Potential effect of the risk of ovarian cancer algorithm (ROCA) on the mortality outcome of the Prostate, Lung, Colorectal and Ovarian (PLCO) trial

Int J Cancer. 2013 May 1;132(9):2127-33. doi: 10.1002/ijc.27909. Epub 2012 Nov 5.

Abstract

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma, Clear Cell / mortality
  • Adenocarcinoma, Clear Cell / prevention & control
  • Adenocarcinoma, Mucinous / mortality
  • Adenocarcinoma, Mucinous / prevention & control
  • Aged
  • Algorithms*
  • CA-125 Antigen / blood
  • Clinical Trials as Topic
  • Cystadenocarcinoma, Serous / mortality
  • Cystadenocarcinoma, Serous / prevention & control
  • Early Detection of Cancer*
  • Endometrial Neoplasms / mortality
  • Endometrial Neoplasms / prevention & control
  • Fallopian Tube Neoplasms / mortality*
  • Fallopian Tube Neoplasms / prevention & control
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Membrane Proteins / blood
  • Middle Aged
  • Neoplasm Staging
  • Ovarian Neoplasms / mortality*
  • Ovarian Neoplasms / prevention & control
  • Peritoneal Neoplasms / mortality*
  • Peritoneal Neoplasms / prevention & control
  • Prognosis
  • Retrospective Studies
  • Risk Assessment
  • Survival Rate

Substances

  • CA-125 Antigen
  • MUC16 protein, human
  • Membrane Proteins