D. Di Carlo , M. Annereau , M. Vignes , L. Denis , N. Epaillard , S. Dumont , D. Guyon , A. Rieutord , S. Jacobs , V. Salomon , I. Yoldjian , F. Duperray , L. Brunel , X. Baiao , F. Lemos , E. Vauleon , M. Capra , S. Abbou , M. Touat , M. Sanson , J. Grill
{"title":"Real life data of ONC201 (dordaviprone) in pediatric and adult H3K27-altered recurrent diffuse midline glioma: Results of an international academia-driven compassionate use program","authors":"D. Di Carlo , M. Annereau , M. Vignes , L. Denis , N. Epaillard , S. Dumont , D. Guyon , A. Rieutord , S. Jacobs , V. Salomon , I. Yoldjian , F. Duperray , L. Brunel , X. Baiao , F. Lemos , E. Vauleon , M. Capra , S. Abbou , M. Touat , M. Sanson , J. Grill","doi":"10.1016/j.ejca.2024.115165","DOIUrl":"10.1016/j.ejca.2024.115165","url":null,"abstract":"<div><h3>Introduction</h3><div>H3K27-altered diffuse midline gliomas (DMG) have limited therapeutic options and a very poor prognosis. Encouraging responses were observed in early clinical trials with ONC201. As ONC201 was unavailable in Europe, a compassionate use program supported by the French Authorities was launched for patients at progression after standard of care radiotherapy.</div></div><div><h3>Methods</h3><div>This program was developed by the French Society of Pediatric Oncology (SFCE) and Association des Neuro-Oncologues d′Expression Française in collaboration with the French National Agency For Medicines and Health Products Safety and Parents Associations.</div></div><div><h3>Results</h3><div>174 patients (102 children, 72 adults) from 14 countries were treated from November 2021 to August 2023 at Gustave Roussy Institut (Villejuif, France). 37 % received a second course of irradiation at the time of relapse. Median duration of treatment was 57 days or 1,9 months (mo) (range 1–456 days). Median OS since diagnosis for the whole cohort was 466 days or 15,5 mo (112–2612 days); 426 or 14,2 mo (112–2612 days) and 590 or 19,6 mo (range 160–1881) for children and adults, respectively (p = 0.001). Median OS after ONC201 start was 143 days or 4,7 mo (1–711 days) for the whole cohort. Univariate and multivariable analysis identified site (thalamus) and age (older) as favorable prognostic factors. Reirradiation was associated with significantly longer survival after ONC201 start only in children.</div></div><div><h3>Conclusion</h3><div>While the efficacy of ONC201 needs validation in a controlled randomized clinical trial, our real-life data support a better outcome for patients with thalamic tumors treated with ONC201. We demonstrated furthermore the feasibility of a successful academia-driven compassionate use program</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115165"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863729","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}
Johnny Duerinck , Philipp Karschnia , Marike Broekman , Jens Gempt , George E.D. Petrescu , Asgeir S. Jakola , Rachel Grossman , Roland Goldbrunner , Michael D. Jenkinson , Georg Widhalm , Marian Neidert , Thiebaud Picart , Caroline Quoilin , Thierry Gorlia , Emilie Le Rhun , Giuseppe Minniti , Matthias Preusser , Michael Weller
{"title":"Addressing the role of surgery in brain tumour trials: A report from the neurosurgery committee of the EORTC brain tumour group","authors":"Johnny Duerinck , Philipp Karschnia , Marike Broekman , Jens Gempt , George E.D. Petrescu , Asgeir S. Jakola , Rachel Grossman , Roland Goldbrunner , Michael D. Jenkinson , Georg Widhalm , Marian Neidert , Thiebaud Picart , Caroline Quoilin , Thierry Gorlia , Emilie Le Rhun , Giuseppe Minniti , Matthias Preusser , Michael Weller","doi":"10.1016/j.ejca.2024.115198","DOIUrl":"10.1016/j.ejca.2024.115198","url":null,"abstract":"<div><div>The Brain Tumor Group (BTG) of the European Organization for Research and Treatment of Cancer (EORTC) conducts academic clinical trials and translational research to improve clinical management of patients with primary and secondary brain tumors. The EORTC BTG has traditionally played an important role in providing evidence and thus advancing the field, albeit with a main focus on radiotherapy and pharmacotherapy in gliomas. Although examples of well-designed neuro-oncological surgical trials can