treatment data with longitudinal, real-world patient outcomes. Data are collected following a structured framework to ensure interoperability and forward compatibility with other data models. Each cohort undergoes a series of rigorous quality control and assurance protocols which ensures consistency, accuracy, and reliability of the data across multiple institutions before public release of the data. Initial analyses of the BPC data have yielded valuable insights, including the validation of treatment-induced resistance mutations and genomic drivers associated with anatomic sites of metastasis. Additionally, the real-world response endpoints compare favorably to published trial results. Central management and a shared knowledgebase help integrate diverse functional teams in the execution of a complex, multi-institutional data collection effort. Future directions aim to automate significant portions of the clinical annotation process to collect clinical data at scale. These efforts will increase the depth and granularity of the BPC data, as well as expand the overall cohort size and range of cancer types represented.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100097"},"PeriodicalIF":0.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154395","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}

{"title":"Data analytics for real-world data integration in TKI-treated NSCLC patients using electronic health records","authors":"L. Mazzeo ,&nbsp;F. Corso ,&nbsp;P. Baili ,&nbsp;F. Scotti ,&nbsp;V. Torri ,&nbsp;M. Ganzinelli ,&nbsp;V. Mišković ,&nbsp;R. Leporati ,&nbsp;L. Provenzano ,&nbsp;A. Spagnoletti ,&nbsp;C. Silvestri ,&nbsp;C. Giani ,&nbsp;C. Cavalli ,&nbsp;R.M. di Mauro ,&nbsp;M. Meazza Prina ,&nbsp;C. Proto ,&nbsp;M. Brambilla ,&nbsp;M. Occhipinti ,&nbsp;S. Manglaviti ,&nbsp;T. Beninato ,&nbsp;A. Prelaj","doi":"10.1016/j.esmorw.2024.100109","DOIUrl":"10.1016/j.esmorw.2024.100109","url":null,"abstract":"<div><h3>Background</h3><div>Real-world data (RWD) are routinely collected in clinical practice during therapeutic interventions. Data warehouses (DWHs) represent the primary source of RWD in which electronic health records (EHRs) can be rapidly analyzed via natural language processing. This study illustrates an analytic framework that systematically exploits RWD and methods to generate real-world evidence (RWE) about innovative cancer drugs. The framework has been applied to investigate real-world treatment patterns and clinical outcomes of patients with advanced non-small-cell lung cancer (aNSCLC) treated with tyrosine kinase inhibitors (TKIs).</div></div><div><h3>Materials and methods</h3><div>Data from a cohort of 190 epidermal growth factor receptor-positive mutation (EGFRm) patients with aNSCLC were retrospectively collected in an Italian cancer institute between 2014 and 2022. Patients were treated in first-line (1L) with osimertinib or other TKIs (non-osimertinib). A text-mining algorithm was implemented to retrieve RWD from EHRs. Survival endpoints were median time to treatment discontinuation (mTTD) and median overall survival (mOS) estimated with Kaplan–Meier curves. Time-dependent multivariate Cox analysis was carried out to overcome immortal time bias.</div></div><div><h3>Results</h3><div>Approximately 38% of patients received 1L osimertinib, while the remaining 62% received previous-generation TKIs. Longer mTTD [15 months; 95% confidence interval (CI) 11.9-26.4 months] was found for patients treated with 1L osimertinib compared with non-osimertinib (10 months; 95% CI 7.9-13.1 months). In multivariate analysis, osimertinib was an independent protective factor regardless of bone and brain metastases and local radiotherapy. mOS was 27 months (95% CI 21.4-39.5 months) for osimertinib versus 20.2 months (95% CI 17.6-23.1 months) for non-osimertinib.</div></div><div><h3>Conclusions</h3><div>Data analytics frameworks are useful tools to integrate RWE in cancer research and data-driven models are suitable to process large amounts of RWD. This study demonstrates that real-world treatment patterns and outcomes of TKIs are comparable with those found in both clinical trials and other real-world studies. RWE studies can support clinicians in investigating the best treatment strategy and decision makers to drive new health policies.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100109"},"PeriodicalIF":0.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154234","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}

