Researchers from Yale School of Public Health find that genetic profiling for cancer tumors is cost-effective for high- and medium-risk patients with breast cancer, but is unlikely to make a meaningful impact on treatment for low-risk patients.

PLYMOUTH MEETING, Pa. /PRNewswire/ -- New research in the January 2019 issue of JNCCN—Journal of the National Comprehensive Cancer Network reports that using Oncotype DX (ODX)—the most commonly used test for predicting the benefit of adjuvant chemotherapy to reduce the risk of disease recurrence—is not cost-effective for people with breast cancer who are otherwise at low-risk of recurrence. Multigene assays to obtain a gene-expression profile are laboratory tests used to identify the function of specific genes in cancer cells. It can be used to help characterize a malignancy, to understand the prognosis, and to determine whether specific therapies are indicated. In this scenario, oncologists use ODX-testing to determine whether or not women with hormone receptor-positive breast cancer would derive any benefit from undergoing additional chemotherapy.

"Given current emphasis on value-based practice, oncologists should use clinically available tumor characteristics to evaluate patients' risk before ordering ODX-testing," said Shi-Yi Wang, MD, PhD, Associate Professor, Yale Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center | Yale Cancer Center Department of Chronic Disease Epidemiology | Yale School of Public Health. "The NCCN Guidelines^® for Breast Cancer already do not recommend ODX for patients whose tumor size is less than 5 mm. Our findings confirm and may expand on that recommendation by highlighting other prognostication values from tumor characteristics."

The researchers looked at data from the Connecticut Tumor Registry to identify 4,281 women diagnosed with ER-positive, HER2-negative, node-negative breast cancer between 2011 and 2013. Based on PREDICT¹ estimates, they were able to classify the women into clinically low-risk (82.5%), intermediate-risk (11.9%), and high-risk (5.6%) groups. Of the overall group, just over half received ODX-testing (2,245 patients, or 54.6%), with similar distribution of testing within each risk group.

They found that ODX-testing did provide important, cost-effective decision support for patients in the intermediate- and high-risk groups. However, in the low-risk group, only about 3% of patients had results that would lead oncologists to recommend chemotherapy where they otherwise wouldn't. 

"When ODX is used indiscriminately on patients where oncologists normally would not expect to see any benefit from chemotherapy, the test only contributes to cost increases, with a very low likelihood of changing management or outcomes," said Dr. Wang. "What's more, the use of ODX-testing on low-risk patients can create additional anxiety for patients and can unnecessarily delay the remainder of their care."

"I applaud any efforts to reduce unnecessary testing and chemotherapy in patients where there is no benefit," said Lori J. Goldstein, MD, Fox Chase Cancer Center, and Member of the NCCN Guidelines Panel for Breast Cancer. "However, the current recommendation in the NCCN Guidelines for use of ODX to determine the benefit of chemotherapy in patients with lymph node-negative, hormone receptor-positive tumors greater than or equal to 5 mm has been validated in prospective randomized clinical trials. While the present analysis raises some thoughtful questions, until future prospective randomized trials are able to further help confirm subsets of patients with no clear benefit from additional chemotherapy, the NCCN recommendations remain appropriate. The current costs associated with the ODX test seem justifiable based on patient benefit."

To read the entire study visit JNCCN.org. Complimentary access to "Incorporating Tumor Characteristics to Maximize 21-Gene Assay Utility: A Cost-Effective Analysis" is available until April 10, 2019.

The January 2019 issue of JNCCN also features the debut of the journal's redesigned style. The fresh new look incorporates artistic renderings on the cover, new heading colors by article type, and a streamlined table of contents. More changes are coming soon to JNCCN.org to improve the reader experience and make additional research available online ahead-of-print.

¹ PREDICT is a risk calculator developed by the National Health Service, UK. Visit predict.nhs.uk for more information.

About JNCCN—Journal of the National Comprehensive Cancer Network
More than 25,000 oncologists and other cancer care professionals across the United States read JNCCN—Journal of the National Comprehensive Cancer Network. This peer-reviewed, indexed medical journal provides the latest information about best clinical practices, health services research, and translational medicine. JNCCN features updates on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®), review articles elaborating on guidelines recommendations, health services research, and case reports highlighting molecular insights in patient care. JNCCN is published by Harborside Press. Visit JNCCN.org. To inquire if you are eligible for a FREE subscription to JNCCN, visit http://www.nccn.org/jnccn/subscribe.asp. Follow JNCCN on Twitter @JNCCN.

The NCCN Member Institutions are: Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA; Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope National Medical Center, Duarte, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Comprehensive Cancer Center, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at BirminghamComprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Rogel Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

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Media Contact: 
Rachel Darwin
267-622-6624
darwin@nccn.org