中华肿瘤杂志最新文献

{"title":"[Expert consensus of multi-disciplinary collaboration on bladder-preserving treatment for bladder cancer in China (2024 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20240602-00231","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20240602-00231","url":null,"abstract":"<p><p>Bladder cancer is one of the common malignant tumors in urology. According to statistics, there will be 613 791 new cases of bladder cancer in the world in 2022, and the number of new cases of bladder cancer in China will be approximately 92 900, accounting for approximately 15% of new cases of bladder cancer in the world, ranking 11th in the spectrum of malignant tumors in China, among which there are approximately 73 200 new cases in males, ranking 8th in the spectrum of male malignant tumors. Bladder urothelial cancer accounts for approximately 90% of all bladder malignant tumors. It can be divided into non-muscle-invasive bladder cancer and muscle-invasive bladder cancer according to whether it invades the bladder muscle layer. Radical cystectomy is the standard treatment for muscle invasive bladder cancer patients and bacillus calmette-guerin (BCG) unresponsive high-risk non-muscle invasive bladder cancer patients. Nevertheless, due to the patient's underlying diseases and the deterioration of the quality of life caused by surgery, many patients refused or are not suitable for radical cystectomy. Therefore, it is vital to find a bladder-preserving treatment that can achieve cure other than radical cystectomy. Bladder-preserving therapy that balances tumor control and quality of life serves as an alternative and supplement to radical cystectomy. This consensus is based on contemporary evidence-based medicine, combined with native clinical practice and experiences of bladder preservation in a multidisciplinary treatment manner. To some extent, this consensus serves as a guidance for bladder preservation of bladder cancer in China. The consensus aims to discuss issues including organizational structure and workflow of multidisciplinary treatment, the selection of patients for bladder-preserving therapy, treatment options and regimens, efficacy evaluation, follow-up, as well as regimen choices of recurrence after bladder-preserving therapy.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477046","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":"[Perioperative immunotherapy for non-small cell lung cancer: consensus and controversy (2024 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20240821-00361","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20240821-00361","url":null,"abstract":"<p><p>Lung cancer is the malignant tumour with the highest morbidity and mortality rate in China, among which non-small cell lung cancer (NSCLC) is the main pathological type of lung cancer, accounting for about 80% to 85%. Radial surgery is the standard treatment for early-stage NSCLC, but postoperative recurrence is an inevitable problem in clinical practice. Adding perioperative chemotherapy to surgery can only increase the 5-year overall survival rate by about 5%. There is an urgent need for better systemic treatments. In recent years, immunotherapeutic drugs, represented by PD-1/PD-L1 monoclonal antibodies, have brought breakthroughs from subsequent-line treatment to front-line treatment for NSCLC. Several Phase III studies on perioperative immunotherapy have shown that adding immunotherapy during the neoadjuvant and adjuvant treatment can significantly improve survival outcomes for patients, leading to the development of a new standard treatment for resectable NSCLC. In January 2024, the first PD-1 monoclonal antibodies (Toripalimab) were approved for perioperative treatment of NSCLC in China, starting a new era of perioperative immunotherapy. At present, there is still a lack of unified consensus on the application of perioperative immunotherapy at all levels of medical institutions. In order to privide diagnostic and treatment guidance for clinicians, promote the standardization of clinical practice for immunotherapy in resectable NSCLC, and clarify the controversial opinions regarding perioperative immunotherapy, Lung Cancer Expert Committee of the Chinese Anti-Cancer Association, Chinese Thoracic Oncology Group, Lung Cancer Expert Committee of the Chinese Medical Association Oncology Society jointly published this Consensus and Controversy to provide a guidance for the standardized management of perioperative immunotherapy for NSCLC.