R. Di Micco , E. Botteri , C. Canevari , F. Gallivanone , L. Antunovic , P. Scifo , I. Neri , F. Gelardi , P. Magnani , C. Losio , E. Venturini , G. Della Vecchia , G. Ferrarese , N. Rotmensz , V. Zuber , S. Baleri , G. Cisternino , F. Calabretto , S.P. Corona , M. Rampa , O.D. Gentilini
{"title":"[18F]FDG PET/MRI vs sentinel node biopsy for axillary staging of early breast cancer patients. A prospective single-arm trial","authors":"R. Di Micco , E. Botteri , C. Canevari , F. Gallivanone , L. Antunovic , P. Scifo , I. Neri , F. Gelardi , P. Magnani , C. Losio , E. Venturini , G. Della Vecchia , G. Ferrarese , N. Rotmensz , V. Zuber , S. Baleri , G. Cisternino , F. Calabretto , S.P. Corona , M. Rampa , O.D. Gentilini","doi":"10.1016/j.ejca.2025.115519","DOIUrl":"10.1016/j.ejca.2025.115519","url":null,"abstract":"<div><h3>Background</h3><div>Two randomized controlled trials demonstrated the non-inferiority of axillary surgery omission in selected early breast cancer patients. However, clinicians remain hesitant to forgo sentinel lymph node biopsy due to its potential therapeutic implications. A reliable imaging modality for nodal metastases detection could potentially replace surgery. This trial prospectively evaluated the accuracy of hybrid [<sup>18</sup>F]FDG PET/MRI in detecting axillary lymph nodes macro-metastases in women with early breast cancer.</div></div><div><h3>Methods</h3><div>This is a prospective interventional single-arm monocentric trial including patients with breast cancer without nodal involvement on standard preoperative imaging and eligible for upfront surgery. Between June 2020 and April 2024 recruited patients underwent [<sup>18</sup>F]FDG PET/MRI before surgery. Two radiologists and two nuclear medicine physicians, all blinded, independently reviewed the images.</div></div><div><h3>Findings</h3><div>A total of 246 patients were included. Five had bilateral disease, leading to the evaluation of 251 axillae. Mean (SD) age at surgery was 56.3 (10.7) years and mean (SD) tumor size was 17.5 (13.0) mm at final pathology. Macro-metastatic axillary lymph nodes were found in 61 cases (24.3 %). [<sup>18</sup>F]FDG PET/MRI identified 43 (70.5 %) of these cases, and significantly outperformed both [<sup>18</sup>F]FDG PET and MRI alone, which identified 36 (59.0 %; p = 0.016) and 25 (41.0 %; p < 0.001) cases, respectively. Negative predictive value was higher for [<sup>18</sup>F]FDG PET/MRI (89.4 %) than [<sup>18</sup>F]FDG PET (86.4 %, p = 0.021) and MRI (82.9 %, p0.001 <) alone.</div></div><div><h3>Interpretations</h3><div>[<sup>18</sup>F]FDG PET/MRI detected 70.5 % of cases with macro-metastatic axillary lymph nodes in patients with clinically negative axilla, with greater accuracy than [<sup>18</sup>F]FDG PET or MRI alone. Advanced imaging might help refine the surgical strategy for axillary staging.</div><div><u>Trial registration:</u> ClinicalTrials.Gov ID NCT04829643</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"224 ","pages":"Article 115519"},"PeriodicalIF":7.6,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144170374","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}
Emilia Ruggiero , Sukshma Sharma , Augusto Di Castelnuovo , Simona Costanzo , Teresa Panzera , Simona Esposito , Chiara Cerletti , Maria Benedetta Donati , Giovanni de Gaetano , Licia Iacoviello , Marialaura Bonaccio , for the Moli-sani Study Investigators
