1.Monitoring measurable residual disease with multigene mutations ddPCR combined with multiparametric flow cytometry to predict relapse risk in patients with acute my-eloid leukemia
Ye SHAOJIE ; Guo HUIMEI ; Xu JIANMEI ; Su XI ; Wang LIN ; Zhao SONGYING ; Wang JING ; Xue HUA
Chinese Journal of Clinical Oncology 2025;52(15):762-768
Objective:To evaluate the prognostic value of droplet digital PCR(ddPCR)in conjunction with multiparametric flow cytometry(MFC)for measurable residual disease(MRD)detection in predicting relapse risk in patients with acute myeloid leukemia(AML).Methods:In this retrospective cohort study,we have analyzed 78 newly diagnosed patients with AML who underwent combined MRD monitoring using MFC and ddPCR at The Affiliated Hospital of Hebei University(January 2018-January 2025).Clinical outcomes-including MRD negativity rates,cumulative incidence of relapse(CIR),relapse-free survival(RFS),and overall survival(OS)-were systematically evaluated.Prognostic discrim-ination between the MRD-negative and MRD-positive subgroups was compared across standalone and combined detection approaches.Results:With a median follow-up of 17 months(range:2.4-86.7)and a median of one mutation tracked per patient(range:1-3),both MFC-MRD and ddPCR-MRD negative subgroups demonstrated superior 2-year RFS compared with MRD-positive counterparts.Notably,com-bined MFC/ddPCR monitoring enhanced prognostic discrimination,with MRD-negative patients achieving significantly prolonged 2-year RFS compared with MRD-positive patients.MFC-MRD negativity independently predicted improved 2-year OS.Conclusion:ddPCR-based multi-gene MRD profiling provides significant independent prognostic value in patients with AML.The synergistic application of MFC and ddPCR enables superior predictive accuracy for relapse risk and survival outcomes,supporting its integration into standardized MRD monitoring protocols.
2.Clinical outcomes of patients with advanced non-small cell lung cancer enrolled in phase Ⅰ oncology clinical trials
Li LUFENG ; Zhang CHI ; Li ZHI ; Zhang ZIYI ; Li HUI ; Li HAIPENG ; Li HONGTAO
Chinese Journal of Clinical Oncology 2025;52(15):769-775
Objective:To evaluate the efficacy and safety of treatments in phase Ⅰ oncology clinical trials in patients with advanced non-small-cell lung cancer(NSCLC).Methods:We retrospectively analyzed the clinical data of 65 patients with advanced NSCLC who received phase Ⅰ antitumor trial drugs at the Clinical Trial Research Center of The First Affiliated Hospital of Bengbu Medical University from January 2020 to December 2023.The efficacy and occurrence of serious adverse events(SAEs)were analyzed.Results:The objective response rate(ORR)and disease control rate(DCR)were 9.2%and 61.4%,respectively,whereas the median progression-free survival(PFS)and overall survival(OS)were 2.9 and 15.1 months,respectively.Previously receiving second-line or more lines of treatment and SAE occurrence were independent risk factors for a shorter PFS(P<0.05).A history of smoking and previous second-line or more lines of treatment were inde-pendent risk factors for a shorter OS(P<0.05).The SAE incidence was 15.4%,and no treatment-related deaths occurred.Conclusions:Treat-ments in phase Ⅰ oncology clinical trials are beneficial for patients with advanced NSCLC.Patients with a higher number of previous treat-ment lines and those who experienced SAEs during the trial had a shorter PFS,whereas patients with no smoking history and fewer previous treatment lines had a longer overall survival.The overall safety of the treatments was acceptable.
3.Research progress in treating well-differentiated high-grade rectal neuroendocrine tu-mors
Chinese Journal of Clinical Oncology 2025;52(15):796-800
Grade 3 neuroendocrine tumors(G3 NET)are a rare tumor subtype recently defined by WHO.They are distinct from poorly dif-ferentiated neuroendocrine carcinomas(NEC)in histopathological features,therapeutic approach,and prognosis.Due to their low incidence and the scarcity of related studies,standardized diagnostic and treatment guidelines remain incomplete.This review summarizes current evidence on rectal G3 NETs,including clinicopathological characteristics,imaging assessment methods,and major therapeutic approaches,with particular focus on management strategies for both localized and advanced disease.The aim is to provide a reference and to promote the refinement and optimization of management approaches for this uncommon tumor type.