be found, evidence in surgical neuro-oncology predominantly includes data from uncontrolled prospective series or retrospective cohorts. By means of a thorough literature and EORTC database review, we demonstrate, firstly, that while the pathway of the neuro-oncology patient most often starts with neurosurgery, its several aspects have traditionally been poorly acknowledged in clinical trials in neuro-oncology. We also show that the definitions and methods of assessment vary greatly between studies, limiting generalizability. The newly established Neurosurgery Committee of the EORTC BTG aims to address this gap by increasing the number of prospective surgical trials, but also the involvement of neurosurgeons in clinical trial design, promoting standardized terminology for description of the surgical aspects, including extent of resection. We will also explore alternative trial designs when randomization is deemed difficult, as well as focus on defining surgical quality indicators that influence outcome. By addressing these challenges, the committee aims to enhance the quality of neurosurgical evidence in neuro-oncology and define optimal surgical methods and standards of care. This should ultimately improve outcomes and quality of life for patients with brain tumors through evidence-based surgical interventions.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115198"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893148","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}
Frederik Marmé , Eva I. Krieghoff-Henning , Lennard Kiehl , Christoph Wies , Jan Hauke , Eric Hahnen , Philipp Harter , Philip C. Schouten , Tobias Brodkorb , Mohamad Kayali , Florian Heitz , Claudio Zamagni , Antonio González-Martin , Isabelle Treilleux , Stefan Kommoss , Katharina Prieske , Timo Gaiser , Stefan Fröhling , Isabelle Ray-Coquard , Eric Pujade-Lauraine , Titus J. Brinker
{"title":"Predicting benefit from PARP inhibitors using deep learning on H&E-stained ovarian cancer slides","authors":"Frederik Marmé , Eva I. Krieghoff-Henning , Lennard Kiehl , Christoph Wies , Jan Hauke , Eric Hahnen , Philipp Harter , Philip C. Schouten , Tobias Brodkorb , Mohamad Kayali , Florian Heitz , Claudio Zamagni , Antonio González-Martin , Isabelle Treilleux , Stefan Kommoss , Katharina Prieske , Timo Gaiser , Stefan Fröhling , Isabelle Ray-Coquard , Eric Pujade-Lauraine , Titus J. Brinker","doi":"10.1016/j.ejca.2024.115199","DOIUrl":"10.1016/j.ejca.2024.115199","url":null,"abstract":"<div><h3>Purpose</h3><div>Ovarian cancer patients with a Homologous Recombination Deficiency (HRD) often benefit from polyadenosine diphosphate–ribose polymerase (PARP) inhibitor maintenance therapy after response to platinum-based chemotherapy. HR status is currently analyzed via complex molecular tests. Predicting benefit from PARP inhibitors directly on histological whole slide images (WSIs) could be a fast and cheap alternative.</div></div><div><h3>Patients and methods</h3><div>We trained a Deep Learning (DL) model on H&E stained WSIs with “shrunken centroid” (SC) based HRD ground truth using the AGO-TR1 cohort (n = 208: 108 training, 100 test) and tested its ability to predict HRD as evaluated by the Myriad classifier and the benefit from olaparib in the PAOLA-1 cohort (n = 447) in a blinded manner.</div></div><div><h3>Results</h3><div>In contrast to the HRD prediction AUROC of 72 % on hold-out, our model only yielded an AUROC of 57 % external. Kaplan-Meier analysis showed that progression free survival (PFS) in the PARP inhibitor treated PAOLA-1 patients was significantly improved in the HRD positive group as defined by our model, but not in the HRD negative group. PFS improvement in PARP inhibitor-treated patients was substantially longer in our HRD positive group, hinting at a biologically meaningful prediction of benefit from PARP inhibitors.</div></div><div><h3>Conclusion</h3><div>Together, our results indicate that it might be possible to generate a predictor of benefit from PARP inhibitors based on the DL-mediated analysis of WSIs. However, further studies with larger cohorts and further methodological improvements will be necessary to generate a predictor with clinically useful accuracy across independent patient cohorts.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115199"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914043","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}
