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Performance status eligibility requirements and enrollment characteristics in cancer clinical trials leading to US Food and Drug Administration drugs approval (2009–2023) 2009-2023年美国食品和药物管理局药物批准的癌症临床试验的性能状态、资格要求和入组特征
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-26 DOI: 10.1016/j.ejca.2025.115589
Giovanni Maria Iannantuono , Charalampos S. Floudas , Marco Filetti , Tommaso Giovagnoli , Stefano Sganga , Antonio Vitale , Elias Chandran , Pasquale Lombardi , Roberto Rosenfeld , Elena Giudice , Elisabetta Xue , Elvira Rapisarda , Paola Troisi , Andrea B. Apolo , Fatima Karzai , Emilio Bria , James L. Gulley , Gennaro Daniele
{"title":"Performance status eligibility requirements and enrollment characteristics in cancer clinical trials leading to US Food and Drug Administration drugs approval (2009–2023)","authors":"Giovanni Maria Iannantuono ,&nbsp;Charalampos S. Floudas ,&nbsp;Marco Filetti ,&nbsp;Tommaso Giovagnoli ,&nbsp;Stefano Sganga ,&nbsp;Antonio Vitale ,&nbsp;Elias Chandran ,&nbsp;Pasquale Lombardi ,&nbsp;Roberto Rosenfeld ,&nbsp;Elena Giudice ,&nbsp;Elisabetta Xue ,&nbsp;Elvira Rapisarda ,&nbsp;Paola Troisi ,&nbsp;Andrea B. Apolo ,&nbsp;Fatima Karzai ,&nbsp;Emilio Bria ,&nbsp;James L. Gulley ,&nbsp;Gennaro Daniele","doi":"10.1016/j.ejca.2025.115589","DOIUrl":"10.1016/j.ejca.2025.115589","url":null,"abstract":"<div><h3>Background</h3><div>Participants with a low functional status are often excluded from cancer clinical trials, limiting the generalizability of their results. Here we aimed to investigate performance status (PS) eligibility requirements and enrollment characteristics in clinical trials leading to anticancer drug approvals.</div></div><div><h3>Methods</h3><div>We conducted a cross-sectional study on pivotal clinical trials for non-hematologic solid tumors leading to drug approvals by the US Food and Drug Administration from 2009 to 2023. Participants with an Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 were defined as having low functional status (i.e., poor PS).</div></div><div><h3>Results</h3><div>We identified 283 clinical trials with 158,510 total participants. Four (1.4 %) studies did not use PS as an eligibility criterion. Of the remaining 279 trials, 72 (25.8 %) allowed the enrollment of poor-PS participants, with a negative trend over the 15-year interval (p = 0.01). The proportion of studies enrolling ECOG PS ≥ 2 participants was 43.2 % from 2009–2013, 29.6 % from 2014–2018, and 17.5 % from 2019–2023 (p = 0.002). Notably, early-phase studies included poor-PS participants more frequently than phase 3 clinical trials (40.8 % vs 20.2 %; p = 0.01). Finally, over the 15-year interval, the median (interquartile range) proportions of ECOG PS 0, 1, and 2 participants were 53.7 % (38.7 %–65.7 %), 45.1 % (33.5 %–58.8 %), and 4.3 % (1.8 %–7.9 %), respectively.</div></div><div><h3>Conclusions</h3><div>A limited fraction of pivotal clinical trials included participants with poor PS, with a median percentage enrollment of less than 5 %. Sponsors, institutional review boards, and investigators must collaborate to broaden PS eligibility criteria to achieve more representative trial populations.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115589"},"PeriodicalIF":7.6,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144522609","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
Consolidation thoracic radiotherapy after chemoimmunotherapy in ES-SCLC: A multicentric retrospective analysis ES-SCLC化疗免疫治疗后胸部巩固放疗:一项多中心回顾性分析
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-25 DOI: 10.1016/j.ejca.2025.115592
Federico Monaca , Igor Gomez-Randulfe , Gerard Walls , Ornella Cantale , Ana Parreira , Sara Polidori , Mariantonietta Di Salvatore , Vito Longo , Domenico Galetta , Emanuele Vita , Antonella Martino , Maria Antonietta Gambacorta , Luca Boldrini , Yvonne Summers , Giampaolo Tortora , Fiona Blackhall , Silvia Novello , Clara Chan , Emilio Bria , Corinne Faivre-Finn , Raffaele Califano
{"title":"Consolidation thoracic radiotherapy after chemoimmunotherapy in ES-SCLC: A multicentric retrospective analysis","authors":"Federico Monaca ,&nbsp;Igor Gomez-Randulfe ,&nbsp;Gerard Walls ,&nbsp;Ornella Cantale ,&nbsp;Ana Parreira ,&nbsp;Sara Polidori ,&nbsp;Mariantonietta Di Salvatore ,&nbsp;Vito Longo ,&nbsp;Domenico Galetta ,&nbsp;Emanuele Vita ,&nbsp;Antonella Martino ,&nbsp;Maria Antonietta Gambacorta ,&nbsp;Luca Boldrini ,&nbsp;Yvonne Summers ,&nbsp;Giampaolo Tortora ,&nbsp;Fiona Blackhall ,&nbsp;Silvia Novello ,&nbsp;Clara Chan ,&nbsp;Emilio Bria ,&nbsp;Corinne Faivre-Finn ,&nbsp;Raffaele Califano","doi":"10.1016/j.ejca.2025.115592","DOIUrl":"10.1016/j.ejca.2025.115592","url":null,"abstract":"<div><h3>Background</h3><div>The CREST trial established the benefit of consolidative thoracic radiotherapy (TRT) following first line (1L) chemotherapy in extensive-stage small cell lung cancer (ES-SCLC), demonstrating improved 2-year overall survival (OS). However, the role of TRT in the chemoimmunotherapy (CT-IO) era remains unclear, as TRT was excluded from registrational trials.</div></div><div><h3>Methods</h3><div>This retrospective study analysed consecutive patients (pts) with ES-SCLC treated with 1L CT-IO between January 2020 and January 2024 across 4 centres. Pts without radiological progression (PD) at their first post-treatment assessment were included. Intrathoracic recurrence rates, progression-free survival (PFS), and OS were compared between pts who received TRT and those who did not.</div></div><div><h3>Results</h3><div>336 pts were identified, with 111 (33.0 %) receiving TRT. Pts who received TRT had a lower rate of intrathoracic PD compared to those who did not (40.5 % vs 57.8 %, p = 0.003). Among those with intrathoracic PD despite TRT, only 21 (24.1 %) experienced PD within the radiation field. With a median follow-up of 31.3 months, pts who received TRT showed improved PFS (HR 0.89, p = 0.363) and OS (HR 0.82, p = 0.142), although not statistically significant. Multivariate analysis identified baseline liver metastases (LM) and stable disease after CT-IO as independent predictors of shorter PFS. Subgroup analysis revealed a longer PFS for pts receiving higher TRT doses (≥45 Gy vs &lt;45 Gy) and those without LM.</div></div><div><h3>Conclusions</h3><div>In this series, TRT following 1 L CT-IO significantly improved intrathoracic control, although it did not translate into significantly better survival outcomes. Prospective trials are warranted to evaluate the impact of TRT on quality of life and survival.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115592"},"PeriodicalIF":7.6,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144490011","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
