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Prognostic value of patient-reported outcomes in advanced or metastatic melanoma patients treated with immunotherapy: Findings from the CheckMate-067 study 接受免疫疗法治疗的晚期或转移性黑色素瘤患者患者报告结果的预后价值:CheckMate-067研究结果。
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-28 DOI: 10.1016/j.ejca.2024.115099
Dirk Schadendorf , Jennifer Lord-Bessen , Flavia Ejzykowicz , Ling Shi , Peiwen Yu , Swetha Srinivasan
{"title":"Prognostic value of patient-reported outcomes in advanced or metastatic melanoma patients treated with immunotherapy: Findings from the CheckMate-067 study","authors":"Dirk Schadendorf ,&nbsp;Jennifer Lord-Bessen ,&nbsp;Flavia Ejzykowicz ,&nbsp;Ling Shi ,&nbsp;Peiwen Yu ,&nbsp;Swetha Srinivasan","doi":"10.1016/j.ejca.2024.115099","DOIUrl":"10.1016/j.ejca.2024.115099","url":null,"abstract":"<div><h3>Objective</h3><div>Patient-reported outcomes (PROs) that predict survival in cancer patients have yet to be realized as practical tools for clinicians to make better treatment decisions. To identify such PROs in adults with advanced melanoma treated with immunotherapy, this study used 7.5-year follow-up data from CheckMate-067, a phase 3, randomized, double-blind study of nivolumab or nivolumab plus ipilimumab versus ipilimumab.</div></div><div><h3>Methods</h3><div>PRO data assessed using the European Organization of Research for the Treatment of Cancer Core-30 and EQ-5D-3L at baseline and during subsequent visits after treatment initiation were pooled across treatment arms. Associations between baseline PRO or change from baseline (CFB) scores with survival outcomes (progression-free survival [PFS], overall survival [OS], and melanoma-specific survival [MSS]) were examined using Cox proportional hazards models for PFS or OS and cause-specific hazard models for MSS.</div></div><div><h3>Results</h3><div>Baseline and CFB scores for most PRO domains, especially for physical functioning, global health status/quality of life (GHS/QoL), fatigue, and EQ-5D visual analog scale (VAS), were prognostic of all survival outcomes. Achieving meaningful improvement/maintenance of baseline PRO scores at 12 weeks following treatment initiation predicted better survival outcomes than with meaningful worsening from baseline.</div></div><div><h3>Conclusions</h3><div>PROs at baseline and during treatment, particularly for physical functioning, GHS/QoL, fatigue, and EQ-VAS, were prognostic of survival outcomes. This knowledge may accelerate development of prognostic tools to manage treatment in patients with previously untreated unresectable or metastatic melanoma who undergo immunotherapy.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115099"},"PeriodicalIF":7.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142617188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Liquid biopsy with plasma Epstein-Barr virus DNA characterizes biological relapse for the prediction of cancer recurrence in non-disseminated nasopharyngeal carcinoma 利用血浆 Epstein-Barr 病毒 DNA 进行液体活检可确定生物复发的特征,从而预测非扩散性鼻咽癌的复发情况
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-26 DOI: 10.1016/j.ejca.2024.115098
Qixian Zhang , Lin Zhu , Wenjiao Lv , Tingting Xu , Chunying Shen , Wei Qian , Peiyao Liu , Hongmei Ying , Xiayun He , Chaosu Hu , Xin Zhou , Xueguan Lu
