1.Expert consensus on whole-course management of prostate cancer (2025 edition).
Chinese Journal of Oncology 2025;47(7):617-634
Prostate cancer represents a prevalent malignancy within the male genitourinary system. In recent years, its incidence in China has gradually increased, becoming a significant public health issue. While early detection correlates strongly with improved prognosis, the majority of newly diagnosed prostate cancer patients in China are already in intermediate or advanced stages, precluding curative-intent interventions and contributing to marked survival disparities. The progression of prostate cancer is lengthy, typically encompassing diagnosis, treatment, progression, metastasis, and death, accompanied by a decline in quality of life. Personalized treatment plans should be developed based on the disease stage and patient preferences. In non-metastatic prostate cancer, where the tumor is confined to the prostate, surgery and radiotherapy are the primary treatments, supplemented by neoadjuvant and adjuvant therapies to delay metastasis. For metastatic prostate cancer, systemic therapy is prioritized to prolong survival. In metastatic hormone-sensitive prostate cancer, controlling androgen levels is crucial, while treatment options for metastatic castration resistant prostate cancer are relatively limited, necessitating individualized and precise treatment. During prostate cancer management, prostate-specific antigen levels are closely linked to prognosis and require monitoring. Bone metastasis, the most common site in prostate cancer patients, often triggers skeletal-related events, demanding effective prevention and management. Treatment-related adverse reactions are also a clinical challenge, requiring balanced risk-benefit assessments and judicious drug selection to preserve quality of life. Rapid advancements in screening technologies, surgical innovations, drug development, and China-specific epidemiological factors further complicate decision-making in holistic prostate cancer management. To optimize the standardization of prostate cancer diagnosis and treatment in China, the Genitourinary Oncology Committee of Chinese Anti-cancer Association synthesized global guidelines, clinical evidence and clinical expertise, and addressed critical challenges in the whole-course management of prostate cancer to formulate a multidisciplinary consensus. The expert consensus on whole-course management of prostate cancer (2025 edition) establishes standardized protocols to guide clinical practice, improve treatment outcomes, and enhance patient quality of life.
Humans
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Male
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Prostatic Neoplasms/diagnosis*
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Consensus
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Prostate-Specific Antigen/blood*
;
Quality of Life
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Prostatic Neoplasms, Castration-Resistant/pathology*
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China
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Bone Neoplasms/secondary*
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Androgen Antagonists/therapeutic use*
2.Expert consensus on the diagnosis and treatment of advanced non-small cell lung cancer with EGFR PACC mutations (2025 edition).
Chinese Journal of Oncology 2025;47(9):811-829
Lung cancer is the malignancy with the highest incidence and mortality burden globally, ranking first in both morbidity and mortality among all types of malignant tumors. Pathologically, lung cancer is classified into non-small cell lung cancer (NSCLC) and small cell lung cancer, with NSCLC accounting for approximately 85% of cases. Due to the often subtle or nonspecific clinical manifestations in early-stage disease, many patients are diagnosed at a locally advanced or metastatic stage, where treatment options are limited and prognosis remains poor. Therefore, molecular targeted therapy focusing on driver genes has become a key strategy to improve the survival outcomes of patients with advanced NSCLC. The epidermal growth factor receptor (EGFR) is one of the most common driver genes in NSCLC. While EGFR mutations occur in approximately 12% of advanced NSCLC patients globally, the incidence rises to 55.9% in Chinese patients. Among EGFR mutations, P-loop and αC-helix compressing (PACC) mutations account for about 12.5%. Currently, EGFR tyrosine kinase inhibitors (TKIs) have become the first-line standard treatment for advanced NSCLC patients with classical EGFR mutations, with efficacy well-established through clinical studies and real-world evidence. However, with rapid advancements in NSCLC precision medicine and deeper exploration of the EGFR mutation spectrum, EGFR PACC mutations have emerged as a key clinical focus. The structural characteristics of these mutations lead to significant variability in responses to EGFR TKIs, leaving therapeutic options still limited, while detection challenges persist due to the sensitivity constraints of current testing technologies, driving increasing demand for improved diagnostic and treatment approaches. The current clinical evidence primarily stems from retrospective analyses and small-scale exploratory studies, while prospective, large-scale, high-level evidence-based medical research specifically targeting this mutation subtype remains notably insufficient. This evidence gap has consequently led to the absence of standardized guidelines or expert consensus regarding optimal treatment strategies for advanced NSCLC with EGFR PACC mutations. As a clinical consensus specifically addressing EGFR PACC-mutant NSCLC, this document provides a comprehensive framework encompassing the clinical rationale for EGFR PACC mutation testing, therapeutic strategies for advanced-stage disease, management of treatment-related adverse events, and follow-up protocols. The consensus underscores the pivotal role of EGFR PACC mutation detection in precision medicine implementation while offering evidence-based recommendations to guide personalized therapeutic decision-making. By establishing clear clinical pathways encompassing molecular testing, therapeutic intervention, and long-term monitoring for EGFR PACC-mutant NSCLC, this consensus aims to meaningfully improve patient survival outcomes while serving as a robust, evidence-based foundation for developing personalized clinical management approaches.
