The results of a large British trial of more than 200,000 women followed for a median of 16 years turned out to be negative. Researchers Ovarian cancer Using either multimodal screening (MMS) or transvaginal ultrasonography (USS) did not reduce the number of deaths from this invasive cancer, even if MMS chose early-stage disease. ..
“We are disappointed because this is not the result of many years of working that we and everyone involved in the trial have hoped for,” said the MRC Clinical Trials (MCT) Unit of the Institute for Clinical Trials and Methodology. Dr. Usha Menon commented. Senior Researcher in London, UK, and UK Joint Trial of Ovarian Cancer Screening (UKCTOCS).
“UKCTOCS is the first trial to show that screening can reliably detect ovarian cancer early. However, this very large and rigorous trial is based on screening using one of the approaches we have tested. It clearly shows that it did not save lives, “she said in a statement.
“Therefore, we cannot recommend screening for ovarian cancer to the general population using these methods,” she added.
Reflecting these sentiments, MD, a collaborator at the University of New South Wales, Australia, who led the UKCTOCS from 2001 to 2014, found that MMS succeeded in detecting ovarian cancer in the early stages of the disease. But, “Sadly, it didn’t save lives.
“Given the hopes of all involved to save the lives of thousands of women suffering from ovarian cancer each year, this is very disappointing and frustrating,” he added in a statement.
Research Published online May 12 The lancet.
At a press conference in the United Kingdom, Menon emphasized that ovarian cancer is an aggressive disease with a 10-year survival rate of 35%. Diagnosis is difficult, and more than half are diagnosed in the later stages of the disease.
Screening cannot be recommended at this time, so she urged women and doctors to pay attention to and not ignore symptoms that may suggest ovarian cancer.
Recruitment of NHS Trust
The study enrolled 202,562 evaluable postmenopausal women aged 50-74 years recruited through the National Health Service (NHS) Trust in England, Wales and Northern Ireland.
Women were randomly assigned to undergo annual screening with no screening, ultrasound scans, or annual MMS with a CA125 blood test followed by ultrasound scans. The main result was death from ovarian or fallopian tube cancer.
With a median follow-up of 16.3 years, the incidence and mortality of ovarian and tubular cancer are the same in the three groups, the incidence of ovarian and tubular cancer is 1.0%, and the risk of death. Was 0.6%.
The end result was probably even more disappointing, with evidence from trials that MMS detected early-stage disease with high survival.
At 9.5 years after screening, the MMS group had a 47.2% higher incidence of stage I disease and a 24.5% lower incidence of stage IV disease than the unscreened group.
Overall, the MMS group had a 39.2% higher incidence of stage I or II cancer and a 10.2% lower incidence of stage III or IV cancer compared to the unscreened group. There was little change in the incidence of stage III disease.
Also, the stage of cancer detected in the USS group was not different compared to the unscreened group.
Menon speculates in this study why the discovery of early-stage disease did not lead to an overall reduction in mortality, which was an aggressive disease and was probably available at the time (10 years ago). He emphasized that there was no cure and can stop its progression.
Significant improvements have been seen in the treatment of advanced ovarian cancer since the end of the trial 10 years ago, said Dr. Mahesh Parmar, MRC Clinical Trials Unit at the UK Institute for Clinical Trials Methodology. .. paper.
“Our trial has shown that screening is not effective in women who do not have symptoms of ovarian cancer,” Parmar said.
However, he said, “in symptomatological women, the combination of early diagnosis and this better treatment may make a difference in quality of life and improve outcomes.”
The researchers emphasized that the screening trial involved healthy women who were asymptomatic and had no family history of ovarian cancer. Among women at high risk for ovarian cancer, they performed MMS every 3-4 months in combination with risk-reducing surgery, resulting in a significant reduction in the number of women diagnosed with progressive disease. Pointed out.
Not the first attempt to disappoint
UKCTOCS is not the first large-scale screening trial to show that annual screening for ovarian cancer does not reduce mortality over long follow-up periods, said Dr. Lauren Harwitz, National Cancer Institute, Rockville, Mary. Rand, and a colleague said. Ancillary editorial..
The first randomized controlled trial of ovarian cancer screening empowered to assess cancer-specific mortality Cancer screening trials for the prostate, lungs, colorectal polyps, and ovaries (PLCO).. In that study, more than 68,000 women were randomly assigned to undergo an annual CA125 examination in combination with transvaginal ultrasound or to receive routine care.
“After a median follow-up of 12.4 years, screening was not found to reduce ovarian cancer mortality,” Hurvitz and colleagues observe. In addition, nearly 10% of women in the intervention group were diagnosed with false positives. A significant proportion of those patients subsequently underwent surgery.
The editors say that in the current UK trial, the incidence of stage IV ovarian cancer may have been lower in women in the MMS group than in women in the unscreened group. ..
However, somewhat paradoxically, “this difference was associated with a higher case fatality rate for stage I cancer (14.8% in the MMS group vs. 9.4% in the unscreened group),” the editors observe. ..
One limitation of this study was that researchers did not analyze mortality based on the histology of ovarian cancer, such as the most common and deadly histology, high-grade serous ovarian cancer.
Editors say that alternative screening approaches for high-risk women rather than women in the general population are more effective in reducing ovarian cancer mortality and may reduce the potential for harm from false-positive screening. I agree with the author of the study about having sex.
“Ovarian cancer screening remains elusive, but it’s not the cause of its loss. There’s just more to do,” Hurvitz and colleagues conclude.
Investigator Jacobs hopes that more effective screening tests will eventually be found, but by the time new screening tests are evaluated in large clinical trials, “population screening for ovarian cancer is 10 We must reluctantly accept that we have been on the road for more than a year.
This study was funded by the National Institute of Health, the UK Cancer Research Fund, and Eve Appeal. Menon owns a stake awarded by University College London in Abcodia and is funded by Cancer Research UK (MRC), National Institute for Health Research (NIHR), and Eve Appeal.She also holds a patent for breast cancer Diagnosis. Parmar is funded by MRC, Cancer Research UK, NIHR, and Eve Appeal.
The lancet. Published online on May 12, 2021. Full text, editorial
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