Real-world experience with first- versus second-line cemiplimab for advanced basal cell carcinoma 一线与二线西米单抗治疗晚期基底细胞癌的实际经验
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-24 DOI: 10.1016/j.ejca.2025.115590
Viola K. DeTemple , Martin Kaatz , Eggert Stockfleth , Christina Scheel , Yenny Angela , Ralf Gutzmer , Ulrike Leiter , Friedegund Meier , Dirk Schadendorf , Elisabeth Livingstone , Christoffer Gebhardt , Imke von Wasielewski , Michael Weichenthal , Peter Mohr , Jessica Hassel , Claudia Pföhler , Jan Christoph Simon , Franziska Jochims , Patrick Terheyden , Jens Ulrich , Dirk Tomsitz
{"title":"Real-world experience with first- versus second-line cemiplimab for advanced basal cell carcinoma","authors":"Viola K. DeTemple ,&nbsp;Martin Kaatz ,&nbsp;Eggert Stockfleth ,&nbsp;Christina Scheel ,&nbsp;Yenny Angela ,&nbsp;Ralf Gutzmer ,&nbsp;Ulrike Leiter ,&nbsp;Friedegund Meier ,&nbsp;Dirk Schadendorf ,&nbsp;Elisabeth Livingstone ,&nbsp;Christoffer Gebhardt ,&nbsp;Imke von Wasielewski ,&nbsp;Michael Weichenthal ,&nbsp;Peter Mohr ,&nbsp;Jessica Hassel ,&nbsp;Claudia Pföhler ,&nbsp;Jan Christoph Simon ,&nbsp;Franziska Jochims ,&nbsp;Patrick Terheyden ,&nbsp;Jens Ulrich ,&nbsp;Dirk Tomsitz","doi":"10.1016/j.ejca.2025.115590","DOIUrl":"10.1016/j.ejca.2025.115590","url":null,"abstract":"<div><h3>Background</h3><div>The anti-PD1 antibody (PD1i) cemiplimab is approved as second-line treatment for locally advanced or metastatic basal cell carcinoma (BCC), resulting in an ORR of 20–30 %. This study aimed to investigate the efficacy of cemiplimab as first-line or second-line treatment of BCC in a German real-world patient cohort.</div></div><div><h3>Methods</h3><div>Patients with histologically confirmed locally advanced or metastatic BCC who were treated with cemiplimab were retrospectively identified from the prospective multicenter real-world skin cancer registry ADOREG. Study endpoints were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Therapy outcome was compared between patients receiving first-line cemiplimab and patients treated with cemiplimab in second-line.</div></div><div><h3>Results</h3><div>37 patients from 17 skin cancer centers were identified who received cemiplimab. The median follow-up after start of any first-line treatment was 37.1 months, and 17.9 months after initiation of any cemiplimab treatment. Patients who received first-line cemiplimab (n = 8) had an ORR of 62.5 %, compared to an ORR of 31.0 % for patients who received second-line cemiplimab (n = 29); Median PFS was 19.8 months for first-line cemiplimab and 5.3 months for second-line cemiplimab. Reinduction with HHIs after progression on second-line cemiplimab resulted in an ORR of 20.0 % and a median PFS of 3.8 months.</div></div><div><h3>Conclusion</h3><div>We demonstrate a comparable outcome for cemiplimab as second-line treatment of BCC in our real-world patient cohort as reported in previous registration studies. Additionally, we found a trend for a more favorable outcome in first-line therapy, suggesting a rationale to further investigate cemiplimab as first-line treatment of advanced BCC.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115590"},"PeriodicalIF":7.6,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144490012","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
Pan-RAS inhibitor after KRASG12C treatment in pancreatic cancer? KRASG12C治疗胰腺癌后使用泛ras抑制剂?
