中华肿瘤杂志最新文献

{"title":"[A retrospective study of PD-1 monoclonal antibody combined with nab-paclitaxel plus bevacizumab in the treatment of advanced malignant melanoma].","authors":"Y Ren, L J Zhao, Z M Wei, Y Yang, Z Y Zou","doi":"10.3760/cma.j.cn112152-20250723-00359","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20250723-00359","url":null,"abstract":"<p><p><b>Objective:</b> Advanced malignant melanoma still poses significant challenges in treatment. Combining nab-paclitaxel, bevacizumab, and immunotherapy has shown promising efficacy across various cancer types. This retrospective study aimed to assess the efficacy and safety of this regimen in patients with advanced melanoma and explore related biomarkers. <b>Methods:</b> Patients with histologically confirmed inoperable stage Ⅲ or Ⅳ melanoma and Eastern Cooperative Oncology Group Performance Status 0-2 were included in this retrospective study conducted from September 2020 to August 2023. Patients received combination therapy with nab-paclitaxel, bevacizumab, and toripalimab (Q3W) at Nanjing Drum Tower Hospital. Maintenance therapy with bevacizumab and toripalimab was given after 6-8 cycles without disease progression or intolerable adverse reactions. Personalized radiotherapy was delivered. The primary endpoint was the confirmed objective response rate (ORR) and disease control rate (DCR). <b>Results:</b> As of January 20, 2024, 28 out of 41 patients showed tumor shrinkage, including 4.9% (<i>n</i>=2) achieving complete response (CR) and 63.4% (<i>n</i>=26) achieving partial response (PR). The confirmed ORR was 63.4% (95% <i>CI</i>: 46.9%-77.9%) and the DCR was 92.7% (95% <i>CI</i>: 80.1%-98.5%). The median PFS was 14.2 months, the 1-year survival rate was 75.5% (95% <i>CI</i>: 62.7%-90.9%), and the 2-year survival rate was 54.6% (95% <i>CI</i>: 38.1%-78.1%). Moreover, patients who received radiotherapy exhibited a longer median progression-free survival (mPFS) (14.3 months vs 7.0 months, <i>HR</i>=0.45 [95% <i>CI</i>: 0.20-1.01]). Grade 3 treatment-related adverse events were leukopenia, neutropenia, AST/ALT elevation, adrenal insufficiency, hypertriglyceridemia and neurotoxicity. No treatment-related deaths were observed. In addition, biomarker analysis showed that liver metastasis, MET mutation, and NF1 mutation were independent predictors of PFS (<i>P</i>=0.006, 0.038, and 0.002, respectively). <b>Conclusions:</b> This study demonstrates that toripalimab, in combination with nab-paclitaxel and bevacizumab, offers a potential therapeutic option for advanced melanoma with acceptable toxicity. Furthermore, this triplet therapy combined with radiotherapy significantly improves PFS. Preliminary biomarker analysis suggests that patients with liver metastasis, MET or NF1 mutations may be less likely to benefit from this treatment regimen.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 4","pages":"571-585"},"PeriodicalIF":0.0,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China (2026 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20251009-00497","DOIUrl":"10.3760/cma.j.cn112152-20251009-00497","url":null,"abstract":"<p><p>Chemotherapy-induced neutropenia (CIN) is a common hematological adverse event and dose-limiting toxicity of chemotherapy. CIN may lead to dose reduction or delay of chemotherapeutic agents, febrile neutropenia (FN), and severe infections, which results in increased treatment costs, reduced chemotherapy efficacy, and even life-threatening complications. Therefore, standardized assessment of the risk of CIN in cancer patients, timely identification and intervention of FN, and appropriate prevention and treatment are essential to reduce CIN-related complications, improve patients' quality of life, and enhance chemotherapy outcomes. Based on the \"Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China (2023 edition)\", the Committee of Medical Oncology and the Committee of Neoplastic Supportive-care of China Anti-Cancer Association have thoroughly reviewed and summarized the latest evidence and clinical practices worldwide. This update puts forward 11 recommendations regarding the definition, grading, risk assessment, prevention, and treatment strategies for CIN, aiming to provide more timely and standardized guidance for Chinese oncologists in the diagnosis, treatment, and prevention of CIN.