Oncologist最新文献

{"title":"Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial.","authors":"Lichen Tang, Min He, Cuizhi Geng, Zhimin Fan, Rui Ling, Guangdong Qiao, Li Cai, Ting Luo, Feng Jin, Haibo Wang, Anqin Zhang, Hongwei Zhang, Xiaohua Zeng, Xiaojia Wang, Ming Jiang, Zhonghua Wang, Zhimin Shao","doi":"10.1093/oncolo/oyaf101","DOIUrl":"10.1093/oncolo/oyaf101","url":null,"abstract":"<p><strong>Background: </strong>Pegylated liposomal doxorubicin (PLD) was shown to have comparable efficacy to doxorubicin, with significantly reduced cardiotoxicity. This study evaluated the cardiotoxicity and efficacy of the PLD-based regimen compared with those of the doxorubicin-based regimen as adjuvant therapy for early-stage breast cancer (BC).</p><p><strong>Methods: </strong>In this open-label, randomized controlled trial, patients with early-stage BC were assigned to receive either 4 cycles of PLD (study group) or doxorubicin (control group) plus cyclophosphamide followed by 4 cycles of docetaxel/paclitaxel. The primary endpoint was cardiotoxicity.</p><p><strong>Results: </strong>Between November 2017 and September 2019, 247 patients (study group, n = 131; control group, n = 116) were enrolled. Incidence rates of abnormal left ventricular ejection fraction (LVEF, 0 vs. 1.7%) and congestive heart failure (0.0% vs. 0.9%) were similar between the two groups (all P > 0.05). A lower proportion of elevated high-sensitivity cardiac troponin T (3.8% vs. 30.2%, P < 0.001) was observed in the study group. The 5-year disease-free survival (82.7% vs. 83.8%) and overall survival (90.4% vs. 91.6%) rates were comparable (all P > 0.05). Grade 3-4 adverse events in the study group were significantly less than in the control group (43.5% vs. 61.2%, P = 0.005).</p><p><strong>Conclusion: </strong>The PLD-based regimen for early-stage BC showed significantly lower rates of elevated hs-cTnT and grade 3-4 AEs with comparable efficacy to the doxorubicin-based regimen. (ClinicalTrials.gov Identifier: NCT03949634; IRB Approved: Ethics committee institutional review board of Shanghai Cancer Hospital, Fudan University's (No. 1706173-19-1904B) and other center).</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12160816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical utility of companion diagnostic biomarker results below the limit of detection in comprehensive genomic profiling of patients with advanced non-small cell lung cancer.","authors":"Gerald Li, Stephanie B Greene, Baljinder Kaur, Rachel B Keller-Evans, Ryon P Graf, Brennan Decker, David L Smith, Richard S P Huang","doi":"10.1093/oncolo/oyaf159","DOIUrl":"10.1093/oncolo/oyaf159","url":null,"abstract":"<p><strong>Background: </strong>When the limit of blank (LoB) of comprehensive genomic profiling (CGP) for a given biomarker is acceptably demonstrated (ie, α ≤ 0.05 or LoB equal to zero), biomarkers detected below the assay limit of detection (LoD) can be reported with a high degree of confidence. However, it is unknown whether variants detected below LoD have clinical utility.</p><p><strong>Patients and methods: </strong>This study used a de-identified nationwide (US-based) non-small cell lung cancer clinico-genomic database (CGDB) containing linked FDA-approved CGP testing from Foundation Medicine, Inc (FMI). We selected patients who received an FMI CGP report with an actionable biomarker detected below LoD. We assessed clinical utility among those patients who received an appropriately matched targeted therapy, defined as a real-world overall response rate exceeding a prespecified threshold of 30% based on historical chemotherapy response rates.</p><p><strong>Results: </strong>Among 129 patients who had a biomarker detected and reported below LoD, received the appropriate matched targeted therapy, and were assessed for response, partial or complete response was observed in 36/54 (67%, one-tailed 95% CI: >55%, P < .001) patients tested with a tissue-based CGP test and 54/75 (72%, one-tailed 95% CI: >62%, P < .001) patients tested with a liquid-based CGP test, both of which exceeded the prespecified threshold for clinical utility.