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-18 DOI: 10.1016/j.ejca.2025.115588
Léa Swales, Jacques R.R. Mathieu, Michel Ducreux, Fanny Jaulin, Alice Boilève
{"title":"Pan-RAS inhibitor after KRASG12C treatment in pancreatic cancer?","authors":"Léa Swales,&nbsp;Jacques R.R. Mathieu,&nbsp;Michel Ducreux,&nbsp;Fanny Jaulin,&nbsp;Alice Boilève","doi":"10.1016/j.ejca.2025.115588","DOIUrl":"10.1016/j.ejca.2025.115588","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115588"},"PeriodicalIF":7.6,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144330905","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
Exploring isolated tumor cells entity in endometrial cancer 探讨子宫内膜癌中分离的肿瘤细胞实体
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-18 DOI: 10.1016/j.ejca.2025.115586
Vito Andrea Capozzi , Emanuele Perrone , Elisa Scarpelli , Vincenzo Tarantino , Maria Consiglia Giuliano , Marco Carnelli , Pierandrea De Iaco , Anna Myriam Perrone , Andrea Puppo , Giorgio Bogani , Marcello Ceccaroni , Vito Chiantera , Giuseppe Cucinella , Stefano Uccella , Giovanni Scambia , Francesco Fanfani , Roberto Berretta
{"title":"Exploring isolated tumor cells entity in endometrial cancer","authors":"Vito Andrea Capozzi ,&nbsp;Emanuele Perrone ,&nbsp;Elisa Scarpelli ,&nbsp;Vincenzo Tarantino ,&nbsp;Maria Consiglia Giuliano ,&nbsp;Marco Carnelli ,&nbsp;Pierandrea De Iaco ,&nbsp;Anna Myriam Perrone ,&nbsp;Andrea Puppo ,&nbsp;Giorgio Bogani ,&nbsp;Marcello Ceccaroni ,&nbsp;Vito Chiantera ,&nbsp;Giuseppe Cucinella ,&nbsp;Stefano Uccella ,&nbsp;Giovanni Scambia ,&nbsp;Francesco Fanfani ,&nbsp;Roberto Berretta","doi":"10.1016/j.ejca.2025.115586","DOIUrl":"10.1016/j.ejca.2025.115586","url":null,"abstract":"<div><h3>Background</h3><div>Endometrial cancer (EC) management includes nodal staging and molecular classification. Despite molecular advancements, the biological significance of isolated tumor cells (ITC) in EC remains unclear. This study aimed to characterize ITC in the context of pathological and molecular features</div></div><div><h3>Materials and methods</h3><div>A multicenter, retrospective analysis included EC patients diagnosed between June 2018 and May 2024 who underwent surgical staging via sentinel lymph node (SLN) biopsy and molecular profiling. ITC cases detected through SLN ultrastaging or One Step Nucleic Acid Amplification (OSNA) were compared with N0 and N + (micro-/macrometastasis) groups.</div></div><div><h3>Results</h3><div>Among the 1821 patients included, nodal status was N0 in 84.5 %, ITC in 5.1 %, micrometastases in 5.3 %, and macrometastases in 4.5 %. ITC patients exhibited deep myometrial invasion in 67.7 % of cases vs. 28.7 % in N0 (p &lt; 0.001). Diffuse lymphovascular space invasion (LVSI) was significantly higher in ITC (52.1 %) than N0 (12.2 %, p &lt; 0.001). MMR deficiency was more frequent in ITC (33.3 %) vs. N0 (25.0 %, p = 0.07). POLE mutations were more common in N0 (4.2 %) and ITC (3.1 %) vs. N + (1.1 %), though not statistically significant. p53-abnormal tumors were significantly associated with N + status (19.4 %) compared to ITC (7.3 %, OR 0.33, p = 0.008). No relapses occurred among ITC patients with low-risk features.</div></div><div><h3>Conclusions</h3><div>These findings suggest that ITC may represent an early form of nodal involvement, biologically distinct from micro- and macrometastases. The association with MMR deficiency and the absence of aggressive markers such as p53 abnormalities support a less aggressive profile. Integrating molecular and pathological features may refine risk stratification and inform management strategies for EC patients with ITC.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115586"},"PeriodicalIF":7.6,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144364921","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