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 ","pages":"476-490"},"PeriodicalIF":0.0,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Expert consensus on the clinical application of PARP inhibitors in breast cancer (2025 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20251027-00530","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20251027-00530","url":null,"abstract":"<p><p>Breast cancer poses a major threat to women's health in China, with its incidence rate continuously rising, leading to an increasing disease burden and an urgent need for novel and effective treatment strategies. In recent years, poly ADP-ribose polymerase (PARP) inhibitors, as a new class of anti-tumor drugs targeting the DNA damage repair pathway, have demonstrated significant efficacy in the treatment of breast cancer with BRCA1/2 mutations. These agents induce a \"synthetic lethality\" effect by specifically inhibiting DNA repair in tumor cells, offering a new option for precision therapy. Currently, PARP inhibitors such as olaparib and fluzoparib have been approved for clinical use. Based on the latest evidence-based medical data, the Professional Committee on Clinical Research of Oncology Drugs, China Anti-Cancer Association, Expert Committee for Monitoring the Clinical Application of Antitumor Drugs and Breast Cancer Expert Committee of National Cancer Quality Control Center, Cancer Chemotherapy Quality Control Expert Committee of Beijing Cancer Treatment Quality Control and Improvement Center have jointly organized and invited domestic oncology experts with rich diagnosis and treatment experience as well as relevant interdisciplinary experts to compile the \"Expert consensus on the clinical application of PARP inhibitors in breast cancer (2025 edition)\". This consensus aims to provide guidance on the standardized application and safety management of PARP inhibitors in breast cancer treatment, with the goal of supporting clinical practice.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 4","pages":"451-461"},"PeriodicalIF":0.0,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Expert consensus on intravesical therapy for non-muscle invasive bladder cancer (2025 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20250913-00455","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20250913-00455","url":null,"abstract":"<p><p>Bladder cancer is one of the common malignant tumors. In 2022, China is estimated to have approximately 92,900 new cases of bladder cancer, including about 73,200 cases in males and 19,700 cases in females. It is projected that around 41,400 deaths will be attributed to bladder cancer, with about 32,500 deaths among males and 8,800 among females. With 75% of bladder cancers being non-muscle invasive and having a high recurrence rate after surgery. Intravesical therapy is a useful method to either directly kill tumor cells by infusing cytotoxic drugs into the bladder, or directly or indirectly induce local immune responses of the body by infusing immune agents, such as Bacillus Calmette-Guérin, and thus reduce the risk of tumor recurrence and progression. In 2021, the Urological Chinese Oncology Group issued the \"Expert consensus on intravesical therapy for non-muscle invasive bladder cancer (2021 edition)\", Since then, great progress has been achieved domestically and abroad, including refined assessment of bacillus calmette-guérin (BCG) failure disease, optimized intravesical strategies for high-risk non-muscle invasive bladder cancer, and the clinical application of novel intravesical agents. This updated consensus synthesizes the latest evidence-based data with current Chinese clinical practice and experience. Building upon the \"Expert consensus on intravesical therapy for non-muscle invasive bladder cancer (2021 edition)\", it offers contemporary guidance for the standardized management of intravesical therapy in non-muscle invasive bladder cancer within China.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 4","pages":"462-475"},"PeriodicalIF":0.0,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Consensus on clinical diagnosis and treatment of breast cancer with low expression and ultralow expression of HER-2 (2025 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20250920-00471","DOIUrl":"10.3760/cma.j.cn112152-20250920-00471","url":null,"abstract":"<p><p>The treatment of breast cancer with low expression of human epidermal growth factor receptor 2 (HER-2) has become a focused area in recent years. With the proved therapeutic effect of antibody-drug conjugates on breast cancer patients with HER-2-low expression, this subgroup has become a new targeting population in breast cancer. Recent studies have shown that patients with HER-2-ultralow breast cancer can also benefit from novel antibody-drug conjugates. To better