</p><p><strong>Conclusions: </strong>Most patients who receive a targeted therapy matched to a companion diagnostic biomarker detected and reported below LoD demonstrate clinical benefit from that therapy. This clinical observation suggests actionable variants should continue to be reported when detected with FMI CGP tests.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12205977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144477908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neoadjuvant rectal-tumor regression grade combined score as surrogate endpoint for disease-free survival in locally advanced rectal cancer patients after neoadjuvant chemoradiotherapy.","authors":"Weili Zhang, Hui Sun, Rong Yang, Xiaolin Xie, Leen Liao, Weifeng Wang, Ruowei Wang, Xiaojun Wu, Zhenhai Lu, Zhizhong Pan, Feifei Lin, Lingdong Shao, Jianhong Peng","doi":"10.1093/oncolo/oyaf124","DOIUrl":"10.1093/oncolo/oyaf124","url":null,"abstract":"<p><strong>Background: </strong>Existing prognostic models, such as tumor regression grade (TRG) and neoadjuvant rectal (NAR) score, have been validated as important indicators for assessing the efficacy of neoadjuvant therapy in locally advanced rectal cancer (LARC) and predicting disease-free survival (DFS). However, both models have inherent limitations in prognostic prediction. This study aims to construct a composite NAR-TRG score to predict DFS in LARC patients treated with chemoradiotherapy (CRT) followed by radical surgery.</p><p><strong>Patients and methods: </strong>A total of 952 consecutive LARC patients between December 2010 and July 2018 at Sun Yat-sen University Cancer Center and Fujian Cancer Hospital, were enrolled in this study. After calculating the NAR score, patients were categorized into NAR low, medium, and high groups; TRG was dichotomized into TRG low and high groups; the NAR-TRG combined score was then determined based on both NAR and TRG groupings. Survival outcomes were analyzed using Kaplan-Meier, Cox regression. Nomograms were developed to forecast patient DFS, with the area under the curve values of time-dependent receiver operating characteristic (timeROC) and c-index utilized to assess the accuracy and reliability of the nomograms.</p><p><strong>Results: </strong>Significant differences in 5-year DFS were observed among the NAR-TRG score from 1 to 3 (91.4% vs 79.9% vs 72.3%, P < .001). NAR-TRG score was identified as an independent predictor of DFS in multivariate analysis (HR = 1.577, 95% CI: 1.298-1.915, P < .001). The comparison of timeROC AUCs revealed that the NAR-TRG score consistently outperformed both the NAR score and TRG group at various time points (Main cohort: NAR-TRG score vs TRG, P = .002; NAR-TRG score vs NAR, P = .002; Validation cohort: NAR-TRG score vs TRG, P = .003; NAR-TRG score vs NAR, P = .002). The nomogram model including the NAR-TRG score demonstrated a superior c-index and area under the timeROC for DFS compared to models excluding the NAR-TRG score both in the main cohort and validation cohort.</p><p><strong>Conclusions: </strong>The NAR-TRG score effectively stratifies LARC patients receiving neoadjuvant CRT, which can serve as a surrogate endpoint for DFS, contributing to the optimization of decisions related to postoperative therapy and subsequent follow-up strategies.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12205975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144477912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The financial toll of cancer: uncovering the links between financial toxicity and symptom burden.","authors":"Marco Filetti, Pasquale Lombardi, Gabriella Gentile, Paolo Toccaceli, Guglielmo Fumi, Denise Vacca, Emilia Colpani, Giulio Ravoni, Federica Mazzuca, Gennaro Daniele, Giampiero Porzio, Eduardo Bruera, Raffaele Giusti","doi":"10.1093/oncolo/oyaf131","DOIUrl":"10.1093/oncolo/oyaf131","url":null,"abstract":"<p><strong>Purpose: </strong>This prospective observational study investigated the relationship between financial toxicity, symptom burden, disease characteristics and out-of-pocket (OOP) medication use in patients with cancer across 5 Italian institutions.