{"title":"Liquid biopsy with plasma Epstein-Barr virus DNA characterizes biological relapse for the prediction of cancer recurrence in non-disseminated nasopharyngeal carcinoma","authors":"Qixian Zhang ,&nbsp;Lin Zhu ,&nbsp;Wenjiao Lv ,&nbsp;Tingting Xu ,&nbsp;Chunying Shen ,&nbsp;Wei Qian ,&nbsp;Peiyao Liu ,&nbsp;Hongmei Ying ,&nbsp;Xiayun He ,&nbsp;Chaosu Hu ,&nbsp;Xin Zhou ,&nbsp;Xueguan Lu","doi":"10.1016/j.ejca.2024.115098","DOIUrl":"10.1016/j.ejca.2024.115098","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate whether a bounce in plasma Epstein-Barr virus (EBV) DNA during posttreatment surveillance of nasopharyngeal carcinoma (NPC) informs the risk of clinical recurrence and its implication for early therapeutic intervention.</div></div><div><h3>Methods</h3><div>950 non-disseminated NPC patients with completed remission in 3 months after treatment were retrospectively screened. Detectable EBV DNA with no evidence of clinical relapse during follow-up was deemed as DNA bounce. The diagnostic and prognostic performance of EBV DNA bounce was assessed for subsequent failures.</div></div><div><h3>Results</h3><div>Tumor recurrence occurred in 6.6 %, 10.1 % and 65.8 % in the group with persistently negative EBV DNA, single positive test and ≥ 2 positive tests, respectively. EBV DNA bounce over twice was associated with worse disease-free survival (DFS), locoregional recurrence-free survival (LRRFS), and distant metastasis-free survival (DMFS) than the other two groups. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy for the prediction of recurrence were 0.56, 0.95, 0.66, 0.93 and 0.90 using two positive tests, which were hence deemed as biological relapse. Serial cutoffs (EBV DNA 1 ≥ 40 copies/ml or EBV DNA 2 ≥100 copies/ml) further defined a high-risk subgroup with an eventual recurrence rate of 77.9 % and 3-year DFS of merely 20.5 %. Prophylactic medical intervention with capecitabine or S1 significantly improved the 3-year DFS when compared to those with observation.</div></div><div><h3>Conclusions</h3><div>The earliest two positive tests of EBV DNA represent a biomarker of biological relapse that allows early detection of clinical recurrence in EBV-related NPC. For high-risk biological relapse, preemptive intervention provides potential survival benefits.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115098"},"PeriodicalIF":7.6,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142561156","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}
引用次数: 0
Incidence and prognosis of cutaneous melanoma in European adolescents and young adults (AYAs): EUROCARE-6 retrospective cohort results 欧洲青少年皮肤黑色素瘤的发病率和预后:EUROCARE-6回顾性队列结果。
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-24 DOI: 10.1016/j.ejca.2024.115079
Alice Indini , Fabio Didoné , Daniela Massi , Susana Puig , Jordi Rubio Casadevall , Damien Bennett , Alexander Katalinic , Arantza Sanvisens , Andrea Ferrari , Paolo Lasalvia , Elena Demuru , Rosalia Ragusa , Alexandra Mayer-da-Silva , Marcel Blum , Mohsen Mousavi , Claudia Kuehni , Ana Mihor , Mario Mandalà , Annalisa Trama , the EUROCARE-6 Working Group
{"title":"Incidence and prognosis of cutaneous melanoma in European adolescents and young adults (AYAs): EUROCARE-6 retrospective cohort results","authors":"Alice Indini ,&nbsp;Fabio Didoné ,&nbsp;Daniela Massi ,&nbsp;Susana Puig ,&nbsp;Jordi Rubio Casadevall ,&nbsp;Damien Bennett ,&nbsp;Alexander Katalinic ,&nbsp;Arantza Sanvisens ,&nbsp;Andrea Ferrari ,&nbsp;Paolo Lasalvia ,&nbsp;Elena Demuru ,&nbsp;Rosalia Ragusa ,&nbsp;Alexandra Mayer-da-Silva ,&nbsp;Marcel Blum ,&nbsp;Mohsen Mousavi ,&nbsp;Claudia Kuehni ,&nbsp;Ana Mihor ,&nbsp;Mario Mandalà ,&nbsp;Annalisa Trama ,&nbsp;the EUROCARE-6 Working Group","doi":"10.1016/j.ejca.2024.115079","DOIUrl":"10.1016/j.ejca.2024.115079","url":null,"abstract":"<div><h3>Background</h3><div>Cutaneous melanoma (CM) is rare in adolescents and young adults (AYA, 15–39 years at cancer diagnosis) and studies on CM in AYAs are scarce. Our aim is to update CM incidence and survival in European AYAs and to compare incidence and survival both with other age groups and over time.