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2025年中国子宫颈癌诊疗现状白皮书
White paper on the current state of cervical cancer diagnosis and treatment in China in 2025
目的 了解中国子宫颈癌的临床诊疗现状,聚焦系统性治疗实践。通过调研临床医师在生物标志物检测应用、制定治疗方案的考量因素及选择偏好,明确当前临床未满足需求,为诊疗规范化提供依据与参考。方法 于2025年8月至9月,采用全国线上问卷与深度访谈相结合的抽样调查,纳入300名临床医师,其中30名专家参与深度访谈,270名完成线上问卷调研。调研内容涵盖子宫颈癌患者收治情况、临床分期及病理类型分布、生物标志物检测,局部晚期、复发或转移性子宫颈癌一线和二线及后线治疗策略,对免疫检查点抑制剂(ICI)和抗体偶联药物(ADC)的临床认知与应用观念。结果 回收有效问卷270份,30名专家访谈均有效。子宫颈癌患者确诊时,早期(ⅠA1~ⅠB2期、ⅡA1期)、局部晚期(ⅠB3期、ⅡA2~ⅣA期)、复发或转移性(ⅣB)子宫颈癌占比分别为32.2%、35.8%和31.9%。病理类型以鳞癌为主(74.9%)。医师推荐75.0%的患者进行程序性死亡配体1(PD-L1)等生物标志物检测,实际检测率为53.7%。局部晚期子宫颈癌以同步放化疗(CCRT)联合或不联合ICI为首选。复发或转移性子宫颈癌一线治疗以ICI联合化疗±抗血管生成药为首选(占比71%)。二线及后线治疗,以联合方案为主(约75%),其中,既往未接受ICI治疗的患者,首选化疗联合ICI,化疗联合ICI联合抗血管生成药比例分别为37%和34%。既往接受过ICI治疗的患者,其中化疗联合ICI、化疗联合抗血管生成药首选比例分别为30%和23%;含ADC联合方案占比约30%。结论 研究揭示了中国子宫颈癌诊疗现状、生物标志物检测推荐及临床应用的差距;明确了局部晚期、复发或转移性子宫颈癌一线、二线及后线治疗的核心考量因素和方案选择,为推动诊疗规范化提供了数据支撑。
Objective To investigate the current state of clinical diagnosis and treatment for cervical cancer in China,focusing on systemic therapeutic practices. By surveying clinicians on biomarker testing applications,treatment regimen considerations and preferences,this study is aimed to identify unmet clinical needs and provide a reference for standardization of diagnosis and treatment. Methods A nationwide sampling survey combining online questionnaires and in-depth interviews was conducted from August to September 2025,involving 300 clinicians (30 experts participated in interviews,270 completed questionnaires). The survey primarily covered the admission of cervical cancer patients,patient stage and pathology types,biomarker testing,treatment strategies for locally advanced,recurrent,or metastatic cervical cancer (including first-,second- or later-line settings). It also covered clinicians’ insights regarding immune checkpoint inhibitors (ICI) and antibody-drug conjugates (ADC). Results A total of 270 valid questionnaires and 30 valid expert interviews were obtained. At diagnosis,early-stage (ⅠA1-ⅠB2,ⅡA1),locally advanced (ⅠB3,ⅡA2-ⅣA),and recurrent/metastatic (ⅣB) cervical cancer (r/m CC) accounted for 32.2%,35.8%,and 31.9%,respectively. Squamous cell carcinoma was predominant (74.9%). Among the patients,75.0% were recommended for programmed death-ligand 1 (PD-L1) and other biomarker testing,with an actual testing rate of 53.7%. For locally advanced cervical cancer,concurrent chemoradiotherapy (CCRT) with or without ICIs was the first choice. For r/m CC,first-line treatment was mainly ICI combined with chemotherapy±anti-angiogenic agents (71%). For second- or later-line treatment,combination regimens predominated (approximately 75%). Among patients not previously treated with ICIs,chemotherapy combined with ICIs was the first choice,with chemotherapy combined with ICIs and chemotherapy combined with anti-angiogenic agents accounting for 37% and 34% of cases,respectively. For patients with prior ICI exposure,chemotherapy combined with ICIs and chemotherapy combined with anti-angiogenic agents were the first choices at 30% and 23%,respectively;regimens containing ADCs accounted for approximately 30%. Conclusions This study reveals the current status of cervical cancer diagnosis and treatment in China,highlighting gaps in biomarker testing recommendations and clinical application. It identifies core considerations and treatment options for locally advanced and r/m CC in first-line,providing data support for advancing standardized clinical practice.