Genomic profiling of primary tumor and lymph node metastasis in patients with clinically node-positive breast cancer: prospective cohort study within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57–18, ABCSG-53, GBG 101) 临床淋巴结阳性乳腺癌患者原发肿瘤和淋巴结转移的基因组分析:TAXIS前瞻性队列研究(OPBC-03, SAKK 23/16, IBCSG 57-18, abcsg 53, GBG 101)
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-18 DOI: 10.1016/j.ejca.2025.115585
Michael Knauer , Daniel Egle , Stefanie Hayoz , Ákos Sávolt , Christoph Tausch , Susanne Bucher , Colin Simonson , Rok Satler , Jörg Heil , Inga Bekes , Vesna Bjelic-Radisic , William Audeh , Giang Thanh Lam , Andrea Menicucci , Simone Muenst , Valerijus Ostapenko , Christian Kurzeder , Martin Heidinger , Walter P. Weber
{"title":"Genomic profiling of primary tumor and lymph node metastasis in patients with clinically node-positive breast cancer: prospective cohort study within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57–18, ABCSG-53, GBG 101)","authors":"Michael Knauer ,&nbsp;Daniel Egle ,&nbsp;Stefanie Hayoz ,&nbsp;Ákos Sávolt ,&nbsp;Christoph Tausch ,&nbsp;Susanne Bucher ,&nbsp;Colin Simonson ,&nbsp;Rok Satler ,&nbsp;Jörg Heil ,&nbsp;Inga Bekes ,&nbsp;Vesna Bjelic-Radisic ,&nbsp;William Audeh ,&nbsp;Giang Thanh Lam ,&nbsp;Andrea Menicucci ,&nbsp;Simone Muenst ,&nbsp;Valerijus Ostapenko ,&nbsp;Christian Kurzeder ,&nbsp;Martin Heidinger ,&nbsp;Walter P. Weber","doi":"10.1016/j.ejca.2025.115585","DOIUrl":"10.1016/j.ejca.2025.115585","url":null,"abstract":"<div><h3>Introduction</h3><div>Genomic tests informing systemic therapy recommendations for breast cancer (BC) were developed and validated on primary tumor (PT) tissue. Agreement of genomic tests between the PT and matched lymph node metastases (LNm) in patients with BC is currently unclear, which limits their use in nodal tissue.</div></div><div><h3>Methods</h3><div>Prespecified study within the international phase III TAXIS trial (NCT03513614). Tissue from PT and matched LNm were assessed with the primary objective of comparing genomic recurrence risk and subtypes. Clinical risk was assessed using the Adjuvant!Online tool and clinical subtypes were determined based on hormone receptor and Her2 testing. Agreement was assessed using Cohen’s Kappa (Κ).</div></div><div><h3>Results</h3><div>Eighty-nine patients with stage II/III BC from 26 European centers were included. Median age was 63 years (range 50–72). Agreement in genomic risk between the PT and LNm was found in 84.3 % (Κ=0.64). However, 15.6 % exhibited genomic high risk in the LNm and low risk in the PT, while 16.0 % demonstrated low risk in the LNm and high risk in the PT. Genomic subtypes of PT and LNm showed disagreement in 17.1 % of patients with luminal BC (Κ=0.70). 96.5 % of patients were clinically categorized as high risk, whereas genomically, 25.6 % of them were classified as low risk in the LNm (Κ=0.17) and 31.7 % in the PT (Κ=0.13). Genomic subtyping reclassified 35.5 % of the clinically luminal tumor subtypes.</div></div><div><h3>Conclusion</h3><div>Disagreement in genomically estimated risk exists in over 15 % of patients, potentially leading to over- or undertreatment. Consequently, the applicability of genomic tests in LNm remains controversial.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115585"},"PeriodicalIF":7.6,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144501740","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
Veliparib concomitant with first-line chemotherapy and as maintenance therapy in ovarian cancer: Final overall survival and disease-related symptoms results Veliparib伴随一线化疗并作为卵巢癌维持治疗:最终总生存期和疾病相关症状结果
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-17 DOI: 10.1016/j.ejca.2025.115587