{"title":"Alectinib for the treatment of papillary thyroid carcinoma harbouring STRN – ALK fusion","authors":"Silvia Buriolla , Giulia Zapelloni , Claudia Cipri , Giacomo Pelizzari , Alessandro Follador , Francesco Cortiula","doi":"10.1016/j.ejca.2024.115193","DOIUrl":"10.1016/j.ejca.2024.115193","url":null,"abstract":"<div><h3>Background</h3><div>Anaplastic Lymphoma Kinase (<em>ALK</em>) rearrangement is a rare alteration in differentiated thyroid carcinomas (DTCs). Due to its low prevalence, a few evidence are available about the use of <em>ALK</em> inhibitors in advanced DTCs.</div></div><div><h3>Methods</h3><div>We report the case of a striatin (<em>STRN</em>) - <em>ALK</em> translocated advanced thyroid carcinoma.</div><div><em>STRN – ALK</em> translocation was detected by NGS – RNA analysis.</div></div><div><h3>Results</h3><div>A 74-year-old woman received first line alectinib for the treatment of a <em>STRN</em> - <em>ALK</em> translocated advanced thyroid carcinoma with symptomatic bilateral lung localizations.</div><div>The dose of alectinib was progressively reduced due to the toxicity, but the treatment is still ongoing after 17 months with complete radiological response and clinical benefit.</div></div><div><h3>Conclusion</h3><div>Here we report the first case in Europe of <em>STRN</em> - <em>ALK</em> translocated advanced thyroid carcinoma successfully treated with alectinib.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115193"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893150","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}
{"title":"Response to Letter Entitled “Elevated serum magnesium levels prompt favourable outcomes in cancer patients treated with immune checkpoint blockers”","authors":"Yingfang Feng, Huilai Zhang, Xianhuo Wang","doi":"10.1016/j.ejca.2025.115250","DOIUrl":"10.1016/j.ejca.2025.115250","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115250"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022764","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}
Cho-Han Chiang , Junmin Song , Kuan-Yu Chi , Yu-Cheng Chang , Nutchapon Xanthavanij , Yu Chang , Yuan Ping Hsia , Cho-Hung Chiang , Azin Ghamari , Kerry L. Reynolds , Shuwen Lin , Xiaocao “Haze” Xu , Tomas G. Neilan
{"title":"Glucagon-like Peptide‐1 Agonists Reduce Cardiovascular Events in Cancer Patients on Immune Checkpoint Inhibitors","authors":"Cho-Han Chiang , Junmin Song , Kuan-Yu Chi , Yu-Cheng Chang , Nutchapon Xanthavanij , Yu Chang , Yuan Ping Hsia , Cho-Hung Chiang , Azin Ghamari , Kerry L. Reynolds , Shuwen Lin , Xiaocao “Haze” Xu , Tomas G. Neilan","doi":"10.1016/j.ejca.2024.115170","DOIUrl":"10.1016/j.ejca.2024.115170","url":null,"abstract":"<div><h3>Background</h3><div>Immune checkpoint inhibitors (ICIs) are associated with an increased risk of major adverse cardiovascular events (MACE). Glucagon-like peptide-1 agonists (GLP1a), initially developed for type 2 diabetes mellitus (T2DM), have shown promising results in reducing cardiovascular events. We aimed to investigate the effect of GLP1a on cardiovascular events in patients receiving ICIs.</div></div><div><h3>Methods</h3><div>We conducted a retrospective, propensity score-matched cohort study using the TriNetX database. We identified adults with cancer and T2DM who received ICIs between April 2013 and May 2023. The primary efficacy outcome was incident MACE, defined as a composite of myocardial infarction, need for coronary revascularization, heart failure, ischemic stroke, and cardiac arrest. The secondary efficacy outcomes were the individual components of MACE as well as myocarditis and pericarditis. Safety outcomes included the occurrence of immune-related adverse events, serious adverse events related to GLP1a use, and all-cause mortality.