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Original Investigation
January 17, 2019

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

Author Affiliations
  • 1Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston
  • 2Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island
  • 3Department of Surgery, Northwestern University, Chicago, Illinois
  • 4Department of Radiology, University of Michigan, Ann Arbor
  • 5Department of Radiation Oncology, Albert Einstein Healthcare Network, Philadelphia, Pennsylvania
  • 6Department of Pathology, Indiana University, Indianapolis
  • 7National Cancer Institute, Bethesda, Maryland
  • 8Department of Surgical Oncology, Ochsner Medical Center, New Orleans, Louisiana
  • 9Department of Radiology, University of Washington, Seattle
  • 10Gulf South National Cancer Institute Community Oncology Research Program, New Orleans, Louisiana
  • 11Department of Medical Oncology, Hunterdon Medical Center, Flemington, New Jersey
  • 12Department of Surgical Oncology, Lankenau Medical Center, Wynnewood, Pennsylvania
  • 13Department of Surgery, Mercy Hospital, Springfield, Missouri
  • 14Department of Social Science and Health Policy, Wake Forest University Health Sciences, Winston Salem, North Carolina
  • 15Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York
  • 16Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York
JAMA Oncol. 2019;5(7):1036-1042. doi:10.1001/jamaoncol.2018.6269
Key Points

Question  What is the association of breast magnetic resonance imaging and a 12-gene expression assay with the treatment of women with ductal carcinoma in situ of the breast who are candidates for breast conservation surgery and radiotherapy?

Findings  In this nonrandomized clinical trial of a prespecified primary outcome among 339 women with pure ductal carcinoma in situ, after magnetic resonance imaging, 19% of patients eligible for wide local excision converted to mastectomy; 38% of conversions were based on magnetic resonance imaging findings and 62% on other reasons. Wide local excision was the final surgical procedure in 96% of women who received it as the first procedure after magnetic resonance imaging, and adherence to radiotherapy use guided by a 12-gene assay exceeded 90%.

Meaning  Breast magnetic resonance imaging and a 12-gene assay may be used to tailor primary surgical treatment and radiotherapy, respectively, and inform patient and physician decision-making to support more targeted therapy.

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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