MR Imaging in breast cancer – results of the COMICE trial
Lindsay Turnbull2, Ian Harvey2, Sarah Brown1, Andy Hanby3, Phil Drew4, Catherine Olivier1, Vicky Napp1, Julia Brown1
1Clinical Trials Research Unit, University of Leeds, Leeds, UK, 2Centre for MR Investigations, Hull Royal Infirmary, Hull, UK, 3St James's University Hospital, Leeds, UK, 4University of Hull, Hull, UK
The role of the addition of MR imaging (MRI) to routine techniques for loco-regional staging of primary breast cancer is unclear. The COMICE trial considered whether adding an MRI scan to conventional triple assessment (mammogram, ultrasound and biopsy) assisted loco-regional staging and thereby reduced re-operation rates, for patients with primary breast cancer scheduled for wide local excision.
The primary endpoint of the COMICE trial considered the proportion of patients undergoing a repeat operation or mastectomy at further surgery within six months of randomisation, or an avoidable mastectomy at initial surgery (re-operation rate). This was compared using logistic regression adjusting for age, breast density, and surgeon.
Between December 2001 and January 2007 1625 patients were randomised to receive MRI (817) or not (808). Re-operation rate within six months (primary outcome) was 18.8% (MRI) and 19.3% (no MRI). No significant difference between the arms was detected (odds ratio=0.96, 95% CI=[0.75, 1.24], p=0.7691). Secondary endpoints included quality of life, imaging effectiveness and local recurrence.
The results of the COMICE trial indicate no significant benefit in terms of reduction in re-operation rates, by the addition of MRI to conventional triple assessment for this patient group. These results have importance from both health economic and patient burden perspectives.
Acknowledgments
This project was funded by the NIHR Health Technology Assessment (HTA) Programme (project number 99/27/05) and will be published in full in a HTA report.
The view and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health.
