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Sensitivity and Specificity of Multimodal and Ultrasound Screening for Ovarian Cancer, and Stage Distribution of Detected Cancers: Results of the Prevalence Screen of the United Kingdom Collaborative Trial of Ovarian Cancer Screening

2009; Lippincott Williams & Wilkins; Volume: 64; Issue: 9 Linguagem: Inglês

10.1097/01.ogx.0000358020.23155.ac

1533-9866

Usha Menon, Aleksandra Gentry‐Maharaj, Rachel Hallett, Andy Ryan, Matthew Burnell, Aarti Sharma, Sara Lewis, S. J. Davies, Susan Philpott, Alberto Lopes, Keith Godfrey, David Oram, Jonathatn Herod, Karin Williamson, Mourad W. Seif, Ian Scott, Tim Mould, Robert Woolns, John Murdoch, Stephen Dobbs, Nazar N. Amso, Simon Leeson, Derek Cruickshank, Alistair McGuire, Stuart Campbell, Lesley Fallowfield, Naveena Singh, Anne Dawnay, Steven J. Skates, Mahesh Parmar, Ian Jacobs,

Endometriosis Research and Treatment

Diagnosis of ovarian cancer at early stages increases the likelihood for effective treatment and long-term survival. Preliminary data from a randomized controlled trial suggested a survival benefit of routine screening for ovarian cancer sequentially with the CA-125 blood test and ultrasound (multimodal screening). This randomized controlled trial — the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) — assessed the effect of screening with CA-125 and transvaginal ultrasound on mortality. Between 2001 and 2005, a total of 202,638 postmenopausal women aged 50 to 74 years were randomly assigned to 3 groups: (1) a no treatment control group receiving no ovarian screening (n = 101,359); (2) an annual CA-125 screening group with transvaginal ultrasound scan as a second-line test (multimodal screening [MMS] [n = 50,640]); or (3) an annual screening transvaginal ultrasound group (USS) (n = 50, 639). The serum CA-125 tumor marker was measured from blood samples. For the prevalence screen, 50,078 (98·9%) women underwent MMS, and 48,230 (95·2%) were screened with USS. Overall, 4555 (9.1%) of the MMS women and 5779 (12.0%) of the USS women had unsatisfactory or abnormal scans and required a repeat test. A total of 167 (0.3%) of the MMS women and 1894 (3.9%) of the USS women who underwent the initial prevalence screening required clinical evaluation; 97 (0.2%) of the MMS women and 845 (1.8%) of the USS women had surgery to remove both ovaries and fallopian tubes for examination. Primary ovarian or tubal malignancies were detected in 42 women in the MMS group and 45 in the USS group; of these, 8 MMS and 20 USS were borderline tumors. Overall, 48.3% (28/58) of the total invasive cancers detected were early stages I/II (12 MMS and 16 USS). There was no significant difference (P = 0.396) in stage distribution between the groups. Within 1 year of a normal prevalence screen test, 13 additional (interval) ovarian and tubal cancers were diagnosed; 5 were MMS, and 8 USS. The sensitivity and specificity values for MMS to detect primary invasive ovarian and tubal cancers were 89.5% and 99.8% whereas these same values for USS were 75.0%, and 98.2%, respectively. Compared with the USS, these values were significantly higher with the MMS for specificity (P < 0.0001) but not for sensitivity. The investigators conclude from these findings that routine screening of women at normal risk is feasible and may improve detection rates of early ovarian cancer. Whether mortality rates are reduced by screening cannot be determined until the study is completed in 2014.