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Central nervous system effectiveness of selpercatinib retreatment in heavily pretreated NSCLC patient with RET rearrangement: A case report. selpercatinib再治疗重度预处理伴有RET重排的NSCLC患者中枢神经系统的有效性:1例报告。
IF 3.1 4区 医学
Tumori Pub Date : 2026-01-12 DOI: 10.1177/03008916251404267
Margherita Agostini, Samuele Compagno, Francesca Sperandi, Luca Faccioli, Stefania Salvagni, Andrea Ardizzoni, Francesco Gelsomino
{"title":"Central nervous system effectiveness of selpercatinib retreatment in heavily pretreated NSCLC patient with RET rearrangement: A case report.","authors":"Margherita Agostini, Samuele Compagno, Francesca Sperandi, Luca Faccioli, Stefania Salvagni, Andrea Ardizzoni, Francesco Gelsomino","doi":"10.1177/03008916251404267","DOIUrl":"https://doi.org/10.1177/03008916251404267","url":null,"abstract":"<p><strong>Introduction: </strong>RET-rearranged non-small cell lung cancer (NSCLC) is a rare molecular subtype, accounting for 1-2% of all lung cancers. Selpercatinib, a selective RET tyrosine kinase inhibitor (TKI), has demonstrated efficacy in this oncogene-addicted population, but data on rechallenge after disease progression are lacking.</p><p><strong>Case description: </strong>A 70-year-old male was diagnosed with a metastatic RET-positive adenocarcinoma of the lung. At the time of systemic progressive disease on first-line chemo-immunotherapy, he received selpercatinib for 22 months before further central nervous system (CNS) progression. After whole-brain radiotherapy and third-line chemotherapy, selpercatinib was resumed due to further CNS progression and lack of other therapeutic options. Remarkably, the patient achieved an almost complete CNS remission.</p><p><strong>Conclusion: </strong>This case suggests that selpercatinib rechallenge may be effective in difficult-to-treat RET-positive NSCLC patients, including those with uncontrolled CNS disease.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"3008916251404267"},"PeriodicalIF":3.1,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145953268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Mantle cell lymphoma with hypereosinophilia: A case report. 套细胞淋巴瘤伴嗜酸性细胞增多:1例报告及文献复习。
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2025-09-20 DOI: 10.1177/03008916251362124
Xianghui Liu, Tianjie Han, Yue Ma, Zhe Yu
{"title":"Mantle cell lymphoma with hypereosinophilia: A case report.","authors":"Xianghui Liu, Tianjie Han, Yue Ma, Zhe Yu","doi":"10.1177/03008916251362124","DOIUrl":"10.1177/03008916251362124","url":null,"abstract":"<p><strong>Introdution: </strong>Reactive eosinophilia has been reported in several hematological malignancies, including Hodgkin-s lymphoma, T-cell lymphoma/leukemia, and acute leukemia. However, eosinophilia associated with B-cell non-Hodgkin-s lymphoma is rarely reported. Mantle cell lymphoma is a subcategory of non-Hodgkin-s lymphoma originated from mature B cells. In this article, we report for the first time a case of mantle cell lymphoma with hypereosinophilia.</p><p><strong>Case description: </strong>A 69-year-old male patient was diagnosed with mantle cell lymphoma accompanied by eosinophilia, with common secondary causes of eosinophilia ruled out. Following immunochemotherapy, the patient achieved lymphoma remission, and eosinophil levels returned to normal.</p><p><strong>Conclusion: </strong>This case potentially adds to the limited body of literature on eosinophilia in B-cell non-Hodgkin lymphoma. The limitations of this study include the absence of expanded genetic panel testing to confirm eosinophil clonality or T-cell clonality, unmeasured IL-5 levels, and inherent constraints of case reports.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"NP26-NP31"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145092530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Effects of virtual reality exposure on psychological distress in adolescent oncology patients. 虚拟现实暴露对青少年肿瘤患者心理困扰的影响。
