A new study by the Georgetown Lombardi Comprehensive Cancer Center and the National Cancer Institute indicates that Oncotype DX-guided treatment could cut the cost of first year breast cancer care in the U.S. by $50 million. JNCI published the results of the study on Wednesday. Genomic Health Inc. of Redwood City, Calif., produces Oncotype DX.

The 10,723-patient Trial Assigning Individualized Options for Treatment (TAILORx) previously found that women with localized hormone-positive, HER2-negative breast cancer, the most common type, could forgo chemotherapy if they had low (0-10) or intermediate recurrence risk scores (11-25) on the Oncotype DX Breast Recurrence Score Test. The results of that study were presented in the American Society of Clinical Oncology (ASCO) meeting in Chicago in June 2018 and published in the New England Journal of Medicine. (See BioWorld, June 5, 2018.)

The test uses tumor tissue removed during a biopsy or surgery to analyze the activity of 21 genes to predict the likelihood of recurrence.

About 70% of women with hormone-positive, HER2-negative early stage breast cancer fall into the low- or intermediate-risk groups. Women in those ranges received no additional benefit from hormone therapy plus chemotherapy vs. chemotherapy alone.

In October, the National Comprehensive Cancer Network (NCCN) designated Oncotype DX as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative early stage breast cancer in its updated guidelines. NCCN also included Oncotype DX in the algorithms to guide treatment in patients with micrometastases and three or fewer positive lymph nodes.

ASCO, the National Institute for Health Care Excellence, the European Society for Medical Oncology and the German Institute for Quality and Efficiency in Health Care all recommend using Oncotype DX to guide breast cancer adjuvant chemotherapy treatment decisions.

Breaking down the costs

The annual cost of diagnosis and initial treatment for U.S. women newly diagnosed with breast cancer before the TAILORx trial included $2.701 billion for chemotherapy and $115 million for Oncotype DX testing, for a total cost of $2.816 billion in the year following diagnosis. Between 34.8% and 57.2% of women diagnosed with breast cancer received the Oncotype DX testing at the time.

The current study assumed that all women newly diagnosed with breast cancer would have the test, which would increase the overall annual cost of testing from $115 million to $231 million. Oncotype DX costs about $3,400. The researchers then assumed that choosing treatment based on the test results would lead to no women in the low- and intermediate-risk groups receiving chemotherapy, resulting in an 8% or $338 million drop in those costs.

With those projections, the cost of the initial year of care would be $2.766 billion, for a total savings of about $50 million.

"This study only answers the question about whether, in the first 12 months after diagnosis, costs of gene testing are likely to be offset by savings in avoided costs of chemotherapy – and the answer is yes. We did not estimate how the trial results could diffuse into medical practice, since those data will not be available for several years," said Jeanne Mandelblatt, professor of oncology and medicine at Georgetown Lombardi.

"These findings, combined with the landmark TAILORx trial and multiple other cost-savings studies across the world, clearly demonstrate that Oncotype DX improves outcomes and saves the global health care system billions of dollars," said Genomic Health's co-founder and chief scientific officer, Steve Shak.

"When we started offering Oncotype DX in 2004, more than 70% of women were being treated with chemotherapy. We now know – based on TAILORx – that three-quarters of those patients were being overtreated," Shak told BioWorld.

That overtreatment resulted in unnecessary costs to health care systems and avoidable side effects such as hair loss, nausea and fatigue as well as elevated risk of secondary cancers, nerve damage and impaired cognitive function.

While women in the intermediate- and low-risk groups did not benefit from the addition of chemotherapy, the results do not mean that none of those women will experience a recurrence after hormone therapy alone.

"The gene tests are not perfect predictors of who will ultimately have a recurrence of breast cancer, so it will be important to model the long-term outcomes and costs from diagnosis to death," Mandelblatt added.

The TAILORx trial found that 98% of women with intermediate-risk disease who received both chemotherapy and hormone therapy were disease-free at nine years, as were 97% of those who received only hormone therapy.

Customizing treatment may lead to different results, she said. "Individual women's decisions should not be about dollars and cents, but what is right for them based on consideration of the best evidence and personal preferences."

Guidelines recommend Oncotype DX not just to identify women who will not benefit from adjuvant chemotherapy, but also to find those who will, Shak noted. "Oncotype DX is the only way to identify the important minority of women who, according to traditional clinical risk factors would not be candidates for chemotherapy but based on the high Oncotype DX Recurrence Score will derive potentially life-saving benefit from chemotherapy."

Knowing which women fall into that category also has important implications. "Not getting chemotherapy when you were destined to have a distant recurrence can lead to much more expense and loss of quality of life in treatments for metastatic cancer," Mandelblatt told BioWorld.

Genomic Health

Genomic Health estimates that its tests have saved the U.S. health care system more than $5 billion. In addition to the Oncotype DX Breast Recurrence Score Test, the Oncotype DX product line includes genetic tests used to guide treatment for ductal carcinoma in situ as well as both early and late-stage prostate cancer and colon cancer. More than 1 million patients have used the tests.

Traded on Nasdaq (GHDX), Genomic Health reported $394.1 million in revenue and non-GAAP net income of $39.7 million for 2018, which exceeded projections. The company projected revenue growth of 11% to 14% and net income growth of 35% to 50% for 2019.

"We believe this study in combination with TAILORx will continue to drive increasing demand for Oncotype DX globally, as we have seen since the results were published last June," said Genomic Health's director of investor relations, Emily Faucette. "This is already reflected in our 2019 guidance."

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