A large-scale study launched in December will follow 85,000 women in Europe and Israel to review the risk of each developing breast cancer and provide a personalized response, organizers said Friday.
“MyPeBS” (for “My Personalized Breast Screening”) will mobilize 20,000 women volunteers in France, 30,000 in Italy, 15,000 in Israel, 10,000 in Belgium and 10,000 in the United Kingdom for six years.
The study brings together 26 European, Israeli and American groups and institutions.
“This is the largest study in the world on the subject, and individualization is a major trend. There is another similar study in the United States,” said Suzette Delaloge, coordinator of MyPeBS and oncologist at Paris’s Gustave Roussy research institute.
With 360,000 new cases diagnosed and 92,000 deaths each year in Europe, breast cancer is the most common cancer in women. In Israel around 4,500 cases are diagnosed each year, and 900 die.
The study aims to “assess, in women aged 40 to 70 years old, if breast cancer screening adapted to a women’s projected 5-years risk of breast cancer is more effective than current standard screening,” according to the MyPeBS website.
The effectiveness of current cancer screening programs through periodical mammograms has been questioned, with studies showing the practice has not been able to significantly reduce mortality rates.
Delaloge explained: “We have a lot of people who do tests for nothing, the sensitivity is not perfect, there are still a lot of interval cancers (between two mammograms), there are false positives — women who have a suspicious image that will prove to be benign, but we will be forced to make a biopsy.
“There is also the problem of overdiagnosis — or 10% to 20% of cancers that would not have evolved,” she added.
The unnecessary treatment of such cancers can do more harm to patients than good. The screenings themselves can also be potentially harmful due to radiation exposure.
The study will randomly allocate women aged 40 to 70 into two groups, one to be screened, and the other to be monitored according to three levels of risk: very low (less than 1% risk of developing breast cancer within 5 years), medium (3%) and high (6%).
The risk is defined according to age, family history, breast density and salivary test: “We use a genotyping chip, we look for 300 DNA variations that have been formally demonstrated in recent years to have been associated with the risk of developing breast cancer,” Delaloge said.
The frequency of the women’s radiological exams will be determined by their risk group.
The study, conducted in 30 departments, is based on the current screening network in France. It must prove that the new strategy “does at least as well and if possible better than the current standard.”
If it succeeds, it could lead to a better targeted screenings, avoiding unnecessary exams for healthy women as well as interventions that can be mutilating, while providing better coverage for at-risk women.
The study in Israel is being led by Tel Aviv’s Assuta Medical Center.