standardize the rational clinical diagnosis and treatment of HER-2-low and HER-2-ultralow breast cancer, the Breast Cancer Professional Committee of China Anti-Cancer Association, along with Breast Cancer Prevention and Treatment Research Professional Committee of Maternal and Child Health Research Society of China reviewed the latest domestic and international clinical studies and important publications in recent years. Integrating the clinical experience of Chinese pathologists and oncologists, and following expert panel discussions, a consensus on the clinical diagnosis and treatment of HER-2-low and HER-2-ultralow breast cancer was developed. This consensus aims to deepen clinicians' understanding of HER-2-low and HER-2-ultralow breast cancer, promote more precise clinical decision-making, and ultimately improve patient survival and quality of life.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 ","pages":"345-358"},"PeriodicalIF":0.0,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145991066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[The value of fine-needle aspiration biopsy wash-out fluid in the detection for medullary thyroid carcinoma].","authors":"J Zhao, L H Zhao, Y Deng, L Zhang, X Q Wang, X Q Zheng, X Wei","doi":"10.3760/cma.j.cn112152-20250715-00341","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20250715-00341","url":null,"abstract":"<p><p><b>Objective:</b> To investigate the preoperative diagnostic value of ultrasound-guided fine-needle aspiration biopsy wash-out fluid (FNA-CT) in medullary thyroid carcinoma (MTC) with mildly elevated serum calcitonin levels. <b>Methods:</b> 267 patients with MTC diagnosed in Tianjin Cancer Hospital between Jan 2015 and Jan 2024 were enrolled in the study. Based on serum calcitonin, patients were divided into two groups:＞100 ng/L and 10-100 ng/L. Sonographic features, clinicopathological characteristics and prognostic outcomes were evaluated between the two groups. The diagnostic efficacy of serum calcitonin and FNA-CT in MTC and non-medullary thyroid carcinoma with slightly high serum calcitonin were evaluated. The best cutoff values of serum calcitonin and FNA-CT were calculated by subject operating characteristic curve (ROC). The diagnostic efficacy was analyzed for MTC with mildly elevated serum calcitonin according the best cut off points. <b>Results:</b> Compared to the >100 ng/L group, MTC patients with serum calcitonin 10-100 ng/L exhibited distinct ultrasonographic features: taller-than-wide shape, non-adjacent to thyroid capsule, less vascularity, and CACA-TIRADS 4 (all <i>P</i>＜0.05). Clinicopathologically, the serum calcitonin 10-100 ng/L group demonstrated single focus rather than multifocality, smaller tumor size, higher prevalence of microcarcinoma, a lower degree of local invasion, earlier tumor stages (T stage, N stage, TNM stage), smaller extent of thyroidectomy and lymphadenectomy and lower diagnostic accuracy of FNA (all <i>P</i>＜0.05). The group also showed higher biochemical cure rate (90.0% and 54.2%)and lower rates of biochemical recurrence (5.5% and 23.1%) and tumor recurrence (3.6% and 22.6%, <i>P</i>＜0.001). Among MTC with serum calcitonin 10-100 ng/L, the median of serum calcitonin levels were 40.0 ng/L (19.5, 65.8 ng/L) for MTC vs. 16.6 ng/L (13.2, 20.8 ng/L, <i>P</i>＜0.001) for non-medullary thyroid carcinoma. The median of FNA-CT were 2 000.0 ng/L (1 334.0, 2 000.0 ng/L) vs. 0.8 ng/L (0.5, 2.0 ng/L, <i>P</i>＜0.001). The best cutoff points were 22.9 ng/L for serum calcitonin and 58.7 ng/L for FNA-CT. The sensitivity, specificity, negative predictive value, positive predictive value and the area under curve (AUC) were 67.3%, 82.9%, 65.4%, 61.2% and 0.829 (95% <i>CI</i>: 0.731-0.903) at the best cutoff point of 22.9 ng/L for serum calcitonin. The sensitivity, specificity, negative predictive value, positive predictive value and AUC were 98.2%, 97.6%, 97.61%, 98.1% and 0.998 (95% <i>CI</i>: 0.989-0.998) at the best cutoff point of 58.7 ng/L for FNA-CT. <b>Conclusions:</b> MTC with slightly elevated serum calcitonin commonly correlates with an early-stage disease. FNA-CT has demonstrated near-perfect diagnostic performance and improved the early detection in this population.