</div></div><div><h3>Methods</h3><div>We used the EUROCARE-6 database (108 cancer registries; 29 EU countries), calculating incidence rates (IR) per 100,000 individuals/year in the European population (years of diagnosis: 2006–2013), 5-year relative survival (RS), and 5-year RS conditional to surviving the first year after diagnosis, for the follow-up period 2010–2014 (cases diagnosed in 2006–2013).</div></div><div><h3>Results</h3><div>The IR of CM in AYA was greater in females than in males, standing at 7. CM IR was higher in the limbs and lower in the head and neck (H&amp;N) and trunk in females compared to males. Five-year RS was 94 % in AYA and 80 % in older age groups. Survival was higher in limb than in H&amp;N and trunk CM. The incidence of CM increased more in older age groups than in AYA. CM survival rose over time for all ages.</div></div><div><h3>Conclusions</h3><div>Differences in IR between males and females may be due to different behaviors and CM biology. The increase in survival can be attributed to healthcare improvements, early diagnosis, and locoregional surgical treatments. The incidence trends are reassuring in terms of tumor burden in AYA. Our findings support the idea that CM is more aggressive with increasing age and gender differences partially explain survival differences between age groups.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115079"},"PeriodicalIF":7.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
16S rRNA target sequencing of human tumors validates findings of Lachnoclostridium abundance in human melanomas that are heavily CD8+ T-cell infiltrated 人类肿瘤的 16S rRNA 目标测序验证了在 CD8+ T 细胞大量浸润的人类黑色素瘤中大量存在拉氏梭菌的结论。
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-24 DOI: 10.1016/j.ejca.2024.115084
Lingeng Lu, Caroline Johnson, Sajid Khan, Harriet Kluger
{"title":"16S rRNA target sequencing of human tumors validates findings of Lachnoclostridium abundance in human melanomas that are heavily CD8+ T-cell infiltrated","authors":"Lingeng Lu,&nbsp;Caroline Johnson,&nbsp;Sajid Khan,&nbsp;Harriet Kluger","doi":"10.1016/j.ejca.2024.115084","DOIUrl":"10.1016/j.ejca.2024.115084","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115084"},"PeriodicalIF":7.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544530","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}
引用次数: 0
Response to letter entitled: Re: Indirect comparison of capmatinib treatment from GEOMETRY mono-1 trial to SOC in German patients with locally advanced or metastatic NSCLC harboring METex14 skipping mutations 对题为Re:在德国携带 METex14 跳过突变的局部晚期或转移性 NSCLC 患者中,将 GEOMETRY mono-1 试验中的卡马替尼治疗与 SOC 进行间接比较。
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-24 DOI: 10.1016/j.ejca.2024.115086
Anna Kron, Matthias Scheffler, Juergen Wolf
{"title":"Response to letter entitled: Re: Indirect comparison of capmatinib treatment from GEOMETRY mono-1 trial to SOC in German patients with locally advanced or metastatic NSCLC harboring METex14 skipping mutations","authors":"Anna Kron,&nbsp;Matthias Scheffler,&nbsp;Juergen Wolf","doi":"10.1016/j.ejca.2024.115086","DOIUrl":"10.1016/j.ejca.2024.115086","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115086"},"PeriodicalIF":7.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557480","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}
引用次数: 0
Resection of colorectal liver metastases with second-line aflibercept plus FOLFIRI: Results from the RESECTION prospective French cohort 结直肠肝转移灶切除术与二线aflibercept加FOLFIRI疗法:法国前瞻性队列RESECTION的研究结果
