The UK NIHR multicentre randomised COMICE trial of MRI planning for breast conserving treatment for breast cancer.

CTRC-AACR San Antonio Breast Cancer Symposium: 2008 Abstracts Abstract #51 The role of the addition of MR imaging (MRI) to routine techniques for loco-regional staging of primary breast cancer is unclear. The UK NIHR HTA multicentre 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. This project was funded by the NIHR Health Technology Assessment (HTA) Programme (project number 99/27/05) and will be published in full in an HTA report.The view and opinions expressed therein are those of the authors and do not necessarily reflect those of the UK Department of Health. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 51.