ESMO Real World Data and Digital Oncology最新文献

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Neutrophil to lymphocyte ratio and tumour burden for treatment efficacy stratification in renal cell carcinoma patients receiving nivolumab plus ipilimumab 中性粒细胞/淋巴细胞比和肿瘤负荷对纳武单抗联合伊匹单抗治疗肾癌患者疗效分层的影响
ESMO Real World Data and Digital Oncology Pub Date : 2025-01-04 DOI: 10.1016/j.esmorw.2024.100106
M. Oshima , S. Washino , S. Shirotake , H. Takeshita , M. Inoue , Y. Miura , A. Nakayama , S. Nagamoto , T. Nakayama , K. Izumi , M. Oyama , S. Kawakami , K. Saito , Y. Matsuoka , T. Miyagawa
{"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}
引用次数: 0
Reply to the Correspondence regarding “Sequencing the anti-EGFR-TKIs; route to the longest survival” by H.G. Güzel et al. 关于“抗egfr - tkis测序”函件的答复;h·g·g<e:1>泽尔等人的《最长生存之路》。
ESMO Real World Data and Digital Oncology Pub Date : 2024-12-16 DOI: 10.1016/j.esmorw.2024.100096
Y. Uehara , T. Yoshida
{"title":"Reply to the Correspondence regarding “Sequencing the anti-EGFR-TKIs; route to the longest survival” by H.G. Güzel et al.","authors":"Y. Uehara ,&nbsp;T. Yoshida","doi":"10.1016/j.esmorw.2024.100096","DOIUrl":"10.1016/j.esmorw.2024.100096","url":null,"abstract":"","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100096"},"PeriodicalIF":0.0,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154396","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
Incidence, risk factors, and clinical implications of enfortumab vedotin-related cutaneous toxicity in urothelial carcinoma: a large-scale, real-world study in Japan 尿路上皮癌中与维多汀相关的皮肤毒性的发生率、危险因素和临床意义:一项在日本进行的大规模真实世界研究
ESMO Real World Data and Digital Oncology Pub Date : 2024-12-16 DOI: 10.1016/j.esmorw.2024.100094
Y. Kita , T. Hara , T. Kawahara , K. Hashimoto , Y. Matsushita , H. Ito , T. Abe , A. Igarashi , S. Shimura , T. Sazuka , A. Yokomizo , N. Takaoka , M. Kato , T. Hazama , M. Miyake , Y. Sugino , J. Mutaguchi , A. Takahashi , Y. Shiraishi , S. Tatarano , T. Kobayashi
{"title":"Incidence, risk factors, and clinical implications of enfortumab vedotin-related cutaneous toxicity in urothelial carcinoma: a large-scale, real-world study in Japan","authors":"Y. Kita ,&nbsp;T. Hara ,&nbsp;T. Kawahara ,&nbsp;K. Hashimoto ,&nbsp;Y. Matsushita ,&nbsp;H. Ito ,&nbsp;T. Abe ,&nbsp;A. Igarashi ,&nbsp;S. Shimura ,&nbsp;T. Sazuka ,&nbsp;A. Yokomizo ,&nbsp;N. Takaoka ,&nbsp;M. Kato ,&nbsp;T. Hazama ,&nbsp;M. Miyake ,&nbsp;Y. Sugino ,&nbsp;J. Mutaguchi ,&nbsp;A. Takahashi ,&nbsp;Y. Shiraishi ,&nbsp;S. Tatarano ,&nbsp;T. Kobayashi","doi":"10.1016/j.esmorw.2024.100094","DOIUrl":"10.1016/j.esmorw.2024.100094","url":null,"abstract":"<div><h3>Background</h3><div>Enfortumab vedotin (EV), an innovative antibody–drug conjugate targeting Nectin-4, has emerged as a breakthrough therapy for locally advanced or metastatic urothelial carcinoma (la/mUC). However, EV-related cutaneous toxicity (EVRCT) remains a significant concern because of Nectin-4 expression in skin tissue. This study aimed to understand the incidence, risk factors, and clinical implications of EVRCT, focusing on relationships with treatment efficacy, using one of the largest real-world datasets from a Japanese la/mUC patient cohort.</div></div><div><h3>Materials and methods</h3><div>Data from 207 la/mUC patients treated with EV, mainly as a third-line therapy between 2020 and 2023, were analyzed. Multivariate logistic regression and propensity score matching (PSM) were used to assess the risk factors and impact of EVRCTs on patient overall survival (OS) and progression-free survival (PFS).