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

Constance D. Lehman, Constantine Gatsonis, Justin Romanoff, Seema A. Khan, Ruth Carlos, Lawrence J. Solin, Sunil Badve, Worta McCaskill-Stevens, Ralph L. Corsetti, Habib Rahbar, Derrick W. Spell, Kenneth B. Blankstein, Linda K. Han, Jennifer L. Sabol, John R. Bumberry, Ilana Gareen, Bradley S. Snyder, Lynne I. Wagner, Kathy Miller, Joseph A. Sparano & 1 others Christopher Comstock

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish (US)
JournalJAMA oncology
DOIs
StateAccepted/In press - Jan 1 2019

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Carcinoma, Intraductal, Noninfiltrating
Magnetic Resonance Imaging
Gene Expression
Mastectomy
Radiotherapy
Therapeutics
Breast
Breast Carcinoma In Situ
Patient Preference
Patient Compliance
Transcriptome
Radiology
Randomized Controlled Trials
Outcome Assessment (Health Care)
Biopsy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Lehman, C. D., Gatsonis, C., Romanoff, J., Khan, S. A., Carlos, R., Solin, L. J., ... Comstock, C. (Accepted/In press). Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment. JAMA oncology. https://doi.org/10.1001/jamaoncol.2018.6269

Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment. / Lehman, Constance D.; Gatsonis, Constantine; Romanoff, Justin; Khan, Seema A.; Carlos, Ruth; Solin, Lawrence J.; Badve, Sunil; McCaskill-Stevens, Worta; Corsetti, Ralph L.; Rahbar, Habib; Spell, Derrick W.; Blankstein, Kenneth B.; Han, Linda K.; Sabol, Jennifer L.; Bumberry, John R.; Gareen, Ilana; Snyder, Bradley S.; Wagner, Lynne I.; Miller, Kathy; Sparano, Joseph A.; Comstock, Christopher.

In: JAMA oncology, 01.01.2019.

Research output: Contribution to journalArticle

Lehman, CD, Gatsonis, C, Romanoff, J, Khan, SA, Carlos, R, Solin, LJ, Badve, S, McCaskill-Stevens, W, Corsetti, RL, Rahbar, H, Spell, DW, Blankstein, KB, Han, LK, Sabol, JL, Bumberry, JR, Gareen, I, Snyder, BS, Wagner, LI, Miller, K, Sparano, JA & Comstock, C 2019, 'Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment', JAMA oncology. https://doi.org/10.1001/jamaoncol.2018.6269
Lehman, Constance D. ; Gatsonis, Constantine ; Romanoff, Justin ; Khan, Seema A. ; Carlos, Ruth ; Solin, Lawrence J. ; Badve, Sunil ; McCaskill-Stevens, Worta ; Corsetti, Ralph L. ; Rahbar, Habib ; Spell, Derrick W. ; Blankstein, Kenneth B. ; Han, Linda K. ; Sabol, Jennifer L. ; Bumberry, John R. ; Gareen, Ilana ; Snyder, Bradley S. ; Wagner, Lynne I. ; Miller, Kathy ; Sparano, Joseph A. ; Comstock, Christopher. / Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment. In: JAMA oncology. 2019.
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title = "Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment",
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.",
author = "Lehman, {Constance D.} and Constantine Gatsonis and Justin Romanoff and Khan, {Seema A.} and Ruth Carlos and Solin, {Lawrence J.} and Sunil Badve and Worta McCaskill-Stevens and Corsetti, {Ralph L.} and Habib Rahbar and Spell, {Derrick W.} and Blankstein, {Kenneth B.} and Han, {Linda K.} and Sabol, {Jennifer L.} and Bumberry, {John R.} and Ilana Gareen and Snyder, {Bradley S.} and Wagner, {Lynne I.} and Kathy Miller and Sparano, {Joseph A.} and Christopher Comstock",
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T1 - Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay with Breast Ductal Carcinoma in Situ Treatment

AU - Lehman, Constance D.

AU - Gatsonis, Constantine

AU - Romanoff, Justin

AU - Khan, Seema A.

AU - Carlos, Ruth

AU - Solin, Lawrence J.

AU - Badve, Sunil

AU - McCaskill-Stevens, Worta

AU - Corsetti, Ralph L.

AU - Rahbar, Habib

AU - Spell, Derrick W.

AU - Blankstein, Kenneth B.

AU - Han, Linda K.

AU - Sabol, Jennifer L.

AU - Bumberry, John R.

AU - Gareen, Ilana

AU - Snyder, Bradley S.

AU - Wagner, Lynne I.

AU - Miller, Kathy

AU - Sparano, Joseph A.

AU - Comstock, Christopher

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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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