- Data obtained in real-life setting from more than 800 patients with node-negative or node-positive early-stage breast cancer highlight the test’s impact on clinical practice with chemotherapy-sparing effect
- Publication of landmark TAILORx study results led to greater reduction in chemotherapy recommendations
MADISON, Wis., May 14, 2020 – Exact Sciences Corp. (NASDAQ: EXAS) today announced results from a prospective clinical survey of the Oncotype DX Breast Recurrence Score® test, accepted at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, published online in the ASCO meeting library, and expected to be published in the Journal of Clinical Oncology meeting’s proceedings. The findings, consistent with previous studies, further support the unique value of the test in guiding chemotherapy treatment decisions. Results also highlight the practice-changing impact of the landmark TAILORx study, which showed that the Oncotype DX® test identifies the vast majority of women with node-negative disease who receive no substantial benefit from chemotherapy (approximately 80%), as well as the important minority (with a Recurrence Score result of 26-100) for whom chemotherapy can be life-saving.
The survey results, at ASCO20 summarize physicians’ treatment decisions pre- and post-Recurrence Score results in hospitals across Latin America. A total of 647 patients (20% with one to three positive nodes) were enrolled during routine care at 14 community and academic sites in Argentina, Colombia, Mexico, and Peru, while an additional 155 patients (34% with one to three positive nodes) were treated at the largest public breast cancer hospital in Brazil.
The analysis conducted in Argentina, Colombia, Mexico, and Peru included patients treated before and after the June 2018 publication of TAILORx. Overall, the findings revealed a 36% net decrease in chemotherapy recommendations among patients with node-negative disease and a 46% decrease in those with node-positive disease. Importantly, the decrease in chemotherapy recommendations in node-negative disease was greater following the publication of TAILORx results and went from 28% to 36%.
Of the 155 patients treated in Brazil between August 2018 and April 2019, 70% were classified as having high-risk disease based on traditional clinical parameters, and the majority had tumors larger than 2 centimeters. A total of 151 of the 155 patients (97%) were initially recommended chemotherapy in addition to hormonal therapy based on clinical and pathological features. Based on their Recurrence Score results, 104 of the 151 patients (69%) were spared chemotherapy and received hormonal therapy alone instead.
Results from this public hospital show that clinical and pathological features did not adequately identify patients most likely to benefit from chemotherapy. Testing also led to economic benefits and potential savings, suggesting that the Oncotype DX test should be incorporated in the Brazilian public health system.
“Our findings highlight the unique value of the Oncotype DX test and the practice-changing impact of the TAILORx results to select patients for chemotherapy and to avoid overtreatment as well as undertreatment,” said Dr. Henry Gómez, lead study author and Head, Breast Cancer Multidisciplinary Team, Oncosalud - AUNA, Lima, Peru. “Overall, the availability of Recurrence Score results led to substantial reductions in chemotherapy use and allowed us to tailor treatment plans more accurately and use resources more effectively.”
These results add to the substantial real-world evidence available for the Oncotype DX test, which reflects its growing adoption, particularly since the publication of TAILORx. This landmark study has positively influenced treatment guidelines and is having an important impact on global reimbursement and standard use of the test. More than 1 million patients around the world have used the test to inform their treatment decision.
“The practice-changing precision made possible by the Oncotype DX test can lead to improved quality of care and better use of healthcare resources by directing chemotherapy only to patients who derive substantial benefit,” said Torsten Hoof, General Manager, International at Exact Sciences. “As we continue to generate evidence showing the unique value of our test, we look forward to continuing to work with the relevant authorities to make it available to patients on a broader international scale.”
About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score® test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect™ test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype DX® tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company’s website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.
NOTE: Oncotype, Oncotype DX, Breast Recurrence Score, DCIS Score, Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect, and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences is a trademark or registered trademark of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.
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 Gomez H et al. Abstract #e12539, ASCO 2020.
 Mattar A et al. Abstract #e12518, ASCO 2020.
 Mattar A et al. Abstract #e19380, ASCO 2020.