</div></div><div><h3>Results</h3><div>EVRCTs were observed in 59.9% of patients, with 83% occurring within the first 3 months, defined as early-phase EVRCTs (epEVRCTs). Multivariate analysis identified better Eastern Cooperative Oncology Group performance status (ECOG PS = 0), higher hemoglobin levels (≥11 g/dl), and the standard initial dose (1.25 mg/kg) as significant risk factors for epEVRCTs. Patients with epEVRCTs demonstrated significantly improved PFS and OS compared with those without. Post-PSM analysis confirmed longer OS for patients with epEVRCTs, particularly those with mild (grade 1) toxicities, suggesting that these reactions may be significantly linked to favorable treatment outcomes.</div></div><div><h3>Conclusions</h3><div>Our data suggest that epEVRCTs are common and correlate with better clinical outcomes in la/mUC patients treated with EV, underscoring the importance of proactive EVRCT management to optimize therapeutic benefits.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"7 ","pages":"Article 100094"},"PeriodicalIF":0.0,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143154229","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 impact of targeted therapies on molecular alterations identified by an institutional molecular tumor board: an approach based on ESCAT classification 由机构分子肿瘤委员会确定的靶向治疗对分子改变的影响:基于ESCAT分类的方法
ESMO Real World Data and Digital Oncology Pub Date : 2024-12-01 DOI: 10.1016/j.esmorw.2024.100092
K. Rahmani Narj Abadi , C. Dupain , I. Guillou , R. Sanchez , K. Nedara , G. Marret , S. Hescot , M-P. Sablin , Z. Castel-Ajgal , C. Neuzillet , E. Borcoman , D. Bello Roufai , M. Rodrigues , A. Asnacios Lecerf , C. Callens , O. Trabelsi-Grati , S. Melaabi , K. Driouch , S. Antonio , E. Lemaitre , C. Le Tourneau
{"title":"The impact of targeted therapies on molecular alterations identified by an institutional molecular tumor board: an approach based on ESCAT classification","authors":"K. Rahmani Narj Abadi ,&nbsp;C. Dupain ,&nbsp;I. Guillou ,&nbsp;R. Sanchez ,&nbsp;K. Nedara ,&nbsp;G. Marret ,&nbsp;S. Hescot ,&nbsp;M-P. Sablin ,&nbsp;Z. Castel-Ajgal ,&nbsp;C. Neuzillet ,&nbsp;E. Borcoman ,&nbsp;D. Bello Roufai ,&nbsp;M. Rodrigues ,&nbsp;A. Asnacios Lecerf ,&nbsp;C. Callens ,&nbsp;O. Trabelsi-Grati ,&nbsp;S. Melaabi ,&nbsp;K. Driouch ,&nbsp;S. Antonio ,&nbsp;E. Lemaitre ,&nbsp;C. Le Tourneau","doi":"10.1016/j.esmorw.2024.100092","DOIUrl":"10.1016/j.esmorw.2024.100092","url":null,"abstract":"<div><h3>Background</h3><div>The European Society of Medical Oncology Scale for Clinical Actionability of Molecular Targets (ESCAT) classification system provides a standardized framework for categorizing genomic alterations (GAs) of patients with recurrent, metastatic, or rare cancer. This study aimed to present outcomes of patients discussed at the molecular tumor board (MTB) in general and according to ESCAT.</div></div><div><h3>Patients and methods</h3><div>We included 1226 patients with recurrent and/or metastatic cancer presented at the MTB from 2018 to 2022. Clinical and demographic data collected included age, gender, type of specimen, tumor type, number of prior treatments received, techniques used for molecular analyses, GAs identified, MTB recommendations, and inclusion or not into a clinical trial. The clinical endpoints collected were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), and were correlated with ESCAT.