Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)
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DOI：
10.1016/s1470-2045(09)70026-9
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发表时间：
2009-04-01
期刊：
影响因子：
51.1
通讯作者：
Jacobs, Ian
中科院分区：
文献类型：
--
作者：
Menon, Usha;Gentry-Maharaj, Aleksandra;Jacobs, Ian
背景卵巢癌有很高的病死率，大多数妇女直到疾病晚期才被诊断出来。英国卵巢癌筛查合作试验（UKCTOCS）是一项随机对照试验，旨在评估筛查对死亡率的影响。方法2001年至2005年，共202638例年龄在50-74岁的绝经后妇女被随机分配到无治疗组，对照组（n=101359）;年度CA 125筛查（使用卵巢癌风险算法解释），经阴道超声扫描作为二线检查（多模式筛查[MMS]; n=50640）;或使用计算机生成的随机数算法以2：11的比例单独进行经阴道超声（USS; n=50639）的年度筛查。所有妇女在招募时都提供了血液样本。被随机分配到MMS组的妇女接受了CA 125的血液检测，而被随机分配到US S组的妇女则被预约接受经阴道扫描。筛查异常的妇女进行了重复检查。重复筛查中持续异常的女性接受临床评价，并在适当时进行手术。该试验注册为ISRCTN 22488978，登录ClinicalTrials.gov，编号NCT 00058032。结果在患病率筛查中，50 078名（98.9%）妇女接受了MMS，48 230名（95.2%）妇女接受了USS。退出的主要原因是死亡（2个MMS，28 USS），非卵巢癌或其他疾病（无MMS，66 USS），切除卵巢（5个MMS，29 USS），搬迁（无MMS，39 USS），未能参加三次筛查预约（72 MMS，757 USS）和参与者改变主意（483 MMS，1490 USS）。总体而言，MMS组50078名女性中的4355名（8.7%）和USS组48230名女性中的5779名（12.0%）需要重复检测，MMS组167名（0.3%）和USS组1894名（3.9%）女性需要临床评价。MM组50078例中97例（0.2%）和US组48230例中845例（1.8%）接受了手术。原发性卵巢和输卵管癌42例（MMS）和45例（USS），其中交界性肿瘤28例（MMS 8例，USS 20例）。28/58例（48.3%; 95%CI 35.0-61.8）浸润性癌（16例MMS，12例USS）为I/II期，两组间分期分布无差异（p=0.396）。另有13名（5名MMS，8名USS）妇女在筛查后的一年内患上了原发性卵巢癌。MMS对所有原发性卵巢癌和输卵管癌的敏感性、特异性和阳性预测值分别为89.4%、99.8%和43.3%，USS为84.9%、98.2%和5-3%。对于原发性浸润性上皮性卵巢癌和输卵管癌，MMS的敏感性、特异性和阳性预测值分别为89.5%、99.8%和35.1%，USS的敏感性、特异性和阳性预测值分别为75.0%、98.2%和2.8%。特异性差异有显著性（p
Background Ovarian cancer has a high case-fatality ratio, with most women not diagnosed until the disease is in its advanced stages. The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is a randomised controlled trial designed to assess the effect of screening on mortality. This report summarises the outcome of the prevalence (initial) screen in UKCTOCS.Methods Between 2001 and 2005, a total of 202638 post-menopausal women aged 50-74 years were randomly assigned to no treatment (control; n=101359); annual CA125 screening (interpreted using a risk of ovarian cancer algorithm) with transvaginal ultrasound scan as a second-line test (multimodal screening [MMS]; n=50640); or annual screening with transvaginal ultrasound (USS; n=50639) alone in a 2:11 ratio using a computer-generated random number algorithm. All women provided a blood sample at recruitment. Women randomised to the MMS group had their blood tested for CA125 and those randomised to the US S group were sent an appointment to attend for a transvaginal scan. Women with abnormal screens had repeat tests. Women with persistent abnormality on repeat screens underwent clinical evaluation and, where appropriate, surgery. This trial is registered as ISRCTN22488978 and with ClinicalTrials.gov, number NCT00058032.Findings In the prevalence screen, 50 078 (98.9%) women underwent MMS, and 48 230 (95.2%) underwent USS. The main reasons for withdrawal were death (two MMS, 28 USS), non-ovarian cancer or other disease (none MMS, 66 USS), removal of ovaries (five MMS, 29 USS), relocation (none MMS, 39 USS), failure to attend three appointments for the screen (72 MMS, 757 USS), and participant changing their mind (483 MMS, 1490 USS). Overall, 4355 of 50078 (8.7%) women in the MMS group and 5779 of 48230 (12.0%) women in the USS group required a repeat test, and 167 (0.3%) women in the MMS group and 1894 (3.9%) women in the USS group required clinical evaluation. 97 of 50 078 (0.2%) women from the MM S group and 845 of 48 230 (1.8%) from the U S S group underwent surgery. 42 (MMS) and 45 (USS) primary ovarian and tubal cancers were detected, including 28 borderline tumours (eight MMS, 20 USS). 28 (16 MMS, 12 USS) of 58 (48.3%; 95% CI 35.0-61.8) of the invasive cancers were stage I/II, with no difference (p=0.396) in stage distribution between the-groups. A further 13 (five MMS, eight USS) women developed primary ovarian cancer during the year after the screen. ne sensitivity, specificity, and positive-predictive values for all primary ovarian and tubal cancers were 89.4%, 99.8%, and 43.3% for MMS, and 84.9%, 98.2%, and 5-3% for USS, respectively. For primary invasive epithelial ovarian and tubal cancers, the sensitivity, specificity, and positive-predictive values were 89.5%, 99.8%, and 35.1% for MMS, and 75.0%, 98.2%, and 2.8% for USS, respectively. There was a significant difference in specificity (p