{"title":"Olive oil consumption and risk of breast cancer: Prospective results from the Moli-sani Study, and a systematic review of observational studies and randomized clinical trials","authors":"Emilia Ruggiero , Sukshma Sharma , Augusto Di Castelnuovo , Simona Costanzo , Teresa Panzera , Simona Esposito , Chiara Cerletti , Maria Benedetta Donati , Giovanni de Gaetano , Licia Iacoviello , Marialaura Bonaccio , for the Moli-sani Study Investigators","doi":"10.1016/j.ejca.2025.115520","DOIUrl":"10.1016/j.ejca.2025.115520","url":null,"abstract":"<div><h3>Background</h3><div>Breast cancer (BC) is the leading cause of cancer-related death among women worldwide. Olive oil, rich in monounsaturated fats and polyphenols, has been linked to a reduced BC risk, but epidemiological evidence remains limited. This study examined the association between olive oil consumption and BC risk in a large cohort of adult Italian women and conducted a systematic review on this association.</div></div><div><h3>Methods</h3><div>Longitudinal analyses were performed on 11,442 women (mean age 54.7 ± 11.6 years) enrolled in the Moli-sani Study (2005–2010). Cox proportional hazard models were used to estimate BC risk in relation to olive oil consumption. A systematic review was conducted by searching Scopus, EMBASE, PubMed, and MEDLINE databases up to October 2024 for observational studies and RCTs.</div></div><div><h3>Results</h3><div>Compared with lower olive oil consumption (≤2 tbsp./day), multivariable-adjusted HRs associated with highest intake (>3 tbsp./d) for overall, premenopausal, and postmenopausal BC were 0.71(95 %CI 0.48–1.05), 0.80 (95 %CI 0.28–2.28), and 0.70 (95 %CI 0.46–1.08), respectively.</div><div>An increase of 1-tbsp./d of olive oil was associated with a lower risk of ER<img> and PR<img> breast cancers (HR=0.32; 95 %CI 0.13–0.77), particularly ER<img> cases (HR=0.32; 95 %CI 0.15–0.69); additionally, a lowered hazard of HER2– BC incidence was observed at highest consumption of olive oil compared to the bottom category (HR=0.54; 95 %CI 0.31–0.96).</div><div>The systematic review included 13 observational studies (11 case-control and 2 prospective) and 1 RCT. While case-control studies and the RCT suggested a protective effect associated with olive oil consumption, longitudinal studies reported no association.</div></div><div><h3>Conclusions</h3><div>Findings from the Moli-sani Study suggest an inverse association between olive oil consumption and the risk of hormone receptor-negative breast cancers, particularly ER<img> subtype, while results were inconclusive for overall BC risk. The systematic review revealed that case-control studies more frequently reported a protective association, whereas prospective studies did not consistently support this finding.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"224 ","pages":"Article 115520"},"PeriodicalIF":7.6,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144170366","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}
Joanna M. Porter , Cici Jin , Michael Churchman , Ian Croy , Catriona M. Gourley , Oni Glyn-Wright , Marianne Stewart , Elizabeth Brownsell , Basil Monks , Peter Sanderson , Rachel Nirsimloo , C. Simon Herrington , Charlie Gourley , Robert L. Hollis
{"title":"Antibody drug conjugate targets are highly differentially expressed across the major types of ovarian cancer","authors":"Joanna M. Porter , Cici Jin , Michael Churchman , Ian Croy , Catriona M. Gourley , Oni Glyn-Wright , Marianne Stewart , Elizabeth Brownsell , Basil Monks , Peter Sanderson , Rachel Nirsimloo , C. Simon Herrington , Charlie Gourley , Robert L. Hollis","doi":"10.1016/j.ejca.2025.115522","DOIUrl":"10.1016/j.ejca.2025.115522","url":null,"abstract":"<div><h3>Background</h3><div>Antibody-drug conjugates (ADCs) are emerging anti-cancer agents. The folate receptor alpha (FOLRα)-directed ADC mirvetuximab soravtansine recently demonstrated clinical activity in platinum-resistant ovarian cancer, with other ADCs currently in development. The relative expression of FOLRα and other ADC targets is largely unknown across ovarian cancer histotypes.