最新刊期

    35 2 2025

      Specialist's Commentary

    • Yufeng LU, Han WANG, Yifan XIE, Yizhou JIANG, Zhimin SHAO
      Vol. 35, Issue 2, Pages: 143-153(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.001
      摘要:Breast cancer is the most prevalent malignant tumor that poses a threat to women's health in China, with incidence and mortality rates persistently increasing. Given this critical situation, there is an urgent need to optimize therapeutic options through basic translational research to address current treatment challenges. This article provided a comprehensive overview of the significant advancements in fundamental translational breast cancer research in China over the past five years, aiming to provide a scientific basis and new directions for precision treatment of breast cancer. This research encompasses a range of subjects, including molecular typing, biomarker identification, exploration of drug resistance mechanisms, optimization of precision treatment strategies, and identification of new targets in breast cancer. In the domain of molecular typing, researchers have revealed substantial disparities in treatment responses among distinct subtypes of breast cancer through in-depth analysis. This has led to the proposal of specific therapeutic strategies for each subtype, thereby establishing a robust theoretical foundation for individualized treatment approaches. The identification of biomarkers plays a pivotal role in selecting appropriate treatment options for patients. Recent research advancements have demonstrated the potential of liquid biopsy and proteomics technologies in uncovering promising biomarkers, offering novel prospects for the early diagnosis and prognostic assessment of breast cancer. In the investigation of resistance mechanisms, researchers have elucidated the molecular underpinnings of resistance to endocrine therapy and human epidermal growth factor receptor 2 (HER2)-targeted therapy and proposed potential strategies to overcome resistance. This has paved the way for novel approaches to enhance therapeutic efficacy. In the context of immunotherapy and targeted therapies, the discernment of novel targets and biomarkers has facilitated novel perspectives on breast cancer treatment. Based on advanced comprehension of tumor heterogeneity, researchers constantly optimize precision treatment strategies through multiomics analysis, thus offering patients with breast cancer enhanced personalized treatment options. Concurrently, the implementation of novel technologies has been instrumental in facilitating the advancement of precision treatment for breast cancer. For instance, the application of artificial intelligence technology has demonstrated considerable potential in the early screening, diagnosis, efficacy assessment and prognosis prediction of breast cancer. Conversely, the advent of innovative drug delivery systems facilitated by nanotechnology has led to enhanced targeting and efficacy of pharmaceutical agents. Furthermore, research into hydrogel patch technology and tumor vaccines has yielded novel strategies for the treatment of breast cancer. Overall, China has accomplished remarkable achievements in the field of basic translational research on breast cancer. These findings not only enhance our understanding of the molecular mechanisms of breast cancer, but also provide new directions and hope for the development of future therapeutic strategies. With the advancement of multidisciplinary integration and the application of new emerging technologies, precision therapy is expected to provide more benefits to breast cancer patients.  