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477047","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":"[Chinese expert consensus on diagnosis, treatment and prevention of pulmonary infection in patients with solid tumors (2024 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20240606-00242","DOIUrl":"10.3760/cma.j.cn112152-20240606-00242","url":null,"abstract":"<p><p>Patients with solid tumors have an increased risk of developing pneumonia during the management of tumor. The prevention, diagnosis, and treatment of pneumonia in these patients have different characteristics compared to the general population, such as the correction of specific risk factors for pneumonia and the rational use of prophylactic antimicrobial drugs, the strategy of invasive sampling diagnostic techniques application, differential diagnosis from anti-tumor treatment associated pulmonary conditions, and consideration of pathogens and drug resistance in empirical antimicrobial treatment. In order to standardize the diagnosis, treatment, and prevention of pneumonia in patients with solid tumors, Oncology Respiratory Disease Committee initiated the \"Chinese expert consensus on the diagnosis and treatment of pneumonia in patients with solid tumors\". Based on a review of the latest evidence in this field, the consensus provides diagnostic and treatment pathways as well as recommendations. This consensus applies to oncologists, pulmonologists, infectious disease physicians, surgeons, emergency medicine physician, and general practice healthcare professionals involved in the management of solid tumors in adults.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477045","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":"[Applications of artificial intelligence for imaging-driven diagnosis and treatment of bone and soft tissue tumors].","authors":"C B Jiao, L Liu, W F Liu","doi":"10.3760/cma.j.cn112152-20231024-00215","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20231024-00215","url":null,"abstract":"<p><p>Bone and soft tissue tumors occur in the musculoskeletal system, and malignant bone tumors of bone and soft tissue account for 0.2% of all human malignant tumors, and if not diagnosed and treated in a timely manner, patients may be at risk of a poor prognosis. Image interpretation plays an increasingly important role in the diagnosis of bone and soft tissue tumors. Artificial intelligence (AI) can be applied in clinical treatment to integrate large amounts of multidimensional data, derive models, predict outcomes, and improve treatment decisions. Among these methods, deep learning is a widely employed technique in AI that predominantly utilizes convolutional neural networks (CNN). The network is implemented through repeated training of datasets and iterative parameter adjustments. Deep learning-based AI models have successfully been applied to various aspects of bone and soft tissue tumors, encompassing but not limiting in image segmentation, tumor detection, classification, grading and staging, chemotherapy effect evaluation, recurrence and prognosis prediction. This paper provides a comprehensive review of the principles and current state of AI in the medical image diagnosis and treatment of bone and soft tissue tumors. Additionally, it explores the present challenges and future prospects in this field.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297794","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":"[Five-year survival analysis of gastric cancer from population-based cancer registration data in Zhejiang province, China].","authors":"H Z Li, H T Zhu, Y Y Chen, R S Zheng, G F Jin, L B Du, X D Cheng","doi":"10.3760/cma.j.cn112152-20231024-00233","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20231024-00233","url":null,"abstract":"<p><p><b>Objective:</b> To analyze epidemiology of gastric cancer five-year survival distribution in Zhejiang population-based cancer registration. <b>Methods:</b> The follow-up data of registrated gastric cancer cases diagnosed from 2008 to 2019 in 22 national cancer registry areas of Zhejiang Province were collected and divided into three diagnostic periods: 2008-2011, 2012-2015 and 2016-2019 to calculate five-year observed survival rates (OSRs), five-year relative survival rates (RSRs) and five-year age-standardized relative survival rates (ARSRs). The distribution of population characteristics (including gender, urban/rural, age group and occupation) and clinical characteristics (including the highest diagnostic institution, sub-site, pathological type and degree of differentiation) of gastric cancer survival rates in each period were analysed. <b>Results:</b> 51 663 new cases of gastric cancer in 2008-2019 in the cancer registration area of Zhejiang Province were included in the analysis, and the ARSR of gastric cancer in 2008-2011, 2012-2015 and 2016-2019 showed