子宫颈癌 / 治疗 / 免疫检查点抑制剂 / 抗体药物偶联物 / 白皮书
cervical cancer / diagnosis / treatment / immune checkpoint inhibitor / antibody-drug conjugate (ADC) / white paper
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In 2015, the second cycle of the CONCORD programme established global surveillance of cancer survival as a metric of the effectiveness of health systems and to inform global policy on cancer control. CONCORD-3 updates the worldwide surveillance of cancer survival to 2014.CONCORD-3 includes individual records for 37·5 million patients diagnosed with cancer during the 15-year period 2000-14. Data were provided by 322 population-based cancer registries in 71 countries and territories, 47 of which provided data with 100% population coverage. The study includes 18 cancers or groups of cancers: oesophagus, stomach, colon, rectum, liver, pancreas, lung, breast (women), cervix, ovary, prostate, and melanoma of the skin in adults, and brain tumours, leukaemias, and lymphomas in both adults and children. Standardised quality control procedures were applied; errors were rectified by the registry concerned. We estimated 5-year net survival. Estimates were age-standardised with the International Cancer Survival Standard weights.For most cancers, 5-year net survival remains among the highest in the world in the USA and Canada, in Australia and New Zealand, and in Finland, Iceland, Norway, and Sweden. For many cancers, Denmark is closing the survival gap with the other Nordic countries. Survival trends are generally increasing, even for some of the more lethal cancers: in some countries, survival has increased by up to 5% for cancers of the liver, pancreas, and lung. For women diagnosed during 2010-14, 5-year survival for breast cancer is now 89·5% in Australia and 90·2% in the USA, but international differences remain very wide, with levels as low as 66·1% in India. For gastrointestinal cancers, the highest levels of 5-year survival are seen in southeast Asia: in South Korea for cancers of the stomach (68·9%), colon (71·8%), and rectum (71·1%); in Japan for oesophageal cancer (36·0%); and in Taiwan for liver cancer (27·9%). By contrast, in the same world region, survival is generally lower than elsewhere for melanoma of the skin (59·9% in South Korea, 52·1% in Taiwan, and 49·6% in China), and for both lymphoid malignancies (52·5%, 50·5%, and 38·3%) and myeloid malignancies (45·9%, 33·4%, and 24·8%). For children diagnosed during 2010-14, 5-year survival for acute lymphoblastic leukaemia ranged from 49·8% in Ecuador to 95·2% in Finland. 5-year survival from brain tumours in children is higher than for adults but the global range is very wide (from 28·9% in Brazil to nearly 80% in Sweden and Denmark).The CONCORD programme enables timely comparisons of the overall effectiveness of health systems in providing care for 18 cancers that collectively represent 75% of all cancers diagnosed worldwide every year. It contributes to the evidence base for global policy on cancer control. Since 2017, the Organisation for Economic Co-operation and Development has used findings from the CONCORD programme as the official benchmark of cancer survival, among their indicators of the quality of health care in 48 countries worldwide. Governments must recognise population-based cancer registries as key policy tools that can be used to evaluate both the impact of cancer prevention strategies and the effectiveness of health systems for all patients diagnosed with cancer.American Cancer Society; Centers for Disease Control and Prevention; Swiss Re; Swiss Cancer Research foundation; Swiss Cancer League; Institut National du Cancer; La Ligue Contre le Cancer; Rossy Family Foundation; US National Cancer Institute; and the Susan G Komen Foundation.Copyright © 2018 Elsevier Ltd. All rights reserved.
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中国抗癌协会宫颈癌专业委员会. 局部晚期子宫颈癌治疗指南(2025年版)[J]. 中国实用妇科与产科杂志, 2025, 41(2):186-193. DOI:10.19538/j.fk2025020111.
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蒋芳, 向阳. 帕博利珠单抗或安慰剂联合放化疗序贯帕博利珠单抗或安慰剂治疗新诊断的高危局部晚期子宫颈癌(KEYNOTE-A18):一项随机、双盲、Ⅲ期临床试验[J]. 中国实用妇科与产科杂志, 2024, 40(8):859-864.DOI:10.19538/j.fk2024080118.