Robert L. Coleman , Gini F. Fleming , Mark F. Brady , Elizabeth M. Swisher , Karina D. Steffensen , Michael Friedlander , Aikou Okamoto , Kathleen N. Moore , Charles A. Leath III , David Cella , Zhaowen Sun , Shilpen Patel , Zequn Tang , Christine K. Ratajczak , Carol Aghajanian , Michael A. Bookman
{"title":"Veliparib concomitant with first-line chemotherapy and as maintenance therapy in ovarian cancer: Final overall survival and disease-related symptoms results","authors":"Robert L. Coleman ,&nbsp;Gini F. Fleming ,&nbsp;Mark F. Brady ,&nbsp;Elizabeth M. Swisher ,&nbsp;Karina D. Steffensen ,&nbsp;Michael Friedlander ,&nbsp;Aikou Okamoto ,&nbsp;Kathleen N. Moore ,&nbsp;Charles A. Leath III ,&nbsp;David Cella ,&nbsp;Zhaowen Sun ,&nbsp;Shilpen Patel ,&nbsp;Zequn Tang ,&nbsp;Christine K. Ratajczak ,&nbsp;Carol Aghajanian ,&nbsp;Michael A. Bookman","doi":"10.1016/j.ejca.2025.115587","DOIUrl":"10.1016/j.ejca.2025.115587","url":null,"abstract":"<div><h3>Introduction</h3><div>In the VELIA trial, the addition of veliparib to standard first-line platinum-based chemotherapy and continued as maintenance resulted in significantly longer median progression-free survival (PFS) compared with carboplatin plus paclitaxel induction therapy alone (23.5 vs 17.3 months; p &lt; 0.001) in patients with ovarian cancer. We now report final overall survival (OS) and updated safety and disease-related symptoms (DRS) from patient-reported outcomes of the trial.</div></div><div><h3>Methods</h3><div>This randomized, placebo-controlled, double-blind, multicenter, phase 3 study enrolled adult women with an initial diagnosis of stage III/IV high-grade serous ovarian cancer undergoing primary or interval cytoreductive surgery. Patients were randomized 1:1:1 to chemotherapy plus veliparib followed by veliparib maintenance (veliparib-throughout), chemotherapy plus veliparib followed by placebo maintenance (veliparib-combination-only), or chemotherapy plus placebo followed by placebo maintenance (placebo-throughout). PFS was the primary endpoint; OS and DRS were secondary endpoints.</div></div><div><h3>Results</h3><div>In the intention-to-treat population (N = 1140), median OS was 59.2 months (95 % confidence interval: 52.1, 68.2) for the veliparib-throughout group, 58.0 (50.6, 64.1) months for veliparib-combination-only, and 57.8 (52.3, 63.8) months for placebo-throughout. OS outcomes were not significantly different between arms overall or in the <em>BRCA</em>-deficient and homologous recombination-deficient cohorts. No new safety signals were identified during the longer follow-up period and DRS analyses indicated there was no significant additional symptom-related burden overall when veliparib was added to chemotherapy or used for maintenance.</div></div><div><h3>Conclusion</h3><div>No OS or DRS benefit of addition of veliparib to platinum-based chemotherapy and continued as maintenance therapy was detected in this study, despite an observed benefit over chemotherapy alone in PFS.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115587"},"PeriodicalIF":7.6,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144364522","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
Clinical benefit and cost of plasma-first next-generation sequencing in patients with newly diagnosed advanced non-small cell lung cancer in Ireland: The PLAN study 爱尔兰新诊断的晚期非小细胞肺癌患者血浆优先下一代测序的临床效益和成本:PLAN研究
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-17 DOI: 10.1016/j.ejca.2025.115582
David O'Reilly , Anthony O'Grady , Conor Hayes , Laura Piggott , Ruaidhri Keane , Orla M. Fitzpatrick , Michael Conroy , Nicholas Kruseman Aretz , David Synnott , Rachel Dillon , Gavin P. Dowling , Daniel J. Ryan , Emmet O’Brien , Ross Morgan , Oscar Breathnach , Liam Grogan , Patrick Morris , Megan Greally , Minh Yuen Teo , Adrian Murphy , Jarushka Naidoo
