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基于人群的亚洲女性乳腺癌筛查患病率及检测随机试验的中间测量结果:新加坡乳腺癌筛查项目

Results of intermediate measures from a population-based, randomized trial of mammographic screening prevalence and detection of breast carcinoma among Asian women: the Singapore Breast Screening Project.

作者信息

Ng E H, Ng F C, Tan P H, Low S C, Chiang G, Tan K P, Seow A, Emmanuel S, Tan C H, Ho G H, Ng L T, Wilde C C

机构信息

Singapore Breast Cancer Screening Project Working Committee, Ministry of Health, Singapore.

出版信息

Cancer. 1998 Apr 15;82(8):1521-8.

PMID:9554530
Abstract

BACKGROUND

Although increasing rates of breast carcinoma incidence have been observed in Asian countries, appropriate strategies for detecting early stage breast carcinoma in such communities have been difficult to formulate, particularly because no large population screening trial specifically involving Asian women has been reported. The objective of this study was to evaluate the effectiveness and quality of mammography as a screening technique for Singaporean women, who are predominantly Chinese.

METHODS

In this prospective study, 166,600 women in Singapore ages 50-64 years were randomized to either 2-view mammography without physical examination (67,656) or observation (97,294, controls) over 2 years.

RESULTS

Of these women, 28,231 (41.7%) responded and were screened; they were more likely to be married, have more formal education, be working, be Chinese, and be in a higher socioeconomic group (P < 0.001 for all variables). To assess for response bias that could affect outcome, results were also evaluated for nonrespondents (n = 39,425). The incidence rate of cancers among nonrespondents (1 per 1000 woman-years) was less than the 1.3 in women not invited to have screening (P = 0.03, relative risk [RR], 1.3; 95% confidence interval [CI], 1.0-1.7). However, cancers arising from nonrespondents did not differ significantly in stage distribution when compared with cancers within the control group. For every 1000 women screened, 4.8 cancers were detected. The prevalence ratio (the number of cancers detected per 1000 women at first screening divided by the corresponding incidence rate in controls per year) was 3.6 for screened women and 2.4 for women invited to have screening. The majority of cancers detected through screening were early stage, with 64% as either ductal carcinoma in situ (26%) or Stage I disease (38%) and was significantly more than the corresponding 26% in women not invited to have screening (P < 0.001). When only invasive cancers were considered, screened women still had more early cancers, with 65% having no lymph node involvement, compared with 47% in the group not invited to have screening (P = 0.001; RR, 1.4; 95% CI, 1.2-1.7). Women who were screened had half the risk of having Stage II or later cancers (P < 0.0001; RR, 0.5; 95% CI, 0.4-0.7) when compared with women not invited to have screening. This higher detection rate of early cancers through screening was accomplished with acceptable recall rates of 8% for further mammographic films or physical examination and a biopsy rate of 1.0% (10 per 1000 women screened). The interval cancer rate was 2.1 per 10,000 women screened in the first year of follow-up.

CONCLUSIONS

These positive results of intermediate measures suggest that, in Asian communities, screening mammography could be an important modality for detecting early stage breast carcinoma. However, the low compliance rates suggest that health education efforts must focus on issues related to acceptability if such programs are to succeed.

摘要

背景

尽管亚洲国家乳腺癌发病率不断上升,但在这些人群中制定早期乳腺癌的适当检测策略一直很困难,尤其是因为尚未有专门针对亚洲女性的大规模人群筛查试验报道。本研究的目的是评估乳腺钼靶摄影作为新加坡主要为华裔女性的筛查技术的有效性和质量。

方法

在这项前瞻性研究中,166,600名年龄在50 - 64岁的新加坡女性被随机分为两组,一组在两年内接受双侧乳腺钼靶摄影且不进行体格检查(67,656人),另一组进行观察(97,294人,为对照组)。

结果

这些女性中,28,231人(41.7%)做出回应并接受了筛查;她们更有可能已婚、接受过更多正规教育、有工作、是华裔且属于较高社会经济群体(所有变量的P < 0.001)。为评估可能影响结果的回应偏差,还对未回应者(n = 39,425)的结果进行了评估。未回应者中的癌症发病率(每1000妇女年1例)低于未被邀请进行筛查的女性中的发病率(1.3例)(P = 0.03,相对风险[RR]为1.3;95%置信区间[CI]为1.0 - 1.7)。然而,与对照组中的癌症相比,未回应者中发生的癌症在分期分布上没有显著差异。每1000名接受筛查的女性中,检测到4.8例癌症。患病率比(首次筛查时每1000名女性中检测到的癌症数除以对照组每年相应的发病率),接受筛查的女性为3.6,被邀请进行筛查的女性为2.4。通过筛查检测到的大多数癌症为早期,其中64%为导管原位癌(26%)或I期疾病(38%),显著高于未被邀请进行筛查的女性中的相应比例26%(P < 0.001)。仅考虑浸润性癌症时,接受筛查的女性中仍有更多早期癌症,65%无淋巴结受累,而未被邀请进行筛查的组中这一比例为47%(P = 0.001;RR为1.4;95% CI为1.2 - 1.7)。与未被邀请进行筛查的女性相比,接受筛查的女性患II期或更晚期癌症的风险降低一半(P < 0.0001;RR为0.5;95% CI为0.4 - 0.7)。通过筛查实现了早期癌症的较高检出率,进一步乳腺钼靶摄影或体格检查的可接受召回率为8%,活检率为1.0%(每1000名接受筛查的女性中有10例)。在随访的第一年,每10,000名接受筛查的女性中,间期癌发病率为2.1例。

结论

这些中期措施的积极结果表明,在亚洲人群中,乳腺钼靶摄影筛查可能是检测早期乳腺癌的重要方式。然而,低依从率表明,如果此类项目要取得成功,健康教育工作必须关注与可接受性相关的问题。

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