GENEVA, June 1, 2015 /PRNewswire/ -- Genomic Health announced results from multiple studies with the Oncotype DX tests presented at the recent 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentations reinforce the robustness of the Oncotype DX® tests across invasive breast cancer, ductal carcinoma in situ (DCIS) and prostate cancer, which, to date, have helped guide treatment decisions for more than half a million patients worldwide.
Two DCIS studies reinforce independent value of Oncotype DX DCIS Score™ result
A secondary analysis1 from the second large validation study of the Oncotype DX test in patients with a pre-invasive form of breast cancer known as DCIS (ductal carcinoma in situ) evaluated the DCIS Score™ result as a predictor of local recurrence in 718 patients treated with breast-conserving surgery (BCS) alone with any surgical margin width. The analysis showed that, in all patients regardless of margin status, the DCIS Score result was significantly associated with the 10-year risk of local recurrence (p<0.001). These results underscore the value of the DCIS Score result in providing unique tumour biology information that is not readily apparent by margin status alone.
A separate secondary analysis2 evaluated the correlation between the DCIS Score result and clinicopathologic features, such as age, tumour size, nuclear grade and multifocality. The results from 571 women with DCIS who had BCS alone and clear margins showed that the DCIS Score result quantifies risk of local recurrence independent of clinicopathologic features, reconfirming findings from the previous clinical validation study.3
"These scientific presentations emphasise the importance of accurately assessing a patient's individual risk of her cancer returning," said Professor Nigel Bundred, Professor in Surgical Oncology, University Hospital of South Manchester NHS Foundation Trust. "A tool such as the Oncotype DX test provides important information beyond traditional measures and can help us better understand the individual tumour biology in order to make more informed treatment decisions in patients with this pre-invasive form of the disease."
In Europe, as many as 50,000 women may be diagnosed with DCIS every year. After a diagnosis of DCIS, the first step is usually breast-conserving surgery to remove the DCIS tumour. In addition, the vast majority of women with DCIS will receive radiation therapy. The Oncotype DX DCIS Score result provides more precise information about the individual risk of a recurrence of either DCIS or invasive breast cancer by looking at 12 genes within a tumour sample to reveal the aggressiveness of the disease – a key factor in deciding treatment after surgery.
Baseline patient characteristics from TAILORx study confirm consistency of Oncotype DX Recurrence Score® results across race and ethnicity
An analysis4 of the study population enrolled in TAILORx - Trial Assigning IndividuaLized Options for Treatment (Rx) - examined baseline patient characteristics, including race, ethnicity and body mass index (BMI), as well as their Recurrence Score results. The results showed no significant difference in Recurrence Score result distribution among Caucasian, African-American, Hispanic or Asian patients despite the clinical differences between those patient groups. These data are consistent with prior studies that have shown that the Recurrence Score result provides information beyond that provided by clinical and pathologic features.
TAILORx is designed to evaluate the effect of chemotherapy in breast cancer patients with mid-range Recurrence Score results, as previous studies have confirmed the benefit of adjuvant chemotherapy for those with high Recurrence Score disease and minimal, if any, benefit for patients with low Recurrence Score disease. TAILORx is one of the largest breast cancer adjuvant treatment trials, with more than 10,000 patients enrolled from 1,500 sites in the United States, Canada, Ireland, Peru and Australia. The reporting of the TAILORx long-term outcome results for patients in the mid-range group is anticipated in 2016-2017.
Study of Oncotype DX Genomic Prostate Score underscores value of analysing gene groups in prostate cancer
In prostate cancer, a study5 of 3,500 patient tumour samples processed in Genomic Health's commercial laboratory highlighted the importance of utilising multiple biological pathways to predict tumour behaviour. In this study, each of the four gene groups incorporated in the Oncotype DX Genomic Prostate Score (GPS) showed large variations in expression and meaningfully affected the GPS results, underscoring the importance of analysing distinct genes across multiple pathways to provide more accurate risk assessment than currently available clinical risk factors and help improve treatment decision making.
In Europe, more than 400,000 men are diagnosed with prostate cancer every year. The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. The test result is reported as a Genomic Prostate Score (GPS) that ranges from 0 to 100 and is combined with other clinical factors to further clarify a man's risk prior to treatment intervention. This first-of-its-kind, multi-gene test has been validated to guide treatment decisions using the prostate needle biopsy sample taken before the prostate is removed − thereby providing the opportunity for low-risk patients to avoid invasive treatments such as radical prostatectomy or radiation.
"Our mission at Genomic Health is to improve the quality of cancer treatment decisions by developing high-value diagnostics that enable more personalised decisions based on the genomic activity within a patient's individual tumour," said Calvin Chao, Senior Director of International Medical Affairs at Genomic Health. "The data presented continue to highlight the distinguishing features and value of the Oncotype DX platform in guiding the treatment of early stage cancer."
About Genomic Health
Genomic Health, Inc. is a world-leading provider of genomic-based diagnostic tests that inform treatment decisions and help to ensure each patient receives appropriate treatment for early stage cancer. The company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey; from screening and surveillance, through diagnosis and treatment selection. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about the Oncotype DX test, visit: www.OncotypeDX.com
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the test to physicians, patients and payors. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the ability of test results to change treatment decisions; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's quarterly report on Form 10-Q for the year ended March 31, 2015. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
1 Rakovitch E et al. "Risk after local excision alone for DCIS patients" (Abstract #1013)
2 Rakovitch E et al. "Correlation between the DCIS Score and traditional clinicopathologic features in the prospectively-designed Ontario population-based validation study" (Abstract #581)
3 Solin LJ et al. J Natl Cancer Inst. 2013; May 15;105(10):701-10
4 Rubinstein M et al. "Recurrence score and clinicopathologic characteristics of TAILORx participants by race and ethnicity" (Abstract #533)
5 Knezevic D et al. "Evaluation of the contribution of individual gene groups to a 17-gene prognostic prostate cancer signature" (Abstract #5060)
SOURCE Genomic Health, Inc.