Dataset Information

Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection.

ABSTRACT:

Background

Abbreviated breast MRI (A-MRI) substantially reduces the image acquisition and reading times and has been reported to have similar diagnostic accuracy as a full diagnostic protocol but has not been evaluated prospectively with respect to impact on psychological distress in women with a prior history of breast cancer (PHBC). This study aimed to determine if surveillance mammography (MG) plus A-MRI reduced psychological distress and if A-MRI improved cancer detection rates (CDR) as compared to MG alone.

Methods

This prospective controlled trial of parallel design was performed at a tertiary cancer center on asymptomatic women with PHBC who were randomized into two groups: routine surveillance with MG or intervention of MG plus A-MRI in a 1:1 ratio. Primary outcome was anxiety measured by four validated questionnaires at three different time-points during the study. Other parameters including CDR and positive predictive value for biopsy (PPV3) were compared between imaging modalities of MG and A-MRI. Tissue diagnoses or 1 year of follow-up were used to establish the reference standard. Linear mixed models were used to analyze anxiety measures and Fisher's exact test to compare imaging outcomes.

Results

One hundred ninety-eight patients were allocated to either MG alone (94) or MG plus A-MRI (104). No significant group difference emerged for improvement in trait anxiety, worry and perceived health status (all Time-by-surveillance group interaction ps > .05). There was some advantage of A-MRI in reducing state anxiety at Time 2 (p < .05). Anxiety scores in all questionnaires were similarly elevated in both groups (50.99 ± 4.6 with MG alone vs 51.73 ± 2.56 with MG plus A-MRI, p > 0.05) and did not change over time. A-MRI detected 5 invasive cancers and 1 ductal carcinoma in situ (DCIS), and MG detected 1 DCIS. A-MRI had higher incremental CDR (48/1000(5/104) vs MG 5/1000(1/198, p = 0.01)) and higher biopsy rates (19.2% (20/104) vs MG 2.1% (2/94), p < 0.00001) with no difference in PPV3 (A-MRI 28.6% (6/21) vs MG 16.7% (1/6, p > .05).

Conclusion

There was no significant impact of A-MRI to patient anxiety or perceived health status. Compared to MG alone, A-MRI had significantly higher incremental cancer detection in PHBC. Despite a higher rate of biopsies, A-MRI had no demonstrable impact on anxiety, worry, and perceived health status.

Trial registration

ClinicalTrials.gov ( NCT02244593 ). Prospectively registered on Sept. 14, 2014.

SUBMITTER: Fonseca MM

PROVIDER: S-EPMC9287889 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection.

Fonseca Marina Mohallem MM Alhassan Tasneem T Nisha Yashmin Y Koszycki Diana D Schwarz Betty Anne BA Segal Roanne R Arnaout Angel A Ramsay Tim T Lau Jacqueline J Seely Jean M JM

BMC cancer 20220715 1

<h4>Background</h4>Abbreviated breast MRI (A-MRI) substantially reduces the image acquisition and reading times and has been reported to have similar diagnostic accuracy as a full diagnostic protocol but has not been evaluated prospectively with respect to impact on psychological distress in women with a prior history of breast cancer (PHBC). This study aimed to determine if surveillance mammography (MG) plus A-MRI reduced psychological distress and if A-MRI improved cancer detection rates (CDR) ...[more]

PMID: 35840916

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Project description:PURPOSE:To investigate the feasibility of abbreviated magnetic resonance imaging (AB-MRI) in women with a personal history (PH) of breast cancer as a screening tool. MATERIALS AND METHODS:We retrospectively reviewed 1880 screening AB-MRIs in 763 women with a PH of breast cancer (median age, 55 years; range, 23-89 years) between October 2015 and October 2016. The total acquisition times of AB-MRI were 8.3 min and 2.8 min with and without T2-weighted imaging, respectively. The tissue diagnosis or one-year follow-up status was used as the reference standard. The characteristics of tumor recurrences detected on AB-MRI screenings were analyzed. The cancer detection rates (CDRs) and additional CDRs for the 1st round and overall rounds of AB-MRI screening were calculated. The recall rate, sensitivity, specificity, positive predictive values for recall (PPV1) and biopsy (PPV3) for the 1st round of AB-MRI screening were calculated. The diagnostic performance of the combination of mammography and ultrasonography was compared with that of AB-MRI by receiver operating characteristic (ROC) curve analysis. RESULTS:Fifteen of a total of 21 recurrences were detected on the 1st round of AB-MRI screening: 93.3% were node-negative T1 tumors (median tumor size, 1.02 cm; range, 0.1-2 cm) or Tis; 66.7% were high-grade tumors; 8 of these 15 were mammographically and ultrasonographically occult. The CDR and additional CDR for the 1st round of AB-MRI screening were 0.019 and 0.010 per woman, respectively. The sensitivity, specificity, recall rate, PPV1 and PPV3 for the 1st round of AB-MRI screening were 100%, 96.0%, 14.3%, 13.8% and 58.3%, respectively. For detecting secondary cancer, AB-MRI showed a higher sensitivity and PPV than the combination of mammography and ultrasonography (95.2%, 57.1% vs 47.6%, 38.5%). The area under the ROC curve was higher for AB-MRI (0.966; 95% CI: 0.951-0.978) than the combination of mammography and ultrasonography (0.727; 95% CI: 0.694-0.759) (P<0.0001). CONCLUSION:AB-MRI improved cancer detection with a high specificity, sensitivity and PPV in women with a PH of breast cancer. AB-MRI could be a useful screening tool for detecting secondary cancer considering its high diagnostic performance and short examination time.

