REDWOOD CITY, Calif., May 31, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results of 10 studies being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, underscoring the company's commitment to optimizing cancer treatment. New data include studies of the Oncotype DX® RT-PCR-based breast, colon and prostate cancer tests and a large next generation sequencing (NGS) study that reports novel methods for detection of gene fusions to enhance the understanding of breast cancer tumor biology for future clinical developments.
"Through continued research in breast, colon and prostate cancers, and our next generation sequencing program, we continue to lead the way in how to translate vast amounts of genomic data into actionable information to improve health outcomes by eliminating 'one-size-fits-all' treatment in cancer," said Steven Shak, M.D., chief medical officer at Genomic Health. "The new Oncotype DX research reflects our commitment to expanding our understanding of the biology of cancer and clinical utility of our tests for cancer patients throughout the course of their disease."
"As physicians continue to strive to deliver on the promise of precision medicine, Oncotype DX represents a critical tool to enhance our ability to treat every breast cancer patient based on her individual biology," said Lee Schwartzberg, M.D., medical director of the West Clinic Memphis, Tenn. "The new data on this test adds to the large body of evidence illustrating the clinical value of Oncotype DX for patients and physicians, highlighting the test's ability to change treatment decisions in the real-world clinical setting."Oncotype DX Provides Prognostic Information in Metastatic Breast Cancer
- The study evaluated the association between the Recurrence Score and time to progression and overall survival in patients with advanced breast cancer enrolled in TBCRC 013, a registry evaluating the primary tumor in patients presenting with stage IV disease. Researchers concluded that Oncotype DX is prognostic for time to progression and for overall survival in ER positive, HER2 negative stage IV breast cancer, and provides information beyond that provided by patient age, tumor size, and the site of the metastasis. The new findings, discussed in an oral presentation, suggest that a high Recurrence Score may influence treatment decisions for patients with metastatic disease and add to the body of evidence supporting the value of the Oncotype DX test across the continuum of breast cancer, including pre-invasive (DCIS), early-stage invasive node negative and node positive disease, and now in advanced breast cancer. (Abstract #507)
- Results of this NCCTG cooperative group study in 901 patients treated with adjuvant trastuzumab (Herceptin) demonstrated that quantitative reporting for HER2 gene expression, as measured by the Oncotype DX breast cancer test using the RT-PCR platform, had a greater than 90 percent concordance with both fluorescence in situ (FISH) and immunohistochemistry (IHC) testing. Genomic Health began including HER2 single gene expression in 2008 as part of the Oncotype DX Recurrence Score results, with the goal of providing added biological insight into a patient's tumor in cases where HER2 results by IHC and FISH are uncertain or conflicting. These new results are consistent with two previously published positive concordance studies comparing RT-PCR, IHC and FISH performed in collaboration with Kaiser Permanente and the Eastern Cooperative Oncology Group. The study also explored the association between the Recurrence Score and adjuvant trastuzumab (Herceptin) benefit, and suggests as has been reported previously, that there may be some benefit of trastuzumab in the adjuvant breast cancer setting for patients with low levels of HER2 expression. The findings support further research including investigation of gene expression and mutations using next generation sequencing (NGS) that might identify more patients who can benefit from Herceptin. (Abstract #520)
- A large prospective observational study involving 890 patients enrolled at 16 U.S. sites between November 2009 and March 2012 analyzed the real-world use of the Oncotype DX test in clinical practice to evaluate the association between Recurrence Score results and treatment decisions. The findings demonstrated a wide range of Recurrence Score results within the different clinical and pathologic categories: patients with low Recurrence Score results were more likely to receive hormonal therapy alone, whereas patients with a high score were more likely to also receive chemotherapy. This trend was observed across categories of patient age, tumor grade and size, and nodal status, demonstrating the impact of the Recurrence Score on chemotherapy treatment decisions. The results of this first analysis of the registry are consistent with previously-described distribution of Recurrence Score values and clinical experience, emphasizing the importance of understanding a patient's breast cancer biology in order to make more informed and individualized treatment decisions. (Abstract #565)
- Building on previously published research demonstrating the ability to conduct whole transcriptome RNA-Seq on fixed paraffin-embedded breast cancer tissue samples, this exploratory NGS study in a total of 212 patients used new analytical and bioinformatic methods to identify 100 novel breast cancer gene fusions. A number of these gene fusions were observed to associate with a worse clinical outcome. Importantly, while the vast majority of these gene fusions were unique to individual patients, some were shared among several patients, including a novel fusion involving the estrogen receptor gene. (Abstract: 11018)
- The recently launched Oncotype DX prostate cancer test assesses tumor tissue from diagnostic needle biopsies and provides information beyond standard clinical factors, such as PSA and biopsy Gleason Score, to help physicians and their prostate cancer patients confidently choose the most appropriate treatment based on risk assessment. Based on the initial development study conducted in collaboration with Cleveland Clinic, this investigation evaluated whether gene expression patterns in normal-appearing tissue adjacent to areas of tumor involvement, including the Oncotype DX Genomic Prostate Score (GPS), are predictive of clinical outcomes. The results show that the GPS and other genes, assessed in normal-appearing tissue adjacent to the tumor, were predictive for clinical recurrence and prostate cancer-specific mortality, suggesting that there is an underlying field effect associated with the development of aggressive prostate cancer. (Abstract #5029)
- An analysis of 141 patients from 17 sites in the Mayo Clinic Cancer Research Consortium provided real-world confirmation that in patients with stage II colon cancer, the Oncotype DX colon cancer test can impact treatment decisions and leads to reduction in direct medical costs while preserving quality-adjusted life years. In addition to showing the decision impact where physician recommendations for adjuvant chemotherapy decreased by 22 percent after receiving the Recurrence Score results, an economic impact analysis model projected cost savings of $1,683 per patient. (Abstract #3640)
- An analysis evaluating the differences in Oncotype DX score among Hispanic and Caucasian women concluded that Hispanic women with estrogen receptor-positive, HER2 negative, early-stage breast cancer have higher tumor proliferation markers than Caucasian women. (Abstract #560)
- A comparative analysis of distant recurrence risk assessment by Oncotype DX alone, and integrated with pathology and clinical measures. (Abstract #598)
- An overview of the Adjuvant Dynamic marker-Adjusted Personalized Therapy (ADAPT) trial, which is designed to optimize risk assessment and therapy response prediction in early-stage breast cancer. (Abstract #TPS655)
- A prospective analysis of the use of the Recurrence Scores to select pre-operative chemotherapy for patients with hormone receptor-positive breast cancer. (Abstract #562)