      关键词:Breast cancer;Fundamental translational research;Drug resistance mechanisms;Precision therapy;Biomarkers;Immunotherapy   
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    • Jialin LIN, Wenna WANG, Binghe XU
      Vol. 35, Issue 2, Pages: 154-166(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.002
      摘要:Antibody-drug conjugates (ADCs) represent a breakthrough in precision therapy for breast cancer, offering a unique targeted drug delivery mechanism that enhances tumor selectivity while reducing the nonspecific toxicity associated with conventional chemotherapy. In recent years, the clinical applications of ADCs in breast cancer have expanded significantly, particularly in human epidermal growth factor receptor 2 (HER2)-positive and HER2-low breast cancer, reshaping the therapeutic landscape. Trastuzumab emtanserin (T-DM1) was the first ADC drug to replace lapatinib plus capecitabine as a second-line treatment for HER2-positive breast cancer, while trastuzumab deruxtecan (T-DXd) demonstrated remarkable efficacy in HER2-low breast cancer in the DESTINY-Breast04 trial, becoming the first approved ADC for this patient subgroup. Furthermore, trophoblast cell surface antigen 2 (Trop-2)-targeting ADCs, such as sacituzumab govitecan (SG), have shown promising clinical benefits in patients with triple-negative breast cancer (TNBC) and hormone receptor-positive/HER2-negative breast cancer. Advances in next-generation ADC technologies, including improvements in linker stability, drug-to-antibody ratio (DAR) optimization, and enhanced bystander effects, have further improved the therapeutic efficacy and safety profile of these agents, reinforcing their role in the precision treatment of breast cancer. Although ADCs have demonstrated substantial clinical benefits, they are associated with target- and payload-related toxicities. However, with ongoing advancements in management strategies, their safety profile has been significantly improved. HER2-targeting ADCs present specific adverse events, including interstitial lung disease (ILD) associated with T-DXd, thrombocytopenia, and liver function abnormalities observed with T-DM1, while Trop-2-targeting ADCs such as SG are linked to hematologic toxicity and gastrointestinal side effects. Notably, structural optimizations in next-generation ADCs have led to significant improvements in their safety profile. Early monitoring, individualized dose modifications, and supportive care measures have been shown to effectively reduce the incidence of severe adverse events. Clinical studies indicate that toxicity management strategies for ADCs have matured, with most adverse effects being effectively controlled through optimized treatment regimens and adjunctive supportive care. Thus, in clinical practice, it is essential to consider patient-specific factors, prior treatment history, and comorbidities to devise an optimal ADC treatment strategy that maximizes both efficacy and safety. As ADC technology continues to evolve, breast cancer treatment is expected to become increasingly precise. The development of novel HER2-Trop-2 bispecific ADCs offers new therapeutic options for patients with HER2-low and HER2-negative breast cancer. Additionally, studies investigating the combination of T-DXd with immune checkpoint inhibitors (ICIs), CDK4/6 inhibitors, and poly (ADP-ribose) polymerase (PARP) inhibitors have demonstrated synergistic antitumor effects, further expanding the prospects for precision medicine in breast cancer. This review systematically summarized the latest advancements in ADCs for breast cancer, with a focus on the clinical applications, safety management strategies, and future development of HER2- and Trop-2-targeting ADCs, aiming to provide valuable insights for the future of precision breast cancer treatment.  
      关键词:Antibody-drug conjugate;Breast cancer;Targeted therapy;Human epidermal growth factor receptor-2;Trop-2   
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    • Progress of important clinical research on breast cancer in China in 2024

      Xin YANG, Qianfeng SHI, Qiang LIU
      Vol. 35, Issue 2, Pages: 167-175(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.003
      摘要:Breast cancer, is the cancer type with highest incidence rate in women globally. To improve the treatment for breast cancer patients, Chinese scientists have done extensive research on breast cancer. Reviewing the progress made in 2024, Chinese scholars have achieved significant advancements in various aspects of breast cancer research. In the field of surgery, new optical imaging techniques have aided the accurate assessment of surgical margins, and targeted axillary dissection (TAD) continues to provide evidence-based support for de-escalation therapy in surgery. Radiomics combined with artificial intelligence (AI) also assists in surgical decision-making. In targeted therapy, tyrosine kinase inhibitors (TKIs) have shown excellent clinical outcomes. The PILHLE-001 study explored new subtypes for the use of pyrotinib, offering new therapeutic approaches for luminal/human epidermal growth factor receptor 2 (HER2) low breast cancer. The efficacy and safety of anlotinib and apatinib are also reliable. Dual-targeted HER2 regimens in neoadjuvant therapy (NAT) and adjuvant therapy for early HER2-positive patients have demonstrated significant benefits over single-target regimens, improving survival rates. Various antibody-drug conjugates (ADCs) have shown significant clinical applicability, enhancing patient survival benefits, and novel drugs developed in China are making their way onto the international stage, increasing their global influence. Additionally, immunotherapy and precision treatment based on Fudan subtypes have shown varied degrees of survival improvement. In chemotherapy, different NAT strategies have been explored, offering more treatment options for doctors and patients. In endocrine therapy, the critical role of CDK4/6 inhibitors (CDK4/6i) in advanced hormone receptor positive/HER2-negative breast cancer has been further solidified, and issues concerning previously undetermined drug formulations of gonadotrophin releasing hormone analogue (GnRHa) have been examined. In radiotherapy, local radiotherapy combined with targeted therapy has significantly extended the survival of HER2-positive breast cancer patients with brain metastases, and optimizations have been made regarding the cardiotoxic side effects associated with radiotherapy. This article summarized the key clinical research on breast cancer in China in 2024, providing a reference for scholars and experts in related fields.  
