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. FINDINGS 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). INTERPRETATION 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. FUNDING National Institute for Health Research's Health Technology Assessment Programme.

[1]  Les Irwig,et al.  Accuracy and surgical impact of magnetic resonance imaging in breast cancer staging: systematic review and meta-analysis in detection of multifocal and multicentric cancer. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[2]  P. Bult,et al.  The impact of preoperative breast MRI on the re-excision rate in invasive lobular carcinoma of the breast , 2009, Breast Cancer Research and Treatment.

[3]  H. Burdett.  ST. BARTHOLOMEW'S HOSPITAL , 1903, British medical journal.

[4]  D. Moher,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. , 2001, Journal of the American Podiatric Medical Association.

[5]  W. Kaiser,et al.  MR imaging of the breast: fast imaging sequences with and without Gd-DTPA. Preliminary observations. , 1989, Radiology.

[6]  J. Kurtz.  How to predict the risk of local relapse in the preserved breast. , 1996, Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer.

[7]  J. Pater.  Quality of life and pharmacoeconomics in clinical trials , 1996 .

[8]  C. Geyer,et al.  Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in five National Surgical Adjuvant Breast and Bowel Project node-positive adjuvant breast cancer trials. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[9]  J. Hendriks,et al.  Histologic multifocality of tis, T1–2 breast carcinomas implications for clinical trials of breast‐conserving surgery , 1985, Cancer.

[10]  Rolf Vosshenrich,et al.  Signalverhalten maligner und benigner Läsionen in der dynamischen 2D-MRT der Mamma , 1993 .

[11]  D. Schultz,et al.  Role of magnetic resonance imaging and magnetic resonance imaging--guided surgery in the evaluation of patients with early-stage breast cancer for breast conservation treatment. , 1999, American journal of clinical oncology.

[12]  C. Kuhl,et al.  Dynamic breast MR imaging: are signal intensity time course data useful for differential diagnosis of enhancing lesions? , 1999, Radiology.

[13]  P. Drew,et al.  Multicentre randomised controlled trial examining the cost-effectiveness of contrast-enhanced high field magnetic resonance imaging in women with primary breast cancer scheduled for wide local excision (COMICE). , 2010, Health Technology Assessment.

[14]  N. Warner.  Lobular carcinoma of the breast , 1969, Cancer.

[15]  D. Moher,et al.  The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials , 2001, The Lancet.

[16]  Rebecca S Lewis,et al.  Diagnostic accuracy of mammography, clinical examination, US, and MR imaging in preoperative assessment of breast cancer. , 2004, Radiology.

[17]  Nehmat Houssami,et al.  Review of Preoperative Magnetic Resonance Imaging (MRI) in Breast Cancer: Should MRI Be Performed on All Women with Newly Diagnosed, Early Stage Breast Cancer? , 2009, CA: a cancer journal for clinicians.

[18]  A. Kasuya.  EuroQol--a new facility for the measurement of health-related quality of life. , 1990, Health policy.

[19]  M. Cobleigh,et al.  Should multicentric disease be an absolute contraindication to the use of breast-conserving therapy? , 1994, International journal of radiation oncology, biology, physics.

[20]  A. Williams.  EuroQol : a new facility for the measurement of health-related quality of life , 1990 .

[21]  L. Esserman,et al.  Utility of magnetic resonance imaging in the management of breast cancer: evidence for improved preoperative staging. , 1999, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  M. Schnall,et al.  Relationship of breast magnetic resonance imaging to outcome after breast-conservation treatment with radiation for women with early-stage invasive breast carcinoma or ductal carcinoma in situ. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[23]  C Kuhl,et al.  Pre-operative staging of breast cancer with breast MRI: one step forward, two steps back? , 2007, Breast.

[24]  D S Tulsky,et al.  Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[25]  E Grabbe,et al.  Breast carcinoma: effect of preoperative contrast-enhanced MR imaging on the therapeutic approach. , 1999, Radiology.

[26]  S. Astley,et al.  New avenues in 3-D computerised (stereopathological) imaging of breast cancer (review). , 1996, Anticancer research.

[27]  D. Tulsky,et al.  The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. , 1993, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[28]  J. Jacquemier,et al.  Breast‐conserving Therapy for Macroscopically Multiple Cancers , 1990, Annals of surgery.

[29]  S. Schnitt,et al.  Results of conservative surgery and radiation therapy for multiple synchronous cancers of one breast. , 1987, International journal of radiation oncology, biology, physics.

[30]  E Grabbe,et al.  [Signal characteristics of malignant and benign lesions in dynamic 2D-MRT of the breast]. , 1993, RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin.