abstract:
Extended mortality results for ovarian cancer screening in the PLCO trial with median 15years follow-up
Highlights
- •After 15 years median follow-up, screening with CA-125 and transvaginal ultrasound did not reduce ovarian cancer mortality
- •The risk ratio (intervention compared to usual care arm) for ovarian cancer mortality was 1.06 (95% CI: 0.87–1.30)
- •Ovarian cancer survival was not significantly different by trial arm, with similar survival rates at 10 years
Background
The
Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial
originally reported no mortality benefit of ovarian cancer screening
after a median of 12.4 years 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) (4 years) and
CA-125 (6 years), with a fixed cutoff at 35 U/mL for CA-125. The
original follow-up period was for up to 13 years (median follow-up
12.4 years); in this analysis follow-up for mortality was extended by up
to 6 years.
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 14.7 years in each arm and maximum follow-up
19.2 years 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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