Constance D Lehman1, Constantine Gatsonis2, Justin Romanoff2, Seema A Khan3, Ruth Carlos4, Lawrence J Solin5, Sunil Badve6, Worta McCaskill-Stevens7, Ralph L Corsetti8, Habib Rahbar9, Derrick W Spell10, Kenneth B Blankstein11, Linda K Han6, Jennifer L Sabol12, John R Bumberry13, Ilana Gareen2, Bradley S Snyder2, Lynne I Wagner14, Kathy D Miller6, Joseph A Sparano15, Christopher Comstock16. 1. Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston. 2. Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island. 3. Department of Surgery, Northwestern University, Chicago, Illinois. 4. Department of Radiology, University of Michigan, Ann Arbor. 5. Department of Radiation Oncology, Albert Einstein Healthcare Network, Philadelphia, Pennsylvania. 6. Department of Pathology, Indiana University, Indianapolis. 7. National Cancer Institute, Bethesda, Maryland. 8. Department of Surgical Oncology, Ochsner Medical Center, New Orleans, Louisiana. 9. Department of Radiology, University of Washington, Seattle. 10. Gulf South National Cancer Institute Community Oncology Research Program, New Orleans, Louisiana. 11. Department of Medical Oncology, Hunterdon Medical Center, Flemington, New Jersey. 12. Department of Surgical Oncology, Lankenau Medical Center, Wynnewood, Pennsylvania. 13. Department of Surgery, Mercy Hospital, Springfield, Missouri. 14. Department of Social Science and Health Policy, Wake Forest University Health Sciences, Winston Salem, North Carolina. 15. Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York. 16. Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
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.
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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