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-22 DOI: 10.1016/j.ejca.2024.115082
David Tougeron , Frederic Bibeau , Benoist Chibaudel , Stefano Kim , Thierry Nguyen , Jean-Marc Phelip , Dominique Mille , Mohamed Bouattour , David Tavan , Yves Rinaldi , Thierry Lecomte , Hervé Perrier , Dominique Spaeth , François-Xavier Caroli Bosc , Jean-Philippe Metges , Marc Ferec , Vincent Hautefeuille , Marion Deslandres-Cruchant , Jerome Danion , Pascal Hammel , René Adam
{"title":"Resection of colorectal liver metastases with second-line aflibercept plus FOLFIRI: Results from the RESECTION prospective French cohort","authors":"David Tougeron ,&nbsp;Frederic Bibeau ,&nbsp;Benoist Chibaudel ,&nbsp;Stefano Kim ,&nbsp;Thierry Nguyen ,&nbsp;Jean-Marc Phelip ,&nbsp;Dominique Mille ,&nbsp;Mohamed Bouattour ,&nbsp;David Tavan ,&nbsp;Yves Rinaldi ,&nbsp;Thierry Lecomte ,&nbsp;Hervé Perrier ,&nbsp;Dominique Spaeth ,&nbsp;François-Xavier Caroli Bosc ,&nbsp;Jean-Philippe Metges ,&nbsp;Marc Ferec ,&nbsp;Vincent Hautefeuille ,&nbsp;Marion Deslandres-Cruchant ,&nbsp;Jerome Danion ,&nbsp;Pascal Hammel ,&nbsp;René Adam","doi":"10.1016/j.ejca.2024.115082","DOIUrl":"10.1016/j.ejca.2024.115082","url":null,"abstract":"<div><h3>Aim</h3><div>To evaluate R0/R1 resection rate in patients with colorectal liver metastases (CLM) treated with aflibercept plus FOLFIRI after failure of a prior oxaliplatin-based regimen in daily clinical practice.</div></div><div><h3>Methods</h3><div>This French, multicentre, prospective, observational cohort (NCT05178745) included patients with CLM (alone or predominant; up to 5 lung nodules &lt;2 cm allowed) initiating aflibercept plus FOLFIRI every 2 weeks per physician choice. Primary endpoint was R0/R1 resection rate. Secondary endpoints included overall survival (OS), progression-free survival (PFS), radiological and pathological responses, and safety.</div></div><div><h3>Results</h3><div>A total of 137 patients (median age 65 years, <em>RAS/BRAF</em> mutant 57 %/9 %) were enrolled at 22 French sites. CLM (median 4) were synchronous in 82 %, bilobar in 71 % and located in liver only in 54 %. Overall, 17 % of patients had R0/R1 resection (21 % for patients with liver-only disease). A major pathological response per Blazer score was observed in 55 % of resected patients, along with significantly longer OS (median 34.8 vs 9.1 months, p &lt; 0.0001) and PFS (median 11.4 vs 4.9 months, p &lt; 0.0001) compared to non-resected patients. Post-operative complications occurred in 17 % of patients (all Dindo-Clavien grade I-II) and there was no post-operative deaths. Overall, 34 % had grade ≥ 3 adverse events, mainly general health deterioration and diarrhea.</div></div><div><h3>Conclusions</h3><div>Results suggest that aflibercept plus FOLFIRI, after failure of a prior oxaliplatin-based regimen, allows R0/R1 resection of CLM in almost 20 % of patients with a major pathological response in most cases and a median OS prolonged by more than 3-fold versus non-resected patients.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115082"},"PeriodicalIF":7.6,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142561097","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}
引用次数: 0
Classic Hodgkin Lymphoma: The LYSA pragmatic guidelines 典型霍奇金淋巴瘤:LYSA 实用指南
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-22 DOI: 10.1016/j.ejca.2024.115073
Cédric Rossi , Guillaume Manson , Amira Marouf , Aurélie Cabannes-Hamy , Emmanuelle Nicolas-Virelizier , Marie Maerevoet , Marion Alcantara , Lysiane Molina , Antony Ceraulo , Marilyne Poirée , Jean Galtier , Nadia Diop , Caroline Delette , Amandine Segot , Sydney Dubois , Agathe Waultier , Sophie Bernard , Robin Noël , Stéphanie Guidez , Milena Kohn , Hervé Ghesquières
