Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Int J Cancer. 2013 May 1;132(9):2127-33. doi: 10.1002/ijc.27909. Epub 2012 Nov 5.
Recently, the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial reported no mortality benefit for annual screening with CA-125 and transvaginal ultrasound (TVU). Currently ongoing is the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), which utilizes the risk of ovarian cancer algorithm (ROCA), a statistical tool that considers current and past CA125 values to determine ovarian cancer risk. In contrast, PLCO used a single cutoff for CA125, based on current levels alone. We investigated whether having had used ROCA in PLCO could have, under optimal assumptions, resulted in a significant mortality benefit by applying ROCA to PLCO CA125 screening values. A best-case scenario assumed that all cancers showing a positive screen result earlier with ROCA than under the PLCO protocol would have avoided mortality; under a stage-shift scenario, such women were assigned survival equivalent to Stage I/II screen-detected cases. Updated PLCO data show 132 intervention arm ovarian cancer deaths versus 119 in usual care (relative risk, RR = 1.11). Forty-three ovarian cancer cases, 25 fatal, would have been detected earlier with ROCA, with a median (minimum) advance time for fatal cases of 344 (147) days. Best-case and stage-shift scenarios gave 25 and 19 deaths prevented with ROCA, for RRs of 0.90 (95% CI: 0.69-1.17) and 0.95 (95% CI: 0.74-1.23), respectively. Having utilized ROCA in PLCO would not have led to a significant mortality benefit of screening. However, ROCA could still show a significant effect in other screening trials, including UKCTOCS.
最近，前列腺、肺、结肠和卵巢（PLCO）试验报告称，每年用 CA-125 和经阴道超声（TVU）进行筛查不能降低死亡率。目前正在进行的英国卵巢癌筛查协作试验（UKCTOCS）利用卵巢癌风险算法（ROCA），这是一种统计工具，它考虑当前和过去的 CA125 值来确定卵巢癌的风险。相比之下，PLCO 仅基于当前水平使用 CA125 的单一截止值。我们研究了如果在 PLCO 中使用 ROCA，通过将 ROCA 应用于 PLCO 的 CA125 筛查值，是否可以在最佳假设下导致显著的死亡率获益。最佳情况下假设，所有用 ROCA 比 PLCO 方案更早显示阳性筛查结果的癌症都可以避免死亡；在分期转移的情况下，这些女性被分配到与 I/II 期筛查检测病例相当的生存时间。更新的 PLCO 数据显示，干预组有 132 例卵巢癌死亡，而常规护理组有 119 例（相对风险，RR = 1.11）。如果使用 ROCA，有 43 例卵巢癌病例，其中 25 例致命，将更早被发现，致命病例的中位（最小）提前时间为 344（147）天。最佳情况和分期转移情况分别用 ROCA 预防了 25 例和 19 例死亡，RR 分别为 0.90（95%CI：0.69-1.17）和 0.95（95%CI：0.74-1.23）。在 PLCO 中使用 ROCA 不会导致筛查的死亡率显著获益。然而，ROCA 仍可能在其他筛查试验中显示出显著效果，包括 UKCTOCS。