</div></div><div><h3>Results</h3><div>Successful molecular profiling was carried out in 895 of 1226 (73%) patients. Actionable GAs were found in 595 (49%) patients, and 206 (17%) patients were oriented to matched therapies. Eventually, 101 (8%) patients received a matched therapy. For these patients, PFS and OS were significantly longer for GAs classified as ESCAT tiers I/II, compared with tiers III/IV (<em>P</em> = 0.009 and <em>P</em> = 0.014, respectively).</div></div><div><h3>Conclusions</h3><div>Detection of actionable GAs through MTB molecular screening enabled to treat 8% of patients with matched therapy. Patients treated with matched therapy based on ESCAT tiers I/II had statistically longer PFS and OS, compared with ESCAT tiers III/IV.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"6 ","pages":"Article 100092"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143173393","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
Bridging research and practice: enhancing regulatory decisions with pragmatic clinical trials in oncology 桥接研究和实践:加强监管决策与实用临床试验在肿瘤学
ESMO Real World Data and Digital Oncology Pub Date : 2024-12-01 DOI: 10.1016/j.esmorw.2024.100065
M.D. Stewart , A.E. McKee , R.S. Herbst , H.S. Andrews , B.A. McKelvey , E.V. Sigal , J.D. Allen
{"title":"Bridging research and practice: enhancing regulatory decisions with pragmatic clinical trials in oncology","authors":"M.D. Stewart ,&nbsp;A.E. McKee ,&nbsp;R.S. Herbst ,&nbsp;H.S. Andrews ,&nbsp;B.A. McKelvey ,&nbsp;E.V. Sigal ,&nbsp;J.D. Allen","doi":"10.1016/j.esmorw.2024.100065","DOIUrl":"10.1016/j.esmorw.2024.100065","url":null,"abstract":"","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"6 ","pages":"Article 100065"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143173395","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
Editoiral Board Editoiral董事会
ESMO Real World Data and Digital Oncology Pub Date : 2024-12-01 DOI: 10.1016/S2949-8201(24)00079-1
{"title":"Editoiral Board","authors":"","doi":"10.1016/S2949-8201(24)00079-1","DOIUrl":"10.1016/S2949-8201(24)00079-1","url":null,"abstract":"","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"6 ","pages":"Article 100101"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143174431","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
Characteristics and impact of real-world evidence studies in oncology: comprehensive mapping review of publications evaluating targeted therapies in solid tumours 肿瘤学中真实世界证据研究的特点和影响:对实体肿瘤靶向治疗评价出版物的综合制图回顾
ESMO Real World Data and Digital Oncology Pub Date : 2024-12-01 DOI: 10.1016/j.esmorw.2024.100091
A. Pellat , T. Grinda , P. Cresta Morgado , A. Prelaj , V. Miskovic , A. Valachis , I. Zerdes , D. Martins-Branco , L. Provenzano , A. Spagnoletti , G. Nader-Marta , B.E. Wilson , Y.-H. Yang , G. Pentheroudakis , S. Delaloge , L. Castelo-Branco , M. Koopman
{"title":"Characteristics and impact of real-world evidence studies in oncology: comprehensive mapping review of publications evaluating targeted therapies in solid tumours","authors":"A. Pellat ,&nbsp;T. Grinda ,&nbsp;P. Cresta Morgado ,&nbsp;A. Prelaj ,&nbsp;V. Miskovic ,&nbsp;A. Valachis ,&nbsp;I. Zerdes ,&nbsp;D. Martins-Branco ,&nbsp;L. Provenzano ,&nbsp;A. Spagnoletti ,&nbsp;G. Nader-Marta ,&nbsp;B.E. Wilson ,&nbsp;Y.-H. Yang ,&nbsp;G. Pentheroudakis ,&nbsp;S. Delaloge ,&nbsp;L. Castelo-Branco ,&nbsp;M. Koopman","doi":"10.1016/j.esmorw.2024.100091","DOIUrl":"10.1016/j.esmorw.2024.100091","url":null,"abstract":"<div><h3>Background</h3><div>A mapping review of real-world evidence (RWE) publications on targeted therapy (TT) for solid tumours was carried out to describe their characteristics, strengths, and limitations.