      关键词:Breast cancer;Clinical research;Clinical trial   
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    • Xing LI, Ziqi PENG, Xinmiao YU, Feng JIN
      Vol. 35, Issue 2, Pages: 176-185(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.004
      摘要:The diagnosis rate of early breast cancer has significantly increased with the proliferation of tumor screening and heightened health awareness. Clinical research, as the evidence base for guidelines and consensus, provides optimized treatment plans for breast cancer. This article summarized and classified several pivotal clinical studies that changed the clinical practice of early breast cancer, according to updates in domestic and international guidelines and consensus from 2023 to 2024. These included the optimization of neoadjuvant and adjuvant therapies, the escalation of adjuvant endocrine therapy, the optimization of local treatment, and attention to quality of life, etc. In the optimization of neoadjuvant and adjuvant therapies, the KEYNOTE-522 study established the therapeutic role of pembrolizumab combined with chemotherapy in early high-risk triple-negative breast cancer (TNBC). The FDChina study confirmed the non-inferiority of the subcutaneous formulation of trastuzumab combined with pertuzumab (H+P) in neoadjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer, offering a more convenient administration method. The KATHERINE study clarified the adjuvant role of trastuzumab emtansine (T-DM1) in HER2-positive breast cancer patients who did not achieve a pathologic complete response (pCR) after neoadjuvant therapy. In the escalation of adjuvant endocrine therapy, the MonarchE and NATALEE studies confirmed the efficacy of abemaciclib and ribociclib combined with endocrine therapy in high-risk hormone receptor (HR)-positive HER2-negative early breast cancer patients, promoting the application of cyclin-dependent kinase (CDK) 4/6 inhibitors in early breast cancer treatment. In the optimization of local treatment, the ACOSOG Z11102 study supported the feasibility of breast-conserving surgery for multicentric breast cancer, the SENOMAC study provided evidence for exempting sentinel lymph node (SLN) low-burden breast cancer patients from axillary lymph node dissection (ALND), the SOUND study supported the exemption of sentinel lymph node biopsy (SLNB) for T1 and cN0 breast cancer patients, and the ICARO study suggested the feasibility of exempting ALND for patients with isolated tumor cells (ITCs) found after neoadjuvant chemotherapy with SLNB or targeted axillary dissection (TAD). The NSABP B-51/RTOG 1304 study provided a basis for the de-escalation of regional lymph node irradiation (RNI) and local treatment in ypN0 breast cancer after neoadjuvant therapy. In terms of quality of life and chemoprevention, the POSITIVE study proposed a protocol for pausing endocrine therapy for breast cancer patients with fertility needs, and the TAM-01 and IBIS-Ⅱ studies provided strong evidence-based medical evidence for chemoprevention in high-risk breast cancer patients. These pivotal clinical studies have profoundly impacted the clinical practice of early-stage breast cancer, not only optimizing treatment plans but also focusing on the quality of life and disease prevention of breast cancer patients. This article discussed the impact of the aforementioned clinical studies on the clinical practice of early breast cancer, centered on updates to various domestic and international breast cancer diagnosis and treatment guidelines and consensus.  