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Locally advanced cervical cancer is treated with chemoradiotherapy (standard of care), but many patients still relapse and die from metastatic disease. We investigated chemoradiotherapy with or without induction chemotherapy to determine whether induction chemotherapy improves both progression-free survival and overall survival.The INTERLACE trial was a multicentre, randomised phase 3 trial done at 32 medical centres in Brazil, India, Italy, Mexico, and the UK. Adults (aged ≥18 years) with locally advanced cervical cancer (FIGO 2008 stage IB1 disease with nodal involvement, or stage IB2, IIA, IIB, IIIB, or IVA disease) were randomly assigned (1:1), by minimisation, using a central electronic system, to standard cisplatin-based chemoradiotherapy (once-a-week intravenous cisplatin 40 mg/m for 5 weeks with 45·0-50·4 Gy external beam radiotherapy delivered in 20-28 fractions plus brachytherapy to achieve a minimum total 2 Gy equivalent dose of 78-86 Gy) alone or induction chemotherapy (once-a-week intravenous carboplatin area under the receiver operator curve 2 and paclitaxel 80 mg/m for 6 weeks) followed by standard cisplatin-based chemoradiotherapy. Stratification factors were recruiting site, stage, nodal status, three-dimensional conformal radiotherapy or intensity modulated radiotherapy, age, tumour size, and histology (squamous vs non-squamous). Primary endpoints were progression-free survival and overall survival within the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01566240, and EUDRACT, 2011-001300-35.Between Nov 8, 2012, and Nov 17, 2022, 500 eligible patients were enrolled and randomly assigned to the chemoradiotherapy alone group (n=250) or the induction chemotherapy with chemoradiotherapy group. Of 500 patients, 354 (70%) had stage IIB disease and 56 (11%) stage IIIB disease. Pelvic lymph nodes were positive in 215 (43%) patients. 230 (92%) patients who received induction chemotherapy had at least five cycles. Median interval between induction chemotherapy and chemoradiotherapy was 7 days. Four or more cycles of cisplatin were given to 212 (85%) participants in the induction chemotherapy with chemoradiotherapy group and to 224 (90%) of participants in the chemoradiotherapy alone group. 462 (92%) participants received external beam radiotherapy and brachytherapy with a median overall treatment time of 45 days. After a median follow-up of 67 months, 5-year progression-free survival rates were 72% in the induction chemotherapy with chemoradiotherapy group and 64% in the chemoradiotherapy alone group with a hazard ratio (HR) of 0·65 (95% CI 0·46-0·91, p=0·013). 5-year overall survival rates were 80% in the induction chemotherapy with chemoradiotherapy group and 72% in the chemoradiotherapy alone group, with an HR of 0·60 (95% CI 0·40-0·91, p=0·015). Grade 3 or greater adverse events were reported in 147 (59%) of 250 individuals in the induction chemotherapy with chemoradiotherapy group versus 120 (48%) of 250 individuals in the chemoradiotherapy alone group.Short-course induction chemotherapy followed by chemoradiotherapy significantly improves survival of patients with locally advanced cervical cancer.Cancer Research UK and University College London-University College London Hospitals Biomedical Research Centre.Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
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The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10-GEICO 68-C-JGOG1084-GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone.In this investigator-initiated, randomised, open-label, phase 3 trial, patients from 92 sites in Europe, Japan, and the USA with metastatic (stage IVB), persistent, or recurrent cervical cancer that was measurable, previously untreated, and not amenable to curative surgery or radiation were randomly assigned 1:1 to receive standard therapy (cisplatin 50 mg/m or carboplatin area under the curve of 5, paclitaxel 175 mg/m, and bevacizumab 15 mg/kg, all on day 1 of every 3-week cycle) with or without atezolizumab 1200 mg. Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal, or death. Stratification factors were previous concomitant chemoradiation (yes vs no), histology (squamous cell carcinoma vs adenocarcinoma including adenosquamous carcinoma), and platinum backbone (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours version 1.1 and overall survival analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03556839, and is ongoing.Between Oct 8, 2018, and Aug 20, 2021, 410 of 519 patients assessed for eligibility were enrolled. Median progression-free survival was 13·7 months (95% CI 12·3-16·6) with atezolizumab and 10·4 months (9·7-11·7) with standard therapy (hazard ratio [HR]=0·62 [95% CI 0·49-0·78]; p<0·0001); at the interim overall survival analysis, median overall survival was 32·1 months (95% CI 25·3-36·8) versus 22·8 months (20·3-28·0), respectively (HR 0·68 [95% CI 0·52-0·88]; p=0·0046). Grade 3 or worse adverse events occurred in 79% of patients in the experimental group and in 75% of patients in the standard group. Grade 1-2 diarrhoea, arthralgia, pyrexia, and rash were increased with atezolizumab.Adding atezolizumab to a standard bevacizumab plus platinum regimen for metastatic, persistent, or recurrent cervical cancer significantly improves progression-free and overall survival and should be considered as a new first-line therapy option.F Hoffmann-La Roche.Copyright © 2024 Elsevier Ltd. All rights reserved.
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利益冲突 所有参与本研究的人员均声明不存在利益冲突
北京整合医学学会发起并为研究的顺利开展提供关键支持与保障
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