</div></div><div><h3>Methods</h3><div>Expression levels of the ADC targets FOLRα, TROP2 and B7-H4 were assessed by immunohistochemistry in patient cohorts using tumour tissue microarrays of the major ovarian cancer histotypes: high grade serous (HGSOC, n = 331); endometrioid (EnOC, n = 101) and clear cell ovarian carcinoma (CCOC, n = 60). Degree of expression was quantified by membrane histoscore.</div></div><div><h3>Results</h3><div>We observed differences in ADC target expression patterns across ovarian cancer histotypes. FOLRα expression was highest in HGSOC, with few EnOC or CCOC demonstrating positivity (HGSOC: 70.9 % FOLRα histoscore ≥50 vs 21.1 % and 29.3 % in EnOC and CCOC). B7-H4 was expressed in HGSOC, EnOC and CCOC (99.7 %, 89.8 % and 80.7 % with histoscore ≥50). CCOC were mostly TROP2 negative (89.3 % with histoscore <50); a subset of HGSOC and EnOC expressed TROP2 (54.8 % and 57.7 % with histoscore ≥50, respectively). There was no significant association between ADC target expression and molecular subtypes of HGSOC (<em>BRCA1</em>/<em>2</em>-mutant, <em>CCNE1</em>-gained, other) or EnOC (<em>TP53</em>-mutant, <em>CTNNB1</em>-mutant, <em>POLE</em>-mutant, MMR deficient, no specific molecular profile). In CCOC, <em>ARID1A</em>/<em>B</em> mutation was associated with lower B7-H4 expression (P-adj=0.024).</div></div><div><h3>Conclusion</h3><div>EnOC and CCOC are usually FOLRα negative, while HGSOC, EnOC and CCOC frequently express B7-H4. TROP2 positivity is limited to HGSOC and EnOC. Careful consideration of histotype and ADC target expression levels is warranted when designing and analysing clinical studies of ADCs.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"224 ","pages":"Article 115522"},"PeriodicalIF":7.6,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144170367","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}
Jiashiang Lin , So Sato , Shotaro Aso , Kiyohide Fushimi , Hiroki Matsui , Hideo Yasunaga
{"title":"Corrigendum to “Association of comorbid schizophrenia with cancer stage at admission, treatments, length of stay, and 30-day in-hospital mortality in patients with pancreatic cancer: A retrospective matched-pair cohort study in Japan” [Eur J Cancer, Vol. 222 (2025), Article 115468]","authors":"Jiashiang Lin , So Sato , Shotaro Aso , Kiyohide Fushimi , Hiroki Matsui , Hideo Yasunaga","doi":"10.1016/j.ejca.2025.115495","DOIUrl":"10.1016/j.ejca.2025.115495","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"223 ","pages":"Article 115495"},"PeriodicalIF":7.6,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144089639","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}
M. Bloem , K.P.M. Suijkerbuijk , M.J.B. Aarts , F.W.P.J. van den Berkmortel , C.U. Blank , W.A.M. Blokx , M.J. Boers-Sonderen , C.D.M. Boreel , J.W.B. de Groot , J.B.A.G. Haanen , G.A.P. Hospers , E. Kapiteijn , O.J. van Not , D. Piersma , B. Rikhof , A.M. Stevense-den Boer , A.A.M. van der Veldt , G. Vreugdenhil , M.W.J.M. Wouters , A.J.M. van den Eertwegh
{"title":"Efficacy of encorafenib plus binimetinib in patients with BRAF-mutated melanoma brain metastases: Results from the Dutch Melanoma Treatment Registry","authors":"M. Bloem , K.P.M. Suijkerbuijk , M.J.B. Aarts , F.W.P.J. van den Berkmortel , C.U. Blank , W.A.M. Blokx , M.J. Boers-Sonderen , C.D.M. Boreel , J.W.B. de Groot , J.B.A.G. Haanen , G.A.P. Hospers , E. Kapiteijn , O.J. van Not , D. Piersma , B. Rikhof , A.M. Stevense-den Boer , A.A.M. van der Veldt , G. Vreugdenhil , M.W.J.M. Wouters , A.J.M. van den Eertwegh","doi":"10.1016/j.ejca.2025.115514","DOIUrl":"10.1016/j.ejca.2025.115514","url":null,"abstract":"<div><h3>Aim</h3><div>Data on the effectiveness of encorafenib/binimetinib in melanoma patients with brain metastases (BMs) are limited.