Comparing the Effectiveness of Breast Cancer Screening and Diagnostic Tests among Women with Different Breast Densities -- The BCSC-ADVANCE Study Final Report

Final Report Published for PCORI-Funded BCSC ADVANCE Study

Posted by at 11:00 AM on May 3, 2024

The final report for the PCORI-funded BCSC ADVANCE study "Comparing the effectiveness of breast cancer screening and diagnostic test among women with different breast densities" was published with the abstract below.

Miglioretti DL, Onega T, Su YR, et al; Breast Cancer Surveillance Consortium. (2023). Comparing the Effectiveness of Breast Cancer Screening and Diagnostic Tests among Women with Different Breast Densities—The BCSC-ADVANCE Study. Patient-Centered Outcomes Research Institute (PCORI).https://doi.org/10.25302/09.2023.PCS.150430370

Objective

To compare, by breast density, the effect of (1) digital mammography versus digital breast tomosynthesis (DBT) with or without breast MRI on breast cancer screening benefits and harms and patient-reported outcomes; (2) having versus not having a preoperative MRI on breast cancer recurrence and patient-reported outcomes among women with breast cancer receiving diagnostic mammography

Study Design

Design Element	Description
Design	Observational: cohort studies
Population	Data from 7 breast imaging registries across the United States: Study 1: 504,150 women ages 40–79 without a history of breast cancer who completed at least 1 of the 1,377,902 screening breast imaging exams between 2005 and 2019 Study 2: 20,383 women ages 18–89 with a pathologically confirmed diagnosis of ductal carcinoma in situ or invasive breast cancer between 2005 and 2020 A random subset of 2,329 women in study 1 and 957 women in study 2 completed a survey.
Interventions/ Comparators	Study 1: Digital mammography versus DBT Digital mammography or DBT with or without breast MRI Study 2: Diagnostic mammography plus preoperative MRI versus diagnostic mammography alone
Outcomes	Study 1: screening benefits including rate of early-stage cancer detection; screening failures including rates of interval cancer and advanced cancer; screening harms including rates of false-positive recall and biopsy recommendations; patient-reported outcomes including screening confidence and cancer worry Study 2: rate of additional breast cancer detected within 6 months of initial diagnosis; rate of second breast cancer within 3 years; patient-reported outcomes including decision quality, decisional conflict, decision regret, and cancer worry
Timeframe	Study 1: Up to 1 year follow-up for study outcomes Study 2: Up to 3-year follow-up for study outcomes starting 1 year after surgery

These observational cohort studies compared the effect of breast imaging tests on screening benefits, harms, and failures; breast cancer recurrence; and patient-reported outcomes.

Study 1 included breast cancer screening data from 504,150 women who had digital mammography or DBT with or without a screening breast MRI. Study 2 included data from 20,383 women diagnosed with breast cancer who did or did not have a preoperative MRI.

In both studies, researchers analyzed outcomes separately for women with dense and non-dense breasts.

Women who had breast cancer, doctors, and patient advocates provided input during the studies.

Results

Women with dense breasts.

Study 1. Compared with DBT, women who had digital mammography did not differ significantly on clinical and most patient-reported outcomes except having lower cancer worry.

Compared with not having a screening MRI, women who had a screening MRI had higher screening benefits, screening harms, screening confidence, and cancer worry. Screening failures did not differ significantly between women who did and did not have a screening MRI.

Study 2. Compared to women with breast cancer who did not have a preoperative MRI, those who had one had higher rates of additional cancer detected at six months and higher cancer worry. Rates of second breast cancer at three years and other patient-reported outcomes did not differ significantly between women with and without a preoperative MRI.

Women with non-dense breasts.

Study 1. Compared with digital mammography, DBT had higher screening benefits and lower screening harms; screening failures and patient-reported outcomes did not differ significantly.

Compared with not having a screening MRI, women who had a screening MRI had higher screening benefits, screening harms, screening confidence, and cancer worry; screening failures did not differ significantly.

Study 2. Compared to women with breast cancer who did not have a preoperative MRI, those who had one had higher rates of additional cancer detected at six months and higher decision quality; rates of second breast cancer at three years and other patient-reported outcomes did not differ significantly.

Limitations

Researchers did not randomize participants; women may have differed systematically by cancer risk, reasons for screening, or unmeasured confounding variables, such as insurance type.

Conclusions and Relevance

Women with non-dense breasts had improved screening benefits and decreased harms with DBT versus digital mammography. Compared with mammography alone, supplemental MRI was associated with increased screening benefits and harms for women regardless of breast density.

Preoperative MRI was not associated with increased long-term detection of additional breast cancers.

Future Research Needs

Future research comparing screening and diagnostic tests among women with varying breast densities could adjust for additional confounding variables.