</p><p><strong>Methods: </strong>A cross-sectional survey assessed financial toxicity, symptom burden and OOP costs sustained by patients with cancer using validated questionnaires (COST, PERSONS). Associations between financial toxicity (COST score), symptom burden (PERSONS score) and clinical variables were explored.</p><p><strong>Results: </strong>Among 211 respondents, mean COST score was 23 (SD 9.1) and 128 (60%) scored < 26, indicating financial toxicity. Symptom burden measured by the PERSONS score was associated with a higher OOP medications use (r = 0.449, P < .001) and inversely related to financial toxicity (r = -0.431; P < .001). In our study population, median number of OOP drug was 2 (IQR 1-2), most commonly analgesics and laxatives. There was a significantly worse COST score among patients using OOP analgesic: 19.8 (SD 9.5) vs 25.6 (SD 7.9), P < .001 and laxatives: 19.2 (SD 8.2) vs 24.4 [(SD 9.1), P < .00]. Overall, OOP drugs were linked to higher symptom burden (P < .001) and financial toxicity (P < .001).</p><p><strong>Conclusions: </strong>The severity of symptoms and their management with OOP medications was significantly associated with patients' financial toxicity. These findings highlight the importance of integrating financial toxicity assessment into routine cancer care to optimize patient outcomes and well-being.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12199244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oligometastatic pancreatic cancer: current state of management and emerging therapies.","authors":"Andrii Khomiak, Nicole B Balmaceda, Sumaya A Ghaffar, Christopher H Lieu, Marco Del Chiaro, Wells A Messersmith, Robert W Lentz","doi":"10.1093/oncolo/oyaf154","DOIUrl":"10.1093/oncolo/oyaf154","url":null,"abstract":"<p><p>Oligometastatic pancreatic cancer is a distinct clinical entity with limited metastatic burden. This unique subset of patients harbor a favorable tumor biology and potentially better prognosis compared to widespread metastatic disease. This review explores definitions of oligometastatic pancreatic cancer and the current state of management, including systemic therapy, surgery, and locoregional techniques. While there are few randomized clinical trials directing the management of oligometastatic pancreatic cancer, we provide insights into the treatment challenges, evolving therapeutic approaches, and future directions for this unique subset of patients.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204394/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144327759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical features and prognostic factors of intravascular large B-cell lymphoma: a cohort study of 20 patients from 2018 to 2024.","authors":"Yaqing Li, Suxiao Li, Xiyang Liu, Weili Xue, Lijuan Han, Yulai Li, Xudong Zhang, Mingzhi Zhang","doi":"10.1093/oncolo/oyaf156","DOIUrl":"10.1093/oncolo/oyaf156","url":null,"abstract":"<p><strong>Background: </strong>Intravascular large B-cell lymphoma (IVLBCL) is a rare, aggressive lymphoma characterized by lymphoma cells proliferating within small blood vessels, lacking an extravascular mass. Its low incidence complicates diagnosis and treatment.</p><p><strong>Methods: </strong>This study analyzed 20 IVLBCL patients diagnosed between 2018 and 2024, aiming to describe their clinical presentations, diagnostic procedures, treatment, and outcomes.</p><p><strong>Results: </strong>All patients had stage IV disease with poor ECOG performance status and high-risk IPI scores (100% ≥ 4). Common symptoms included fever (65%), impaired consciousness (30%), and respiratory issues (25%). Laboratory findings revealed cytopenias (60% anemia, 60% thrombocytopenia, and 35% leukocytopenia), elevated lactate dehydrogenase (20/20, 100%), C-reactive protein (14/14, 100%), and erythrocyte sedimentation rate (11/12, 91.7%). Five of six patients had extreme IL-10 elevation. Imaging studies showed a high incidence of adrenal gland involvement (9/20, 45%), reproductive system involvement (7/20, 35%), central nervous system (CNS) involvement (6/20, 30%), and splenomegaly (9/20, 45%). Nineteen of 20 patients were non-GCB (CD10-MUM1+). Seven of 14 patients tested positive for CD5. Eighteen of 20 patients received CD20 antibody plus chemotherapy as first-line therapy, with complete responses (CRs) achieved in 7 of 18 patients. After a median follow-up of 42.4 months, the 1-year and 2-year overall survival rates were 71.3% and 65.4%, respectively. Unfavorable risk factors included central nervous system (CNS) and bone marrow (BM) involvement, and elevated creatinine.</p><p><strong>Conclusion: </strong>The study highlights the high incidence of adrenal and reproductive system involvement in IVLBCL, with CNS, BM, and elevated creatinine contributing to rapid disease progression.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204696/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144334461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The prognostic role of Geriatric 8 in patients with cancer: a meta-analysis and systematic review.","authors":"Runzhi Chen, Dongmei Yang, Mengxing Tian, Huiting Xu, Xin Jin","doi":"10.1093/oncolo/oyaf118","DOIUrl":"10.1093/oncolo/oyaf118","url":null,"abstract":"<p><strong>Objective: </strong>Previous studies have reported conflicting results regarding the association between the Geriatric 8 (G-8) geriatric screening tool and prognosis in patients with cancer. This meta-analysis aimed to evaluate the prognostic value of the G-8 score in patients with cancer.</p><p><strong>Methods: </strong>PubMed, Cochrane Library, Embase, and Medline databases were searched to identify trials exploring the association between G-8 score and prognosis in patients with cancer. Meta-analyses of overall survival (OS) and progression-free survival (PFS) between the high and low G-8 scores were performed. The quality of the included studies was assessed using the Quality In Prognosis Studies tool.</p><p><strong>Results: </strong>A total of 42 studies involving 9053 patients with cancer were included. The prevalence of frailty, evaluated using the G-8 tool across trials, ranged from 27% to 91%. A low G-8 score was associated with poor OS (Hazard ratio [HR] 2.11; 95% CI:1.93-2.31, P <.001) and PFS (HR 1.78, 95% CI,1.55-2.05, P <.001) in patients with cancer. Overall survival were shorter in patients with low G-8 scores than in those with high G-8 scores in digestive system tumors, head and neck cancer, lung cancer, gynecologic tumors, hematologic malignancies, and prostate cancer. The predictive role of the G-8 tool was also confirmed in subgroups with G-8 cutoff values of 9-14. Patients with low G-8 scores had more advanced disease stages and higher ECOG performance status scores.</p><p><strong>Conclusions: </strong>The prevalence of frailty was high among patients with cancer according to the G-8 geriatric screening tool. Decreased G-8 scores are significantly associated with poor survival in patients with cancer. G-8 is a promising tool for frailty screening.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictive and prognostic factors of efficacy of third-line chemotherapy in patients with unresectable pancreatic cancer: a cohort-based study.","authors":"Camille Evrard, Antoine Pelras, Simon Rivet, Jean-Baptiste Bachet, Olivier Dubreuil, Anne-Laure Pointet, Julien Taieb, Widad Lahlou, Alix Portal, Céline Lepère, Thierry Lecomte, Romain Chautard, Nicolas Williet, Jean-Marc Phelip, Clélia Coutzac, Emilie Soularue, Lysiane Marthey, Raëf Abdallah, Anne Thirot Bidault, Pascal Artru, Jérome Desrame, Bertrand Le Roy, Marine Jary, Pascal Hammel, Isabelle Trouilloud, Nelson Lourenco, Vincent Hautefeuille, Laëtitia Dahan, Simon Pernot, Dominique Béchade, Astrid Pozet, Franck Bonnetain, Christophe Locher, Johann Dréanic, Romain Coriat, Bélinda Tchoundjeu, Yohann Foucher, David Tougeron","doi":"10.1093/oncolo/oyaf125","DOIUrl":"10.1093/oncolo/oyaf125","url":null,"abstract":"<p><strong>Background: </strong>Advanced pancreatic ductal adenocarcinoma (aPDAC) has a poor prognosis with median overall survival (OS) of about 12 months. It is therefore important to explore factors that predict the efficacy of third-line chemotherapy (L3) to identify patients who may benefit from this controversial treatment.