</div></div><div><h3>Methods</h3><div>All patients with <em>BRAF V600-</em>mutated melanoma and BMs treated with encorafenib/binimetinib between 2019 and 2022 in the Netherlands were included from the nationwide Dutch Melanoma Treatment Registry. Patients previously treated with other BRAF/MEK inhibitors were excluded. We analyzed objective response rates (ORR), progression-free survival (PFS), and overall survival (OS). Multivariable Cox regression identified factors associated with survival. Subgroup analyses included asymptomatic versus symptomatic BMs and line of treatment (first-line versus later-line).</div></div><div><h3>Results</h3><div>In total, 190 patients were included. Symptomatic BMs were present in 63 % of patients. Encorafenib/binimetinib was the first-line treatment in 64 % of all patients, while 36 % had prior immunotherapy. Overall, the ORR was 69.4 %, median PFS was 5.5 months (95 %CI 4.9–6.2), and median OS 11.9 months (95 %CI 10.0–15.7). Age ≥ 70, ECOG PS ≥ 2, symptomatic BMs, and elevated LDH were significantly associated with worse survival. Patients with prior immunotherapy had a median PFS of 6.9 months (95 %CI 4.3–9.6) and OS of 17.9 months (95 %CI 13.7–31.2), while this was 4.9 months (95 %CI 4.3–5.5) and 10.1 months (95 %CI 8.1–13.0) in treatment-naïve patients. Median PFS and OS in patients with asymptomatic versus symptomatic BMs were 6.1 months (95 %CI 4.9–9.8) and 20.5 (95 %CI 14.0-NA) versus 5.3 months (95 %CI 4.9–6.3) and 10.7 (95 %CI 8.9–13.7), respectively.</div></div><div><h3>Conclusions</h3><div>Encorafenib/binimetinib has clinical activity in real-world melanoma patients with BMs. Their prognosis is determined by the presence of symptomatic BMs, age, ECOG PS, and LDH levels.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"223 ","pages":"Article 115514"},"PeriodicalIF":7.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124291","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":"Case report of two fatal cerebral hemorrhages in patients with metastatic colorectal cancer treated with Fruquintinib.","authors":"E Hafliger, R Nili-Asgari, J Netter, J Taieb","doi":"10.1016/j.ejca.2025.115517","DOIUrl":"https://doi.org/10.1016/j.ejca.2025.115517","url":null,"abstract":"","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":" ","pages":"115517"},"PeriodicalIF":7.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144131955","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}
Neal Shore , Alicia K. Morgans , Martin Boegemann , Elaine Gallagher , Noman Paracha , Paul Serafini , Divya Pushkarna , Mir-Masoud Pourrahmat , Murat Kurt , Keith R. Abrams
{"title":"Radiological progression-free survival as a surrogate for overall survival in patients with metastatic hormone-sensitive prostate cancer: A bivariate meta-analysis","authors":"Neal Shore , Alicia K. Morgans , Martin Boegemann , Elaine Gallagher , Noman Paracha , Paul Serafini , Divya Pushkarna , Mir-Masoud Pourrahmat , Murat Kurt , Keith R. Abrams","doi":"10.1016/j.ejca.2025.115513","DOIUrl":"10.1016/j.ejca.2025.115513","url":null,"abstract":"<div><h3>Background</h3><div>Overall survival (OS) is the standard efficacy endpoint in various solid tumor trials; however, it requires longer follow-up time for assessment than potential intermediate endpoints. This study evaluated radiological progression-free survival (rPFS) as a surrogate for OS in metastatic hormone-sensitive prostate cancer (mHSPC) using aggregate-level data from randomized controlled trials (RCTs).