an increasing trend (39.2%, 41.3% and 44.7%, respectively). In 2016-2019, the ARSR was similar across gender and urban and rural areas (44.4% for men and 45.7% for women; 44.9% in urban areas and 44.2% in rural areas); Among people with different occupations, the ARSR was highest among business and service workers (55.3%), the agriculture, forestry, animal husbandry and fisheries, water conservancy production workers and domestic workers were lower (41.5% and 43.2%, respectively). The highest diagnostic institution was the provincial hospital with a higher gastric cancer survival rate (47.0%) than the municipal (43.4%) and district (43.6%) levels. The ARSR for gastric cancer was relatively high in the lesser curvature (59.7%), pylorus (50.4%), antrum (49.3%), and greater curvature (48.7%), and lowest in cardia (38.9%). Among the major pathological types, adenocarcinoma (NOS) had an ARSR of 48.1%, mucinous adenocarcinoma 41.3%, imprinted cell carcinoma 39.4%, and squamous carcinoma 33.4%. The ARSR for highly differentiated, moderately differentiated, poorly differentiated and undifferentiated gastric cancers were 80.6%, 57.9%, 43.2% and 36.8%, respectively. <b>Conclusion:</b> The 5-year survival rate of gastric cancer in Zhejiang Province is high and on the rise, with similar survival rates in different genders, urban and rural areas, and significant differences in the survival rates of gastric cancer patients with different occupational groups, highest diagnostic institutions, tumour sub-sites, pathological types and differentiation degrees.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297760","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":"[Effects of normal mitochondrial transplantation on proliferation, apoptosis and stemness of triple-negative breast cancer cells].","authors":"L L Ma, K Zhang, J N Lu, L X Sun, L Yu, Y L Ran, L C Sun","doi":"10.3760/cma.j.cn112152-20231222-00381","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20231222-00381","url":null,"abstract":"&lt;p&gt;&lt;p&gt;&lt;b&gt;Objectives:&lt;/b&gt; To observe the mitochondrial morphology of normal and triple-negative breast cancer cells, extract mitochondria from normal cells, and investigate the effects of mitochondrial transplantation on proliferation, apoptosis, and stemness of triple-negative breast cancer cells. &lt;b&gt;Methods:&lt;/b&gt; The morphology of mitochondria was observed by transmission electron microscope. Mitochondria were extracted by mitochondrial extraction kit, mitochondrial protein was identified by western blot, and mitochondrial activity was detected by mitochondrial membrane potential detection kit. MitoTracker Green or MitoTracker Deep Red fluorescent probes were used to label the mitochondria of living cells, and the degree of mitochondria entering LTT cells was observed by confocal laser microscopy at 12, 24, and 96 hours. The effects of mitochondrial transplantation on proliferation, apoptosis, and stemness of breast cancer cells were examined by CCK8, colony formation assay, flow cytometry, and sphere formation assay after 24 hours of mitochondrial transplantation. &lt;b&gt;Results:&lt;/b&gt; The mitochondria of normal cells were rod-shaped or elongated, while the mitochondria of triple-negative breast cancer cells were swollen and vacuolated. Western blot results showed that cytochrome c oxidase subunit I (MT-CO1) protein encoded by mitochondria was present in the isolated mitochondria. The content of heat shock protein 60 (HSP60) was higher in mitochondria than that in cytoplasm. The result of the multi-mode microplate reader showed that the content of mitochondrial J-aggregates/monomer was 1.67±0.06, which was significantly higher than 0.35±0.04 of the control group (&lt;i&gt;P&lt;/i&gt;＜0.001). Exogenous mitochondria were observed in LTT cells at 12, 24, and 96 hours after mitochondrial transplantation. The results of the CCK8 experiment showed that OD450 of LTT cells was 0.27±0.13 after 48 hours transplantation, which was lower than 0.62±0.36 of the control group (&lt;i&gt;P&lt;/i&gt;=0.023). The OD450 of MDA-MB-468 cells was 0.30±0.03, which was lower than 0.65±0.10 of the control group (&lt;i&gt;P&lt;/i&gt;=0.004). After 120 hours of mitochondrial transplantation, OD450 in both groups was still significantly lower than that in the control group &lt;i&gt;(P&lt;/i&gt;＜0.01). The number of clones formed by mitochondrial transplantation of LTT cells was 21.33±7.31, which was lower than 35.22±13.59 of the control group (&lt;i&gt;P&lt;/i&gt;=0.016). Flow cytometry showed that the early apoptosis rate of LTT cells was (30.07±2.15)% after 24 hours of mitochondrial transplantation, which was higher than 2.07±1.58 of