Humans
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Carcinoma, Non-Small-Cell Lung/pathology*
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ErbB Receptors/antagonists & inhibitors*
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Mutation
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Lung Neoplasms/pathology*
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Protein Kinase Inhibitors/therapeutic use*
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Molecular Targeted Therapy
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Consensus
3.Expert consensus on diagnosis and treatment of advanced non-small cell lung cancer with HER-2 alterations (2025 edition).
Chinese Journal of Oncology 2025;47(9):830-839
Mutations in the human epidermal growth factor receptor 2 (HER-2) gene are recognized as significant but relatively rare driver alterations in non-small cell lung cancer (NSCLC). These mutations predominantly manifest as gene mutation, amplification, and protein overexpression, with an estimated prevalence from 2.8% to 15.4% among NSCLC patients in China. Research indicates that HER-2 mutations, particularly exon 20 insertions (ex20ins), are strongly correlated with aggressive tumor biology, poor prognosis, and limited responsiveness to immunotherapy, thereby exhibiting characteristics of "cold tumors". Overexpression and amplification of HER-2 are also indicative of a heightened risk of chemotherapy resistance and unfavorable survival outcomes, suggesting a distinct molecular subtype with unique biological behaviors. In recent years, novel antibody-drug conjugates (ADCs), particularly trastuzumab deruxtecan (T-DXd), have demonstrated groundbreaking efficacy in HER-2-mutant advanced NSCLC patients. These ADCs have shown significant clinical benefits, including high objective response rates and progression-free survival advantages, making T-DXd the first targeted therapy approved for this patient population globally. Additionally, ADCs have exhibited therapeutic potential in patients with HER-2 overexpression, thus broadening the scope of their indications. To standardize the clinical diagnosis and treatment of HER-2 variant NSCLC, the Chinese Anti-cancer Association convened multidisciplinary experts from oncology, pulmonology, thoracic surgery, pathology, and molecular diagnostics to develop this consensus based on the latest evidences from both domestic and international studies, coupled with China's clinical practice experience. This consensus focuses on the molecular characteristics, clinical significance, diagnostic strategies, treatment options, and safety management of HER-2 alterations, addressing ten critical clinical questions in a systematic manner. It is recommended that HER-2 status be routinely tested at initial diagnosis, disease progression, or recurrence in NSCLC. Mutation detection should prioritize next-generation sequencing (NGS), while protein overexpression may be assessed using immunohistochemistry (IHC) standards for gastric cancer. Fluorescence in situ hybridization (FISH) is recommended for detecting HER-2 amplification. Regarding treatment, for HER-2-mutant patients, first-line therapy may involve chemotherapy with or without immune checkpoint inhibitors (ICIs), similar to treatment approaches for driver-gene negative populations. Upon failure of first-line treatment, trastuzumab deruxtecan, may be considered as alternative therapeutic options. For patients with HER-2 overexpression, ADCs should be considered after failure of standard systemic therapy. However, the management of HER-2 amplification remains insufficiently supported by evidence, necessitating a cautious, individualized approach. The consensus also includes detailed recommendations for screening and managing adverse effects associated with ADCs, such as interstitial lung disease (ILD), emphasizing the crucial role of safety management in ensuring treatment efficacy. The publication of this consensus aims to drive the standardization of molecular diagnosis and treatment pathways for HER-2 variant NSCLC, improve clinical outcomes and quality of life for patients, and facilitate the implementation of personalized precision treatment strategies.