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 3","pages":"437-444"},"PeriodicalIF":0.0,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Genitourinary Oncology Committee of Chinese Anti-Cancer Association (CACA-GO) guideline for prostate cancer for patients (2025 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20250428-00190","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20250428-00190","url":null,"abstract":"<p><p>Prostate cancer is a relatively common malignant tumor in the genitourinary system of elderly men, posing a heavy burden to the public health. In order to disseminate the knowledge of early screening and diagnosis of prostate cancer, effectively promote the prevention and treatment of prostate cancer in China, and improve patients' cognition of prostate cancer,the Genitourinary Oncology Committee of Chinese Anti-Cancer Association organized a panel of experts to formulate the \"Genitourinary Oncology Committee of China Anti-Cancer Association (CACA-GO) guideline for prostate cancer for patients (2025 edition)\", with the aim of enhancing the understanding of prostate cancer diagnosis and treatment among patients and their families, assisting clinicians in more effectively conducting prostate cancer diagnosis and treatment, thereby improving patients' survival outcomes and quality of life, benefiting more prostate cancer patients, and contributing to the grand goal of \"Healthy China 2030\".</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 3","pages":"310-324"},"PeriodicalIF":0.0,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Cancer incidence and mortality across diverse geographical regions in China, 2024].","authors":"K X Sun, L Li, S M Wang, R Chen, B F Han, R S Zheng, M C Liu, H M Zeng, W Q Chen, J He","doi":"10.3760/cma.j.cn112152-20260205-00079","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20260205-00079","url":null,"abstract":"&lt;p&gt;&lt;p&gt;&lt;b&gt;Objective:&lt;/b&gt; The National Central Cancer Registry estimates the cancer diseases burden in China in 2024. &lt;b&gt;Methods:&lt;/b&gt; We incorporated the surveillance data from 919 cancer registries of year 2019 and the longitudinal surveillance data from 106 registries during 2010 to 2019. We estimated the age-standardized incidence (ASIR) and mortality rates (ASMR) of overall and 23 major cancers in China in 2024 using the age-period-cohort model, stratified by sex and area. The age-standardized incidence (ASIRC) and mortality (ASMRC) rates by Chinese population were calculated based on the age structure of the population from the national census in 2000. The age-standardized incidence (ASIRW) and mortality (ASMRW) rates by World population were calculated using Segi's world standard age structure. &lt;b&gt;Results:&lt;/b&gt; In 2024, there were approximately 5 150 600 new cancer cases in China (2 672 000 for males and 2 478 600 for females), with an ASIRW of 207.70 per 100 000 (215.71 per 100 000 in urban areas and 193.74 per 100 000 in rural areas). The estimated number of cancer deaths in China was 2 582 200 (1 640 500 for males and 941 700 for females), with an ASMRW of 90.90 per 100 000 (87.34 per 100 000 in urban areas and 96.27 per 100 000 in rural areas). When comparing between different sexes, the cancer ASIRs for both males and females were relatively close. The ASMRs for males were 1.9 times that of females. When comparing among different areas, the crude cancer incidence rate in rural areas was higher than that in urban areas, while the ASIRs were lower than that in urban areas. Both the crude mortality rate and the ASMRs in rural areas were higher than those in urban areas. Among different cancer types, lung cancer ranked first in terms of both incidence and mortality, with 1 175 900 new cases and 743 300 deaths, accounting for 22.8% and 28.8% of all cancer cases and deaths, respectively. In both males and females, the ASIRs and ASMRs of liver, stomach and esophageal cancer in rural areas were higher than those in urban areas, while the ASIRs and ASMRs of colorectal cancer in urban areas were higher than those in rural areas. The ASIRs and ASMRs of cervical cancer in rural areas were higher than those in urban areas. The disease burden of prostate cancer and breast cancer in urban areas was higher than that in rural areas. The incidence and mortality rates of lung cancer ranked first in most provinces of China. The incidence rate of nasopharyngeal cancer was relatively high in Guangxi, Guangdong, Hainan and Jiangxi. Renal cancer was more prevalent in northern regions, and prostate cancer was more common in economically developed areas. The incidence rate of thyroid cancer ranked second in Zhejiang, Fujian and Xinjiang. The incidence rates of esophageal cancer and cervical cancer were significantly lower in Beijing, Tianjin, Shanghai and Guangdong. &lt;b&gt;Conclusions:&lt;/b&gt; The overall burden of cancer in China remains significant. Different