{"title":"Classic Hodgkin Lymphoma: The LYSA pragmatic guidelines","authors":"Cédric Rossi ,&nbsp;Guillaume Manson ,&nbsp;Amira Marouf ,&nbsp;Aurélie Cabannes-Hamy ,&nbsp;Emmanuelle Nicolas-Virelizier ,&nbsp;Marie Maerevoet ,&nbsp;Marion Alcantara ,&nbsp;Lysiane Molina ,&nbsp;Antony Ceraulo ,&nbsp;Marilyne Poirée ,&nbsp;Jean Galtier ,&nbsp;Nadia Diop ,&nbsp;Caroline Delette ,&nbsp;Amandine Segot ,&nbsp;Sydney Dubois ,&nbsp;Agathe Waultier ,&nbsp;Sophie Bernard ,&nbsp;Robin Noël ,&nbsp;Stéphanie Guidez ,&nbsp;Milena Kohn ,&nbsp;Hervé Ghesquières","doi":"10.1016/j.ejca.2024.115073","DOIUrl":"10.1016/j.ejca.2024.115073","url":null,"abstract":"<div><div>Classic Hodgkin lymphoma (HL) is a distinct entity among hematological malignancies of B-cell origin. It is characterized by its unique histopathological features and generally favorable prognosis. Over the years, advancements in understanding its pathogenesis, coupled with refined diagnostic and evaluation modalities, as well as therapeutic strategies, have significantly transformed the landscape of HL management. In this article, we present a comprehensive set of recommendations for the management of HL, encompassing various aspects of diagnosis, risk stratification, evaluation, and treatment. These recommendations are based on the latest evidence-based guidelines, expert consensus opinions, and clinical trial data, aiming to provide clinicians with a practical framework for delivering optimal care to patients with HL.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115073"},"PeriodicalIF":7.6,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessing the real-world effectiveness of 8 major metastatic breast cancer drugs using target trial emulation 利用靶向试验模拟评估 8 种主要转移性乳腺癌药物的实际疗效。
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-22 DOI: 10.1016/j.ejca.2024.115072
Alison Antoine , David Pérol , Mathieu Robain , Thomas Bachelot , Rémy Choquet , William Jacot , Béchir Ben Hadj Yahia , Thomas Grinda , Suzette Delaloge , Christine Lasset , Youenn Drouet
{"title":"Assessing the real-world effectiveness of 8 major metastatic breast cancer drugs using target trial emulation","authors":"Alison Antoine ,&nbsp;David Pérol ,&nbsp;Mathieu Robain ,&nbsp;Thomas Bachelot ,&nbsp;Rémy Choquet ,&nbsp;William Jacot ,&nbsp;Béchir Ben Hadj Yahia ,&nbsp;Thomas Grinda ,&nbsp;Suzette Delaloge ,&nbsp;Christine Lasset ,&nbsp;Youenn Drouet","doi":"10.1016/j.ejca.2024.115072","DOIUrl":"10.1016/j.ejca.2024.115072","url":null,"abstract":"<div><h3>Background</h3><div>Demonstration of trial emulation ability to benchmark randomised controlled trials (RCTs) from real-world data (RWD) is required to increase confidence in the use of routinely collected data for decision making in oncology.</div></div><div><h3>Methods</h3><div>To assess the frequency with which emulation findings align with RCTs regarding effect size on overall survival (OS) in metastatic breast cancer (MBC), 8 of 13 pre-selected pivotal RCTs in MBC were emulated using data from 32,598 patients enrolled in the French ESME-MBC cohort between January 1, 2008 and December 31, 2021. Adjustment methods and confounders were selected <em>a priori</em> for each emulation; stabilized weight was the reference method to mitigate confounding. Concordance in OS hazard ratios with associated 95 % confidence intervals between RCTs and emulations were assessed used predefined metrics based on statistical significance, estimates, and standardized differences.