Humans
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Carcinoma, Non-Small-Cell Lung/pathology*
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Lung Neoplasms/pathology*
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Receptor, ErbB-2/metabolism*
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Mutation
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Immunoconjugates/therapeutic use*
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Consensus
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Trastuzumab/therapeutic use*
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Camptothecin/analogs & derivatives*
4.A retrospective study of BRAF inhibitors and EGFR inhibitors combined with immune checkpoint inhibitors in patients with microsatellite stable, BRAF V600E mutated metastatic colorectal cancer
Zhi JI ; Jinguo MA ; Xia WANG ; Jiaqi XIN ; Lijun MA ; Yixuan WANG ; Nan ZHANG ; Chunyan ZENG ; Rui LIU
Chinese Journal of Oncology 2025;47(9):922-928
Objective:To explore the efficacy and safety of B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitor and epidermal growth factor receptor (EGFR) inhibitor combined with immune checkpoint inhibitor in microsatellite stable (MSS) BRAF V600E metastatic colorectal cancer (mCRC) patients.Methods:The data and outcomes of mCRC patients with MSS BRAF V600E who received BRAF inhibitor, EGFR inhibitor combined with immune checkpoint inhibitor in Tianjin Medical University Cancer Hospital from May 2022 to April 2024 were retrospectively collected.Results:A total of 12 mCRC patients were included in this study, the objective response rate was 50.0%, the disease control rate was 66.7%, and the median disease control time of patients who achieved objective response was 8.0 months. The median progression-free survival was 6.8 months and the median overall survival was 8.4 months. Overall adverse reactions were controllable, the most common treatment-related adverse events were fatigue (8 cases), fever (5 cases), and rash (4 cases). There were no grade 4 adverse event, serious adverse event, and treatment-related death.Conclusion:BRAF inhibitor and EGFR inhibitor combined with immune checkpoint inhibitor show good efficacy and controllable safety in BRAF V600E mCRC patients.
5.Interpretation of the Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2025 edition)
Bo ZHANG ; Runbo ZHONG ; Hua ZHONG
Chinese Journal of Oncology 2025;47(10):981-986
The "Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2025 edition)" was collaboratively completed under the leadership of Professor Han Baohui from the Department of Pulmonary and Critical Care Medicine at Shanghai Chest Hospital and Professor Wang Jie from the Department of Medical Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences & Peking Union Medical College. The guideline involved the cooperation of more than 50 lung cancer diagnosis and treatment institutions and over 100 experts across China. Since the completion of the first edition in 2018, the guideline is typically revised annually to promptly incorporate the latest advancements in the field of lung cancer. The most distinctive feature of these guidelines is that they exclusively reference the indications approved by the National Medical Products Administration of China. At the same time, particular emphasis is placed on integrating clinical research data from Chinese scholars based on Chinese patients, thereby enhancing the guidelines' authority, applicability, and drug accessibility. The "Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2025 edition)" was officially published in September 2025. To better introduce the key points of the guidelines to peers, this interpretation has been prepared.
6.The role of principles of surgical oncology in the development of minimally invasive surgery for head and neck cancers
Shuxin WEN ; Kaixue WEN ; Yuhao ZHANG ; Rui WANG ; Chen WANG
Chinese Journal of Oncology 2025;47(10):987-990
The classic principles of oncological surgery were accepted based the procedures from radical surgery for breast cancer described by Halsted in 1894, which can be summarized as tumor en bolc resection, clean surgical margin, regional lymph nodes dissection, and tumor-free technique. The classic principles of oncological surgery are the cornerstone of cancer surgical treatment and have significantly promoted the development of oncological surgery. The minimally invasive surgery is the trend of contemporary oncological surgery for the characteristics of minimal invasion, better tissue identification, precise manipulation, and fast postoperative recovery. Head and neck cancers are usually related to the upper aerodigestive tract, as well as important nerves and blood vessels in head and neck. The anatomical structures of the relative organs are intricate and delicate, and their functions are crucial. Therefore, there is an urgent need for minimally invasive surgical techniques. However, the head and neck cancers which are larger or located in some special sites such as the skull base have to be removed by piecemeal resection in minimally invasive surgery. The piecemeal resection of tumor increases the risks of tumor positive surgical margins and tumor implantation metastasis. The goal of radical surgery for cancers is to completely remove the tumor and obtain a really clean surgical margin. If head and neck cancer is indication for radical surgery, appropriate operative manipulation (en bloc or piecemeal resection) is able to achieve the goal of radical surgery. Giving attention to both the advantages of the principles of oncological surgery and minimally invasive surgical techniques benefits more patients with head and neck cancers from better survival rate and minor invasive morbidities.