</div></div><div><h3>Methods</h3><div>A systematic literature review identified mHSPC RCTs published through December 2023, reporting hazard ratios for rPFS (HR<sub>rPFS</sub>) and OS (HR<sub>OS</sub>). Correlation between HR<sub>rPFS</sub> and HR<sub>OS</sub> was assessed using bivariate random-effects meta-analysis (BRMA). Predictive validity was assessed with leave-one-out cross-validation (LOOCV). The surrogate threshold effect (STE), or minimum rPFS benefit predicting an OS benefit, was estimated using recent mHSPC trial sample sizes. Sensitivity analyses (1) omitted trials that had only one of the endpoints reported, (2) omitted HRs that violated proportional hazards assumptions, (3) omitted trials that allowed cross-over and (4) investigated different assumed values of the within-study correlation.</div></div><div><h3>Results</h3><div>The primary analysis included 35 treatment comparisons from 31 trials. The estimated rPFS-OS correlation was 0.95 (95 % CrI: 0.75, 1.00). LOOCV confirmed HR<sub>OS</sub> were within 95 % prediction intervals. The estimated STE ranged from 0.55 to 0.71 depending on the trial size being predicted. Sensitivity analyses produced strong but slightly lower correlations (0.87, 0.89, 0.91) than the primary analysis, with full coverage of the reported HR<sub>OS</sub> in cross validation. Increasing within-study correlation slightly reduced between-study correlation.</div></div><div><h3>Conclusions</h3><div>The derived surrogacy equation enables OS estimation based on reported rPFS benefits in mHSPC, meeting NICE’s 95 % surrogate validity threshold. These findings support rPFS as a reliable surrogate for OS, facilitating prediction of OS benefits in future mHSPC trials.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"223 ","pages":"Article 115513"},"PeriodicalIF":7.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124292","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}
Adhemar Villani Júnior , Maristela P. Freire , Felippe Lazar Neto , Luis Alberto De Padua Covas Lage , Maura Salaroli Oliveira , Edson Abdala , Fatima L.S. Nunes , Anna Sara S. Levin
{"title":"Prediction of bacterial and fungal bloodstream infections using machine learning in patients undergoing chemotherapy","authors":"Adhemar Villani Júnior , Maristela P. Freire , Felippe Lazar Neto , Luis Alberto De Padua Covas Lage , Maura Salaroli Oliveira , Edson Abdala , Fatima L.S. Nunes , Anna Sara S. Levin","doi":"10.1016/j.ejca.2025.115516","DOIUrl":"10.1016/j.ejca.2025.115516","url":null,"abstract":"<div><h3>Purpose</h3><div>This study aimed to develop a machine learning (ML) model to predict bloodstream infection (BSI) in chemotherapy patients.</div></div><div><h3>Patients and methods</h3><div>We included all cancer patients undergoing chemotherapy at a tertiary cancer hospital from 2017 to 2022. Data were collected per chemotherapy cycle, including chemotherapy drugs, indications, cycle number, cancer type, body mass index, age, gender, complete blood count, creatinine levels, and microbial cultures. BSI was assessed within 21 days after chemotherapy. The ML algorithms tested included logistic regression, ridge regression, k-nearest neighbors, Naive Bayes, Perceptron, neural networks, decision trees, boosting methods, Random Forests, and Support Vector Machines. The SHapley Additive exPlanations (SHAP) method was used to measure feature importance.