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Advances in Breast Surgery, 2002-2012

Stephen B. Edge

The past 40 years have brought dramatic changes in breast cancer treatments, resulting in a 30% reduction in breast cancer mortality. This is largely the result of new concepts tested in a steady stream of large, well-designed, coordinated clinical trials. Early trials showed that extended surgery (“local therapy”) does not improve mortality over less aggressive surgery. Trials conducted in the 1970s and 1980s clearly showed that radical surgery involving removal of the breast provides no outcome advantage over breast-conserving therapy (BCT). One concern with BCT has been a higher rate of local recurrence compared with mastectomy, with initial studies before the routine use of systemic therapy reporting rates of 10% to 20% with BCT. Modern series define a risk of local recurrence after BCT of 2% to 5%, about the same as with mastectomy. The improvement is partly due to improved standards in surgery, radiation oncology, and pathology. However, it is primarily due to the use of systemic endocrine and chemotherapy. BCT is appropriate for most women with breast cancer. This article explores the advancements in breast surgery over the past 10 years.

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The NCCN Guidelines Program and Opportunities for Quality Improvement

Stephen B. Edge

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Evidence and Controversies in the Use of Post-Mastectomy Radiation

Shaneli A. Fernando and Stephen B. Edge

Radiation after mastectomy is recommended for women with positive nodes, larger tumors, or positive margins. In addition to its role in reducing the risk for locoregional recurrence, it has an additive effect to the survival benefit seen with adjuvant systemic therapy. This article reviews the role of post-mastectomy radiation (PMRT) based on the recommendations in the 2007 NCCN Breast Cancer Clinical Practice Guidelines in Oncology and addresses the risk factors for recurrence after mastectomy. The data supporting both improvement in locoregional failure and survival are reviewed in detail. This article also discusses controversial areas in PMRT, including regional nodal radiation in women with 1 to 3 positive lymph nodes, PMRT in node-negative women with large tumors, and inclusion of internal mammary nodes. The final section discusses radiation field design and potential complications.

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Counterpoint: Sentinel Lymph Node Biopsy Is Not Indicated for Ductal Carcinoma In Situ

Stephen B. Edge and David G. Sheldon

The purpose of axillary surgery in breast cancer is to provide prognostic information to guide the choice of adjuvant systemic therapy. Axillary surgery for ductal carcinoma in situ (DCIS) was abandoned in the 1980s because of the extremely low risk of lymph node metastases and high survival rates. Most women with metastases probably harbored an unrecognized focus of invasion or had metastases subsequent to an invasive local recurrence. Increased use of the less morbid sentinel node biopsy (SNB) for axillary staging of invasive cancer and the recognition that many patients will harbor micrometastases in nodes only recognized by cytokeratin immunohistochemistry (IHC) led two groups to perform SNB with IHC in women with DCIS. One group included all subtypes of DCIS and found metastases in 13% (half of which were detected only on IHC). The other group studied only patients with “high-risk” DCIS. They found metastases in 12% (7 of 9 by IHC only). These groups recommend SNB for women with DCIS. However, the use of SNB in DCIS should be tempered by the uncertainty of the prognostic significance of IHC-detected metastases, the conflicting results of these 2 studies, and the real potential to cause more harm than good from the morbidity of the procedure, the application of unnecessary axillary dissection, and the use of unwarranted adjuvant systemic chemotherapy. These results should be used to generate hypotheses for clinical trials addressing these problems. However, SNB for DCIS remains investigational and should not be generally applied.

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Is There a Need for Axillary Dissection in Breast Cancer?

Jason P. Wilson, David Mattson, and Stephen B. Edge

The involvement of axillary nodes remains a significant prognostic factor in breast cancer. However, management has changed from complete surgical staging to sentinel lymph node biopsies. Although little controversy exists regarding patients with negative sentinel lymph node biopsies, some remains regarding what to do with patients with small volume of axillary disease. This article focuses on the examination of recent evidence in management of the axilla. It focuses on both the prognostic and therapeutic information gleaned from isolated tumor cells and micrometastatic disease and on the use of completion axillary lymph node dissections or axillary radiation in preventing regional recurrence.

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NCCN Roundtable:Value-Based Decision-Making at the Bedside

Peter B. Bach, Stephen B. Edge, Linda House, Jennifer Malin, James L. Mohler, and Clifford Goodman

As part of the NCCN 20th Annual Conference: Advancing the Standard of Cancer Care, a distinguished and diverse group of experts on value-based decision-making in oncology discussed guidelines and pathways and how their use has impacted bedside evidence-based decision-making for both physicians and patients. Moderated by Clifford Goodman, PhD, the roundtable also reflected on the criteria used to assess shared decision-making and the relationship between outcomes and cost when determining value.

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Breast Cancer Center: Improving Access to Patient Care

Jatinder Singh, Stephen B. Edge, Ermelinda Bonaccio, Kathleen Trapp Schwert, and Brian Braun

To improve access for patients to the Breast Cancer Center at Roswell Park Cancer Institute, the Opportunities for Improvement Project team defined 3 goals: reduce the delay to initial appointment, reduce delays in treatment at the Breast Cancer Center, and reduce delays in the start of endocrine therapy. The team developed a set of tools using Lean methodology that helped to address variables contributing to inefficiencies that result in delays. The idea behind these tools was to integrate all the business variables, such as volume, clinical space, physician availability, services offered in the Breast Program, and patient types, to produce a system or schedule that is more predictable. A new schedule for physicians, independent mid-level clinics, a survivorship program, a primary nursing model, and new roles and responsibilities were defined and implemented. Mean scores in a Press Ganey survey for wait-time questions improved by 10 points, and patient complaints decreased by almost 40%. The team concluded that delays in the Breast Program were symptoms of a larger dysfunction in systems. Fixing the problems required a comprehensive approach to review all the variables that resulted in delays.

