TY - JOUR
T1 - Preoperative breast magnetic resonance imaging in women with local ductal carcinoma in situ to optimize surgical outcomes
T2 - Results from the randomized Phase III Trial IRCIS
AU - Balleyguier, Corinne
AU - Dunant, Ariane
AU - Ceugnart, Luc
AU - Kandel, Marguerite
AU - Chauvet, Marie Pierre
AU - Chérel, Pascal
AU - Mazouni, Chafika
AU - Henrot, Philippe
AU - Rauch, Philippe
AU - Chopier, Jocelyne
AU - Zilberman, Sonia
AU - Doutriaux-Dumoulin, Isabelle
AU - Jaffre, Isabelle
AU - Jalaguier, Aurélie
AU - Houvenaeghel, Gilles
AU - Guérin, Nicole
AU - Callonnec, Françoise
AU - Chapellier, Claire
AU - Raoust, Ines
AU - Mathieu, Marie Christine
AU - Rimareix, Françoise
AU - Bonastre, Julia
AU - Garbay, Jean Rémi
N1 - Publisher Copyright:
© 2019 by American Society of Clinical Oncology.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - PURPOSE We evaluated the addition of breast magnetic resonance imaging (MRI) to standard radiologic evaluation on the re-intervention rate in women with ductal carcinoma in situ (DCIS) undergoing breastconserving surgery. PATIENTS AND METHODS Women with biopsy-proven DCIS corresponding to a unifocal microcalcification cluster or a mass less than 30 mm were randomly assigned to undergo MRI or standard evaluation. The primary end point was the re-intervention rate for positive or close margins (, 2 mm) in the 6 months after randomization (ClinicalTrials.gov identifier: NCT01112254). RESULTS A total of 360 patients from 10 hospitals in France were included in the study. Of the 352 analyzable patients, 178 were randomly assigned to theMRI arm, and 174 were assigned to the control arm. In the intentto- treat analysis, 82 of 345 patients with the assessable end point were reoperated for positive or closemargins within 6 months, resulting in a re-intervention rate of 20% (35 of 173) in the MRI arm and 27% (47 of 172) in the control arm. The absolute difference of 7% (95% CI, 22% to 16%) corresponded to a relative reduction of 26% (stratified odds ratio, 0.68; 95% CI, 0.41 to 1.1; P = .13). When considering only the per-protocol population with an assessable end point, the difference was 9% (stratified odds ratio, 0.59; 95% CI, 0.35 to 1.0; P = .05). Totalmastectomy rates were 18% (31 of 176) in theMRI arm and 17% (30 of 173) in the control arm (stratified P = .93). For 100 lesions seen on MRI, nonmass-like enhancement was more predominant (82%) than mass enhancement (20%). Nevertheless, no specific morphologic and kinetic parameters for DCIS were identified. CONCLUSION The study did not show sufficient surgical improvement with the use of preoperative MRI to be clinically relevant in DCIS staging. However, this could be reconsidered with the improvement of new MRI sequences and new modalities in magnetic resonance techniques.
AB - PURPOSE We evaluated the addition of breast magnetic resonance imaging (MRI) to standard radiologic evaluation on the re-intervention rate in women with ductal carcinoma in situ (DCIS) undergoing breastconserving surgery. PATIENTS AND METHODS Women with biopsy-proven DCIS corresponding to a unifocal microcalcification cluster or a mass less than 30 mm were randomly assigned to undergo MRI or standard evaluation. The primary end point was the re-intervention rate for positive or close margins (, 2 mm) in the 6 months after randomization (ClinicalTrials.gov identifier: NCT01112254). RESULTS A total of 360 patients from 10 hospitals in France were included in the study. Of the 352 analyzable patients, 178 were randomly assigned to theMRI arm, and 174 were assigned to the control arm. In the intentto- treat analysis, 82 of 345 patients with the assessable end point were reoperated for positive or closemargins within 6 months, resulting in a re-intervention rate of 20% (35 of 173) in the MRI arm and 27% (47 of 172) in the control arm. The absolute difference of 7% (95% CI, 22% to 16%) corresponded to a relative reduction of 26% (stratified odds ratio, 0.68; 95% CI, 0.41 to 1.1; P = .13). When considering only the per-protocol population with an assessable end point, the difference was 9% (stratified odds ratio, 0.59; 95% CI, 0.35 to 1.0; P = .05). Totalmastectomy rates were 18% (31 of 176) in theMRI arm and 17% (30 of 173) in the control arm (stratified P = .93). For 100 lesions seen on MRI, nonmass-like enhancement was more predominant (82%) than mass enhancement (20%). Nevertheless, no specific morphologic and kinetic parameters for DCIS were identified. CONCLUSION The study did not show sufficient surgical improvement with the use of preoperative MRI to be clinically relevant in DCIS staging. However, this could be reconsidered with the improvement of new MRI sequences and new modalities in magnetic resonance techniques.
UR - http://www.scopus.com/inward/record.url?scp=85064478861&partnerID=8YFLogxK
U2 - 10.1200/JCO.18.00595
DO - 10.1200/JCO.18.00595
M3 - Article
C2 - 30811290
AN - SCOPUS:85064478861
SN - 0732-183X
VL - 37
SP - 885
EP - 892
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 11
ER -