</div></div><div><h3>Results</h3><div>We identified 7651 patients eligible for inclusion, among which 479 received GLP1a and 7172 received non-GLP1a diabetes medications. After matching (469 patients each), baseline characteristics were well-balanced. Over a median 12-month follow-up, the GLP1a cohort had a significantly lower MACE incidence than the non-GLP1a cohort (9.0 vs. 17.1 events per 100 patient-years) with a 54 % lower risk of MACE (Hazard ratio (HR),0.46 [95 % CI: 0.32–0.67]). There were reductions in myocardial infarction or need for coronary revascularization, heart failure, and all-cause mortality, with no differences in other cardiovascular events. GLP1a use did not increase risk of adverse events, including pancreatitis, biliary disease, bowel obstruction, gastroparesis, and immune-related adverse events.</div></div><div><h3>Conclusion</h3><div>GLP1a use in cancer patients with T2DM receiving ICIs was associated with reduced MACE and all-cause mortality without an increased risk in serious adverse events.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115170"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876427","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}
{"title":"Could intratumoural microbiota be key to unlocking treatment responses in hepatocellular carcinoma?","authors":"Kin Lam Yu , Sj Shen","doi":"10.1016/j.ejca.2024.115195","DOIUrl":"10.1016/j.ejca.2024.115195","url":null,"abstract":"<div><div>Hepatocellular carcinoma (HCC) is the third cause of cancer-related mortality worldwide. Current treatments include surgery and immunotherapy with variable response. Despite aggressive treatment, disease progression remains the biggest contributor to mortality. Thus, there is an urgent unmet need to improve current treatments through a better understanding of HCC tumourigenesis. The gut microbiota has been intensively examined in the context of HCC, with evidence showing gut modulation has the potential to modulate tumourigenesis and prognosis. In addition, recent literature suggests the presence of an intratumoural microbiota that may exert significant impacts on the development of solid tumours including HCC. By drawing parallels between the gut and hepatic/tumoural microbiota, we explore in the present review how the hepatic microbiota is established, its impact on tumourigenesis, and how modulation of the gut and hepatic microbiota may be key to improving current treatments of HCC. In particular, we highlight key bacteria that have been discovered in HCC tumours, and how they may affect the tumour immune microenvironment and HCC tumourigenesis. We then explore current therapies that target the intratumoural microbiota. With a deeper understanding of how the intratumoural microbiota is established, how different bacteria may be involved in HCC tumourigenesis, and how they can be targeted, we hope to spark future research in validating intratumoural microbiota as an avenue for improving treatment responses in HCC.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115195"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893156","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}
Anna N.H. Walstra , Harriet L. Lancaster , Marjolein A. Heuvelmans , Carlijn M. van der Aalst , Juul Hubert , Dana Moldovanu , Sytse F. Oudkerk , Daiwei Han , Jan Willem C. Gratama , Mario Silva , Harry J. de Koning , Matthijs Oudkerk
{"title":"Feasibility of AI as first reader in the 4-IN-THE-LUNG-RUN lung cancer screening trial: impact on negative-misclassifications and clinical referral rate","authors":"Anna N.H. Walstra , Harriet L. Lancaster , Marjolein A. Heuvelmans , Carlijn M. van der Aalst , Juul Hubert , Dana Moldovanu , Sytse F. Oudkerk , Daiwei Han , Jan Willem C. Gratama , Mario Silva , Harry J. de Koning , Matthijs Oudkerk","doi":"10.1016/j.ejca.2024.115214","DOIUrl":"10.1016/j.ejca.2024.115214","url":null,"abstract":"<div><h3>Background</h3><div>Lung cancer screening (LCS) with low-dose CT (LDCT) reduces lung-cancer-related mortality in high-risk individuals. AI can potentially reduce radiologist workload as first-read-filter by ruling-out negative cases. The feasibility of AI as first reader was evaluated in the European 4-IN-THE-LUNG-RUN (4ITLR) trial, comparing its negative-misclassifications (NMs) to those of radiologists and the impact on referral rates.