      关键词:Early breast cancer;Guidelines;Consensus;Clinical research   
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    • Song WU, Yang YUAN, Zefei JIANG
      Vol. 35, Issue 2, Pages: 186-194(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.005
      摘要:With advancements in molecular biology research and precision medicine, treatment options for advanced breast cancer have become increasingly diverse. In 2024, significant research progress has been achieved across different molecular subtypes of advanced breast cancer. Endocrine therapy combined with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors has become the standard first-line treatment for hormone receptor-positive advanced breast cancer. Fulvestrant combined with abemaciclib serves as a treatment option after failure in CDK4/6 inhibitors. For patients with mutations in the AKT pathway, fulvestrant combined with the AKT inhibitor capivasertib provides significant long-term survival benefits. Trastuzumab deruxtecan (T-DXd) has emerged as a novel treatment option for patients with HER2 ultra-low expression. For HER2-positive advanced breast cancer, taxanes combined with trastuzumab and pertuzumab or pyrotinib remain the standard first-line treatments for trastuzumab-sensitive patients. The DESTINY-Breast07 trial evaluated the feasibility of using T-DXd as a first-line treatment, showing that whether used as monotherapy or in combination with pertuzumab, progression-free survival (PFS) was non-inferior to standard regimens reported in previous studies. For HER2-positive patients with brain metastases, updated results from the PERMEATE trial indicated that the combination of pyrotinib and capecitabine could provide overall survival benefits. The DESTINY-Breast12 trial demonstrated that T-DXd had similar antitumor activity against systemic and intracranial lesions, making it an effective treatment option for HER2-positive patients with brain metastases. Treatment strategies for advanced triple-negative breast cancer (TNBC) are shifting from conventional chemotherapy to regimens centered on chemotherapy combined with immunotherapy and antibody-drug conjugates (ADCs). The TORCHLIGHT trial showed that chemotherapy combined with the immune checkpoint inhibitor toripalimab improved the prognosis of patients with advanced TNBC. The NCC2167 trial found that when chemotherapy was combined with immunotherapy, metronomic chemotherapy offered superior efficacy and lower toxicity compared to conventional approaches. This article reviewed the significant research progress in advanced breast cancer in 2024. By summarizing related research data, it provides insights into the clinical experience of managing and making treatment decisions for patients with advanced breast cancer, serving as a reference for peers. Looking ahead, future clinical research should focus on individual differences among patients, tumor heterogeneity, and treatment resistance, aiming to improve treatment outcomes and the quality of life for patients with advanced breast cancer.  
      关键词:Advanced breast cancer;Cyclin-dependent kinase 4/6 inhibitors;Antibody-drug conjugate;Immune checkpoint inhibitor   
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    • Cheng ZENG, Yuanyi WANG, Jiani WANG, Fei MA
      Vol. 35, Issue 2, Pages: 195-204(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.006
      摘要:Breast cancer is the most prevalent malignancy among women worldwide. In recent years, immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic strategy across different molecular subtypes of breast cancer, demonstrating significant clinical potential. This review systematically summarized the progress and clinical applications of ICIs in hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-overexpressing (HER2-positive), and triple-negative breast cancer (TNBC). In HR-positive breast cancer, the KEYNOTE-756 and CheckMate 7FL trials demonstrated that ICIs combined with neoadjuvant chemotherapy significantly improved the pathological complete response (pCR) rate, with greater benefits observed in programmed cell death-ligand 1 (PD-L1)-positive patients. Furthermore, the PROMENADE study indicated that estrogen receptor (ER)-low HER2-negative breast cancer patients achieved a pCR rate closer to that of TNBC rather than HR-positive breast cancer following ICIs treatment. In metastatic HR-positive breast cancer, the SACI-IO and DOLAF studies suggested that ICIs combined with antibody-drug conjugates (ADC) or poly (ADP-ribose) polymerase (PARP) inhibitors may provide clinical benefits for specific subgroups of patients. For HER2-positive breast cancer, the Keyriched-1 and Neo-PATH studies revealed that ICIs combined with anti-HER2 therapy might improve pCR rates in HR-negative/HER2-positive patients. However, the Impassion-050 and KATE2 trials failed to demonstrate widespread clinical benefits of ICIs in HER2-positive breast cancer. In TNBC, long-term follow-up data from the KEYNOTE-522 study showed that ICIs combined with neoadjuvant chemotherapy not only improved pCR rates but also conferred long-term survival benefits. Additionally, the Impassion-130, KEYNOTE-355, and TORCHLIGHT studies confirmed that ICIs combined with chemotherapy prolonged both progression-free survival (PFS) and overall survival (OS) in PD-L1-positive advanced TNBC patients. Meanwhile, treatment strategies combining ICIs with anti-angiogenic therapy, PARP inhibitors and ADCs have demonstrated promising efficacy in TNBC (SPARK and BEGONIA trial). Currently, ICIs combined with chemotherapy remains the primary treatment approach, while combination strategies involving ICIs with anti-HER2 therapy, endocrine therapy, ADCs, and anti-angiogenic therapy are actively being explored. However, challenges remain, including complex resistance mechanisms, heterogeneous treatment responses, and the management of immune-related adverse events. Future research should focus on refining patient stratification strategies and developing more precise combination therapies to improve long-term survival outcomes for breast cancer patients.  