{"title":"Cardiovascular toxicities in cancer patients treated with immune checkpoint inhibitors: multicenter study using natural language processing on Belgian hospital data","authors":"D. Delombaerde ,&nbsp;C.L. Oeste ,&nbsp;V. Geldhof ,&nbsp;L. Croes ,&nbsp;I. Bassez ,&nbsp;A. Verbiest ,&nbsp;L. Tack ,&nbsp;D. Hens ,&nbsp;C. Franssen ,&nbsp;P.R. Debruyne ,&nbsp;H. Prenen ,&nbsp;M. Peeters ,&nbsp;J. De Sutter ,&nbsp;C. Vulsteke","doi":"10.1016/j.esmorw.2024.100111","DOIUrl":"10.1016/j.esmorw.2024.100111","url":null,"abstract":"<div><h3>Background</h3><div>Immune checkpoint inhibitor (ICI) use may be associated with diverse cardiovascular (CV) adverse events (AEs), but their baseline prevalence and incidence after ICI initiation are poorly known. We aimed to describe CV events using real-world hospital data from Belgian cancer patients.</div></div><div><h3>Materials and methods</h3><div>Electronic health records (EHRs) from patients receiving at least one ICI between March 2017 and August 2022 at three Belgian hospitals were processed into an Observational Medical Outcomes Partnership Common Data Model warehouse. Structured data were enriched with unstructured data that were processed using a natural language processing (NLP) pipeline. We analyzed CV events from first ICI administration until last follow-up, identifying and validating the first detection of a CV event at the patient level.</div></div><div><h3>Results</h3><div>We included 1571 patients (66% male, median age 67 years); CV events were detected in 196 (12.5%) patients [median (min-max) follow-up: 8 (0-63) months]. The CV AEs detected were heart failure (5.3%), atrial fibrillation (4.6%), myocardial infarction (2.0%), atrioventricular block (1.9%), myocarditis (1.2%), vasculitis (0.8%), pericarditis (0.4%), and Takotsubo cardiomyopathy (&lt;0.3%). Median time (min-max) to onset ranged from 109 days (17-849 days) for myocarditis to 529 days (91-967 days) for Takotsubo cardiomyopathy.</div></div><div><h3>Conclusions</h3><div>To our knowledge, this is the first study using a dataset enriched with NLP-processed EHRs that describes the frequency and onset time of CV events. CV event frequencies were higher than those reported in clinical trials, but similar to other real-world studies. However, we observed a later time to onset. Hence, clinicians should note that CV AEs can present in various ways and at any time during or after treatment.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100111"},"PeriodicalIF":0.0,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154398","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}

{"title":"Human epidermal growth factor receptor 2 (HER2) expression dynamics between diagnosis and recurrence in patients with breast cancer using artificial intelligence and electronic health records: the RosHER study","authors":"E. López-Miranda ,&nbsp;P. Tolosa-Ortega ,&nbsp;M.A. Perelló-Martorell ,&nbsp;L. Sánchez-Lorenzo ,&nbsp;C. Hinojo-González ,&nbsp;S. Servitja ,&nbsp;S. Recalde-Penabad ,&nbsp;C. Olier-Gárate ,&nbsp;J.A. Guerrero ,&nbsp;S. García-Vicente ,&nbsp;L. Mina ,&nbsp;D. Alcalá-López ,&nbsp;L. López-Montero ,&nbsp;C. Jiménez-Cortegana ,&nbsp;M. Sampayo-Cordero ,&nbsp;G. Antonarelli ,&nbsp;J.M. Pérez-García ,&nbsp;J. Cortés ,&nbsp;A. Llombart-Cussac","doi":"10.1016/j.esmorw.2024.100107","DOIUrl":"10.1016/j.esmorw.2024.100107","url":null,"abstract":"<div><h3>Background</h3><div>Human epidermal growth factor receptor 2 (HER2) is a treatment target in breast cancer (BC), driving therapeutic strategies. Changes over time in HER2 expression have been described and understanding of these fluctuations is crucial for personalized medicine. We aimed to assess HER2 expression dynamics using real-world data and natural language processing (NLP) from electronic health records (EHRs).</div></div><div><h3>Material and methods</h3><div>RosHER is a retrospective, observational, longitudinal, population-based, multicenter study (NCT05217381). An NLP tool extracted HER2 information from EHRs of adult patients with early, locally advanced, or <em>de novo</em> metastatic BC, who were initially diagnosed between 2005 and 2021. The primary endpoint was to evaluate HER2 dynamics in HER2 status and expression between initial diagnosis and recurrence or progression using NLP. The secondary endpoints were description of baseline clinicopathological characteristics and treatment patterns.