Comparative effectiveness of MRI in breast cancer (COMICE) trial: a randomised controlled trial.
BACKGROUND
MRI might improve diagnosis of breast cancer, reducing rates of reoperation. We assessed the clinical efficacy of contrast-enhanced MRI in women with primary breast cancer.


METHODS
We undertook an open, parallel group trial in 45 UK centres, with 1623 women aged 18 years or older with biopsy-proven primary breast cancer who were scheduled for wide local excision after triple assessment. Patients were randomly assigned to receive either MRI (n=816) or no further imaging (807), with use of a minimisation algorithm incorporating a random element. The primary endpoint was the proportion of patients undergoing a repeat operation or further mastectomy within 6 months of random assignment, or a pathologically avoidable mastectomy at initial operation. Analysis was by intention to treat. This study is registered, ISRCTN number 57474502.


RESULTS
816 patients were randomly assigned to MRI and 807 to no MRI. Addition of MRI to conventional triple assessment was not significantly associated with reduced a reoperation rate, with 153 (19%) needing reoperation in the MRI group versus 156 (19%) in the no MRI group, (odds ratio 0.96, 95% CI 0.75-1.24; p=0.77).


CONCLUSIONS
Our findings are of benefit to the NHS because they show that MRI might be unnecessary in this population of patients to reduce repeat operation rates, and could assist in improved use of NHS services.


BACKGROUND
National Institute for Health Research's Health Technology Assessment Programme.
Turnbull
Lindsay
L
Centre for Magnetic Resonance Investigations, Hull Royal Infirmary, Hull, UK. l.w.turnbull@hull.ac.uk
Brown
Sarah
S
Harvey
Ian
I
Olivier
Catherine
C
Drew
Phil
P
Napp
Vicky
V
Hanby
Andrew
A
Brown
Julia
J
D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000473:pathology* / Q000601:surgery; D003287:Contrast Media; D003362:Cost-Benefit Analysis; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000191:economics; D008327:Mammography; D008408:Mastectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D017698:Postmenopause; D011788:Quality of Life; D013222:State Medicine / Q000191:economics; D016896:Treatment Outcome; D016217:Ultrasonography, Mammary; D006113:United Kingdom
D003287:Contrast Media; D019786:Gadolinium DTPA