the control group (&lt;i&gt;P&lt;/i&gt;＜0.001). The proportion of early apoptosis in MDA-MB-468 cells was 24.47%±5.22%, which was higher than (7.83±2.06)% in the control group (&lt;i&gt;P&lt;/i&gt;=0.007). In addition, the number of mitochondria transplanted LTT cells into the cell sphere was 46.25±5.40, which was significantly lower than 62.58±6.43 of the control group (&lt;i&gt;P&lt;/i&gt;＜0.001). &lt;b&gt;Conclusion:&lt;/b&gt; Normal mitochondria can ","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297796","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":"[Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2024 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20240510-00189","DOIUrl":"10.3760/cma.j.cn112152-20240510-00189","url":null,"abstract":"<p><p>To further standardize lung cancer prevention and treatment measures in China, enhance the quality of diagnosis and treatment, improve patient prognosis, and provide evidence-based medical guidance for clinicians at all levels, the Chinese Medical Association convened experts from respiratory medicine, oncology, thoracic surgery, radiotherapy, imaging, and pathology to develop the Chinese Medical Association's Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2024 edition). This consensus resulted in several updates from the 2023 version. The 2024 guidelines highlight that the risk of lung cancer in smokers remains higher than that of non-smokers even 15 years after quitting. Additionally, a new lung cancer incidence risk model is expected to become a critical tool for screening high-risk groups. In pathology, the guidelines now include pathological evaluation of surgically resected lung cancer specimens following neoadjuvant therapy and suggest that immunohistochemical staining of certain transcription factors may aid in the classification of small cell lung cancer (SCLC). In molecular detection, the guidelines propose simultaneous detection of driver gene variations based on both RNA and DNA from specimens. The new edition also provides detailed descriptions of patient selection and surgical requirements for thoracic sub-lobectomy, aligned with the 9th TNM staging. Moreover, the guidelines expand treatment options, approving more therapies for immunoadjuvant and EGFR-TKI resistant lung cancer patients, as well as additional drug options for advanced non-small cell lung cancer (NSCLC) patients with EGFR mutations, EGFR 20 insertions, ALK fusions, and MET exon 14 skipping. These recommendations are based on state-approved drug applications, international guidelines, and current clinical practices in China, integrating the latest evidence-based medical research in screening, diagnosis, pathology, genetic testing, immune molecular marker detection, treatment methods, and follow-up care. The goal is to provide comprehensive and reasonable recommendations for clinicians, imaging specialists, laboratory technicians, rehabilitation professionals, and other medical staff at all levels.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141752978","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":"[Trends of stomach cancer incidence and mortality in Shandong province from 2012 to 2012 and predictions from 2023 to 2030].","authors":"F Jiang, Z T Fu, Z L Lu, J Chu, X H Xu, X L Guo, J X Ma","doi":"10.3760/cma.j.cn112152-20231227-00387","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20231227-00387","url":null,"abstract":"<p><p><b>Objective:</b> We aimed to analyse the trend of incidence and mortality of stomach cancer in Shandong province from 2012 to 2022 and predict the development trend from 2023 to 2030. <b>Methods:</b> Data on incidence and mortality of stomach cancer in Shandong province from 2012 to 2022 were obtained from Shandong Cancer Registry. The incidence, age-specific incidence, mortality and age-specific mortality in different years, sexes and urban and rural areas were calculated, the rates were standardized based on the age composition of the Chinese standard population in 2000. The average annual percent change (AAPC) of incidence and mortality was calculated using Joinpoint software. The Bayesian age-period-cohort model was used to predict the trend of stomach cancer incidence and mortality from 2023 to 2030. <b>Results:</b> From 2012 to 2022, the stomach cancer age-standardized incidence rate (ASIR) and age-standardized mortality rate (ASMR) showed a decreasing trend. The ASIR decreased from 27.47/100 000 in 2012 to 16.06/100 000 in 2022 (AAPC=-5.10%, <i>P</i>＜0.001), and the ASMR decreased from 17.69/100 000 to 11.09/100 000 (AAPC=-5.52%, <i>P</i>＜0.001). The ASIR and ASMR of male, female, urban and rural population also showed downward