American Society of Breast Surgeons

View all recommendations from this society

Released June 27, 2016

Don’t routinely order specialized tumor gene testing in all new breast cancer patients.

There are multiple new tumor multi-gene signature tests that provide selected patients with information about their risk of distant cancer recurrence, dying of cancer or the likelihood they will benefit from chemotherapy. These tests are helpful in selected patients, including those with early stage hormone receptor positive cancers with low scores on 21 gene recurrence testing, who can safely omit chemotherapy. There is no evidence these tests should be used routinely in every patient. These tests should not be done in patients who indicate the test results would not change their choice of treatment.


These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items on this list or their individual situation should consult their physician.

How The List Was Created

The American Society of Breast Surgeons (ASBrS) Patient Safety and Quality Committee (PSQC) received approval from the ASBrS Board of Directors to create and rank a list of appropriateness domains of breast care to be submitted to the ABIM Foundation Choosing Wisely campaign. The PSQC discussed the goals of Choosing Wisely and solicited candidate measures from its members at their 2014 and 2015 Annual Meetings. The PSQC members were asked to identify measures that addressed the goals of Choosing Wisely. Committee members were provided with a full description of the Choosing Wisely campaign and its goals, as well as its emphasis on decreasing unnecessary tests and interventions. In addition, PSQC members were provided with the previous Choosing Wisely recommendation from other organizations for breast. Specific recommendations were made to consider domains of care that reflected appropriateness, waste and value as noted in recent publications, randomized trials and meta-analysis.

Committee members were instructed to rank candidate choices specifically as follows:

Rank for appropriateness and value of care; value to be defined by quality of care in the numerator and burdens of care in the denominator. Burdens would include cost of care and non-cost patient burdens of care, such as the unnecessary need for a second surgery or a procedure or a test. Rank based on the importance criteria of the National Quality Forum (NQF) for creation of quality measures. The four pillars of NQF importance were described to members. PSQC members were asked to consider the number of patients nationally that could be helped by our choices; i.e., the number of patients at risk for inappropriate care when you estimate the difference between perceived or measured actual care and achievable care.

After creation of a list of candidate choices, two rounds of modified Delphi process ranking were performed electronically in March, 2014 and July, 2015 following the iterative and analytic methodology described by Fitch K, Bernstein SJ, Aguilar MD, et al., in “The Rand/UCLA Appropriateness Method User’s Manual”. Arlington, VA: RAND, 2001. Thirty eight domain choices were included in the final round of ranking.

Each candidate choice was ranked on a scale of 1–9 where 1 meant the statement had no value or importance and was not appropriate for a patient and 9 meant it had the highest possible value, importance and appropriateness. Panelists were asked to score by their opinion, not how they thought other surgeons or experts would score it.

After each round of ranking, a spreadsheet with ranking results was provided to committee members. The spreadsheet was formatted from top to bottom by committee median score. Inter-round electronic communication followed with opportunity for participants to discuss the choices, lobbying for either increasing or decreasing a choice’s rank.

There were 16 choices deemed appropriate (median score 7–9) by the panelists as defined by the Rand/UCLA User’s Manual. The top five choices had median ranks of 8 or 9. Four of the ASBrS top five choices were already part of the Choosing Wisely Campaign of other organizations, so these were excluded from the ASBrS final list. To finish our list of five, we used the next highest ranked choices.

The final list of five choices was distributed to the entire PSQC twice by email for further vetting. As a result, minor word edits but no substantive content changes were made. Subsequently, the document was reviewed and edited by the ASBrS Research Committee, then sent to the ASBrS Board of Directors for review.The ASBrS Board of Directors approved the final five choices in April 2016.

ASBrS Patient Safety and Quality Committee Members:

  • Jeffrey Landercasper MD, Gundersen Medical Foundation, La Crosse, WI, USA
  • Lisa Bailey MD, Bay Area Breast Surgeons, Inc., Oakland, CA USA
  • Tiffany S. Berry MD, Norton Healthcare, Louisville, KY, USA
  • Robert R. Buras MD, Anne Arundel Medical Center, Annapolis, MD, USA
  • Amy C. Degnim MD, Mayo Clinic, Rochester, MN, USA
  • Oluwadamilola M. Fayanju MD, MD Anderson, Houston, Texas
  • Joshua Froman MD, Mayo Clinic Health System, Owatonna, MN, USA
  • Jennifer Gass MD, Women and Infants Hospital, Providence, RI, USA
  • Caprice Greenberg MD, University of Wisconsin School of Public Health and Medicine, Madison, WI, USA
  • Starr Koslow Mautner MD, Baptist Health South Florida, Miami, FL, USA
  • Helen Krontiras, MD, University of Alabama at Birmingham, Birmingham, AL, USA
  • Roshni Rao MD, University of Texas Southwestern Medical Center, Dallas, TX, USA
  • Michelle Sowden DO, University of Vermont Medical Center, Burlington, VT, USA
  • Judy A. Tjoe MD, Aurora Health Care, Milwaukee, WI, USA
  • Barbara Wexelman MD, Trihealth Cancer Institute, Cincinnati, OH, USA
  • Lee Wilke MD, University of Wisconsin of Madison, Madison, WI, USA
  • Steven L Chen MD, MBA, OasisMD, San Diego, CA, USA

Sources

NCCN Clinical Practice Guidelines for Breast Cancer. Version 3 [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2015 [cited 2016 Apr 21]. Available from: www.nccn.org.

Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N.A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004 Dec 30;351(27):2817-26.

Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S.. Prediction of risk of distant recurrence using the 21-gene recurrence score in node negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010 Apr10;28(11):1829-34.

Augustovski F, Soto N, Caporale J, Gonzalez L, Gibbons L, Ciapponi A. Decision-making impact on adjuvant chemotherapy allocation in early node-negative breast cancer with a 21-gene assay: systematic review and metaanalysis. Breast Cancer Res Treat. 2015 Aug; 152(3):611-25.

Carlson JJ, Roth JA. The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis. Breast Cancer Res Treat. 2013 Aug; 141(1):13-22.