science
ROCA has the potential to be a major breakthrough for the early
diagnosis of ovarian cancer. The diagnosis of ovarian cancer is usually
made when the disease has spread outside the ovaries and as a result the
outcome is poor. In the 80% of cases of ovarian cancer in which
diagnosis occurs in the later stages, the 5-year survival rate is less
than 20%. If diagnosed early, 5-year survival exceeds 85%. Hence the
need for early diagnosis, in the hope that current treatments will be
more effective. Around the world, an estimated 200,000 new cases of
ovarian cancer are diagnosed in women each year and there are over
125,000 deaths.
ROCA is a test being validated for the screening
of ovarian cancer. It was invented by Professor
Ian Jacobs, Dean &
Head School of Medicine, Faculty of Medical & Human Sciences,
University of Manchester, and formerly of Queen Mary, University of
London, and
Dr Steven Skates of the Biostatistics Center, MGH, who
together
studied longitudinal patterns of CA125 in multiple cohorts of
post-menopausal women to develop a statistical algorithm efficiently
combining information in age and serial CA125 levels. ROCA has since
shown excellent specificity, Positive Predictive Value (PPV) and
sensitivity in large studies including UKCTOCS (UK Collaborative Trial
of Ovarian Cancer Screening) and UKFOCSS (UK Familial Ovarian Cancer
Screening Study).
A recent study1 by the MD Anderson Cancer
Center in
normal risk postmenopausal women reported a specificity of
99.9% and a PPV of 40% for ROCA
when ultrasound was used as a secondary
test. This confirms, in a USA population, results previously reported by
the larger
UKCTOCS trial involving 202,000 normal risk postmenopausal
women. The published results from UKCTOCS2 indicate that, as well as
achieving high specificity and PPV, ROCA can achieve a sensitivity of
89% for screen detection of ovarian cancer. UKCTOCS is a randomised
trial comparing screening with standard care,
and in 2015 will provide
results on the impact of screening with ROCA on mortality and survival
from ovarian cancer. The final data from UKCTOCS will be of great
importance in guiding future clinical use of the ROCA in clinical
practice.
Commenting on the recent MD Anderson publication,
Professor Ian Jacobs, also Director of the UKCTOCS trial said “I am
delighted to see the outcome of the MD Anderson 11 year study. The
results reassuringly confirm in a USA setting those reported from the
UKCTOCS prevalence study published in 2009. We now await further data
from UKCTOCS in 2015 to establish whether the encouraging specificity
and sensitivity data translate into improvements in survival and
mortality which through early detection can help women affected by
ovarian cancer.” .......
"The eventual clinical use will of course be informed
and guided by the outcome of UKCTOCS and other clinical trials.”"