</div></div><div><h3>Results</h3><div>The effect sizes were consistent with RCT results in 7 out of the 8 emulations; 4 emulations achieved full statistical significance agreement; 5 emulations had a point estimate included in the RCT CI (estimate agreement); 6 emulations reported no significant differences between RCT and emulation (standardized difference agreement). Discrepancies related to residual confounders and significant shifts in prescription practices post-drug approval may arise in some cases.</div></div><div><h3>Conclusion</h3><div>Target trial emulation from RWD combined with appropriate adjustment can provide conclusions similar to RCTs in MBC. In oncology, this methodology offers opportunities for confirming the impact on long-term survival, for expanding indications in patients excluded from RCTs and for comparative effectiveness in single-arm trials using external control arms.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115072"},"PeriodicalIF":7.6,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intensified alkylating chemotherapy for patients with oligometastatic breast cancer harboring homologous recombination deficiency: Primary outcomes from the randomized phase III OLIGO study 对携带同源重组缺陷的寡转移性乳腺癌患者进行强化烷化化疗:随机III期OLIGO研究的主要结果
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-20 DOI: 10.1016/j.ejca.2024.115083
A. van Ommen-Nijhof , T.G. Steenbruggen , T.G. Wiersma , S. Balduzzi , A. Daletzakis , M.J. Holtkamp , M. Delfos , M. Schot , K. Beelen , E.J.M. Siemerink , J. Heijns , I.A. Mandjes , J. Wesseling , E.H. Rosenberg , M.J.T. Vrancken Peeters , S.C. Linn , G.S. Sonke
{"title":"Intensified alkylating chemotherapy for patients with oligometastatic breast cancer harboring homologous recombination deficiency: Primary outcomes from the randomized phase III OLIGO study","authors":"A. van Ommen-Nijhof ,&nbsp;T.G. Steenbruggen ,&nbsp;T.G. Wiersma ,&nbsp;S. Balduzzi ,&nbsp;A. Daletzakis ,&nbsp;M.J. Holtkamp ,&nbsp;M. Delfos ,&nbsp;M. Schot ,&nbsp;K. Beelen ,&nbsp;E.J.M. Siemerink ,&nbsp;J. Heijns ,&nbsp;I.A. Mandjes ,&nbsp;J. Wesseling ,&nbsp;E.H. Rosenberg ,&nbsp;M.J.T. Vrancken Peeters ,&nbsp;S.C. Linn ,&nbsp;G.S. Sonke","doi":"10.1016/j.ejca.2024.115083","DOIUrl":"10.1016/j.ejca.2024.115083","url":null,"abstract":"<div><h3>Background</h3><div>Oligometastatic breast cancer (OMBC) is a clinical entity with a prospect of long-term survival, but uncertainty remains on its optimal treatment. We studied whether intensified alkylating chemotherapy (IACT) improves long-term outcome compared to conventional-dose chemotherapy (CDCT) as part of a multimodality approach for patients with OMBC harboring homologous recombination deficiency (HRD).</div></div><div><h3>Patients and methods</h3><div>Eligible patients had HER2-negative OMBC, harboring HRD, with ≤ 3 distant metastases, pathologic proof of distant disease and a favorable response to three cycles CDCT. Participants were randomized 1:1 to continue with either CDCT or IACT. IACT consisted of one mobilization course followed by two cycles of mini-CTC (carboplatin, thiotepa and cyclophosphamide) supported by peripheral blood progenitor cell reinfusion. Primary outcome was event-free survival (EFS). Secondary endpoints included overall survival (OS), quality of life and safety.</div></div><div><h3>Results</h3><div>Seventy-five patients were randomized to either IACT (n = 36) or CDCT (n = 39). Twenty-three (31 %) patients had hormone receptor-positive disease and 52 (69 %) had triple-negative disease. Median EFS in the IACT-group was 28 months (95 % confidence interval [CI] 21-not reached [NR]) versus 25 months (95 %CI 14-NR) in the CDCT-group (hazard ratio [HR] for recurrence or death 0.78, 95 %CI 0.42–1.42). Median OS was 67 months (95 %CI 37-NR) in the IACT-group and 36 (95 %CI 26-NR) in the CDCT-group (HR 0.74, 95 %CI 0.37–1.48).