{"title":"Clinical benefit and cost of plasma-first next-generation sequencing in patients with newly diagnosed advanced non-small cell lung cancer in Ireland: The PLAN study","authors":"David O'Reilly ,&nbsp;Anthony O'Grady ,&nbsp;Conor Hayes ,&nbsp;Laura Piggott ,&nbsp;Ruaidhri Keane ,&nbsp;Orla M. Fitzpatrick ,&nbsp;Michael Conroy ,&nbsp;Nicholas Kruseman Aretz ,&nbsp;David Synnott ,&nbsp;Rachel Dillon ,&nbsp;Gavin P. Dowling ,&nbsp;Daniel J. Ryan ,&nbsp;Emmet O’Brien ,&nbsp;Ross Morgan ,&nbsp;Oscar Breathnach ,&nbsp;Liam Grogan ,&nbsp;Patrick Morris ,&nbsp;Megan Greally ,&nbsp;Minh Yuen Teo ,&nbsp;Adrian Murphy ,&nbsp;Jarushka Naidoo","doi":"10.1016/j.ejca.2025.115582","DOIUrl":"10.1016/j.ejca.2025.115582","url":null,"abstract":"<div><h3>Background</h3><div>We report a pilot clinical trial investigating the feasibility of liquid biopsy genotyping (LBG) at the time of radiological suspicion of advanced NSCLC, incorporating a micro-cost model (MCM). (PLAsma Genomic Testing in Advanced NSCLC; The PLAN trial, ClinicalTrials.gov Identifier: NCT05542485).</div></div><div><h3>Methods</h3><div>Patients with a radiologic suspicion of stage III-IV lung cancer were recruited from four cancer centres in Ireland between August 2023 and July 2024. LBG was performed using the Archer LiquidplexTM NGS assay. The MCM considered staff time, consumables and capital costs and savings from avoidance of repeat tissue biopsy genotyping (TBG) or inappropriate systemic therapy such as immunotherapy for EGFR + NSCLC.</div></div><div><h3>Results</h3><div>A total of 138 patients were enrolled in the study with 38 excluded from the primary analysis (Squamous=16; SCLC = 22). Of patients that were eligible, LBG was completed in 100 % (100/100). TBG was completed in 68 % (68/100; insufficient tissue 20 %; 20/100; declining ECOG PS 12 %; 12/100). Repeat tissue biopsies were avoided in 12 % (12/100) of patients due to available LBG reports. The median calendar days from LBG to receipt of genomic report was 21 days shorter for LBG (z = -6.8, p &lt; 0.01) versus TBG, as a median (range: 1–104 days). For evaluable paired cases with both TBG and LBG available (n = 68), concordance was 90 % (61/68). LBG resulted in detection of 5 actionable variants. LBG (€1135) was less than half the cost of TBG (€2404). LBG also resulted in overall cost savings of €20,288 (reduced TBG; use of immunotherapy).</div></div><div><h3>Conclusions</h3><div>LBG reduces the time to genomic diagnosis in patients with newly diagnosed NSCLC compared to tissue genotyping, identifies actionable variants not reported in tissue, and results in overall cost savings.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115582"},"PeriodicalIF":7.6,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144480705","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
Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial 鲁卡帕尼用于铂敏感复发性卵巢癌的维持治疗:3期随机、安慰剂对照ARIEL3试验的最终结果
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-17 DOI: 10.1016/j.ejca.2025.115584
Jonathan A. Ledermann , Amit M. Oza , Domenica Lorusso , Carol Aghajanian , Ana Oaknin , Andrew Dean , Nicoletta Colombo , Johanne I. Weberpals , Andrew R. Clamp , Giovanni Scambia , Alexandra Leary , Robert W. Holloway , Margarita Amenedo Gancedo , Peter C. Fong , Jeffrey C. Goh , David M. O’Malley , Deborah K. Armstrong , Susana Banerjee , Jesús García-Donas , Elizabeth M. Swisher , Robert L. Coleman