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2025-10-21 DOI: 10.1177/03008916251356848
Andrea Paulis, Valerio Marri, Andrea De Salvo, Valentina Di Ruscio, Stefania Gaspari, Maria Debora De Pasquale, Giada Del Baldo, Roberto Premuselli, Michela Origlia, Angela Mastronuzzi, Giuseppe Maria Milano
{"title":"Effects of virtual reality exposure on psychological distress in adolescent oncology patients.","authors":"Andrea Paulis, Valerio Marri, Andrea De Salvo, Valentina Di Ruscio, Stefania Gaspari, Maria Debora De Pasquale, Giada Del Baldo, Roberto Premuselli, Michela Origlia, Angela Mastronuzzi, Giuseppe Maria Milano","doi":"10.1177/03008916251356848","DOIUrl":"10.1177/03008916251356848","url":null,"abstract":"<p><p>Adolescents and young adults (AYA) with cancer often experience significant psychological distress during hospitalization. Virtual reality (VR) is a non-pharmacological intervention, yet its application in pediatric oncology remains limited. In this study, 35 patients aged 12-21 were assigned to either an experimental group (n=20), which received four VR sessions over two weeks in addition to standard care, or a control group (n=15), which received standard care only. Psychological measures included the Distress Thermometer (DT), State-Trait Anxiety Inventory-Y1 (STAI-Y1), and Hospital Anxiety and Depression Scale (HADS). The experimental group showed significant reductions in distress (DT), state anxiety (STAI-Y1), and depressive symptoms (HADS-D) (all p<.05; Cohen's d medium to large size). No significant changes were observed in the control group. These findings suggest that VR is a feasible, well-tolerated, and potentially effective tool for reducing psychological distress in AYA oncology patients. Such preliminary results support its integration into multidisciplinary care. Further large-scale studies are needed to confirm its efficacy.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"529-534"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638458/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145337673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Trabectedin-irinotecan as a potential therapeutic option in desmoplastic small round cell tumor: A small case series. trabectetin -伊立替康作为促结缔组织增生小圆细胞瘤的潜在治疗选择:一个小病例系列。
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2025-11-09 DOI: 10.1177/03008916251390668
Andrea Ferrari, Stefano Chiaravalli, Walter Ferrari Bravo, Luca Bergamaschi, Antonio Ruggiero, Francesco De Leonardis, Eulalia Galea, Patrizia Bertolini, Reineke A Schoot, Sandro Pasquali, Michela Casanova
{"title":"Trabectedin-irinotecan as a potential therapeutic option in desmoplastic small round cell tumor: A small case series.","authors":"Andrea Ferrari, Stefano Chiaravalli, Walter Ferrari Bravo, Luca Bergamaschi, Antonio Ruggiero, Francesco De Leonardis, Eulalia Galea, Patrizia Bertolini, Reineke A Schoot, Sandro Pasquali, Michela Casanova","doi":"10.1177/03008916251390668","DOIUrl":"10.1177/03008916251390668","url":null,"abstract":"<p><p>IntroductionDesmoplastic small round cell tumor (DSRCT) is a rare and aggressive mesenchymal malignancy driven by the EWS-WT1 gene fusion. Prognosis remains poor despite intensive multimodal therapy. Preclinical studies indicate that trabectedin combined with irinotecan exerts synergistic antitumor effects in translocation-driven sarcomas.Case descriptionWe report a case series of eight young patients (age range 11-23 years) with advanced and relapsed DSRCT treated between 2021 and 2024 at five Italian pediatric oncology centers. The trabectedin-irinotecan combination (given on compassionate grounds) was administered as second-line therapy in six cases, and third-line in two. The regimen included trabectedin at 1.3 mg/m², 24-hour infusion, day 1, and irinotecan at 20 mg/m², days 8-12. Observed