USciences Study is the First to Compare Gene Expression Profiling Tests for Breast Cancer

New research from University of the Sciences’ Mayes College of Healthcare Business and Policy suggests that MammaPrint – a gene expression profiling (GEP) test used to identify whether women with early-stage breast cancer would benefit from chemotherapy – is the more cost-effective and clinically-useful test than the most frequently used GEP in practice in the United States today. The findings have strong implications for health policy makers and health insurance reimbursement decisions, as well as, for health providers and patient outcomes.  

To date, Oncotype DX – a 21-gene profile assay – is the most commonly used GEP in clinical practice in the United States. Oncotype DX produces a numerical recurrence score, which places patients in three categories: high risk, intermediate risk and low risk. MammaPrint – a 70-gene profile microarray evaluation used more frequently in Europe – reports results via two categories: high risk or low risk for recurrence.

The research of Amalia M. Issa, PhD, MPH, chair of the Department of Health Policy and Public Health and director of the Program in Personalized Medicine and Targeted Therapeutics, as well as  which was published online by Cancer in February 2012, compared Oncotype DX and MammaPrint from a third-party payer’s perspective. A 10-year Markov model, which represents changing health states over time, was developed to evaluate the costs and quality-adjusted life years associated with using the two most popular GEP-guided treatment strategies in a hypothetical cohort of 1,000 women with early stage, lymph node-negative, estrogen receptor-positive breast cancer. Outcomes included no recurrence, recurrence, and death. The costs considered included the expenses generated from the administration of the gene test, dispensation of adjuvant chemotherapy and other chemotherapy, as well as cost of treating recurrence, adverse events and end-of-life care.

“Our study is the first to compare two specific gene expression profiling assays head-to-head,” explained Dr. Issa. “As personalized genomic medicine continues its progress forward, this study demonstrates the value of doing this type of research for society – to make decisions based on empirical evidence.”

Specifically, the results indicate that patients who received the Oncotype DX test spent $27,882 and gained 7.36 quality of life years, whereas patients who received the MammaPrint spent $21,598 and gained 7.461 quality of life years. This represents a 29% cost-effective advantage, with better quality of life years than the most frequently used GEP test in the United States.

Breast cancer is the second most common malignancy for women in the United States, with more than 200,000 women diagnosed annually. Each day, patients and their health providers must make difficult decisions about treatment and the utilization of adjuvant chemotherapy to reduce the risk of reoccurrence or death. Increasingly, providers are utilizing GEP tests to evaluate prognostic and risk information and determine the best course of treatment.

“New genomic diagnostics and personalized medicine applications are increasingly entering the market, and this broader availability of diagnostics has major implications for health care delivery,“ continued Dr. Issa.  “The unexpected findings of this study demonstrate the need for further translational research studies of this type to be conducted before a novel personalized medicine application is implemented widely into practice.”

Co-authors on this study are Mo Yang, MS, a graduate student mentored by Dr. Issa, and Suja Rajan, PhD.

This work was supported by a grant from InHealth, the Institute for Health Technology Studies. 

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