Oncotype DX® Predicts 10-year Risk of Developing Metastatic Prostate Cancer in Low- and Intermediate-risk Patients

Excerpt:

“Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of new results from a large multi-center validation study, which confirmed that the Oncotype DX® Genomic Prostate Score™ (GPS) is a strong independent predictor of metastases at 10 years in prostate cancer patients across all National Comprehensive Cancer Network (NCCN) clinical risk groups. The clinical validation study data were designated one of the ‘best posters’ (abstract #352) at the 32nd Annual European Association of Urology (EAU) Congress in London.”

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Chemotherapy May Not Be Necessary for Intermediate-Risk, Early-Stage Breast Cancer

Excerpt:

“Women with early-stage breast cancer and an intermediate risk recurrence score from a 21-gene expression assay may be able to avoid chemotherapy, according to a retrospective study published in Cancer.

” ‘Through years of research discoveries, it became clear that we were overtreating many women with breast cancer, especially those with early-stage breast cancer,’ Carlos H. Barcenas, MD, assistant professor of breast medical oncology at The University of Texas MD Anderson Cancer Center, said in a press release. ‘In addition to chemotherapy’s obvious side effects, there were also long-term complications for these women as survivors.’ ”

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Chemo Benefit Unclear in Breast Cancer Patients With Higher Recurrence Scores

Excerpt:

“In patients with hormone receptor–positive, HER2-negative, lymph node–negative breast cancer with a recurrence score (RS) based on a 21-gene expression assay of 11 to 25, outcomes were similar whether chemotherapy was used or not used, according to a retrospective analysis. However, the study’s limited follow-up means a benefit from chemotherapy in these patients cannot be ruled out.

“The Oncotype DX 21-gene expression assay is the most commonly used test of this kind in breast cancer in the United States. It offers an RS, and previous research has shown that patients with an RS below 11 fare very well when treated with endocrine therapy alone. ‘To our knowledge, it is unknown whether chemotherapy provides any additional benefit in outcomes in patients with hormone receptor–positive, HER2-negative, lymph node–negative, early-stage breast cancer with an RS of 11 to 25 who are treated with endocrine therapy,’ wrote study authors led by Carlos H. Barcenas, MD, MSc, of the University of Texas MD Anderson Cancer Center in Houston.”

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Four New Studies of Oncotype DX® Genomic Prostate Score™ (GPS) Reconfirm Value of Test in Guiding Early-stage Prostate Cancer Risk Assessment and Treatment Selection

Excerpt:

“Genomic Health, Inc. (GHDX) announced today the presentation of results from four studies evaluating the clinical value and utility of its Oncotype DX® Genomic Prostate Score (GPS) in the management of early-stage prostate cancer. Collectively, these new data highlight the test’s ability to predict disease aggressiveness and refine risk stratification across National Comprehensive Cancer Network (NCCN) clinical risk groups.

” ‘We now have 22 clinical studies, involving more than 4,200 prostate cancer patients, that distinguish Oncotype DX as the only test developed specifically for men who are deciding between active surveillance or definitive treatment. The test is validated to provide individualized information about both the current state and future risk of patients’ prostate cancer,’ said Phil Febbo, M.D., chief medical officer, Genomic Health. ‘Together with the recently published economic analysis demonstrating substantial cost savings of more than $2,200 per patient tested, the data presented will support increased adoption and reimbursement of Oncotype DX as physicians aim to bring precision medicine to their prostate cancer patients.’ “

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Genomic Health Announces Positive Topline Clinical Validation Study Results Demonstrating Oncotype DX® Prostate Cancer Test Predicts Risk of Metastasis and Mortality

Excerpt:

“Genomic Health, Inc. (GHDX) today announced topline results from a large clinical validation study of its biopsy-based Oncotype DX® Genomic Prostate Score™ (GPS). The study, performed in collaboration with a large integrated healthcare system, met its primary endpoint by demonstrating that the multi-gene Oncotype DX® test, assessed in prostate needle biopsy tumor tissue, is a strong predictor of the development of metastasis and prostate cancer death in patients with early-stage prostate cancer. With these new results, the Oncotype DX test becomes the first genomic test validated in all major short- and long-term end points: adverse pathology, biochemical recurrence, metastasis and prostate cancer-specific death.”

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Oncotype Dx Gene Test Has a Big Impact on Oncologists' Chemo Recommendations

Excerpt:

“The 21-gene Recurrence Score (RS) assay significantly influenced clinicians’ decisions to recommend breast cancer patients for adjuvant chemotherapy, analysis of a population-based dataset showed.

“Used to predict disease recurrence and benefit of chemotherapy in estrogen receptor-positive, lymph node-negative early-stage breast cancer (EBC), the assay had the strongest association with recommendation for chemotherapy, with an adjusted odds ratio (aOR) of 83 for high assay scores and 12 for intermediate scores, both relative to low scores.

“Test use was significantly associated with younger age, white race, academic centers, private insurance, and pT2/pN0(i+) grade 2 to 3 disease, Peter Kabos, MD, of the University of Denver, Aurora, CO, and colleagues reported online in the Journal of Clinical Oncology.”

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New Diagnostic Tools for Prostate Cancer

“Dan Woska was weighing his treatment options after he was found to have prostate cancer two years ago when a friend mentioned a new genomic test that could gauge how lethal his tumor was.

“The test, called Oncotype DX, which looks at the expression of 17 genes in a tumor, cost about $4,000 and was not covered by Mr. Woska’s insurance. But through a patient assistance program, the company that created it, Genomic Health, ran it for him free, using a tiny grain of tissue left over from his biopsy. The results indicated there was an 81 percent probability that Mr. Woska’s tumor would not spread beyond the prostate. On an aggressiveness scale of zero to 100, the tumor was an indolent 15.

“Thrilled and relieved, Mr. Woska decided to forgo radiation and surgery.”


Study Supports Prognostic Potential of Genomic Health's Oncotype DX in Breast Cancer

“In a study published in the latest issue of the New England Journal of Medicine, an international team led by investigators in the US validated Genomic Health’s Oncotype DX as a means to stratify treatment in a prospective trial of women with a relatively low risk breast cancer subtype.”


To Type or to Print? Oncotype DX and Mamma/BluePrint Tests for Breast Cancer


Women diagnosed with localized breast cancer face difficult decisions with their doctors. What kind of neoadjuvant (before surgery) treatment to choose? Should chemotherapy follow surgery? Based on the subtype of breast cancer, should specific chemotherapy drugs be used? Continue reading…