</p><p><strong>Methods: </strong>We conducted a multicenter retrospective cohort-based study of 202 French patients treated for aPDAC who received at least three treatment lines from January 2011 to March 2022. We used penalized Cox regressions to predict progression-free survival (PFS) and OS in patients on L3.</p><p><strong>Results: </strong>Median age at the start of L3 was 64.3 years old and 63.5% had an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1. The most frequent regimens for L3 were FOLFIRI (25.2% of patients). Median PFS was 2.2 months, while median OS was 4.2 months. In multivariate models, we identified the following predictors of both PFS and OS: age, sex, surgery for the primary tumor, FOLFIRINOX as the first-line therapy, duration of first and second-line treatments, and for L3: ECOG-PS level, peritoneum, liver and/or lung metastasis and depletion of therapeutic resources. The model incorporating these factors provided acceptable discrimination between event and event-free patients at 6 months post-L3 (area under the ROC curve of 0.83 for PFS and 0.73 for OS).</p><p><strong>Conclusion: </strong>The characteristics of patients and their aPDAC are readily available in clinical practice and were able to predict survival with L3. The online calculator we propose here could help physicians determine whether L3 chemotherapy would be beneficial.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12166115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144295379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse health outcomes in testis cancer survivors-the price for our success?","authors":"Danish Mazhar, Sophie Heritage, Han Wong","doi":"10.1093/oncolo/oyaf117","DOIUrl":"10.1093/oncolo/oyaf117","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12166120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144295375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pooled biomarker analysis of the association of baseline T regulatory cells with response and T-cell recovery profiles with blinatumomab treatment.","authors":"Yuliya Katlinskaya, Bharat Panwar, Yi Zeng, Paul Gordon, Erik Rasmussen, Virginie Naegele, Matthias Klinger, Gerhard Zugmaier","doi":"10.1093/oncolo/oyaf137","DOIUrl":"10.1093/oncolo/oyaf137","url":null,"abstract":"<p><strong>Introduction: </strong>Blinatumomab, a bispecific T-cell engager, requires the activity of CD3+ T-cells for tumor lysis. This pooled analysis aimed to re-examine baseline T regulatory cells (Tregs) as a biomarker of blinatumomab efficacy across multiple clinical trials and provide insights into peripheral T-cell dynamics during blinatumomab therapy in hematological malignancies.</p><p><strong>Methods: </strong>Tregs and peripheral T-cells were enumerated by fluorescence-activated cell sorting and were statistically evaluated using the Wilcoxon rank-sum test and linear mixed effect modeling, respectively.</p><p><strong>Results: </strong>Comparable baseline percentages of Tregs were observed in responders and non-responders of blinatumomab treatment (N = 325) in adults with leukemia or lymphoma. Peripheral T-cell count recovery occurred early during blinatumomab dosing, and before blinatumomab-free interval in patients (N = 233) from 4 clinical trials.</p><p><strong>Conclusion: </strong>The pooled analysis revealed that baseline Treg levels do not serve as a predictive marker for blinatumomab response and that there is rapid peripheral T-cell recovery following blinatumomab dosing. These results suggest that patients with varying levels of Tregs can benefit from blinatumomab treatment and that blinatumomab-free intervals of 7 days may suffice in blinatumomab treatment regimens.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 6","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12166117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144295378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}