7.Design principles and statistical considerations in oncological non-inferiority clinical trials
Yamei LIU ; Tao CHEN ; Yang WANG ; Chao LI
Chinese Journal of Oncology 2025;47(10):991-1000
Non-inferiority clinical trials are a research paradigm that employs randomized controlled methods to evaluate whether the treatment effect of the experimental group is not inferior to that of the active control group within a predefined acceptable margin. This article systematically summarizes the applicable conditions, key design elements, and statistical analysis methods for non-inferiority trials. By integrating representative case studies in the field of oncology, it elucidates the unique value of non-inferiority designs in balancing benefits and risks and in optimizing therapeutic decisions. Through reviewing theoretical frameworks and addressing common misconceptions in methodological practices, this study aims to provide clear guidance for the standardized design and scientific interpretation of non-inferiority trials, thereby promoting their high-quality application in clinical research.
8.A comparative study of radial ultrasound combined with cryobiopsy and forceps biopsy under thin-layer CT navigation in the diagnosis of malignant peripheral lung lesions
Ting GAO ; Xiaopeng HE ; Peiwen ZHAO ; Juanzhi LI ; Shuli YUAN ; Lei ZHANG
Chinese Journal of Oncology 2025;47(10):1001-1008
Objective:Comparative study on the application value of bronchial ultrasound combined with different biopsy methods under thin-layer CT navigation in the diagnosis of malignant peripheral lung lesions.Methods:A retrospective analysis of patients with suspected malignant peripheral lung lesions identified by chest CT from January 2019 to September 2024 at the Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College, and Xianyang Central Hospital, who underwent routine bronchoscopy with negative results (209 cases). These patients were diagnosed using bronchial ultrasound under thin-layer CT navigation. The cases were divided into a cryobiopsy group (127 cases) and a conventional forceps biopsy group based on the biopsy method (82 cases). The diagnostic rates of the two groups were statistically analyzed, along with factors influencing the diagnostic rates. The tissue size obtained from both groups was compared, and the occurrence of complications was summarized.Results:This study included 209 cases with 216 peripheral lung lesions. A total of 209 cases with 210 lesions were successfully located through thin-slice CT guidance, resulting in a guiding success rate of 97.2% (210/216). Among the 130 lesions in the cryobiopsy group, 78 lesions were diagnosed as lung malignancies, with a diagnostic rate of 82.1% (64/78) for cryobiopsy in lung malignant lesions. In the forceps biopsy group, 46 of the 86 lesions were diagnosed as lung malignancies, with a diagnostic rate of 87.0% (40/46) for forceps biopsy in lung malignant lesions. There was no statistically significant difference between the two diagnostic rates ( P=0.473). The average longest diameter of tissue obtained by cryobiopsy was (6.11±0.23) mm, while the average longest diameter of tissue obtained by forceps biopsy was (1.58±0.43) mm. There was a statistically significant difference in tissue longest diameter between the two groups ( P<0.001). When the distance from the bronchoscopic tip to the lesion was ≥3 cm and the most distal bronchus visible under bronchoscopy was ≤5th generation, the diagnostic rate of forceps biopsy was higher [83.3%(25/30) and 94.1%(32/34)] than that of cryobiopsy [79.3%(23/29) and 78.0%(46/59)], and the difference was statistically significant ( P<0.05). Regarding complications, one case (1.3%, 1/78) of clinically significant complications occurred in the cryobiopsy group, while no complications occurred in the forceps biopsy group. Conclusions:Under thin-layer CT navigation, bronchial ultrasound combined with different biopsy methods demonstrates a high diagnostic rate for malignant peripheral lung lesions and is safe to operate. Cryobiopsy allows for the collection of larger tissue specimens.
