E-Newsletter - December 2017

Preoperative Breast MRI: Effects on Surgery, Costs and Quality of Life

Alliance A011104 - Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer

This randomized study will determine the effect of preoperative breast magnetic resonance imaging (MRI) on surgical outcomes in patients deemed eligible for breast conserving surgery by conventional clinical criteria. This study will provide important information about the clinical and biologic relevance of occult disease identified by MRI alone. Currently, the importance of these additional MRI-detected foci remains controversial and there is concern that the enhanced sensitivity of breast MRI may result in unnecessary mastectomy. The results of this study evaluating local recurrence rates in women who do and those who do not undergo preoperative MRI will provide critical information about the significance of these additional MRI detected foci. If the study results demonstrate that women who undergo breast conservation therapy (BCT) without the benefit of preoperative MRI have higher local recurrence rates compared to women staged preoperatively with breast MRI, then this would suggest that the occult areas of carcinoma, detected by MRI alone, are clinically relevant and if not surgically addressed, result in inferior local control. This finding would justify the routine use of preoperative MRI for staging of patients and selection for BCT. However, if the use of preoperative breast MRI does not improve on long-term local control rates, this would suggest that the increased sensitivity of breast MRI in detecting otherwise occult disease is not clinically significant and/or these additional areas are well controlled through the use of adjuvant radiation and systemic therapies. Therefore, the use of preoperative MRI for routine staging of women prior to breast surgery would not be warranted and the increased rates of mastectomy seen with utilization of breast MRI would not be justified.

In this study, patients eligible for breast conserving surgery will be randomized to standard preoperative breast cancer local-regional staging without the addition of MRI or standard preoperative breast cancer local-regional staging with the use of MRI. The primary objective is to compare the rates of local-regional recurrence (LRR) following attempted breast conserving therapy in a cohort of women with triple negative or HER-2 amplified breast cancer. Secondary endpoints and correlative studies include a comparison of the rates of re-excision between the arms as well as a cost efficacy analysis.

The cost effectiveness component to this study will capture significant data about the costs associated with the two treatment strategies and test the hypothesis that although preoperative breast MRI is expensive, these costs will be offset, in the short term, by reducing the number of operative interventions required to achieve margin negative BCT and, in the long term, by reduction in local recurrence events. In addition, QOL measurements of fatigue and overall perception of QOL will be assessed upon registration in this study. Evidence shows that baseline single-item assessments of fatigue and overall QOL are strong prognostic indicators for survival in cancer patients, independent of performance status.

Refer to the study protocol (Alliance A011104), which can be found on the Alliance website (AllianceforClinicalTrialsinOncology.org) for complete information on the trial design, treatment plan and patient eligibility. The Alliance Study Chair is Isabelle Bedrosian, MD, University of Texas MD Anderson Cancer Center, e-mail: ibedrosian@mdanderson.org.

Learn more about the Alliance A011104 trial here.


For other articles in the December issue of the Alliance E-News newsletter, see below.