4.Application progress on the predictive value of immune-related adverse events for ef-ficacy in immunotherapy of extensive stage-small cell lung cancer
Chinese Journal of Clinical Oncology 2025;52(15):801-806
Small cell lung cancer(SCLC)is a neuroendocrine tumor that is highly heterogeneous and invasive.SCLC is prone to distant meta-stasis,and most patients are diagnosed in the extensive stage(ES-SCLC)after metastasis has occurred.Immune checkpoint inhibitors(ICIs)combined with chemotherapy currently serve as standard first-line treatment for ES-SCLC.However,the accompanying immune-related ad-verse events(irAEs)may affect patients'quality of life and treatment efficacy.Studies suggest a correlation between irAE occurrence and treatment response rates as well as survival benefits,although the mechanisms underlying this correlation are not fully understood.This art-icle provides a comprehensive review of the application of ICIs in ES-SCLC,exploring the association between irAEs and clinical ICI efficacy,the potential underlying biological mechanisms of their association,predictive biomarkers of irAEs,and strategies for managing irAEs.This study offers insights for optimizing immunotherapy for treating ES-SCLC.
5.Pro-tumorigenic mechanisms of tumor-associated macrophages in oral cancer
Xu XIAOYI ; Wang BIN ; Yang MENGMENG ; Shen JUN
Chinese Journal of Clinical Oncology 2025;52(15):783-790
Oral cancer is a common inflammation-associated malignant tumor of the head and neck.In recent years,the role of the tumor microenvironment in the progression of oral cancer has received increasing attention.In the microenvironment of solid tumors,including or-al cancer,tumor-associated macrophages(TAMs)are among the most common type of immune cell and are closely associated with the poor prognosis of more than 80%of human malignant tumors.An increasing body of evidence indicates that TAMs play important roles in the oc-currence and progression of oral cancer.On the basis of the most recent research progress,both domestic and international,we systematic-ally reviewed the phenotypic characteristics,clinicopathological correlations,and molecular regulatory mechanisms of TAMs in the microen-vironment of oral squamous cell carcinoma(OSCC).In particular,we focus on the key signaling pathways promoting tumorigenesis and de-velopment and immune escape mechanisms,with the aim of constructing a systematic theoretical framework for developing therapeutic strategies targeting TAMs and providing a scientific basis for clinical translational research.
6.NLRP3 inflammasome regulatory network in head and neck squamous cell carcinoma tumor microenvironments and targeted therapeutic strategies
Chinese Journal of Clinical Oncology 2025;52(15):791-795
Head and neck squamous cell carcinoma(HNSCC)progression is closely associated with chronic inflammation mediated by the NLRP3 inflammasome within the tumor microenvironment(TME).The NLRP3 inflammasome integrates pathogen-associated and stress-in-duced signals to dynamically regulate IL-1β/IL-18 secretion and pyroptosis.Through its action,NLRP3 inflammasome exhibits a functional du-ality,exerting tumor-suppressive effects by activating the Caspase-1/GSDMD pathway to induce tumor cell pyroptosis while also driving ma-lignant progression through remodeling of immunosuppressive TMEs.This remodeling includes driving M2-type macrophage polarization and suppressing NETs-associated pyroptosis,thereby promoting cancer stem cell maintenance and contributing to chemotherapy resistance.Preclinical studies have confirmed that NLRP3-targeted strategies,including small-molecule inhibitors(MCC950 and BAY11-7082),Bacopa monnieri,and IL-1 signaling biologics,significantly suppress tumor growth and metastasis in HNSCC and other cancers.In this review,we systematically decipher the NLRP3 regulatory network,evaluate the translational potential of targeted interventions,and offer novel thera-peutic avenues to overcome treatment barriers in HNSCC.
7.Expert consensus on breast oncoplastic surgery and radiation treatment
Chinese Journal of Clinical Oncology 2025;52(16):811-819
With the development of breast oncoplasty,a large proportion of Chinese patients with breast cancer have opted for surgical in-terventions using oncoplastic techniques.For patients requiring radiation therapy,a multidisciplinary decision regarding the inclusion of irra-diation in the comprehensive treatment is advocated owing to the adverse impact of irradiation on breast tissue.Guidelines and consensus regarding the application of breast oncoplastic surgery and subsequent radiation are currently lacking.The China Anti-Cancer Association Committee of Oncoplastic Surgery invited experts nationwide to formulate the first consensus on breast oncoplasty and radiation based on evidence-based studies and years of clinical experience.The resulting consensus focuses on breast conservation and post-mastectomy re-construction,integrating breast imaging,pathology,radiation,and surgery to provide guidance for clinical practice.
8.Therapeutic advances for epidermal growth factor receptor non-classical mutations in non-small cell lung cancer after targeted therapy resistance
Ma JILI ; Wang JIAYI ; Qiao HUI
Chinese Journal of Clinical Oncology 2025;52(16):854-859
The epidermal growth factor receptor(EGFR)is a key oncogenic driver in non-small cell lung cancer(NSCLC),and its mutations have significant clinical implications.While classical mutations,such as exon 19 deletions and exon 21 L858R substitutions,are well estab-lished,increasing attention has shifted toward less common,non-classical EGFR mutation subtypes.The widespread adoption of high-throughput sequencing technologies such as next-generation sequencing(NGS)has substantially improved the detection rate of non-classic-al EGFR mutations.Thus,their molecular characteristics and therapeutic responses have been increasingly elucidated.However,due to their significant heterogeneity,substantial variability exists in the sensitivity of different non-classical mutations to EGFR tyrosine kinase inhibitors(EGFR-TKIs).Furthermore,the scarcity of clinical samples limits the availability of robust evidence.Additionally,prolonged clinical use of EGFR-TKIs can also lead to acquired resistance,further complicating treatment strategies.Despite these challenges,ongoing research continues to explore targeted therapies for patients with non-classical EGFR mutations.This review summarizes recent studies on non-classical EGFR mutations in NSCLC,examines current therapeutic approaches,and outlines clinical recommendations for managing patients after EGFR-TKI treatment failure.By integrating existing evidence and clinical experience,this review aims to optimize individualized treatment strategies for these patients,with the ultimate goal of improving their prognosis and quality of life.