outcomes included: one complete remission, three partial responses, two minor responses, one mixed response, one progressive disease. The chemotherapy combination was overall well tolerated, with good preservation of patients' quality of life, and no life-threatening adverse events reported.Conclusions:This descriptive case series of trabectedin-irinotecan in DSRCT supports preclinical evidence of synergistic activity. The regimen was well tolerated and showed potential clinical benefit even in heavily pre-treated patients, providing a rationale for further studies to optimize dosing and explore early integration.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"NP16-NP20"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145483039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Four pathogenic variants co-occurring in a MINAS early-onset breast cancer. 四种致病变异共同发生在MINAS早发性乳腺癌。
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2024-12-11 DOI: 10.1177/03008916241301368
Davide Bondavalli, Mario Urtis, Maurizia Grasso, Carmela Giorgianni, Chiara Cassani, Adele Sgarella, Alberta Ferrari, Gianpiero Rizzo, Eloisa Arbustini
{"title":"Four pathogenic variants co-occurring in a MINAS early-onset breast cancer.","authors":"Davide Bondavalli, Mario Urtis, Maurizia Grasso, Carmela Giorgianni, Chiara Cassani, Adele Sgarella, Alberta Ferrari, Gianpiero Rizzo, Eloisa Arbustini","doi":"10.1177/03008916241301368","DOIUrl":"10.1177/03008916241301368","url":null,"abstract":"<p><p>IntroductionMultilocus Inherited Neoplasia Allele Syndrome (MINAS) is a condition defined by the presence of germline pathogenic variants in more than one Cancer Susceptibility Gene (CSG). MINAS is still underreported in the literature and public databases. Since MINAS-related phenotypes are difficult to predict, case descriptions may contribute to risk assessment, treatment, and personalized surveillance for proband and relatives.Case Description:Here we report a unique case of early onset, bifocal, non-Triple Negative breast cancer in a 31-year-old woman. Fast metastatic dissemination involving the brain caused the death of the patient in a few months. Her multigene panel testing showed the co-occurrence of pathogenic variants in <i>PALB2</i> (c.1221del; p.Thr408fs*40), <i>ATM</i> (c.8545C>T; p.Arg2849*), <i>PMS2</i> (c.1919C>A; p.Ser640*), and <i>MUTYH</i> (c.1103G>A; p.Gly368Asp). The patient inherited the <i>ATM</i> and <i>MUTYH</i> variants from the mother, and <i>PALB2</i> and <i>PMS2</i> variants from the father. The brother inherited the maternal <i>ATM</i> and paternal <i>PMS2</i> variants. A baseline imaging-based family screening excluded malignancies in both parents and in the brother. Tailored monitoring is ongoing based on the risk predicted by pathogenic variants identified in family members.Conclusions:Currently, there are no predictive tools available to determine organ-specific cancer risk in MINAS patients. Given the uncertainty in predicting the phenotypic effect of multiple variants in CSGs, ongoing clinical surveillance and sharing data from complex cases are crucial for improving risk stratification in this condition.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"NP1-NP6"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12638455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Combined CAR-T/HSCT approach in a patient with refractory acute lymphoblastic leukemia and cystic fibrosis. CAR-T/HSCT联合治疗难治性急性淋巴细胞白血病合并囊性纤维化1例。
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2024-12-17 DOI: 10.1177/03008916241301912
Benedetta E Di Majo, Francesca Vendemini, Sonia Bonanomi, Pietro Casartelli, Sara Napolitano, Giorgio Ottaviano, Giulia Prunotto, Marta Verna, Alessandra Sala, Guglielmo M Migliorino, Francesco Petrella, Lorenzo Rosso, Laura Claut, Paola Rafaniello Raviele, Carmelo Rizzari, Andrea Biondi, Adriana Balduzzi, Giovanna Lucchini
