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مقاله شماره ۳۰
#Gynecology
#Oncology
عنوان:
Supplemental MRI Screening for Women With Extremely Dense Breast Tissue
مجله:
The New England Journal of Medicine
نوع مطالعه:
RCT
تاریخ انتشار:
Nov, 2019
سایتیشن:
Bakker et al.
چکیده:
BACKGROUND
Extremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients.
METHODS
In this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.
RESULTS
The interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; P<0.001). Of the women who were invited to undergo MRI, 59% accepted the invitation. Of the 20 interval cancers that were diagnosed in the MRI-invitation group, 4 were diagnosed in the women who actually underwent MRI (0.8 per 1000 screenings) and 16 in those who did not accept the invitation (4.9 per 1000 screenings). The MRI cancer-detection rate among the women who actually underwent MRI screening was 16.5 per 1000 screenings (95% CI, 13.3 to 20.5). The positive predictive value was 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing and 26.3% (95% CI, 21.7 to 31.6) for biopsy. The false positive rate was 79.8 per 1000 screenings. Among the women who underwent MRI, 0.1% had either an adverse event or a serious adverse event during or immediately after the screening.
CONCLUSIONS
The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period.
DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa1903986
توضیحات مهم:
✅ در این مطالعه، ۴۰۳۷۳ زن در محدودع سنی ۵۰ تا ۷۵ سال با بافت پستان extremely dense و نتایج غربالگری نرمال ماموگرافی بصورت رندوم به دو گروه supplemental MRI و فقط ماموگرافی تقسیم شدند.
✔️ The interval cancer rate was significantly lower in the MRI-invitation group compared with the mammography-only group.
✔️ Among the 20 interval cancers diagnosed in the MRI-invitation group, 4 were diagnosed in women who underwent MRI and 16 were diagnosed in those who did not accept the invitation.
✔️Among the women who underwent MRI screening, the cancer-detection rate was 16.5 per 1000 screenings.
✔️ The positive predictive value was 17.4% for recall for additional testing and 26.3% for biopsy, whereas the false-positive rate was 79.8 per 1000 screenings.
✔️✔️ نتایج این مطالعه نشان می دهد که supplemental MRI در زنان با بافت پستان extremely dense و ماموگرافی نرمال منجر به تشخیص کمتر قابل توجهی از کنسرهای interval در مقایسه با ماموگرافی به تنهایی می شود.
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