{"title":"Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial","authors":"Jonathan A. Ledermann ,&nbsp;Amit M. Oza ,&nbsp;Domenica Lorusso ,&nbsp;Carol Aghajanian ,&nbsp;Ana Oaknin ,&nbsp;Andrew Dean ,&nbsp;Nicoletta Colombo ,&nbsp;Johanne I. Weberpals ,&nbsp;Andrew R. Clamp ,&nbsp;Giovanni Scambia ,&nbsp;Alexandra Leary ,&nbsp;Robert W. Holloway ,&nbsp;Margarita Amenedo Gancedo ,&nbsp;Peter C. Fong ,&nbsp;Jeffrey C. Goh ,&nbsp;David M. O’Malley ,&nbsp;Deborah K. Armstrong ,&nbsp;Susana Banerjee ,&nbsp;Jesús García-Donas ,&nbsp;Elizabeth M. Swisher ,&nbsp;Robert L. Coleman","doi":"10.1016/j.ejca.2025.115584","DOIUrl":"10.1016/j.ejca.2025.115584","url":null,"abstract":"<div><h3>Background</h3><div>In ARIEL3, rucaparib maintenance significantly improved progression-free survival (PFS; primary endpoint) and long-term follow-up (LTFU) outcomes (including PFS2: time to disease progression on subsequent therapy or death) versus placebo in patients with recurrent, platinum-sensitive ovarian cancer. Here we report the final analysis of overall survival (OS; key secondary endpoint), LTFU outcomes, and safety.</div></div><div><h3>Methods</h3><div>OS and updated LTFU efficacy outcomes were analyzed (data cutoff date: April 4, 2022) across three nested populations (<em>BRCA</em>-mutated, homologous recombination deficient [HRD], and intention to treat [ITT]).</div></div><div><h3>Results</h3><div>Patients were randomized 2:1 to rucaparib (600 mg BID; n = 375) or placebo (n = 189). Median follow-up was 77.0 months. 168 patients in the placebo arm received subsequent treatment; of these, 77 (46 %) received a poly(ADP-ribose) polymerase inhibitor–containing treatment. Median OS from randomization post chemotherapy for rucaparib vs placebo was 45.9 vs 47.8 months (HR 0.83, 95 % CI 0.58–1.19) for the <em>BRCA</em>-mutated population; no OS benefit was found with rucaparib in the HRD and ITT populations. Median PFS2 for rucaparib vs placebo was 26.1 vs 18.4 months (HR 0.67, 95 % CI 0.48–0.94) for the <em>BRCA</em>-mutated population. Rucaparib numerically improved PFS2 and other LTFU outcomes versus placebo in the HRD and ITT populations. Safety was consistent with prior reports; myelodysplastic syndrome and/or acute myeloid leukemia occurred in 4 % and 3 % of patients in the rucaparib and placebo arms, respectively.</div></div><div><h3>Conclusions</h3><div>OS was similar between treatment arms. PFS benefit with rucaparib was maintained through the subsequent therapy line. These data support rucaparib as maintenance treatment for recurrent ovarian carcinoma.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115584"},"PeriodicalIF":7.6,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144501741","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
Corrigendum to” Cardiological adverse events in hepatocellular carcinoma patients receiving immunotherapy: Influence of comorbidities and clinical outcomes,” [Eur J Cancer 2025 May 15:221:115404.] “肝细胞癌患者接受免疫治疗的心血管不良事件:合并症和临床结果的影响”的更正[J]癌症杂志2025年5月15日:221:115404。]
IF 7.6 1区 医学
European Journal of Cancer Pub Date : 2025-06-12 DOI: 10.1016/j.ejca.2025.115581
Marta Fortuny , Marta García-Calonge , Óscar Arrabal , Marco Sanduzzi-Zamparelli , Andrés Castaño-García , Enric Cascos , Alicia Mesa , Ana María Piedra-Cerezal , Neus Llarch , Gemma Iserte , Marta Campos , Melina González , Aida Marsal , Rebeca Lorca , Manuel Rodríguez , Ferran Torres , María Varela , María Reig
{"title":"Corrigendum to” Cardiological adverse events in hepatocellular carcinoma patients receiving immunotherapy: Influence of comorbidities and clinical outcomes,” [Eur J Cancer 2025 May 15:221:115404.]","authors":"Marta Fortuny ,&nbsp;Marta García-Calonge ,&nbsp;Óscar Arrabal ,&nbsp;Marco Sanduzzi-Zamparelli ,&nbsp;Andrés Castaño-García ,&nbsp;Enric Cascos ,&nbsp;Alicia Mesa ,&nbsp;Ana María Piedra-Cerezal ,&nbsp;Neus Llarch ,&nbsp;Gemma Iserte ,&nbsp;Marta Campos ,&nbsp;Melina González ,&nbsp;Aida Marsal ,&nbsp;Rebeca Lorca ,&nbsp;Manuel Rodríguez ,&nbsp;Ferran Torres ,&nbsp;María Varela ,&nbsp;María Reig","doi":"10.1016/j.ejca.2025.115581","DOIUrl":"10.1016/j.ejca.2025.115581","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"225 ","pages":"Article 115581"},"PeriodicalIF":7.6,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144297163","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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