</div></div><div><h3>Results</h3><div>Among 107,757 cycles from 19,225 patients, 91.7 % had solid tumors, primarily breast (36.8 %) and gastrointestinal (19.4 %) cancers. The first cycle accounted for 23.7 % of cycles, and palliative chemotherapy made up 52.9 %. Alkylating agent was the most common drug class used (55.5 %). BSI occurred in 1.33 % of cycles, with 34 % of these cases occurring in neutropenic patients. Of the bacteremia cases, 11.8 % were polymicrobial, and 69.3 % involved gram-negative bacteria. The best model was a neural network with one hidden layer (5 neurons), achieving 70.7 % sensitivity, 93.49 % specificity, 93.19 % accuracy, and an area under a receiver operating characteristic curve of 91.93 %. Key predictors included the first cycle, antimetabolite use, palliative chemotherapy, monocytopenia, and hematological malignancies.</div></div><div><h3>Conclusion</h3><div>ML effectively predicts bacteremia in chemotherapy patients, including non-neutropenic cases, and could be used in clinical practice to guide treatment and infection workup.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"223 ","pages":"Article 115516"},"PeriodicalIF":7.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144071464","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}
Sebastiano Nazzani , Adele Busico , Valentina Bernasconi , Martina Bruniera , Martina Gianninò , Daniele Rusconi , Jessica Gualtieri , Carlo Silvani , Alberto Macchi , Tullio Torelli , Silvia Stagni , Antonio Tesone , Cesare Saitta , Iolanda Capone , Tommaso Cascella , Rodolfo Lanocita , Marco Barella , Biagio Paolini , Federica Perrone , Giancarlo Albo , Nicola Nicolai
{"title":"Clinical evaluation of the role of miRNA 371 in small testicular masses. Results of the “S1STeM 371” Trial","authors":"Sebastiano Nazzani , Adele Busico , Valentina Bernasconi , Martina Bruniera , Martina Gianninò , Daniele Rusconi , Jessica Gualtieri , Carlo Silvani , Alberto Macchi , Tullio Torelli , Silvia Stagni , Antonio Tesone , Cesare Saitta , Iolanda Capone , Tommaso Cascella , Rodolfo Lanocita , Marco Barella , Biagio Paolini , Federica Perrone , Giancarlo Albo , Nicola Nicolai","doi":"10.1016/j.ejca.2025.115494","DOIUrl":"10.1016/j.ejca.2025.115494","url":null,"abstract":"<div><h3>Aim of the study</h3><div>Incidental small testicular masses (STMs) pose the dilemma of invasive Vs surveillance. To test miRNA 371 kit (M371, CE approved) in predicting germ cells tumor (GCT) in patients with STM.</div></div><div><h3>Methods</h3><div>Thirty-two consecutive men with a STM between 5 and 20 mm have been prospectively accrued. All patients had miRNA 371 blood testing before surgery. Serum miRNA processation was standardized and certified and following transcription into cDNA with an endogeneous control. The Relative Quantity (RQ) was determined by quantitative polymerase chain reaction (qPCR) following preamplification. Different RQ cut-offs were tested. The results of pre-surgery 371 miRNA were compared to definitive pathology.</div></div><div><h3>Results</h3><div>Median lesion size was 14 mm (IQR 8–18 mm). 21 of 32 patients (65.6 %) had GCTs: 14 seminomatous (S)GCTs, 6 non-seminomatous (NS)GCTs, 1 in-situ germ cell neoplasia (GCNIS). Median RQ was 57.50 (IQR 18.50, 223.75) among GCT patients and 5.00 (IQR 1.00, 13.50) in patients without GCTs. We tested for sensitivity (SE), specificity (SP), positive (PPV) and negative predictive value (NPV) at different RQ cut-offs of 5 and 10. SE, SP, PPV and NPV were 100 %, 45 %, 78.1 %, 100 % 95.2 %, 63.7 %, 83.6 %, 87.3 %, respectively.</div></div><div><h3>Conclusions</h3><div>Serum miRNA 371 can predict GCTs in selected patients with 5–20 mm STM. These results need to be refined by standardizing the analytical process.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"223 ","pages":"Article 115494"},"PeriodicalIF":7.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144071463","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}