Kalsi Jatinderpal, Gentry-Maharaj Aleksandra, Ryan Andy, Singh Naveena, Burnell Matthew, Massingham Susan, Apostolidou Sophia, Sharma Aarti, Williamson Karin, Seif Mourad, Mould Tim, Woolas Robert, Dobbs Stephen, Leeson Simon, Fallowfield Lesley, Skates Steven J, Parmar Mahesh, Campbell Stuart, Jacobs Ian, McGuire Alistair, Menon Usha
Department of Women's Cancer, Institute for Women's Health, University College London, London WC1E 6HU, UK.
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London WC1V 6LJ, UK.
Cancers (Basel). 2021 Feb 18;13(4):858. doi: 10.3390/cancers13040858.
Randomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultrasound arm of UKCTOCS. 44,799 of the 50,639 women who were randomised to annual screening with transvaginal ultrasound attended annual incidence screening between 28 April 2002 and 31 December 2011. Transvaginal ultrasound was used both as the first and the second line test. Participants were followed up through electronic health record linkage and postal questionnaires. Out of 280,534 annual incidence screens, 960 women underwent screen-positive surgery. 113 had ovarian/tubal cancer (80 invasive epithelial). Of the screen-detected invasive epithelial cancers, 37.5% (95% CI: 26.9-49.0) were Stage I/II. An additional 52 (50 invasive epithelial) were diagnosed within one year of their last screen. Of the 50 interval epithelial cancers, 6.0% (95% CI: 1.3-16.5) were Stage I/II. For detection of all ovarian/tubal cancers diagnosed within one year of screen, the sensitivity, specificity, and positive predictive values were 68.5% (95% CI: 60.8-75.5), 99.7% (95% CI: 99.7-99.7), and 11.8% (95% CI: 9.8-14) respectively. When the analysis was restricted to invasive epithelial cancers, sensitivity, specificity and positive predictive values were 61.5% (95% CI: 52.6-69.9); 99.7% (95% CI: 99.7-99.7) and 8.3% (95% CI: 6.7-10.3), with 12 surgeries per screen positive. The low sensitivity coupled with the advanced stage of interval cancers suggests that ultrasound scanning as the first line test might not be suitable for population screening for ovarian cancer. Trial registration: ISRCTN22488978. Registered on 6 April 2000.
卵巢癌（OC）筛查的随机对照试验尚未证明对疾病死亡率有影响。与此同时，临床试验的筛查数据是了解所用筛查方式性能的丰富资源。我们在此报告英国卵巢癌筛查协作试验（UKCTOCS）超声组的发病率筛查情况。在50639名被随机分配接受每年经阴道超声筛查的女性中，有44799名在2002年4月28日至2011年12月31日期间参加了年度发病率筛查。经阴道超声被用作一线和二线检测方法。通过电子健康记录链接和邮政问卷对参与者进行随访。在280534次年度发病率筛查中，960名女性接受了筛查阳性手术。其中113人患有卵巢/输卵管癌（80例为浸润性上皮癌）。在筛查发现的浸润性上皮癌中，37.5%（95%置信区间：26.9 - 49.0）为I/II期。另外52例（50例为浸润性上皮癌）在其最后一次筛查后的一年内被诊断出来。在这50例间期上皮癌中，6.0%（95%置信区间：1.3 - 16.5）为I/II期。对于在筛查后一年内诊断出的所有卵巢/输卵管癌，其敏感性、特异性和阳性预测值分别为68.5%（95%置信区间：60.8 - 75.5）、99.7%（95%置信区间：99.7 - 99.7）和11.8%（95%置信区间：9.8 - 14）。当分析仅限于浸润性上皮癌时，敏感性、特异性和阳性预测值分别为61.5%（95%置信区间：52.6 - 69.9）；99.7%（95%置信区间：99.7 - 99.7）和8.3%（95%置信区间：6.7 - 10.3），每例筛查阳性有12例手术。低敏感性加上间期癌的晚期阶段表明，超声扫描作为一线检测方法可能不适用于卵巢癌的人群筛查。试验注册：ISRCTN22488978。于2000年4月6日注册。