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Indications for Breast MRI in the Patient with Newly Diagnosed Breast Cancer

Constance D. Lehman, Wendy DeMartini, Benjamin O. Anderson, and Stephen B. Edge

Edited by Kerrin G. Robinson

Use of breast MRI in the preoperative evaluation of patients recently diagnosed with breast cancer has increased significantly over the past 10 years because of its well-documented high sensitivity for detecting otherwise occult breast cancer in the affected and contralateral breasts. However, published research reports on the impact of this improved cancer detection are limited. Equally important are growing concerns that the quality of breast MRI may vary significantly across practice sites, and therefore the published value of MRI may not be achieved for many patients. This article describes the peer-reviewed, published clinical research trials evaluating breast MRI in patients with newly diagnosed breast cancer on which the National Comprehensive Cancer Network (NCCN) practice guidelines are based. The current NCCN guidelines recommend that breast MRI be considered for patients with a newly diagnosed breast cancer to evaluate the extent of ipsilateral disease and to screen the contralateral breast, particularly for women at increased risk for mammographically occult disease. In addition, the guidelines indicate that breast MRI may be used for patients with axillary nodal adenocarcinoma to identify the primary malignancy. The guidelines stress the importance of having proper equipment, imaging technique, and provider training necessary to achieve high-quality breast MRI, and emphasize that MRI practice sites should have the ability to perform MRI-guided biopsy or needle localization. In addition to describing the data regarding use of breast MRI in women with newly diagnosed cancer, this article provides recommendations for the performance of high-quality breast MRI and suggestions for future research.

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Predictors and Temporal Trends of Adjuvant Aromatase Inhibitor Use in Breast Cancer

Tiffany H. Svahn, Joyce C. Niland, Robert W. Carlson, Melissa E. Hughes, Rebecca A. Ottesen, Richard L. Theriault, Stephen B. Edge, Anne F. Schott, Michael A. Bookman, and Jane C. Weeks

After the first report of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial, adjuvant aromatase inhibitor use increased rapidly among National Comprehensive Cancer Network member institutions. Increased aromatase inhibitor use was associated with older age, vascular disease, overexpression of human epidermal growth factor receptor 2 (HER2), or more advanced stage, and substantial variation was seen among institutions. This article examines adjuvant endocrine therapy in postmenopausal women after the first report of the trial, identifies temporal relationships in aromatase inhibitor use, and examines characteristics associated with choice of endocrine therapy among 4044 postmenopausal patients with hormone receptor–positive nonmetastatic breast cancer presenting from July 1997 to December 2004. Multivariable logistic regression analysis examined temporal associations and characteristics associated with aromatase inhibitor use. Time-trend analysis showed increased aromatase inhibitor and decreased tamoxifen use after release of ATAC results (P < .0001). In multivariable regression analysis, institution (P <. 0001), vascular disease (P <. 0001), age (P = .0002), stage (P = .0002), and HER2 status (P = .0009) independently predicted aromatase inhibitor use. Institutional rates of use ranged from 15% to 66%. Adjuvant aromatase inhibitor use increased after the first report of ATAC, with this increase associated with older age, vascular disease, overexpression of HER2, or more advanced stage. Substantial variation was seen among institutions.

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Treating Second Breast Events After Breast-Conserving Surgery for Ductal Carcinoma in Situ

Michael J. Hassett, Wei Jiang, Melissa E. Hughes, Stephen Edge, Sara H. Javid, Joyce C. Niland, Richard Theriault, Yu-Ning Wong, Deborah Schrag, and Rinaa S. Punglia

Background: Because of screening mammography, the number of ductal carcinoma in situ (DCIS) survivors has increased dramatically. DCIS survivors may face excess risk of second breast events (SBEs). However, little is known about SBE treatment or its relationship to initial DCIS care. Methods: Among a prospective cohort of women who underwent breast-conserving surgery (BCS) for DCIS from 1997 to 2008 at institutions participating in the NCCN Outcomes Database, we identified SBEs, described patterns of care for SBEs, and examined the association between DCIS treatment choice and SBE care. Using multivariable regression, we identified features associated with use of mastectomy, radiation therapy (RT), or antiestrogen therapy (AET) for SBEs. Results: Of 2,939 women who underwent BCS for DCIS, 83% received RT and 40% received AET. During the median follow-up of 4.2 years, 200 women (6.8%) developed an SBE (55% ipsilateral, 45% invasive). SBEs occurred in 6% of women who underwent RT for their initial DCIS versus 11% who did not. Local treatment for these events included BCS (10%), BCS/RT (30%), mastectomy (53%), or none (6%); only 28% of patients received AET. Independent predictors of RT or mastectomy for SBEs included younger age, shorter time to SBE diagnosis, and RT or AET for the initial DCIS. Conclusions: A sizable proportion of patients with SBEs were treated with mastectomy, most especially those who previously received RT for their initial DCIS and those who developed an ipsilateral SBE. Despite the occurrence of an SBE, relatively few patients received AET. Future studies should investigate optimal treatment approaches for SBEs, including the benefit of mastectomy versus lumpectomy for an ipsilateral SBE and the benefit of AET for a hormone-receptor–positive SBE contingent on AET use for the initial DCIS diagnosis.