Results From Four Rounds of Ovarian Cancer Screening in a Randomized Trial
| Autor: | Bruce Kessel, Saundra S. Buys, Joel L. Weissfeld, Craig Williams, Gerald L. Andriole, Claudine Isaacs, Jian Lun Xu, Robert T. Greenlee, Christine Cole Johnson, Aimée R. Kreimer, Edward E. Partridge, Lawrence R. Ragard, Timothy R. Church, Sheryl L. Ogden |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
medicine.medical_specialty
Randomization law.invention Randomized controlled trial Predictive Value of Tests law medicine Humans Mass Screening Mass screening Aged Neoplasm Staging Ultrasonography Ovarian Neoplasms Gynecology Evidence-Based Medicine business.industry Obstetrics and Gynecology Cancer General Medicine Middle Aged medicine.disease Annual Screening Clinical trial CA-125 Antigen Predictive value of tests Patient Compliance Female business Ovarian cancer |
| Zdroj: | Obstetrics & Gynecology. 113:775-782 |
| ISSN: | 0029-7844 |
| DOI: | 10.1097/aog.0b013e31819cda77 |
| Popis: | To test whether annual screening with transvaginal ultrasonography and CA 125 reduces ovarian cancer mortality.Data from the first four annual screens, denoted T0-T3, are reported. A CA 125 value at or above 35 units/mL or an abnormality on transvaginal ultrasonography was considered a positive screen. Diagnostic follow-up of positive screens was performed at the discretion of participants' physicians. Diagnostic procedures and cancers were tracked and verified through medical records.Among 34,261 screening arm women without prior oophorectomy, compliance with screening ranged from 83.1% (T0) to 77.6% (T3). Screen positivity rates declined slightly with transvaginal ultrasonography, from 4.6 at T0 to 2.9-3.4 at T1-T3; CA 125 positivity rates (range 1.4-1.8%) showed no time trend. Eighty-nine invasive ovarian or peritoneal cancers were diagnosed; 60 were screen detected. The positive predictive value (PPV) and cancer yield per 10,000 women screened on the combination of tests were similar across screening rounds (range 1.0-1.3% for PPV and 4.7-6.2 for yield); however, the biopsy (surgery) rate among screen positives decreased from 34% at T0 to 15-20% at T1-T3. The overall ratio of surgeries to screen-detected cancers was 19.5:1. Seventy-two percent of screen-detected cases were late stage (III/IV).Through four screening rounds, the ratio of surgeries to screen-detected cancers was high, and most cases were late stage. However, the effect of screening on mortality is as yet unknown.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00002540II. |
| Databáze: | OpenAIRE |
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