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Extended mortality results for ovarian cancer screening in the PLCO trial with median 15years follow-up.

Authors

Pinsky PF, Yu K, Kramer BS, Black A, Buys SS, Partridge E, Gohagan J, Berg CD, Prorok PC

Affiliations

  • Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, United States. Electronic address: pp4f@nih.gov.
  • Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, United States.
  • Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, United States.
  • University of Utah School of Medicine, United States.
  • University of Alabama at Birmingham School of Medicine, United States.
  • Office of Disease Prevention, National Institutes of Health, United States.

Abstract

BACKGROUND: The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial originally reported no mortality benefit of ovarian cancer screening after a median of 12.4years of follow-up. The UKCTOCS screening trial failed to show a statistically significant mortality reduction in the primary analysis but reported an apparent increased mortality benefit in trial years 7-14 compared to 0-7. Here we report an updated analysis of PLCO with extended mortality follow-up.

METHODS: Participants were randomized from 1993 to 2001 at ten U.S. centers to an intervention or usual care arm. Intervention arm women were screened for ovarian cancer with annual trans-vaginal ultrasound (TVU) (4years) and CA-125 (6years), with a fixed cutoff at 35U/mL for CA-125. The original follow-up period was for up to 13years (median follow-up 12.4years); in this analysis follow-up for mortality was extended by up to 6years.

RESULTS: 39,105 (intervention) and 39,111 (usual care) women were randomized, of which 34,253 and 34,304, respectively, had at least one ovary at baseline. Median follow-up was 14.7years in each arm and maximum follow-up 19.2years in each arm. A total of 187 (intervention) and 176 (usual care) deaths from ovarian cancer were observed, for a risk-ratio of 1.06 (95% CI: 0.87-1.30). Risk-ratios were similar for study years 0-7 (RR=1.04), 7-14 (RR=1.06) and 14+ (RR=1.09). The risk ratio for all-cause mortality was 1.01 (95% CI: 0.97-1.05). Ovarian cancer specific survival was not significantly different across trial arms (p=0.16).

CONCLUSION: Extended follow-up of PLCO indicated no mortality benefit from screening for ovarian cancer with CA-125 and TVU.

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Publication Details

PubMed ID
27615399

Publication
Gynecol. Oncol. 2016 Nov; Volume 143 (Issue 2): Pages 270-275

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