</div></div><div><h3>Methods</h3><div>RWE publications were identified that: (i) focused on TTs in patients with solid tumours; (ii) included study objectives of effectiveness, predictive or prognostic factors, safety or quality of life; (iii) were published between 1 January 2020 and 22 December 2022. Associations between study variables and journal impact factor (IF) were explored through regression and cluster network analyses.</div></div><div><h3>Results</h3><div>Of 7775 publications identified, 1251 were eligible for analysis. The number of publications per year increased over time. Most studies were conducted in Asia (50%), Europe (25%), and North America (17%), with only 8% in more than one country. Data sources were mostly health records (55%) and registries (11%). Most studies were retrospective (85%) and only 16% were population based. Gastrointestinal tumours were the most frequently studied (30%), followed by lung (22%) and breast (21%). The median journal IF was 4.4. Involvement of &gt;10 centres and studies originating from Europe were significantly associated with a higher IF (≥7) in multivariable analysis. Network analysis demonstrated strong associations between countries and the number of publications in specific tumour types.</div></div><div><h3>Conclusions</h3><div>The number of RWE publications on TT for solid tumours is increasing, but studies are heterogeneous, mostly retrospective, and published in low IF journals. International collaboration and promotion of standardised data sources is imperative to enhance the relevance of RWE research to complement clinical guidelines and impact clinical practice.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"6 ","pages":"Article 100091"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143173394","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
Neoadjuvant compared to adjuvant chemotherapy combined with trastuzumab in patients with HER2-positive breast cancer: a register-based cohort study HER2阳性乳腺癌患者接受新辅助化疗与曲妥珠单抗联合辅助化疗的比较:一项基于登记的队列研究
ESMO Real World Data and Digital Oncology Pub Date : 2024-11-19 DOI: 10.1016/j.esmorw.2024.100093
S. Hosseini-Mellner , Å. Wickberg , E. Olsson , A. Karakatsanis , A. Valachis
{"title":"Neoadjuvant compared to adjuvant chemotherapy combined with trastuzumab in patients with HER2-positive breast cancer: a register-based cohort study","authors":"S. Hosseini-Mellner ,&nbsp;Å. Wickberg ,&nbsp;E. Olsson ,&nbsp;A. Karakatsanis ,&nbsp;A. Valachis","doi":"10.1016/j.esmorw.2024.100093","DOIUrl":"10.1016/j.esmorw.2024.100093","url":null,"abstract":"<div><h3>Background</h3><div>The aim of the study was to compare trastuzumab-based neoadjuvant therapy (NAT) with adjuvant therapy (AT) in a register-based cohort of Swedish patients with primary operable human epidermal growth factor receptor 2 (HER2)-positive breast cancer.</div></div><div><h3>Patients and methods</h3><div>The Swedish nationwide research database BCBaSe 3.0 was used to identify eligible patients with primary operable HER2-positive breast cancer treated with either NAT or AT between 2008 and 2019. To mitigate confounding by indication bias, propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were applied.</div></div><div><h3>Results</h3><div>In total, 7258 patients with primary operable HER2-positive breast cancer were identified; 1789 (24.6%) received NAT and 5469 (75.4%), AT. After 1 : 1 PSM, 1258 patients in each therapeutic strategy were available for comparisons. No statistically significant differences between NAT and AT were observed [hazard ratio (HR) for distant disease-free survival 0.97, 95% confidence (CI) 0.72-1.30; HR for breast cancer-specific survival (BCSS) 0.69, 95% CI 0.45-1.07; HR for overall (OS) 0.72, 95% CI 0.50-1.05]. In subgroup analysis, NAT resulted in better BCSS (HR 0.44, 95% CI 0.22-0.89) and OS (HR 0.49, 95% CI 0.29-0.90) in patients with clinical node positivity (cN+) at diagnosis.