Cost-Effectiveness Analysis of Gene-Expression Profiling Assay in Breast Cancer
A new report published by Wang et al in JNCCN—Journal of the National Comprehensive Cancer Network found that using Oncotype DX—the most commonly used test for predicting the benefit of adjuvant chemotherapy to reduce the risk of disease recurrence—is not cost-effective for patients 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 prognosis, and to determine whether specific therapies are indicated. In this scenario, oncologists used Oncotype DX 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 Oncotype DX 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 Oncotype DX 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.”
Study Results
The researchers looked at data from the Connecticut Tumor Registry to identify 4,281 women diagnosed with estrogen receptor–positive, HER2-negative, node-negative breast cancer between 2011 and 2013. Based on PREDICT 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 Oncotype DX testing (2,245 patients, or 54.6%), with similar distribution of testing within each risk group.
They found that Oncotype DX 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 Oncotype DX 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 Oncotype DX 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, of 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 Oncotype DX 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 Oncotype DX test seem justifiable based on patient benefit.”
Disclosure: The study authors’ full disclosures can be found at jnccn.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