trends. The incidence and mortality rates of men were always higher than those of women, and the difference between urban and rural areas is gradually narrowing. In 2022, the ASIR (16.09/100 000 in urban and 16.03/100 000 in rural) and the ASMR (11.10/100 000 in urban and 11.08/100 000 in rural) of stomach cancer between urban and rural areas were nearly identical. The Bayesian age-period-cohort model predicted that the ASIR of stomach cancer in Shandong would further decrease from 2023 to 2030 (AAPC=-0.51%, <i>P</i>=0.001), but the change tended to be smooth. The incidences in male (AAPC=-1.46%, <i>P=</i>0.010) and rural areas (AAPC=-1.21%, <i>P</i>＜0.001) were still expected to have a little room for decline. The trend of incidences in female and urban areas were not statistically significant. The trend of mortality was consistent with the incidence. <b>Conclusions:</b> The stomach cancer incidence and mortality in Shandong shows a decreasing trend and it is expected to decrease further by 2030. However, the trend tends to be smooth, and the disease burden should be reduced as early as possible for high-risk population and high-risk factors of stomach cancer.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297762","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":"[Chinese expert consensus on the systemic treatment of advanced clear cell renal cell carcinoma (2024 edition)].","authors":"","doi":"10.3760/cma.j.cn112152-20240322-00117","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20240322-00117","url":null,"abstract":"<p><p>Renal cell carcinoma (RCC) accounts for approximately 2% to 3% of malignant tumors in adults, with a male-to-female ratio of approximately 1.5∶1 worldwide. It can occur in all age groups, with a peak incidence in the 60-70 age range, and the median age is approximately 64 years. The current causes of kidney cancer are still unclear, but smoking, obesity, hypertension, and some genetic factors are considered risk factors for kidney cancer development. Conducive to the gradual popularization of physical examination and screening, more and more patients with kidney cancer are being detected and treated in the early stages. However, nearly 30% of patients still have locally advanced or metastatic kidney cancer at the time of initial diagnosis. Traditional chemotherapy drugs are generally ineffective for advanced RCC, and currently, advanced RCC is mainly treated with anti-vascular and immunotherapy. At present, first-line treatment is mostly stratified based on clinical characteristics such as International mRCC Database Consortium (IMDC) prognosis risk, and there are multiple options available, including anti vascular therapy, anti-vascular combined immunotherapy, and dual immunotherapy. Subsequently, first-line treatment often selects drugs based on the composition, effectiveness, and safety of first-line treatment plans. In recent years, research has found that the molecular typing and metastasis characteristics of RCC also affect the prognosis of patients, leading to many controversies in the treatment of advanced RCC. This consensus is guided by the controversial clinical issues in the management of advanced RCC. After discussion and voting by multidisciplinary clinical experts, a consensus of 10 clinical issues has been reached. At the same time, experts recommend domestic clinical and research institutions to lead or participate in more large-scale clinical trials, providing more basis for clinical decision-making and the selection of the best beneficiaries.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297795","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":"[Expedited program and utilization for anticancer drug approval in China and the United States].","authors":"Q Zhu, H Y Huang, A Q Yu, X Y Meng, Y Leng, H Fang, Z W Li, Y Tang, J Li, N Li","doi":"10.3760/cma.j.cn112152-20231024-00250","DOIUrl":"https://doi.org/10.3760/cma.j.cn112152-20231024-00250","url":null,"abstract":"<p><p><b>Objective:</b> To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021. <b>Methods:</b> Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison. <b>Results:</b> Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, <i>P</i>=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, <i>P</i>=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, <i>P</i>=0.041) and breakthrough therapy (2.3% vs. 50.0%, <i>P</i>＜0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. <b>Conclusions:</b> Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.</p>","PeriodicalId":39868,"journal":{"name":"中华肿瘤杂志","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297759","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}