</div></div><div><h3>Conclusion</h3><div>The study shows an equivalence of NAT and AT in terms of prognosis for patients with operable HER2-positive disease whereas a potential benefit of NAT in patients with cN+ is implied. Considering the emerging treatment strategies in the neoadjuvant setting for HER2-positive breast cancer that are not reflected in the study cohort, NAT should be considered as the strategy with a higher possibility of improving long-term prognosis for patients with HER2-positive disease.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"6 ","pages":"Article 100093"},"PeriodicalIF":0.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698586","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
Real-world evaluation of ImmuCare-PRO patient-reported outcomes in melanoma patients treated with immune checkpoint inhibitors 对接受免疫检查点抑制剂治疗的黑色素瘤患者进行ImmuCare-PRO患者报告结果的真实世界评估
ESMO Real World Data and Digital Oncology Pub Date : 2024-11-19 DOI: 10.1016/j.esmorw.2024.100090
S. Belkaïd , S. Milley , R. Saux , M. Bonjour , A. Augros , P.-J. Souquet , D. Maillet , D. Maucort-Boulch , C. Dolla , L. Thomas , S. Dalle
{"title":"Real-world evaluation of ImmuCare-PRO patient-reported outcomes in melanoma patients treated with immune checkpoint inhibitors","authors":"S. Belkaïd ,&nbsp;S. Milley ,&nbsp;R. Saux ,&nbsp;M. Bonjour ,&nbsp;A. Augros ,&nbsp;P.-J. Souquet ,&nbsp;D. Maillet ,&nbsp;D. Maucort-Boulch ,&nbsp;C. Dolla ,&nbsp;L. Thomas ,&nbsp;S. Dalle","doi":"10.1016/j.esmorw.2024.100090","DOIUrl":"10.1016/j.esmorw.2024.100090","url":null,"abstract":"<div><h3>Background</h3><div>Toxicity profile of immune checkpoint inhibitors (ICI) poses challenges for early detection of immune-related adverse events (IrAEs). In oncology, patient-reported outcomes (PROs) are reported to have a beneficial effect; however, their efficacy for IrAE detection in melanoma patients remains unclear. A remote patient-monitoring system was created in our department; we investigated its real-world impact in detecting grade 2 or above IrAEs occurring during ICI treatment in melanoma patients.</div></div><div><h3>Patients and methods</h3><div>Patients receiving ICI for a melanoma were followed using a weekly online questionnaire containing 11 symptoms suggestive of IrAE. Moderate/severe symptoms generated an alert score and an intervention by an oncology nurse or physician. The system’s performance in detecting grade 2 or above IrAEs, as well as reasons for missed detections, were retrospectively assessed.</div></div><div><h3>Results</h3><div>A total of 5202 questionnaires completed by 136 patients led to 783 (15.0%) alert scores; 64 of them were associated with 69 grade 2 or above IrAEs, with 22 (34.4%) questionnaires correctly detecting 27 grade 2 or above IrAEs, saving a mean 4.1 days on the next scheduled visit and leading to only one emergency room visit. Forty-two grade 2 or above IrAEs (mainly blood disorders, <em>n</em> = 31) were not detected. False alerts often resulted from functional or non-specific symptoms (32.3%), such as fatigue or general pain.</div></div><div><h3>Conclusion</h3><div>The ImmuCare-PRO system correctly detected a third of moderate-to-severe IrAEs, and most of those had clinical impact such as skin toxicities, colitis, and rheumatological IrAEs. This enables earlier management and could avoid unnecessary emergency room visits.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"6 ","pages":"Article 100090"},"PeriodicalIF":0.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698585","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