{"title":"Combined CAR-T/HSCT approach in a patient with refractory acute lymphoblastic leukemia and cystic fibrosis.","authors":"Benedetta E Di Majo, Francesca Vendemini, Sonia Bonanomi, Pietro Casartelli, Sara Napolitano, Giorgio Ottaviano, Giulia Prunotto, Marta Verna, Alessandra Sala, Guglielmo M Migliorino, Francesco Petrella, Lorenzo Rosso, Laura Claut, Paola Rafaniello Raviele, Carmelo Rizzari, Andrea Biondi, Adriana Balduzzi, Giovanna Lucchini","doi":"10.1177/03008916241301912","DOIUrl":"10.1177/03008916241301912","url":null,"abstract":"<p><strong>Introduction: </strong>The association of acute lymphoblastic leukaemia (ALL) and cystic fibrosis (CF) is rare. We present the case of a paediatric patient affected by CF and refractory B-cell precursor (BCP) ALL, who was treated with combined chimeric antigen receptor T-cells (CAR-T) and allogeneic haematopoietic stem cell transplantation (HSCT).</p><p><strong>Case description: </strong>Autologous-CD19 targeting CAR-T allowed to achieve molecular remission and spare chemo-related toxicity. As B-cell aplasia was not achieved, the patient underwent HSCT after total body irradiation (TBI)-based conditioning. The course after HSCT was complicated by veno-occlusive disease, status epileptic and pulmonary invasive fungal infection which showed progressive radiological worsening despite aggressive treatment. Five months after HSCT a left upper lobe lobectomy was successfully performed. Thirteen months after HSCT the patient is in complete disease remission with normal lung function.</p><p><strong>Conclusions: </strong>CAR-T cell therapy bridge-to-HSCT may be an effective approach in paediatric refractory ALL in the context of multiple comorbidities as observed in CF.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"NP21-NP25"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142839678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Inter-hospital heterogeneity in the authorizations of off-label cancer drugs: A project by Associazione Italiana di Oncologia Medica. 非核准抗癌药物授权的医院间异质性:意大利肿瘤医学协会的一个项目。
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2025-10-18 DOI: 10.1177/03008916251386285
Anna Amela Valsecchi, Matilde Scaldaferri, Marcello Tiseo, Gianmauro Numico, Gianluca Russo, Nicola Personeni, Livio Blasi, Alessia Pisterna, Alessandra Zanardi, Claudia Fruttero, Giordano Domenico Beretta, Giulia Dusi, Marina Campione, Alessandra Gennari, Maria Rachele Chiappetta, Francesco Perrone, Massimo Di Maio
{"title":"Inter-hospital heterogeneity in the authorizations of off-label cancer drugs: A project by Associazione Italiana di Oncologia Medica.","authors":"Anna Amela Valsecchi, Matilde Scaldaferri, Marcello Tiseo, Gianmauro Numico, Gianluca Russo, Nicola Personeni, Livio Blasi, Alessia Pisterna, Alessandra Zanardi, Claudia Fruttero, Giordano Domenico Beretta, Giulia Dusi, Marina Campione, Alessandra Gennari, Maria Rachele Chiappetta, Francesco Perrone, Massimo Di Maio","doi":"10.1177/03008916251386285","DOIUrl":"10.1177/03008916251386285","url":null,"abstract":"<p><p>PurposeThis project aimed to describe variability of local evaluations of off-label cancer drug requests by submitting a list of identical requests to different Italian centers.MethodsIn October 2024, oncology unit directors listed in the AIOM Libro Bianco were invited to participate, evaluating 11 clinical cases with solid tumors through their internal approval process. Supporting evidence was retrospective in two cases, based on phase II trials in seven, and phase III trials in two. Inter-rater agreement was measured using Fleiss' kappa.ResultsSeven centers completed evaluations. Two cases were approved by all centers, both with a rare cancer with scant alternatives. The mean number of centers approving the individual requests was 5.36/7 (76.6%) with a poor inter-rater agreement (kappa 0.009, 95% CI -0.120 to 0.138). Single centers approved a mean of 8.4 requests (76.6%). The mean number of centers that approved requests was 5.5 for requests based on retrospective studies, 5.3 for those based on phase II trials, and 5.5 for those based on phase III trials. There was no correlation between estimated cost and chance of approval.ConclusionsThere is a significant inter-hospital variability in off-label oncology drug evaluations, leading to potential disparities in patient's access to care.