9.CAR-T cell therapy for gastric cancer:advances and challenges from target discovery to clinical translation
Liu LIAN ; Tao MIN ; Li JIARUI ; Liu CHANG ; Qi CHANGSONG ; Shen LIN
Chinese Journal of Clinical Oncology 2025;52(16):820-825
Gastric cancer is a malignant tumor with high prevalence worldwide and limited therapeutic options.Chimeric antigen receptor T-cell(CAR-T)therapy has emerged as a promising approach for gastric cancer treatment;however,its application faces substantial challenges.This review provides comprehensive summary of the recent advances in CAR-T cell therapy for gastric cancer,systematic analysis of critical break throughs and core challenges from target discovery to clinical translation,and outlining of future perspectives.We describe the criter-ia for ideal target selection and highlight the current research landscape of major targets,including CLDN18.2 that demonstrated efficacy,and targets facing distinct challenges,including HER-2,CEA,EpCAM,and MUC1.This review also finely dissects three central barriers restrict-ing CAR-T cell efficacy,and discusses corresponding countermeasures:overcoming the immunosuppressive tumor microenvironment through strategies such as local delivery,armored CAR-T cells,and combination therapies;engineering approaches including affinity modula-tion and logic-gate designs to mitigate on-target/off-tumor toxicity;and optimization of manufacturing processes and reduction of costs via early leukapheresis,rapid production platforms,and universal CAR-T cell strategies.Future multidimensional,integrative,and innovative strategies are pivotal for achieving comprehensive break throughs in CAR-T cell therapy for solid tumors.
10.Computational pathology-based tumor microenvironment score for predicting EGFR-TKIs efficacy in patients with EGFR-mutant non-small cell lung cancer
Ding ZHUMIN ; Wang HANYANG ; Xia CONG ; Wang JUNMEI ; Lu LILI ; Zhou JIE ; Wang XIAOMING
Chinese Journal of Clinical Oncology 2025;52(16):826-833
Objective:To investigate the utility of a computational pathology-based tumor microenvironment(TME)score derived from whole slide images(WSIs)in predicting the efficacy of epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKIs)in patients with EGFR mutation-positive non-small cell lung cancer(NSCLC).Methods:This retrospective study collected 240 EGFR-mutant NSCLC pa-tients treated with EGFR-TKIs at The First Affiliated Hospital of Wannan Medical College and analyzed hematoxylin-eosin(H&E)-stained WSIs of biopsy specimens,along with clinical and imaging data.The patients were randomly assigned into a training cohort(n=160)and an inde-pendent validation cohort(n=80)in a 2:1 ratio.Treatment response was assessed based on CT findings at 3 months after EGFR-TKIs initi-ation.Computational pathology was employed to automatically quantify the proportions of four TME components(tumor epithelium,stroma,lymphocytes,and vasculature)within the tumor regions of WSIs.Multivariate Logistic regression in the training cohort identified TME components independently predictive of treatment response(P<0.05),which were then integrated into a TME-score.The predictive performance was evaluated using receiver operating characteristic(ROC)curve analysis and area under the curve(AUC).The TME-score model was compared with a clinical-feature-based model and a combined model(TME-score+clinical features).Finally,the models were val-idated in the independent cohort.Results:In the training cohort,the TME-score,incorporating epithelial and stromal proportions,achieved an AUC of 0.827(95%CI:0.749-0.892)for predicting treatment response,while the validation cohort yielded an AUC of 0.845(95%CI:0.735-0.937).Both outperformed the clinical model(AUCs=0.730[95%CI:0.645-0.804]and 0.712[95%CI:0.586-0.824],respectively).The combined model(TME-score+clinical features,including cytokeratin 19 fragment and non-contrast CT values)further improved predictive performance(AUCs=0.884[95%CI:0.827-0.932]and 0.882[95%CI:0.798-0.950],respectively).Delong's test for pairwise model comparis-ons showed significant differences(all P<0.05)except TME-score and the combined model in the validation cohort(P=0.289).Conclusions:TME-score outperformed clinical models in predicting EGFR-TKIs efficacy in EGFR mutation-positive NSCLC patients and may serve as a novel tool for identifying patients likely to benefit from targeted therapy.

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