</div></div><div><h3>Methods</h3><div>NMs were collected from 3678 baseline LDCTs of the 4ITLR-dataset. LDCTs were read independently by radiologists and dedicated AI software (AVIEW-LCS, v1.1.42.92, Coreline-Soft, Seoul, Korea). A case was designated as NM when nodules > 100 mm<sup>3</sup> were present and either radiologist or AI gave a negative-classification (only nodules <100 mm<sup>3</sup> or no nodules), with an expert-panel as reference standard. A distinction was made between an indeterminate (100–300mm<sup>3</sup>), and positive (>300 mm<sup>3</sup>) classification, warranting referral for clinical-workup. Overall, there were 102 referrals (2.8 %) at baseline.</div></div><div><h3>Results</h3><div>Of the 3678 baseline scans, 438 NMs (11.9 %) were identified (age individuals: 68 (IQR: 64–73) years, 241 men); 31 (0.8 %) by AI and 407 (11.1 %) by radiologists. Among the 31 AI-NMs, 3 were classified positive and 28 indeterminate. Among the 407 radiologist-NMs, 4 were classified positive, and 403 were indeterminate, of which 8 were classified positive after receiving a three-month follow-up CT. Radiologists, as first reader, would have led to 12/102 (11.8 %) missed referrals, higher than the 3/102 (2.9 %) of AI.</div></div><div><h3>Conclusion</h3><div>This study showed AI outperforms radiologists with significantly less NMs and therefore shows promise as first reader in a LCS program at baseline, by independently ruling-out negative cases without substantially increasing the risk of missed clinical referrals.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115214"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926608","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}
Ana Oaknin , Bradley J. Monk , Andreia Cristina de Melo , Hee Seung Kim , Yong Man Kim , Alla S. Lisyanskaya , Vanessa Samouëlian , Domenica Lorusso , Fernanda Damian , Chih-Long Chang , Evgeniy Gotovkin , Shunji Takahashi , Daniella Ramone , Beata Maćkowiak-Matejczyk , Laura Polastro , Eva Maria Guerra Alia , Nicoletta Colombo , Yulia Makarova , Jeffrey C. Goh , Kosei Hasegawa , Krishnansu S. Tewari
{"title":"Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial","authors":"Ana Oaknin , Bradley J. Monk , Andreia Cristina de Melo , Hee Seung Kim , Yong Man Kim , Alla S. Lisyanskaya , Vanessa Samouëlian , Domenica Lorusso , Fernanda Damian , Chih-Long Chang , Evgeniy Gotovkin , Shunji Takahashi , Daniella Ramone , Beata Maćkowiak-Matejczyk , Laura Polastro , Eva Maria Guerra Alia , Nicoletta Colombo , Yulia Makarova , Jeffrey C. Goh , Kosei Hasegawa , Krishnansu S. Tewari","doi":"10.1016/j.ejca.2024.115146","DOIUrl":"10.1016/j.ejca.2024.115146","url":null,"abstract":"<div><h3>Aim</h3><div>Cemiplimab has demonstrated significantly longer survival than physician’s choice of chemotherapy in patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. We report the final survival analysis from the phase III randomized study (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9).</div></div><div><h3>Methods</h3><div>Cemiplimab (n = 304) or chemotherapy (n = 304) were administered every 3 weeks. The primary endpoint was overall survival (OS). Patients were included regardless of programmed cell death-ligand 1 (PD-L1) status.</div></div><div><h3>Results</h3><div>At a median follow-up of 47.3 months (data cut-off: April 20, 2023), median OS was 11.7 versus 8.5 months for patients treated with cemiplimab and chemotherapy, respectively (hazard ratio 0.67, 95 % confidence interval 0.56–0.80, p < .00001). OS benefit was seen in PD-L1 positive and negative populations, even though more patients with PD-L1 < 1 % (n = 92), had poor performance status in the cemiplimab arm than the chemotherapy arm (61.4 % vs 47.9 %).</div></div><div><h3>Conclusion</h3><div>This final analysis confirms that cemiplimab maintains survival benefit compared with chemotherapy in recurrent cervical cancer after progression on first-line platinum therapy, regardless of PD-L1 expression. The safety profile was consistent with published data; incidences of adverse events were similar between cemiplimab and chemotherapy groups. These results support the use of second-line cemiplimab for patients with recurrent cervical cancer.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"216 ","pages":"Article 115146"},"PeriodicalIF":7.6,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970174","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}