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"506-514"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145313702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Sequential therapy of metastatic urothelial cancer with monomethyl auristatin E (MMAE)-containing antibody-drug conjugates for different targets. 转移性尿路上皮癌序贯治疗不同靶点含单甲耳素E (MMAE)的抗体-药物偶联物
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2025-09-29 DOI: 10.1177/03008916251362021
Jiaping Yang, Zhenxia Ma, Weiqin Sun, Mingjuan Sun, Sheng Zhang
{"title":"Sequential therapy of metastatic urothelial cancer with monomethyl auristatin E (MMAE)-containing antibody-drug conjugates for different targets.","authors":"Jiaping Yang, Zhenxia Ma, Weiqin Sun, Mingjuan Sun, Sheng Zhang","doi":"10.1177/03008916251362021","DOIUrl":"10.1177/03008916251362021","url":null,"abstract":"<p><strong>Introduction: </strong>Antibody-drug conjugate (ADC) has become the standard of treatment for metastatic urothelial cancer. Current trials generally test the combination or sequential use of antibody-drug conjugates with different targets and different chemotherapeutic reagents.</p><p><strong>Case description: </strong>We show that in three patients with metastatic urothelial cancer who have progressed on anti-HER2 antibody-drug conjugates, two showed responses when treated with EV (the same monomethyl auristatin E-containing ADC, but with different targets).</p><p><strong>Conclusion: </strong>This result showed the therapeutic potential of sequential use of ADC containing the same chemotherapeutic reagents with different targets for metastatic urothelial cancer.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"NP32-NP36"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Liquid biopsy in prostate cancer: A multidisciplinary expert consensus statement. 前列腺癌液体活检:多学科专家共识声明。
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2025-09-29 DOI: 10.1177/03008916251379317
Francesco Pepe, Davide Seminati, Gustavo Baldassarre, Gabriella Cirmena, Dario De Biase, Paola Francia di Celle, Elena Guerini Rocco, Elisa Melucci, Angelo Minucci, Lidia Moserle, Maria Iole Natalicchio, Giancarlo Pruneri, Maria Scatolini, Maria Cristina Sini, Stefania Tommasi, Simona Vatrano, Fabio Pagni, Umberto Malapelle
{"title":"Liquid biopsy in prostate cancer: A multidisciplinary expert consensus statement.","authors":"Francesco Pepe, Davide Seminati, Gustavo Baldassarre, Gabriella Cirmena, Dario De Biase, Paola Francia di Celle, Elena Guerini Rocco, Elisa Melucci, Angelo Minucci, Lidia Moserle, Maria Iole Natalicchio, Giancarlo Pruneri, Maria Scatolini, Maria Cristina Sini, Stefania Tommasi, Simona Vatrano, Fabio Pagni, Umberto Malapelle","doi":"10.1177/03008916251379317","DOIUrl":"10.1177/03008916251379317","url":null,"abstract":"<p><p>Introduction<i>BRCA1/2</i> testing via liquid biopsy has emerged as a critical, minimally invasive alternative to tissue sampling in metastatic castration-resistant prostate cancer (mCRPC), especially in the context of insufficient, inadequate, or unavailable tumor material.MethodsA multidisciplinary panel of 18 Italian experts from 16 leading academic and clinical institutions convened to develop consensus recommendations on <i>BRCA1/2</i> testing via liquid biopsy. Through virtual and on-site meetings, technical gaps in pre-analytical, analytical, and post-analytical workflows were identified and addressed. Statements were approved by ⩾80% of