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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Prostate Cancer Specialists Argue for Early Chemo

Excerpt:

“Recent studies have reopened discussion of a seemingly closed case against earlier use of chemotherapy in prostate cancer.

“Chemotherapy has an established role in the management of metastatic castration-resistant prostate cancer, but its use in earlier-stage disease has remained controversial. Given the heterogeneous nature of the disease, prolonged clinical course associated with indolent disease, and concern about overdiagnosis and overtreatment, clinicians have reached no consensus about potential patient subgroups that might benefit from earlier use of chemotherapy. Differences of opinion played out again in pro/con articles published online in JAMA Oncology.”

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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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More American Men with Early-Stage Prostate Cancer Could Opt Out of Immediate Treatment

Excerpt:

“A new report on Swedish men with non-aggressive prostate cancer suggests that a lot more American men could safely choose to monitor their disease instead of seeking immediate radiation treatment or surgery.

“Published online October 20 in the Journal of the American Medical Association (JAMA) Oncology, the report shows that well over half of 32,518 men in Sweden diagnosed with prostate cancers least likely to spread chose monitoring during a recent, five-year period over immediate treatment.”

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HIFU Study Makes Case for Role in Prostate Cancer Subgroup

Excerpt:

“Treatment with unilateral high-intensity focused ultrasound (HIFU) led to eradication of all clinically significant cancer in the treated lobe for 94% of patients with early prostate cancer, according to findings presented at the 2016 American Urological Association meeting.

“HIFU resulted in complete ablation of all cancer in the treated lobe for 87 of 101 cases (86%) and absence of any cancer in the whole prostate (including untreated areas) in 68 cases (67%). After 2 years of follow-up, 89% of the patients remained alive without radical therapy (95% CI, 81.0-93.8). Almost 100% of patients had resolution of urinary incontinence at 12 months, and almost 80% of the men had preserved erectile function.”

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Multigene Assay Validated for Risk Assessment in Prostate Cancer

“There has been a preponderance in the healthcare industry to overtreat early-stage, slow-progressing prostate cancer, often subjecting patients to unwarranted, life-altering treatments. According to Genomic Health Inc, provider of genomic-based diagnostic tests, increased surveillance should be the primary outcome in patients with clinically localized prostate cancer (PC). To prevent overtreatment in such patients, they have developed the Oncotype DX test that allows clinical risk assessment for differentiating between high-risk and low-risk patients with prostate cancer (PC).

“Oncotype DX prostate cancer assay is a multigene RT-PCR expression assay compatible with fixed paraffin-embedded diagnostic prostate needle biopsies. The assay measures expression of 12 cancer-related genes (AZGP1, KLK2, SRD5A2, FAM13c, FLNC, GSN, TPM2, GSTM2, TPX2, BGN, COL1A1, and SFRP4) and five reference genes that are algorithmically combined to calculate the Genomic Prostate Score (GPS) ranging from 0 (low) to 100 (high). This 17-gene biopsy-based assay has been analytically and subsequently validated as a predictor of aggressive PC.”


UCSF-led Study Shows Oncotype DX and MRI May Provide Independent Information in Favorable Risk Prostate Cancer

“Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a study led by the University of California, San Francisco (UCSF) showing a broad distribution of Oncotype DX® Genomic Prostate Score (GPS) results among prostate MRI findings, suggesting that these two technologies may provide non-overlapping clinical information in men with localized prostate cancer.

” ‘For the first time, we looked at the association between information provided by a genomic assay and a prostate MRI to better understand the value these two technologies bring to clinical practice,’ said Michael Leapman, M.D., lead investigator from UCSF. ‘These new data show that, in some patients, further risk stratification may be possible, and tools such as GPS may add important biological information to more precisely assess the aggressiveness of a patient’s cancer.’

“In this study, researchers conducted a retrospective evaluation of the statistical association between the Oncotype DX GPS results and contributing gene groups with baseline endorectal MRI in 100 patients with clinically localized prostate cancer. The results showed a large variation of GPS results across MRI findings, demonstrating that Oncotype DX and MRI offer non-overlapping clinical insights in patients with early-stage prostate cancer.”


Older, Sicker Men with Early-Stage Prostate Cancer Do Not Benefit from Aggressive Treatment

“Treating older men with early-stage prostate cancer who also have other serious underlying health problems with aggressive therapies such as surgery or radiation therapy does not help them live longer and, in fact, can be detrimental, according to a study by UCLA researchers.

“The study followed the cases of more than 140,500 men aged 66 and older diagnosed with early-stage prostate cancer between 1991 and 2007 from the Surveillance, Epidemiology and End Results (SEER) Medicare database. Men who also suffered from multiple major medical conditions such as a history of heart attack, chronic obstructive pulmonary disease (COPD) and diabetes in combination did not live any longer after receiving aggressive therapy compared with men receiving no treatment. Additionally, these men were at risk for side effects such as impotence, urinary incontinence and bowel problems that can result from surgery and radiation treatments.”


Longest Prostate Cancer Active Surveillance Study Promising

“The longest follow-up to date of active surveillance in patients with favorable or intermediate-risk prostate cancer shows that it is a safe and feasible approach for as long as 20 years after diagnosis.

“Men in the study cohort had early-stage disease and were managed with surveillance; they were treated only if there were signs of disease progression. Up to 20 years after diagnosis, 1.5% of the 993 men had died, and 3.1% had developed metastatic disease.

“In addition, death was 10 times more likely from other causes than from prostate cancer, reported Laurie Klotz, MD, from the Sunnybrook Research Institute in Toronto.”