</div></div><div><h3>Conclusions</h3><div>The entire study population experienced long-term survival, with median OS well over five years. IACT compared to CDCT did not improve outcome in patients with OMBC harboring study-defined HRD. The optimal therapy for patients with OMBC requires further study.</div></div><div><h3>Trial Registration</h3><div>ClinicalTrials.gov: NCT01646034</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115083"},"PeriodicalIF":7.6,"publicationDate":"2024-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142534875","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}
引用次数: 0
Immune marker expression and prognosis of early breast cancer expressing HER3 表达 HER3 的早期乳腺癌的免疫标记表达和预后。
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2024-10-20 DOI: 10.1016/j.ejca.2024.115081
Dae-Won Lee , Han Suk Ryu , Ilias P. Nikas , Jiwon Koh , Tae-Yong Kim , Hong Kyu Kim , Han-Byoel Lee , Hyeong-Gon Moon , Wonshik Han , Kyung-Hun Lee , Seock-Ah Im
{"title":"Immune marker expression and prognosis of early breast cancer expressing HER3","authors":"Dae-Won Lee ,&nbsp;Han Suk Ryu ,&nbsp;Ilias P. Nikas ,&nbsp;Jiwon Koh ,&nbsp;Tae-Yong Kim ,&nbsp;Hong Kyu Kim ,&nbsp;Han-Byoel Lee ,&nbsp;Hyeong-Gon Moon ,&nbsp;Wonshik Han ,&nbsp;Kyung-Hun Lee ,&nbsp;Seock-Ah Im","doi":"10.1016/j.ejca.2024.115081","DOIUrl":"10.1016/j.ejca.2024.115081","url":null,"abstract":"<div><h3>Introduction</h3><div>There is a strong rationale for targeting HER3, as HER3 contributes to tumorigenesis and treatment resistance. However, the prognostic role of HER3 and their association with immunoregulatory protein expression has not been established.</div></div><div><h3>Methods</h3><div>The main objective of this study was to investigate the prognostic role of HER3 expression and identify immunoregulatory marker expression according to HER3 status. HER3 expression and 10 immunoregulatory protein (PD-1/PD-L1/PD-L2/IDO/TIM-3/OX40/OX40L/B7-H2/B7-H3/B7-H4) expression was identified in 320 stage I-III breast cancer patients who received curative surgery at Seoul National University Hospital in 2008. The median follow-up duration was 88.8 months. Criteria for HER3 IHC was adopted from HER2 IHC score and only those with 3 + was considered positive.</div></div><div><h3>Results</h3><div>Among 320 patients, 213 (67.2 %) had luminal A disease, 30 (9.5 %) had luminal B disease, 28 (8.8 %) had HER2-positive disease, and 46 (14.5 %) had triple negative disease. HER3 expression was shown in 153 patients (47.8 %). Tumors with HER3-expression had more immunogenic tumor microenvironment compared to HER3-negative tumor. In addition, patients with HER3 expression had favorable 5-year relapse free survival compared to HER3-negative patients (5-year RFS 92.5 % <em>vs.</em> 85.2 %, <em>p</em> = 0.038). However, in the multivariate analysis, HER3 expression was not a prognostic factor, but expression of immunoregulatory protein was a prognostic factor.</div></div><div><h3>Conclusions</h3><div>This study identified immunoregulatory protein expression according to HER3 status in breast cancer patients. As tumor with HER3 expression have more immunogenic microenvironment, investigating combination treatment of HER3 targeting agent and immunotherapy in HER3 expressing breast cancer may be promising.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115081"},"PeriodicalIF":7.6,"publicationDate":"2024-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497500","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}
引用次数: 0
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