Challenges and opportunities for real-world evidence in clinical oncology—a view from the UK: proceedings of a national workshop 临床肿瘤学真实世界证据的挑战与机遇--来自英国的观点:全国研讨会记录
ESMO Real World Data and Digital Oncology Pub Date : 2024-11-18 DOI: 10.1016/j.esmorw.2024.100089
M. Craddock , C. Dempsey , D. Abdulwahid , J.P.C. Baldwin , K. Banfill , A. Carver , A. Chaturvedi , S. Cheeseman , G.W. Cowell , M. Daly , A. Dekker , S.R. Dubash , S. Duffield , I. Fornacon-Wood , M.A.C. Garcia , P. Goodley , H. Green , R.J. Holley , S. Ingram , S. Jones , C. Faivre-Finn
{"title":"Challenges and opportunities for real-world evidence in clinical oncology—a view from the UK: proceedings of a national workshop","authors":"M. Craddock ,&nbsp;C. Dempsey ,&nbsp;D. Abdulwahid ,&nbsp;J.P.C. Baldwin ,&nbsp;K. Banfill ,&nbsp;A. Carver ,&nbsp;A. Chaturvedi ,&nbsp;S. Cheeseman ,&nbsp;G.W. Cowell ,&nbsp;M. Daly ,&nbsp;A. Dekker ,&nbsp;S.R. Dubash ,&nbsp;S. Duffield ,&nbsp;I. Fornacon-Wood ,&nbsp;M.A.C. Garcia ,&nbsp;P. Goodley ,&nbsp;H. Green ,&nbsp;R.J. Holley ,&nbsp;S. Ingram ,&nbsp;S. Jones ,&nbsp;C. Faivre-Finn","doi":"10.1016/j.esmorw.2024.100089","DOIUrl":"10.1016/j.esmorw.2024.100089","url":null,"abstract":"<div><div>Real-world data (RWD) are defined as information collected about patients as a routine part of treatment. To understand the status of RWD initiatives in oncology in the UK, an online survey and in-person workshop were conducted which aimed to characterise current perceptions of RWD, establish where real-world evidence (RWE) could support unmet clinical need, and to identify the barriers and solutions to obtaining this evidence. Self-selecting health care professionals including oncologists, physicists, radiographers, and health data researchers, as well as patient representatives, participated in an anonymous survey (<em>N</em> = 55) and/or a 1-day workshop (<em>N</em> = 46). The workshop consisted of introductory presentations followed by three 1 hour grouped breakout sessions. An inductive thematic analysis synthesizing the outcomes of the survey and workshop was carried out <em>post hoc</em>. Despite issues of perceived poor data quality and the prevalence of unstructured data, 92% of survey respondents recognised the potential of RWD to provide novel evidence. Suggested applications of RWE were validation of trial results in the general population, continuous evaluation of new technologies, decision-making in rare disease groups, and resource allocation. Barriers to progression of RWD initiatives identified were data accessibility, data quality, and prioritisation. Potential solutions include streamlining information governance processes, training staff in data science skills, and demonstrating clinical benefit. The potential of RWD to provide novel evidence is strongly recognised in the UK radiotherapy community. While barriers to progress were identified, none of them are insurmountable. To move forwards, the profile of RWE needs to be elevated to attract higher prioritisation and resourcing.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"6 ","pages":"Article 100089"},"PeriodicalIF":0.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698584","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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