</div></div><div><h3>Results</h3><div>Between January 2022 and November 2023, 18 533 patients were selected from seven Spanish sites. A cut-off of ≥6 months was established between initial determination and relapse or progression. The artificial intelligence (AI)-based tool identified 510 patients with two documented HER2 determinations and 209 with HER2 expression by immunohistochemistry/<em>in situ</em> hybridization. Overall discordances were 10.6% in HER2 status and 34.0% in HER2 expression. HER2-zero expression switched to HER2-low (23.2%), but not HER2-positive (0%); HER2-low expression converted to HER2-zero (32.0%) and HER2-positive (7.0%); finally HER2-positive expression switched to HER2-low (20.8%) and HER2-zero (15.1%).</div></div><div><h3>Conclusions</h3><div>This is the first study using NLP to evaluate HER2 discordances, which need to be further investigated. Improving AI methods and implementing similar EHR structures among hospitals would increase the success in clinical data extraction.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100107"},"PeriodicalIF":0.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154399","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}

{"title":"Off-label drug use in oncology: integrating molecular and genetic analysis in an academic center’s real-world approach","authors":"E. Cioli ,&nbsp;G. Suarato ,&nbsp;R. Napolitano ,&nbsp;F. Caraglia ,&nbsp;A. Esposito ,&nbsp;C.M. Giugliano ,&nbsp;S. Cozzolino ,&nbsp;M. Forte ,&nbsp;M.P. Laudato ,&nbsp;E. Martinelli ,&nbsp;F. De Vita ,&nbsp;F. Morgillo ,&nbsp;M. Orditura ,&nbsp;M. Fasano ,&nbsp;S. Napolitano ,&nbsp;C.M. Della Corte ,&nbsp;G. Martini ,&nbsp;F. Ciardiello ,&nbsp;T. Troiani ,&nbsp;V. De Falco","doi":"10.1016/j.esmorw.2024.100108","DOIUrl":"10.1016/j.esmorw.2024.100108","url":null,"abstract":"<div><h3>Background</h3><div>Recent advancements in cancer treatment have shifted the paradigm from chemotherapy to targeted therapies and immunotherapies, proving effective even in early-stage cancers. Regulatory agencies like the Food and Drug Administration, European Medicines Agency, and Italian Agency for Drugs have approved several targeted therapies for specific genetic mutations, significantly improving outcomes for several diseases. These advancements highlight the importance of identifying molecular targets, even in historically difficult-to-treat cancers.</div></div><div><h3>Materials and methods</h3><div>A retrospective observational study was conducted at the University of Campania “Luigi Vanvitelli” from January 2015 to January 2022, involving 83 adult patients with solid tumors. Patients received off-label drugs at no cost. The study analyzed treatment and pathology data, focusing on progression-free survival (PFS) and overall survival (OS), using Kaplan–Meier estimates and the log-rank test for statistical analysis.</div></div><div><h3>Results</h3><div>Patients averaged 63 years old, with a slight male majority. Off-label drugs were primarily requested for upper gastrointestinal cancers (42%) and colorectal carcinoma (21%). The most common molecular testing method was next-generation sequencing (NGS). Immunotherapy was the predominant treatment (67%), followed by targeted therapy and chemotherapy. The median PFS was 3.4 months [95% confidence interval (CI) 2.0-4.5 months], and the median OS was 10 months (95% CI 7.5-12.2 months). Early-line off-label treatment showed a trend toward longer PFS compared with later lines.</div></div><div><h3>Conclusion</h3><div>Early access to off-label drugs, particularly for patients with specific genetic alterations, can improve outcomes. The study underscores the importance of molecular tumor boards and multidisciplinary collaboration in selecting off-label treatments. Despite regulatory and ethical challenges, off-label drug use offers significant therapeutic opportunities, necessitating well-designed clinical trials and registries to better understand their efficacy and safety.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100108"},"PeriodicalIF":0.0,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154233","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}

{"title":"Real-world safety and effectiveness data of trastuzumab deruxtecan and sacituzumab govitecan in breast cancer: a Hellenic Cooperative Oncology Group study","authors":"E. Fountzilas ,&nbsp;S. Karageorgopoulou ,&nbsp;G. Karakatsoulis ,&nbsp;D. Tryfonopoulos ,&nbsp;K. Papazisis ,&nbsp;A. Koutras ,&nbsp;A. Koumarianou ,&nbsp;G. Zafeiri ,&nbsp;E. Biziota ,&nbsp;A. Nikolaidi ,&nbsp;I. Boukovinas ,&nbsp;E. Vrana ,&nbsp;D. Mauri ,&nbsp;E. Aravantinou-Fatorou ,&nbsp;E. Razis ,&nbsp;E. Vorrias ,&nbsp;Z. Saridaki ,&nbsp;D. Bafaloukos ,&nbsp;A. Christopoulou ,&nbsp;A. Boutis ,&nbsp;E. Lalla","doi":"10.1016/j.esmorw.2024.100095","DOIUrl":"10.1016/j.esmorw.2024.100095","url":null,"abstract":"<div><h3>Background</h3><div>The study aimed to evaluate real-world effectiveness and toxicity data of trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in pretreated patients with metastatic breast cancer (mBC).