Magnetic resonance imaging in breast cancer: results of the COMICE trial

The primary endpoint of the COMICE trial considered the proportion of patients undergoing a repeat operation or mastectomy at further surgery within 6 months of randomisation, or an avoidable mastectomy at initial surgery (reoperation rate). This was compared using logistic regression adjusting for age, breast density, and surgeon.Between December 2001 and January 2007, 1,625 patients were randomised to receive MRI (n = 817) or not (n = 808). The reoperation rate within 6 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 reoperation 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.The 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.