Pathologic findings following false-positive screening tests for ovarian cancer in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial

Abstract

Objective In the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO), ovarian cancer screening with transvaginal ultrasound (TVU) and CA-125 produced a large number of false-positive tests. We examined relationships between histopathologic diagnoses, false-positive test group, and participant and screening test characteristics. Methods The PLCO ovarian cancer screening arm included 39,105 women aged 55–74 years assigned to annual CA-125 and TVU. Histopathologic diagnoses from women with false-positive tests and subsequent surgery were reviewed in this analysis: all CA125+ ( n = 121); all CA125+/TVU+ ( n = 46); and a random sample of TVU+ ( n = 373). Demographic and ovarian cancer risk factor data were self-reported. Pathologic diagnoses were abstracted from surgical pathology reports. We compared participant characteristics and pathologic diagnoses by category of false-positive using Pearson χ 2, Fisher's exact, or Wilcoxon–Mann–Whitney tests. Results Women with a false-positive TVU were younger ( P < 0.001), heavier ( P < 0.001), and reported a higher frequency of prior hysterectomy ( P < 0.001). Serous cystadenoma, the most common benign ovarian diagnosis, was more frequent among women with TVU+ compared to CA-125+ and CA-125+/TVU+ ( P < 0.001). Benign non-ovarian findings were commonly associated with all false-positive s, although more frequently with CA-125+ than TVU+ or CA-125+/TVU+ groups ( P = 0.019). Non-ovarian cancers were diagnosed most frequently among CA-125+ ( P < 0.001). Conclusions False-positive ovarian cancer screening tests were associated with a range of histopathologic diagnoses, some of which may be related to patient and screening test characteristics. Further research into the predictors of false-positive ovarian cancer screening tests may aid efforts to reduce false-positive results.