      关键词:Breast cancer;Immune checkpoint inhibitor;PD-L1;Precision therapy   
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    • Junjie LI
      Vol. 35, Issue 2, Pages: 205-212(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.007
      摘要:Breast cancer is the most common malignant tumor in women. Early breast cancer refers to primary lesion localized in the breast and regional lymph nodes, and without distant metastasis. Treatment strategies include preoperative neoadjuvant therapy, local treatment (surgery and/or radiotherapy), and postoperative adjuvant therapy. Early breast cancer is highly heterogeneous, hence currently treatment strategies need to be formulated according to different molecular subtypes and pathology stages. At present, breast cancer is further divided into hormone receptor positive, triple negative breast cancer (TNBC), human epidermal growth factor receptor 2 (HER2) positive and other undefined subtypes. With the in-depth exploration of the biological characteristics of different molecular types, a series of new drugs have been developed, such as CDK4/6 inhibitors for hormone receptor positive, anti HER2 targeted therapy for HER2 positive, immunotherapy for TNBC, poly (ADP-ribose) polymerase (PARP) inhibitors for BRCA mutations, and new generation of antibody-drug conjugates (ADCs) drug have entered clinical practice. Combined with the implementation of precision individualized treatment strategy, the prognosis of early breast cancer is also constantly improving, and local treatment is also updated from the "most tolerable" mode to the "least effective" mode, also known as “less is more”. Breast conserving surgery and sentinel lymph node biopsy have become the standard surgical methods for early breast cancer. The neo-adjuvant treatment has promoted the tumor down-staging, and it has also provided the possibility of surgical step-down for patients who could not have breast conserving surgery or sentinel lymph node biopsy. In recent years, the concept of reducing the scope and trauma of surgery, ensuring treatment effectiveness while reducing the physical, psychological, and economic burden on patients through local treatment, has been increasingly popular. This article reviewed the updated research progress and future prospects of local and systematic treatment of early breast cancer aimed to provide reference for clinical workers.  
