目的:UKCTOCS为探索临床前浸润性上皮性卵巢癌(iEOC)的症状提供了机会。我们报告了临床前(筛查)癌症(PC)与临床诊断(CD)癌症相比的女性症状。
方法:在UKCTOCS中,202638绝经后妇女,在2011年12月31日之前,研究人员使用多模式或超声策略,将年龄在50-74岁(2001年4月17日-2005年9月29日)2:1:1随机分配至无筛查或年度筛查.后续行动是通过国家登记册进行的。结果委员会裁定OC诊断,组织型,阶段。符合条件的女性是在初级审查中被诊断为iEOC的女性(2014年12月31日)。从试验临床评估表格和医疗记录中提取症状细节。描述性统计用于比较患有早期(I/II)和晚期(III/IV/无法分期)高级别浆液性(HGSC)癌症的PC和CD女性的症状。ISRCTN-22488978;ClinicalTrials.gov-NCT00058032。
结果:1133(286PC;847CD)女性发展为iEOC。与CD相比,PC诊断时的中位年龄(岁)更早(66.8PC,68.7CD,p=0.0001)组。在PC组中,48%(112/234;90%,660/730CD)询问时报告了症状。一半PC(50%,13/26PC;36%,29/80CD;p=0.213)有症状的HGSC女性有>1种症状,最常见的腹部症状,两者都在早期(62%,16/26,PC;53%42/80,CD;p=0.421)和高级(57%,49/86,PC;74%,431/580,CD;p=0.001)阶段。在有症状的早期HGSC中,与CD相比,PC女性报告更多的胃肠道(排便习惯和消化不良的改变)(35%,9/26PC;9%,7/80CD;p=0.001)和全身性(主要是嗜睡/疲倦)(27%,7/26PC;9%,7/80CD;p=0.017)症状。
结论:我们的发现,增加了越来越多的证据,我们应该重新考虑什么是早期卵巢癌的警觉症状。我们需要更细微的关键症状,然后在前瞻性试验中进行评估和完善。
UKCTOCS provides an opportunity to explore symptoms in preclinical invasive epithelial ovarian cancer (iEOC). We report on symptoms in women with pre-clinical (screen-detected) cancers (PC) compared to clinically diagnosed (CD) cancers.
In UKCTOCS, 202638 postmenopausal women, aged 50-74 were randomly allocated (April 17, 2001-September 29, 2005) 2:1:1 to no screening or annual screening till Dec 31,2011, using a multimodal or ultrasound strategy. Follow-up was through national registries. An outcomes committee adjudicated on OC diagnosis, histotype, stage. Eligible women were those diagnosed with iEOC at primary censorship (Dec 31, 2014). Symptom details were extracted from trial clinical-assessment forms and medical records. Descriptive statistics were used to compare symptoms in PC versus CD women with early (I/II) and advanced (III/IV/unable to stage) stage high-grade-serous (HGSC) cancer. ISRCTN-22488978; ClinicalTrials.gov-NCT00058032.
1133 (286PC; 847CD) women developed iEOC. Median age (years) at diagnosis was earlier in PC compared to CD (66.8PC, 68.7CD, p = 0.0001) group. In the PC group, 48% (112/234; 90%, 660/730CD) reported symptoms when questioned. Half PC (50%, 13/26PC; 36%, 29/80CD; p = 0.213) women with symptomatic HGSC had >1symptom, with abdominal symptoms most common, both in early (62%, 16/26, PC; 53% 42/80, CD; p = 0.421) and advanced (57%, 49/86, PC; 74%, 431/580, CD; p = 0.001) stages. In symptomatic early-stage HGSC, compared to CD, PC women reported more gastrointestinal (change in bowel habits and dyspepsia) (35%, 9/26PC; 9%, 7/80CD; p = 0.001) and systemic (mostly lethargy/tiredness) (27%, 7/26PC; 9%, 7/80CD; p = 0.017) symptoms.
Our findings, add to the growing evidence, that we should reconsider what constitutes alert symptoms for early tubo-ovarian cancer. We need a more nuanced complex of key symptoms which is then evaluated and refined in a prospective trial.