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Clinical Trial
. 2019 Jul 1;5(7):1036-1042.
doi: 10.1001/jamaoncol.2018.6269.

Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay With Breast Ductal Carcinoma In Situ Treatment

Constance D Lehman  1 , Constantine Gatsonis  2 , Justin Romanoff  2 , Seema A Khan  3 , Ruth Carlos  4 , Lawrence J Solin  5 , Sunil Badve  6 , Worta McCaskill-Stevens  7 , Ralph L Corsetti  8 , Habib Rahbar  9 , Derrick W Spell  10 , Kenneth B Blankstein  11 , Linda K Han  6 , Jennifer L Sabol  12 , John R Bumberry  13 , Ilana Gareen  2 , Bradley S Snyder  2 , Lynne I Wagner  14 , Kathy D Miller  6 , Joseph A Sparano  15 , Christopher Comstock  16
Affiliations
Clinical Trial

Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay With Breast Ductal Carcinoma In Situ Treatment

Constance D Lehman et al. JAMA Oncol. .

Abstract

Importance: Advanced diagnostics, such as magnetic resonance imaging (MRI) and gene expression profiles, are potentially useful to guide targeted treatment in patients with ductal carcinoma in situ (DCIS).

Objectives: To examine the proportion of patients who converted to mastectomy after MRI and the reasons for those conversions and to measure patient adherence to radiotherapy guided by the 12-gene DCIS score.

Design, setting, and participants: Analysis of a prospective, cohort, nonrandomized clinical trial that enrolled women with DCIS on core biopsy who were candidates for wide local excision (WLE) from 75 institutions from March 25, 2015, to April 27, 2016, through the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network trial E4112.

Interventions: Participants underwent breast MRI before surgery, and subsequent management incorporated MRI findings for choice of surgery. The DCIS score was used to guide radiotherapy recommendations among women with DCIS who had WLE as the final procedure and had tumor-free excision margins of 2 mm or greater.

Main outcomes and measures: The primary end point was to estimate the conversion rate to mastectomy and the reason for conversion.

Results: Of 339 evaluable women (mean [SD] age, 59.1 [10.1] years; 262 [77.3%] of European descent) eligible for WLE before MRI, 65 (19.2%; 95% CI, 15.3%-23.7%) converted to mastectomy. Of these 65 patients, conversion was based on MRI findings in 25 (38.5%), patient preference in 25 (38.5%), positive margins after attempted WLE in 10 (15.4%), positive genetic test results in 3 (4.6%), and contraindication to radiotherapy in 2 (3.1%). Among the 285 who had WLE performed after MRI as the first surgical procedure, 274 (96.1%) achieved successful breast conservation. Of 171 women eligible for radiotherapy guided by DCIS score (clear margins, absence of invasive disease, and score obtained), the score was low (<39) in 82 (48.0%; 95% CI, 40.6%-55.4%) and intermediate-high (≥39) in 89 (52.0%; 95% CI, 44.6%-59.4%). Of these 171 patients, 159 (93.0%) were adherent with recommendations.

Conclusions and relevance: Among women with DCIS who were WLE candidates based on conventional imaging, multiple factors were associated with conversion to mastectomy. This study may provide useful preliminary information required for designing a planned randomized clinical trial to determine the effect of MRI and DCIS score on surgical management, radiotherapy, overall resource use, and clinical outcomes, with the ultimate goal of achieving greater therapeutic precision.

Trial registration: ClinicalTrials.gov identifier: NCT02352883.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Lehman serves on a medical history advisory board for GE Healthcare and receives research support through her institution from GE Healthcare. Dr Gatsonis received grants from the National Cancer Institute during the conduct of the study and receives personal fees from Zionexa/Cyclopharma and EBG outside the submitted work. Dr Solin is on the speakers bureau for Genomic Health Inc. Dr Badve is on the speakers bureau and ad hoc advisory boards for Genomic Health Inc. Dr Rahbar receives salary support from a grant from GE Healthcare. Dr Wagner has done consulting for Celgene outside the submitted work. Dr Comstock has received funding from Bracco outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Flow Diagram of a Nonrandomized Clinical Trial
DCIS indicates ductal carcinoma in situ; MRI, magnetic resonance imaging; and WLE, wide local excision.
See this image and copyright information in PMC

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References

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