Project description:Background There is lack of consensus regarding the use of breast MRI for routine surveillance for second breast cancer events in women with a personal history of breast cancer. Purpose To compare performance of surveillance mammography with breast MRI. Materials and Methods This observational cohort study used prospectively collected data and included 13 266 women age 18 years and older (mean age, 60 years ± 13) with stage 0-III breast cancer who underwent 33 938 mammographic examinations and 2506 breast MRI examinations from 2005 to 2012 in the Breast Cancer Surveillance Consortium. Women were categorized into two groups: mammography alone (n = 11 745) or breast MRI (n = 1521). Performance measures were calculated by using end-of-day assessment and occurrence of second breast cancer events within 1 year of imaging. Logistic regression was used to compare performance for breast MRI versus mammography alone, adjusting for women, examination, and primary breast cancer characteristics. Analysis was conducted on a per-examination basis. Results Breast MRI was associated with younger age at diagnosis, chemotherapy, and higher education and income. Raw performance measures for breast MRI versus mammography were as follows, respectively: cancer detection rates, 10.8 (95% confidence interval [CI]: 6.7, 14.8) versus 8.2 (95% CI: 7.3, 9.2) per 1000 examinations; sensitivity, 61.4% (27 of 44; 95% CI: 46.5%, 76.2%) versus 70.3% (279 of 397; 95% CI: 65.8%, 74.8%); and biopsy rate, 10.1% (253 of 2506; 95% CI: 8.9%, 11.3%) versus 4.0% (1343 of 33 938; 95% CI: 3.7%, 4.2%). In multivariable models, breast MRI was associated with higher biopsy rate (odds ratio [OR], 2.2; 95% CI: 1.9, 2.7; P < .001) and cancer detection rate (OR, 1.7; 95% CI: 1.1, 2.7; P = .03) than mammography alone. However, there were no differences in sensitivity (OR, 1.1; 95% CI: 0.4, 2.9; P = .84) or interval cancer rate (OR, 1.1; 95% CI: 0.6, 2.2; P = .70). Conclusion Comparison of the performance of surveillance breast MRI with mammography must account for patient characteristics. Whereas breast MRI leads to higher biopsy and cancer detection rates, there were no significant differences in sensitivity or interval cancers compared with mammography. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Newell in this issue.

Project description:ImportanceImproved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.ObjectiveTo compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.Design, setting, and participantsCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.ExposuresAll women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.Main outcomes and measuresThe primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.ResultsAmong 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).Conclusions and relevanceAmong women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.Trial registrationClinicalTrials.gov Identifier: NCT02933489.

Project description:BackgroundNational patterns of breast imaging in women with a personal history of breast cancer (PHBC) are unknown making evaluation of annual surveillance recommendations a challenge.ObjectiveTo describe variation in use of mammography and breast magnetic resonance imaging (MRI) examinations beginning 6 months after diagnosis among women with PHBC in US community practice. We report on the breast imaging indication, imaging intervals, and time since breast cancer diagnosis by examination type.DesignLongitudinal study using cross-sectional data.SettingBreast Cancer Surveillance Consortium breast imaging facilities.Participants19,955 women diagnosed between 2005 and 2012 with AJCC stage 0-III incident breast cancer who had 69,386 mammograms and 3,553 breast MRI examinations from January 2005 to September 2013; median follow-up of 37.6 months (interquartile range, 22.1-60.7).Main measuresBreast imaging indication, imaging intervals, and time since breast cancer diagnosis by examination type.Key resultsAmong women with a PHBC who received breast imaging, 89.4% underwent mammography alone, 0.8% MRI alone, and 10.3% had both mammography and MRI. About half of mammograms and MRIs were indicated for surveillance vs. diagnostic, with an increase in the proportion of surveillance exams as time from diagnosis increased (mammograms, 45.7% at 1 year to 72.2% after 5 years; MRIs, 54.8% at 1 year to 78.6% after 5 years). In the first post-diagnosis period, 32.8% of women had > 2 breast imaging examinations and of these, 65.8% were less than 6 months apart. During the first 5-year post-diagnosis, the frequency of examinations per year decreased and the interval between examinations shifted towards annual examinations.ConclusionIn women with a PHBC who received post-diagnosis imaging, a third underwent multiple breast imaging examinations per year during the first 2-year post-diagnosis despite recommendations for annual exams. As time since diagnosis increases, imaging indication shifts from diagnostic to surveillance.

Dataset Information

Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection.

Background

Methods

Results

Conclusion

Trial registration

Publications

Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection.

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