Major Findings: In women with BRCA1 and BRCA2 mutations, 13% of invasive cancers in a MRI surveillance group were node positive, compared with 40% in controls.
Data Source: In the nonrandomized study of 1,275 women with BRCA1 and BRCA2 mutations, 445 received annual MRI and mammography and twice-yearly clinical breast exams. A control group of 830 patients underwent annual mammography and twice-yearly clinical breast exams.
Disclosures: The investigator served as a consultant to Berlex and Bayer.
SAN ANTONIO — Adding MRI surveillance to conventional mammography in women with BRCA1 or BRCA2 mutations results in a favorable stage shift, with breast cancers being detected at an earlier, more curable stage, according to a prospective cohort study.
This finding is consistent with the notion that MRI surveillance reduces distant recurrence rates and breast cancer mortality, although definitive proof must await another 5-10 years of study follow-up, Dr. Ellen Warner said at the San Antonio Breast Cancer Symposium.
In the meantime, these encouraging interim results may convince very-high-risk women and their physicians that surveillance with yearly MRI and mammography is a reasonable alternative to prophylactic mastectomy, added Dr. Warner of the University of Toronto.
A randomized, controlled trial comparing MRI surveillance to mammography will never happen for ethical as well as practical reasons, Dr. Warner commented.
The next-best study design would be a prospective cohort study. Such a study is underway in Toronto. It involves 1,275 women with BRCA1 or BRCA2 mutations who to date have been followed for a mean of 3.2 years for incident breast cancer.
The nonrandomized study includes 445 women in a Toronto surveillance program involving annual MRI and mammography along with twice-yearly clinical breast examination, plus a control group comprising 830 women screened by annual mammography and twice-yearly clinical breast exams.
There have been 41 cases of invasive breast cancer detected in the MRI group and 77 in controls. The incidence in the two groups was nearly identical.
However, there was a marked difference in cancer stage. Only 13% of invasive cancers in the MRI group were node positive, compared with 40% in controls (P = .009).
The mean 9-mm tumor size in the MRI group was half that in controls. Only 3% of invasive tumors in the MRI group exceeded 20 mm, compared with 29% in controls. Ductal carcinoma in situ (DCIS) was detected in 2.2% of the MRI group and 1.1% of controls.
After controlling for baseline differences in menopausal status, tamoxifen therapy, and other potential confounders, the MRI cohort was 5.7-fold more likely than controls to be diagnosed with DCIS, threefold more likely to be diagnosed with stage 1 breast cancer, and one-quarter as likely to have stage 2 or higher breast cancer.
This study probably underestimates the true benefit of MRI surveillance, Dr. Warner said. Major advances in MRI technology have occurred since the study began roughly a decade ago, with resultant markedly improved diagnostic sensitivity. Radiologists have grown considerably more experienced in breast MRI in the last several years, as well.
In addition, nearly half of all cancers diagnosed in the MRI cohort were prevalent cancers detected on initial screening.
“It's conceivable that had MRI been done a year or two earlier, these cancers would have been detected at an earlier stage,” Dr. Warner said.
There is a hint of that in the study data: DCIS and stage 1 cancers accounted for all but 1 of the 22 incident cancers in the MRI cohort—those detected in the second year of screening or later, she observed.