</div></div><div><h3>Patients and methods</h3><div>A retrospective multicenter review of medical records of patients with mBC treated with T-DXd and/or SG at 24 Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG) was carried out. Patients with triple-negative BC (TNBC), HER2-positive, and/or hormone receptor (HR)-positive mBC who received at least one cycle of T-DXd and/or SG in any line of treatment were included. The primary endpoint was the toxicity rate of each drug.</div></div><div><h3>Results</h3><div>From January 2020 to April 2024, 312 patients received treatment; 226 (72.4%) received T-DXd and 60 (19.2%) SG, while 26 (8.3%) patients received both agents. Adverse events (AEs) were reported in 57.1% of patients treated with T-DXd and 56.6% of patients treated with SG. The most common AEs were nausea (28.1%) and fatigue (22.5%) among patients treated with T-DXd, and fatigue (20.7%) and neutropenia (12.6%) among those treated with SG. Toxicity-related discontinuation was reported in 12 (8.8%) and 2 (3.2%) patients, respectively, who received T-DXd and SG. Interstitial lung disease was observed in 17 (6.9%) patients treated with T-DXd. The 12-month progression-free survival (PFS) rate was 69.6 [interquartile range (IQR) 61.4-79] in patients with HER2-positive and 46.5 (IQR 28.6-46.5) in patients with HER2-low mBC receiving T-DXd. In patients with TNBC receiving SG, the 12-month PFS rate was 16.2 (IQR 8.1-32.4), whereas in patients with HR-positive/HER2-negative mBC, it was 23.6 (IQR 13.8-40.3).</div></div><div><h3>Conclusions</h3><div>Real-world data on the use of T-DXd and SG in patients with mBC provide significant clinical insights into the toxicity and effectiveness of each agent.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100095"},"PeriodicalIF":0.0,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154228","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}

{"title":"Neutrophil to lymphocyte ratio and tumour burden for treatment efficacy stratification in renal cell carcinoma patients receiving nivolumab plus ipilimumab","authors":"M. Oshima ,&nbsp;S. Washino ,&nbsp;S. Shirotake ,&nbsp;H. Takeshita ,&nbsp;M. Inoue ,&nbsp;Y. Miura ,&nbsp;A. Nakayama ,&nbsp;S. Nagamoto ,&nbsp;T. Nakayama ,&nbsp;K. Izumi ,&nbsp;M. Oyama ,&nbsp;S. Kawakami ,&nbsp;K. Saito ,&nbsp;Y. Matsuoka ,&nbsp;T. Miyagawa","doi":"10.1016/j.esmorw.2024.100106","DOIUrl":"10.1016/j.esmorw.2024.100106","url":null,"abstract":"<div><h3>Background</h3><div>There is a lack of surrogate markers to predict the outcomes of nivolumab plus ipilimumab (Nivo-Ipi) for advanced renal cell carcinoma (RCC), but neutrophil to lymphocyte ratio (NLR) and tumour burden are promising candidates. This study investigated biological and radiological surrogate markers in advanced RCC patients receiving Nivo-Ipi.</div></div><div><h3>Materials and methods</h3><div>Between 2018 and 2022, data were retrospectively collected for patients receiving Nivo-Ipi for previously untreated metastatic or locally advanced RCC with intermediate or poor risk across six centres. We assessed prognostic factors to stratify the outcomes of Nivo-Ipi, including tumour burden and NLR.</div></div><div><h3>Results</h3><div>The study included 129 patients with a median age of 67 years (71% men). Both NLR and tumour burden were negatively associated with tumour response; they were also independently associated with unfavourable overall survival, whereas NLR was the only factor independently associated with unfavourable progression-free survival on multivariate analysis. Combined NLR and tumour burden assessment enabled stratification of the outcomes of Nivo-Ipi. Patients with NLR &lt;3.0 or 3.0-5.9 and tumour burden &lt;200 mm showed significantly superior treatment outcomes relative to the other patients with NLR ≥6.0 or 3.0-5.9 and tumour burden ≥200 mm (objective response rate: 54% versus 26%; complete response rate: 16% versus 0%; median overall survival: 44.3 versus 6.1 months; median progression-free survival: 17.4 versus 4.1 months).</div></div><div><h3>Conclusions</h3><div>NLR and tumour burden were negatively associated with response to Nivo-Ipi in advanced RCC. Combined NLR and tumour burden assessment could efficiently stratify treatment outcomes and survival, potentially aiding treatment selection.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100106"},"PeriodicalIF":0.0,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154230","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}