regions sh","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 3","pages":"400-412"},"PeriodicalIF":0.0,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[China lymphoma diagnosis and treatment guideline (2026 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20250605-00260","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20250605-00260","url":null,"abstract":"<p><p>Lymphoma is one of the most common malignancies in China. Lymphoma exhibited complex pathological subtypes with significant heterogeneity, the treatment strategies varied. In recent years, with a deeper understanding of the mechanisms of oncogenesis and disease progression of lymphoma, significant development has been made in diagnosis and treatment, leading to the improvement of patients' clinical outcomes. In order to update the progress in the diagnosis and treatment of lymphoma. The Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care, the China Anti-cancer Association Lymphoma Committee, and the Chinese Association for Clinical Oncologists organized experts to developed the \"China lymphoma diagnosis and treatment guideline (2026 edition)\". The updated guideline offers systematic and comprehensive revisions on methodology, epidemiological data, clinical manifestations, auxiliary examinations, new drugs, new treatment regimens, and new indications. It also incorporates treatment recommendations along with their evidence levels and grades of recommendation, covering common clinical issues in the diagnosis and management of lymphoma patients, thus providing improved guidance for standardized diagnosis and patient management.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 3","pages":"263-309"},"PeriodicalIF":0.0,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Progress of clinical trials on breast cancer in China, 2011-2022].","authors":"Y Fang, H Y Huang, D W Wu, Y Yu, Y Leng, Y Tang, N Li","doi":"10.3760/cma.j.cn112152-20231129-00340","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20231129-00340","url":null,"abstract":"<p><p><b>Objective:</b> To systematically summarize the research progress of clinical trials on breast cancer drugs in China from 2011 to 2022, as well as provide an overview of the marketed drugs. The goal is to offer data and decision-making evidence for relevant departments. <b>Methods:</b> Based on the registration database of the China National Medical Products Administration's Clinical Trial Registration and Information Disclosure Platform, as well as data from the domestic and imported drug query systems, an analysis was conducted on clinical trials of breast cancer drugs, including information on investigational drugs and marketed drugs from January 1, 2011, to December 31, 2022. The study compared differences between Chinese and foreign enterprises in terms of trial scope, trial phases, number of treatment lines, drug types, and mechanisms of action. <b>Results:</b> From 2011 to 2022, a total of 401 clinical trials for breast cancer were registered in China, accounting for 8.0% of the country's overall anti-tumor clinical trials (401/5 011), with 304 trials (75.8%) initiated by domestic enterprises. Over the past decade, clinical trials for breast cancer showed fluctuating growth, reaching a peak of 84 trials in 2020. These trials involved 254 drugs, with 156 (61.4%) being original drugs and 174 (68.5%) being targeted therapies. The most focused targets included human epidermal growth factor receptor 2 (HER-2), cyclin-dependent kinases 4/6 (CDK4/6), and estrogen receptors (ER). There are 50 drugs targeting HER-2 (28.7%), 35 targeting CDK4/6 (20.1%), and 31 targeting ER (17.8%). During the period from 2011 to 2022, a total of 15 drugs for treating breast cancer were approved and launched in China, covering 19 indications. Among these, 7 indications are for adjuvant or neoadjuvant therapy of early-stage breast cancer, and 12 indications are for advanced breast cancer. <b>Conclusions:</b> Substantial achievements have been made in the development of new breast cancer drugs in China from 2011 to 2022. However, there remains a significant gap in the innovation capabilities of domestic pharmaceutical companies compared to international counterparts in the field of breast cancer. Future efforts should be directed towards strengthening research and development in breast cancer, exploring new target points, and investigating combination therapy mechanisms.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":"48 3","pages":"445-450"},"PeriodicalIF":0.0,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}