9.Clinical analysis of 33 cases of primary pulmonary NUT carcinoma
Lili JIANG ; Yue CHEN ; San'en LI ; Lingchuan GUO
Chinese Journal of Oncology 2025;47(10):1009-1017
Objectives:Cases from our hospital and a systematic review were performed in this paper to get a better understanding on the diagnosis and therapies for primary pulmonary NUT carcinoma (PPNC) patients.Methods:The clinical features, pathological diagnosis, treatment and outcomes of PPNC patients from 2020—2025, including four cases from the First Affiliated Hospital of Soochow University, were collected delicately. The Kaplan-Meier method and Cox proportional hazard regression model were used to calculate cumulative survival and prognostic factors.Results:The male-to-female ratio of PPNC was 18∶15, the left to right ratio was 14∶19, the median age was 36 years old and the median tumor diameter was 6.1 cm. Most patients were already at an advanced stage with the clinical features-cough (16/33) and chest or back pain (13/33) when they first came to the hospital. The tumor cells were arranged in nest pattern with small-medium size, round to oval shape, and nuclei were deeply stained. The high positive staining of NUT (32/32) and CK-pan (16/19) was observed, NUTM1 gene translocation in 24 cases was detected by fluorescence in situ hybridization (FISH), and different gene rearrangements were located by NGS- NUTM1- BRD4 (8/12), NUTM1- BRD3 (2/12), NUTM1- BRD2 (1/12) and NUTM1- ZNF532 (1/12). Most patients accepted different chemotherapy regimens (25/29), including paclitaxel albumin and platinum (13/25), etoposide and platinum (8/25). Meanwhile, 12 cases were treated with PD-1/PD-L1 antibody during the therapy. The median follow-up time was 7 months in 28 cases tracked from 2-90 months. Univariate Cox regression analysis showed that metastasis of this disease affected patient prognosis ( HR=2.55, 95% CI: 0.974-6.677, P=0.057) and the cumulative survival rate was lower in the older ones. Conclusions:PPNC, more often found in middle-aged patients, no difference in sex, can be diagnosed by pathmorphology and immunophenotype, while NUTM1 molecular test is highly suggested for the accurate therapy. Metastasis can be recognized as the prognostic risk factor. Early detection of the cancer improves the chances of successful treatment, especially in patients with older age.
10.Analysis of factors affecting long-term survival in patients with anaplastic thyroid carcinoma and the efficacy of immunotherapy
Jian BU ; Kang NING ; Yongchao YU ; Zan JIAO ; Tong WU ; Zhongyuan YANG ; Weichao CHEN ; Ankui YANG
Chinese Journal of Oncology 2025;47(8):756-762
Objective:To explore the long-term survival outcomes of patients with anaplastic thyroid cancer (ATC) and analyze key factors influencing the prognosis.Methods:A retrospective analysis was conducted on the clinical and follow-up data of 77 ATC patients treated at the Sun Yat-sen University Cancer Center from March 2000 to July 2022, with tumor-specific survival as the primary endpoint. The Kaplan-Meier method was used to plot the survival curves, and univariate and multivariate Cox regression analyses were performed to identify the prognostic factors.Results:Among the 77 patients, 64 underwent surgical treatment, with 33 receiving surgery alone, 8 undergoing surgery combined with chemotherapy, 13 undergoing surgery with radiotherapy, 1 undergoing surgery with chemotherapy and radiotherapy, 2 receiving surgery combined with chemotherapy and targeted therapy, 3 receiving surgery with targeted therapy, and 4 receiving surgery with immunotherapy and targeted therapy. Among the 13 patients who did not undergo surgery, 2 received chemotherapy alone, 3 received targeted therapy alone, 1 received immunotherapy alone, 1 received chemoradiotherapy, 5 received chemotherapy combined with immunotherapy, and 1 received immunotherapy combined with targeted therapy. The median follow-up time was 8.4 months, with 58 patients (75.3%) died, and the median survival time was 6.63 months. Univariate Cox regression analysis showed that C-reactive protein, monocyte count, lymphocyte count, abnormal albumin levels, the maximum diameter of the primary tumor, BMI, and whether immunotherapy was administered were significantly associated with survival in ATC patients (all P<0.05). Multivariate Cox regression analysis indicated that immunotherapy was an independent factor for survival in ATC patients ( HR=0.18, 95% CI: 0.05-0.62, P=0.007). Among the 40 patients admitted after 2015, the 11 patients who received immunotherapy had a median survival time of 17.2 months, which was superior to the 29 patients who did not receive this treatment (median survival time 6.2 months, P=0.03). Conclusions:ATC patients receiving immunotherapy had a better prognosis and longer survival. Additionally, elevated C-reactive protein, abnormal albumin, monocyte count, lymphocyte count, and BMI might be associated with poorer prognosis in ATC. Tailoring treatment based on the individual characteristics of ATC patients may be beneficial for their long-term survival.

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