英国伦敦大学学院Usha Menon团队研究了卵巢癌人群定期筛查和长期随访后的死亡率。2021年5月12日，该研究发表在《柳叶刀》杂志上。
卵巢癌的预后仍然很差，大多数女性被诊断出时已经晚期。研究组进行了英国卵巢癌筛查合作试验，以确定人群筛查是否可以减少因疾病导致的死亡，并报告了该试验长期随访后的卵巢癌死亡率。
在这项随机对照试验中，研究组从英格兰、威尔士和北爱尔兰国家卫生服务信托基金的13个中心招募50-74岁的绝经后妇女。排除双侧卵巢切除，既往卵巢或活动性非卵巢恶性肿瘤，或家族性卵巢癌风险增加的患者。
将参与者按1：1：2随机分配，分别接受年度多模式筛查（MMS）、年度经阴道超声筛查（USS）或不筛查。主要结局是到2020年6月30日因卵巢癌或输卵管癌死亡（WHO 2014标准）。
2001年4月17日至2005年9月29日，研究组共招募了202638名参与者，将其随机分配，最终202562名纳入分析：MMS组50625名，USS组50623名，以及无筛查组101314名。
中位随访16.33年后，共有2055名女性被诊断为输卵管癌或卵巢癌，其中：MMS组中有522名（1.0%），USS组中有517名（1.0%），无筛查组中有1016名（1.0%）。与未筛查组相比，MMS组中I期疾病增加了47.2%，IV期疾病减少了24.5%。
总的来说，与未筛查组相比，MMS组中I、II期发病率增加了39.2%，而III、IV期发病率降低了10.2%。共有1206名女性死于该疾病：MMS组中有296例（0.6%） ，USS组中有291例（0.6%），无筛查组中有619例（0.6%）。与未筛查组相比，MMS或USS组未观察到卵巢癌和输卵管癌死亡的显著减少。
研究结果表明，MMS组III期或IV期疾病发病率的降低不足以转化为挽救生命，鉴于筛查并未显著降低卵巢癌和输卵管癌的死亡率，因此不建议进行一般人群筛查。
附：英文原文
Title: Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial
Author: Usha Menon, Aleksandra Gentry-Maharaj, Matthew Burnell, Naveena Singh, Andy Ryan, Chloe Karpinskyj, Giulia Carlino, Julie Taylor, Susan K Massingham, Maria Raikou, Jatinderpal K Kalsi, Robert Woolas, Ranjit Manchanda, Rupali Arora, Laura Casey, Anne Dawnay, Stephen Dobbs, Simon Leeson, Tim Mould, Mourad W Seif, Aarti Sharma, Karin Williamson, Yiling Liu, Lesley Fallowfield, Alistair J McGuire, Stuart Campbell, Steven J Skates, Ian J Jacobs, Mahesh Parmar
Issue&Volume: 2021-05-12
Abstract:
Background
Ovarian cancer continues to have a poor prognosis with the majority of women diagnosed with advanced disease. Therefore, we undertook the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) to determine if population screening can reduce deaths due to the disease. We report on ovarian cancer mortality after long-term follow-up in UKCTOCS.
Methods
In this randomised controlled trial, postmenopausal women aged 50–74 years were recruited from 13 centres in National Health Service trusts in England, Wales, and Northern Ireland. Exclusion criteria were bilateral oophorectomy, previous ovarian or active non-ovarian malignancy, or increased familial ovarian cancer risk. The trial management system confirmed eligibility and randomly allocated participants in blocks of 32 using computer generated random numbers to annual multimodal screening (MMS), annual transvaginal ultrasound screening (USS), or no screening, in a 1:1:2 ratio. Follow-up was through national registries. The primary outcome was death due to ovarian or tubal cancer (WHO 2014 criteria) by June 30, 2020. Analyses were by intention to screen, comparing MMS and USS separately with no screening using the versatile test. Investigators and participants were aware of screening type, whereas the outcomes review committee were masked to randomisation group. This study is registered with ISRCTN, 22488978, and ClinicalTrials.gov, NCT00058032.
Findings
Between April 17, 2001, and Sept 29, 2005, of 1243282 women invited, 202638 were recruited and randomly assigned, and 202562 were included in the analysis: 50625 (25·0%) in the MMS group, 50623 (25·0%) in the USS group, and 101314 (50·0%) in the no screening group. At a median follow-up of 16·3 years (IQR 15·1–17·3), 2055 women were diagnosed with tubal or ovarian cancer: 522 (1·0%) of 50625 in the MMS group, 517 (1·0%) of 50623 in the USS group, and 1016 (1·0%) of 101314 in the no screening group. Compared with no screening, there was a 47·2% (95% CI 19·7 to 81·1) increase in stage I and 24·5% (41·8 to –2·0) decrease in stage IV disease incidence in the MMS group. Overall the incidence of stage I or II disease was 39·2% (95% CI 16·1 to 66·9) higher in the MMS group than in the no screening group, whereas the incidence of stage III or IV disease was 10·2% (21·3 to 2·4) lower. 1206 women died of the disease: 296 (0·6%) of 50625 in the MMS group, 291 (0·6%) of 50623 in the USS group, and 619 (0·6%) of 101314 in the no screening group. No significant reduction in ovarian and tubal cancer deaths was observed in the MMS (p=0·58) or USS (p=0·36) groups compared with the no screening group.
Interpretation
The reduction in stage III or IV disease incidence in the MMS group was not sufficient to translate into lives saved, illustrating the importance of specifying cancer mortality as the primary outcome in screening trials. Given that screening did not significantly reduce ovarian and tubal cancer deaths, general population screening cannot be recommended.
DOI: 10.1016/S0140-6736(21)00731-5
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00731-5/fulltext
LANCET：《柳叶刀》，创刊于1823年。隶属于爱思唯尔出版社，最新IF：202.731
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