panelists and reviewed to reflect both current evidence and expert practice.ResultsThe survey confirmed widespread implementation or imminent adoption of liquid biopsy testing across Italian centers, despite persistent challenges in standardizing sample collection, testing management, preservation, and reporting. Key technical insights included the importance of cfDNA-preserving tubes, optimal storage conditions, assay sensitivity (LoD <1.0%), and bioinformatic integration for detecting low-frequency variants. Next-generation sequencing was unanimously preferred, with BRCA1/2 coverage extended to coding and flanking regions. A harmonized synoptic report structure was proposed to enhance clinical interpretability and facilitate oncologic decision-making.ConclusionsDespite limitations in tissue availability, the integration of liquid biopsy into a diagnostic algorithm, endorsed by both AIOM and ESMO guidelines, enables broader access to <i>BRCA1/2</i> stratification and supports timely PARP inhibitor therapy. This consensus aims to improve diagnostic consistency and clinical outcomes in the management of mCRPC across Italy.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"496-505"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
A phase II study of nivolumab plus metformin in pre-treated metastatic renal cell carcinoma patients: NivoMet TWINS-GU002 Study. NivoMet TWINS-GU002研究:nivolumab联合二甲双胍治疗转移性肾细胞癌患者的II期研究
IF 3.1 4区 医学
Tumori Pub Date : 2025-12-01 Epub Date: 2025-10-30 DOI: 10.1177/03008916251384162
Chiara Ciccarese, Daniela Arduini, Francesca Primi, Ileana Sparagna, Alessandro Strusi, Iolanda Bisogno, Denis Occhipinti, Romina Rose Pedone, Giovanni Schinzari, Maria Chiara Sighinolfi, Bernardo Rocco, Giampaolo Tortora, Roberto Iacovelli
{"title":"A phase II study of nivolumab plus metformin in pre-treated metastatic renal cell carcinoma patients: NivoMet TWINS-GU002 Study.","authors":"Chiara Ciccarese, Daniela Arduini, Francesca Primi, Ileana Sparagna, Alessandro Strusi, Iolanda Bisogno, Denis Occhipinti, Romina Rose Pedone, Giovanni Schinzari, Maria Chiara Sighinolfi, Bernardo Rocco, Giampaolo Tortora, Roberto Iacovelli","doi":"10.1177/03008916251384162","DOIUrl":"10.1177/03008916251384162","url":null,"abstract":"<p><strong>Aims: </strong>This study evaluates the activity of nivolumab plus metformin in pre-treated metastatic renal cell carcinoma (mRCC) patients.</p><p><strong>Materials and methods: </strong>The NivoMet TWINS-GU002 Study was a prospective, multicentre, single-arm, phase II trial conducted in pre-treated mRCC patients eligible for nivolumab and without diabetes mellitus. Patients received nivolumab (240 mg every two weeks) plus metformin (500 mg orally twice a day) until disease progression. The primary endpoint was the 9-month progression-free survival (PFS) rate. Secondary endpoints included median PFS, overall survival (OS), overall response rate (ORR), and safety.</p><p><strong>Results: </strong>Twelve patients from two sites in Italy were enrolled from November 2020 to April 2023. The trial was terminated early due to slow accrual. The median PFS was 2.7 months, and the 9-month PFS rate was 8%. The median OS was 14.9 months. The ORR was 8%, and the disease control rate (DCR) was 25%. Adverse events (AEs) of any grade occurred in 75% of patients, with only one grade 3 AE (fatigue) not related to treatment. No grade 3 or 4 treatment-related AEs occurred.</p><p><strong>Conclusions: </strong>The combination of nivolumab and metformin showed marginal activity in pre-treated mRCC patients. Further investigations are needed to explore metabolic pathways as potential therapeutic targets.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"523-528"},"PeriodicalIF":3.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145402184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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