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评估有症状女性以进行卵巢癌的早期诊断:前瞻性 DOvE 试点项目的结果。

Assessment of symptomatic women for early diagnosis of ovarian cancer: results from the prospective DOvE pilot project.

机构信息

Gynecologic Oncology Unit, McGill University Health Centre, Montreal, QC, Canada.

出版信息

Lancet Oncol. 2012 Mar;13(3):285-91. doi: 10.1016/S1470-2045(11)70333-3. Epub 2012 Jan 17.

DOI:10.1016/S1470-2045(11)70333-3
PMID:22257524
Abstract

BACKGROUND

Around 90% of deaths from ovarian cancer are due to high-grade serous cancer (HGSC), which is frequently diagnosed at an advanced stage. Several cancer organisations made a joint recommendation that all women with specified symptoms of ovarian cancer should be tested with the aim of making an early diagnosis. In the Diagnosing Ovarian Cancer Early (DOvE) study we investigated whether open-access assessment would increase the rate of early-stage diagnosis.

METHODS

Between May 1, 2008, and April 30, 2011, we enrolled women who were aged 50 years or older and who had symptoms of ovarian cancer. They were offered diagnostic testing with cancer antigen (CA-125) blood test and transvaginal ultrasonography (TVUS) at a central and a satellite open-access centre in Montreal, QC, Canada. We compared demographic characteristics of DOvE patients with those of women in the same age-group in the general population of the area, and compared indicators of disease burden with those in patients with ovarian cancer referred through the usual route to our gynaecological oncology clinic (clinic patients).

FINDINGS

Among 1455 women assessed, 402 (27·6%) were in the highest-risk age group (≥ 65 years). 239 (16·4%) of 1455 required additional investigations. 22 gynaecological cancers were diagnosed, 11 (50%) of which were invasive ovarian cancers, including nine HGSC. The prevalence of invasive ovarian cancer, therefore, was one per 132 women (0·76%), which is ten times higher than that reported in screening studies. DOvE patients were significantly younger, more educated, and more frequently English speakers than were women in the general population. They also presented with less tumour burden than did the 75 clinic patients (median CA-125 concentration 72 U/mL, 95% CI 12-1190 vs 888 U/mL, 440-1936; p=0·010); Eight (73%) tumours were completely resectable in DOvE patients, compared with 33 (44%) in clinic patients (p=0·075). Seven (78%) of the HGSC in the DOvE group originated outside the ovaries and five were associated with only slightly raised CA-125 concentrations and minimal or no ovarian abnormalities on TVUS.

INTERPRETATION

The proportion of HGSC that originated outside the ovaries in this study suggests that early diagnosis programmes should aim to identify low-volume disease rather than early-stage disease, and that diagnostic approaches should be modified accordingly. Although testing symptomatic women may result in earlier diagnosis of invasive ovarian cancer, large-scale implementation of this approach is premature.

FUNDING

Canadian Institutes of Health Research, Montreal General Hospital Foundation, Royal Victoria Hospital Foundation, Cedar's Cancer Institute, and La Fondation du Cancer Monique Malenfant-Pinizzotto.

摘要

背景

约 90%的卵巢癌死亡是由于高级别浆液性癌(HGSC),这种癌症通常在晚期诊断。一些癌症组织联合建议所有有特定卵巢癌症状的妇女都应该接受测试,以进行早期诊断。在早期诊断卵巢癌(DOvE)研究中,我们研究了开放获取评估是否会提高早期诊断率。

方法

2008 年 5 月 1 日至 2011 年 4 月 30 日,我们招募了年龄在 50 岁及以上且有卵巢癌症状的妇女。在加拿大魁北克省蒙特利尔的一个中央和一个卫星开放获取中心,为她们提供了癌症抗原(CA-125)血液检测和经阴道超声(TVUS)的诊断性检测。我们将 DOvE 患者的人口统计学特征与该地区同年龄组一般人群中的女性进行了比较,并将疾病负担指标与通过我们妇科肿瘤学诊所(诊所患者)的常规途径转诊的卵巢癌患者进行了比较。

结果

在 1455 名接受评估的女性中,402 名(27.6%)处于最高风险年龄组(≥65 岁)。1455 名女性中有 239 名(16.4%)需要进一步检查。诊断出 22 例妇科癌症,其中 11 例(50%)为浸润性卵巢癌,包括 9 例 HGSC。因此,浸润性卵巢癌的患病率为每 132 名女性中有 1 例(0.76%),是筛查研究报告的 10 倍。DOvE 患者明显比一般人群中的女性年轻、受教育程度更高、英语水平更高。与 75 名诊所患者相比,他们的肿瘤负担也更小(中位数 CA-125 浓度 72 U/mL,95%CI 12-1190 与 888 U/mL,440-1936;p=0.010);在 DOvE 患者中,8 例(73%)肿瘤完全可切除,而在诊所患者中只有 33 例(44%)可切除(p=0.075)。DOvE 组的 7 例(78%)HGSC 起源于卵巢外,其中 5 例 CA-125 浓度仅略有升高,TVUS 上卵巢异常极小或无。

解释

本研究中卵巢外起源的 HGSC 比例表明,早期诊断计划应旨在识别低容量疾病,而不是早期疾病,并且应相应地修改诊断方法。尽管对有症状的妇女进行检测可能会导致更早期的浸润性卵巢癌诊断,但大规模实施这种方法还为时过早。

资金来源

加拿大卫生研究院、蒙特利尔总医院基金会、皇家维多利亚医院基金会、雪松癌症研究所和莫尼克·马伦法特-皮尼佐托癌症基金会。

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