      关键词:Breast cancer;Breast conserving surgery;Sentinel lymph node biopsy;Neoadjuvant therapy;Adjuvant therapy   
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    • Qing WANG, Yushuai YU, Chenxi WANG, Zirong JIANG, Jialu LI, Shicong TANG, Chuangui SONG
      Vol. 35, Issue 2, Pages: 213-218(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.008
      摘要:Triple-negative breast cancer (TNBC) is a highly aggressive and prognostically unfavorable subtype. Tertiary lymphoid structure (TLS) within the tumor microenvironment, comprising dendritic cells, B cells, T cells, and other immune cells, modulate the tumor immune response. The heterogeneity of TLS in TNBC, such as density, structural maturity, and molecular expression patterns, affects the tumor immune microenvironment and, consequently, treatment responses and clinical outcomes. Studies indicate a positive correlation between the density and maturity of TLS and the pathological complete response (pCR) of TNBC patients, with TLS enhancing the quantity of tumor-infiltrating immune cells and improving anti-tumor immune responses, thereby increasing sensitivity to chemotherapy and immunotherapy. Recent research has found that mature TLS are associated with effective immune responses, becoming significant predictors of treatment response. The combination of TLS with immune checkpoint inhibitors has shown promising prospects. Research demonstrates that promoting the formation or enhancing the functionality of TLS can improve anti-tumor immune effects and enhance treatment outcomes for TNBC patients. Targeting TLS may reduce immune evasion and increase the sensitivity to immunotherapy. However, clinical application of TLS still faces challenges, particularly the impact of their heterogeneity on treatment response. Current assessment methods for TLS are not standardized, lacking a uniform standard and diagnostic system, which limits their widespread application. Future research should focus on resolving these issues by developing standardized assessment tools and further exploring the role of TLS in immune escape and resistance mechanisms. This review aimed to summarize and analyze the existing research progress on TLS in TNBC, in order to provide new ideas for the development of personalized immunotherapy strategies.  
      关键词:Tertiary lymphoid structures;Triple-negative breast cancer;Neoadjuvant therapy;Immune microenvironment   
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    • Yu LAN, Fenghua WANG
      Vol. 35, Issue 2, Pages: 219-227(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.009
      摘要:Gastric cancer is a highly prevalent and aggressive malignancy worldwide, with generally poor prognosis. There are differences in epidemiology, clinicopathological characteristics, treatment modalities, and drug selection for gastric cancer between Eastern and Western populations. Recent advancements in targeted therapy and immunotherapy, the maturation of precision treatment concepts, and the promotion of multidisciplinary therapy have led to continuous updates in clinical research outcomes. Gastric cancer guidelines are annually updated to meet evolving diagnostic and therapeutic needs. This article compared the latest versions of three authoritative global gastric cancer guidelines [National Comprehensive Cancer Network (NCCN) clinical practice guidelines for gastric cancer 2024 version 5, European Society for Medical Oncology (ESMO) online guidelines for gastric cancer 2024, and Chinese Society of Clinical Oncology (CSCO) guidelines for gastric cancer diagnosis and treatment 2024], focusing on clinical treatment strategies for unresectable locally advanced or metastatic esophagogastric junction/gastric adenocarcinoma, and on the whole-process management and precise implementation guided by targets such as human epidermal growth factor receptor 2 (HER2) expression, programmed cell death ligand 1 (PD-L1) expression, mismatch repair (MMR) status,, and novel targets such as Claudin 18.2. Meanwhile, HER2-positive advanced gastric cancer has entered the era of full-line anti-HER2 treatment. Anti-HER2 antibody-drug conjugates (ADCs) has become a new option after first-line trastuzumab resistance. Immunotherapy combined with chemotherapy is regarded as a new standard for the first-line treatment of advanced gastric cancer. The diagnosis and treatment mode based on MMR status and PD-L1 expression promote the precision of immunotherapy. However, the detection of PD-L1 expression has difficulties in clinical promotion and implementation. The three guidelines in 2024 integrate the latest clinical study results, the new indication approval and the updated health care system. In particular, the CSCO gastric cancer guidelines are rewritten based on the rapid development of independently developed drugs in China and the approval of new indications. The three guidelines differ in the recommendation and adoption of targeted therapy and immunotherapy. This article showed different perspectives and focuses based on different guidelines, enriched the dimensions of clinical decision-making, helped the clinical adaptability of evidence-based guidelines to better enlightens clinical practice.  
      关键词:Gastric cancer;Diagnosis and treatment guidelines;CSCO;NCCN;EMSO   
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      Specialist's Article

    • Yongjin LU, Zhiqiang SHI, Tong LI, Yongsheng WANG, Pengfei QIU
      Vol. 35, Issue 2, Pages: 228-236(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.010
      摘要:Background and purpose: With the progressive development of breast cancer surgery toward more individualized and minimally invasive approaches, sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as the standard method for axillary management in certain early-stage breast cancer patients. However, there is ongoing debate in clinical practice regarding whether regional lymph node irradiation (RNI) is necessary for patients with sentinel lymph node (SLN) positive status who have not undergone ALND. This study aimed to analyze the clinicopathological features and survival prognosis of patients with SLN-positive status who did not undergo ALND, evaluate the clinical application value of RNI, and provide evidence to support clinical treatment decisions for this group of patients. Methods: This single-center retrospective study screened breast cancer patients who underwent SLNB at Shandong Cancer Hospital from September 1, 2014, to August 31, 2023. All patients signed informed consent for treatment. Based on whether postoperative radiotherapy included regional lymph node irradiation (internal mammary and/or axillary and/or supra-/infra-clavicular fields), patients were divided into the RNI group and the no-RNI group for follow-up. Additionally, patients were further divided into multiple subgroups based on factors such as the type of breast surgery, tumor molecular subtype, and histological grade, to compare the clinical value of RNI among subgroups. The primary endpoint was locoregional recurrence-free survival (LRRFS), and the secondary endpoints included invasive disease-free survival (iDFS) and overall survival (OS). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was followed for this study. Results: Clinical data of 8 328 breast cancer patients’ were screened for this study, and after applying inclusion and exclusion criteria, 356 patients were included in the analysis, with 186 in the RNI group and 170 in the no-RNI group. There were no significant differences between the two groups in terms of age, body mass index (BMI), menopausal status, tumor location, pathological type, histological grade, vascular invasion, estrogen receptor (ER) and progesterone receptor (PR) status, and human epidermal growth factor receptor 2 (HER-2) expression (P>0.05). However, the number of positive SLNs, T stage, and the proportion of patients undergoing total mastectomy (TM) were significantly higher in the RNI group than in the no-RNI group (P=0.006, P=0.043, P<0.001). After a median follow-up of 38 months, no recurrence or metastasis was observed in the RNI group, while the recurrence and metastasis rate in the no-RNI group was 3.5% (6/170). Of these, 4 cases had local regional recurrence, and 2 had distant metastasis. The RNI group showed superior iDFS compared to the no-RNI group (P=0.017), however there was no statistically significant difference in LRRFS and OS (P=0.051 and P=0.356). Exploratory subgroup analysis indicated that patients with tumor diameter >2 cm (P=0.033) and triple-negative molecular (TNBC) (P=0.020) might benefit from RNI treatment in terms of LRRFS. Conclusion: For certain high-risk patients, such as those with larger tumor diameter, TNBC, or high non-SLN metastatic risk, RNI still plays an important role in reducing the risk of recurrence and metastasis in breast cancer. In clinical practice, an individualized RNI strategy should be developed based on the patient's residual lymph node tumor load, biological behavior of the tumor, and surgical method.  
      关键词:Breast cancer;Axillary lymph nodes;Sentinel lymph node biopsy;Regional lymph node radiotherapy   
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      Article

    • Yuan LI, Lingchuan GUO, Yong YUAN, Qiang ZHENG, Yan JIN, Jian MING
      Vol. 35, Issue 2, Pages: 237-248(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.011
      摘要:Background and purpose: According to the latest data from the National Cancer Center, the incidence rate and mortality of lung cancer in China rank first among all malignant tumors, and 85% are non-small cell lung cancer (NSCLC). In recent years, immunotherapy based on programmed cell death protein-1 (PD-1)/programmed death ligand-1 (PD-L1) immune checkpoint inhibitors (ICIs) has made breakthrough progress in lung cancer, bringing more survival benefits to lung cancer patients. This study aimed to evaluate the cost-effectiveness of three major PD-L1 testing assays in guiding immunotherapy for patients with NSCLC, and to provide empirical evidence to guide the selection of cost-effective diagnosis and ICIs monotherapy regimens for NSCLC patients in China. Methods: From a healthcare system perspective, a decision-tree model was constructed to simulate the cost and effectiveness (percentage of the patients who were successfully diagnosed and who were correctly prescribed and underwent correct treatment according to China treatment guidelines) of employing Ventana PD-L1 IHC (SP263) assay, PD-L1 IHC 22C3 pharmDx, and Dako 22C3 antibody concentrate in early to mid-stage and advanced NSCLC patients in China, respectively. The cost-effectiveness of SP263 assay compared to other testing methods was assessed through the incremental analysis. The robustness of the base case analysis results was validated by using one-way sensitivity analysis and probabilistic sensitivity analysis. Results: When considering atezolizumab monotherapy following chemotherapy for early to mid-stage (Ⅱ A-Ⅲ B) NSCLC patients, in comparison to the 22C3 assay or 22C3 antibody concentrate, the SP263 assay incurred an additional cost of 9 449 yuan per successfully diagnosed and treated patient. The SP263 assay, which can guide multiple ICIs monotherapies (e.g., atezolizumab, pembrolizumab) for advanced (Ⅳ) NSCLC patients, was dominant by achieving a higher percentage of successfully diagnosed and treated patients at a lower cost compared to Dako 22C3 assay and Dako 22C3 antibody concentrate. One-way sensitivity analysis and probabilistic sensitivity analysis both confirmed the robustness of the results. Conclusion: The Ventana PD-L1 IHC SP263 assay was cost-effective, compared to Dako PD-L1 IHC 22C3 assay and Dako 22C3 antibody concentrate for the immunotherapy treatment for both stage Ⅱ A-Ⅲ B and stage Ⅳ NSCLC patients in China.  
      关键词:PD-L1 testing;NSCLC;Immunotherapy;Cost-effectiveness analysis   
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      Review

    • Shuyue CAI, Quan XIE, Yuxuan ZHOU, Qingzhu LIU, Ling QIU, Jianguo LIN
      Vol. 35, Issue 2, Pages: 249-254(2025) DOI: 10.19401/j.cnki.1007-3639.2025.02.012
      摘要:Breast cancer is one of the most prevalent malignant tumor in women worldwide, in which, triple-negative breast cancer (TNBC) is highly invasive and metastatic. In recent years, the incidence rate of TNBC has gradually increased and shown a trend of younger age. With the in-depth research on the molecular mechanism of breast cancer, neuropilin-1 (NRP-1), a transmembrane protein, has been found to be associated with metastasis and prognosis of breast cancer, particularly TNBC. Therefore, NRP-1 has become a promising target for the diagnosis and treatment of breast cancer. The expression and distribution of NRP-1 in breast cancer can be detected by nuclear medicine, optical imaging and multimodal imaging methods in a non-invasive, real-time and accurate manner, which has significant application value in the early diagnosis, staging, treatment, and prognosis evaluation of breast cancer. Nuclear medicine probes specifically target tumor cells or tissues by combining radionuclides (e.g., 68Ga and 99mTc) with specific molecular ligands, and the signal is captured using positron emission tomography (PET) or single-photon emission computed tomography (SPECT), allowing for sensitive diagnosis of breast cancer. With the development of medical imaging and other interdisciplinary subjects, the NRP-1 targeted multimodal molecular probe [68Ga]Ga-NODAGA-K(Cy5)DKPPR combined the high sensitivity of PET with the high resolution advantage of near-infrared fluorescence (NIRF) to achieve precise diagnosis of breast cancer and provide real-time fluorescence navigation during surgery, enhancing the accuracy of tumor tissue identification and excision. In this paper, the advantages and disadvantages of NRP-1 targeted molecular probes in the diagnosis of breast cancer were systematically compared, and the application scope and latest research progress of various probes in the diagnosis and treatment of breast cancer were described, in order to provide reference for the development and clinical application of breast cancer targeted molecular probes.  
      关键词:Breast cancer;Neuropilin-1 (NRP-1);Tumor diagnosis;Molecular imaging;Molecular probes   
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      更新时间:2025-12-31
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