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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Use of Radiotherapy After Prostate Cancer Surgery Declining, Despite Evidence of Benefit

“Despite strong evidence and guidelines supporting its use, post-surgical radiation therapy for prostate cancer patients at risk of recurrence is declining in the United States. The study, published online in the journal European Urology, finds fewer than 10 percent of patients at risk of recurrence received postoperative radiotherapy within six months of surgery in the U.S.

“Although radical prostatectomy (RP) is a common curative treatment for localized prostate cancer, about 30% of patients will develop biochemical recurrence after surgery, meaning their prostate-specific antigen (PSA) level will again rise. For some patients with more aggressive cancers, as many as 60% to 70% can experience biochemical recurrence (also called biochemical failure).

“Three large randomized prospective clinical trials, two done in Europe and one in the United States, have demonstrated that postoperative radiotherapy (RT) in patients with adverse pathological features reduces risk of PSA recurrence, may prevent the need for androgen deprivation therapy (ADT), and may reduce metastasis and improve survival.”


Smokers at Twice Risk of Prostate Cancer Recurring after Surgery

“Current smokers, and those who have quit smoking less than 10 years previously, have twice the risk of a recurrence of prostate cancer after surgery, according to new research presented at the European Association of Urology conference in Madrid.

“Prostate cancer is the third most common male cancer in Europe, accounting for over 92,000 deaths in 2012 (9% of male deaths). Around 30% of all prostate cancer patients treated with radical prostatectomy experience biochemical recurrence (defined by an increase in PSA, prostate specific antigen) within 10 years after surgery

“An international group of scientists and clinicians from the USA and Europe retrospectively looked at biochemical prostate cancer recurrence – in 7191 men who had had their prostate removed by radical prostatectomy. Of these men, roughly a third were never smokers (2513, or 34.9%), a third were former smokers (2269, or 31.6%) and a third were current smokers (3409, or 33.5%). These patients were followed up for an average of 28 months.

“The results showed that after a median of 28 months, current smokers had around double (HR 2.26) the chance of the cancer recurring than did patients who had never smoked (see abstract below for full results). Even those who had quit smoking within the last 10 years still had a significantly higher risk of cancer recurrence, at about the same level (HR 2.03) as that for current smokers. It wasn’t until 10 years after a patient had quit smoking that the risk of cancer recurrence dropped significantly.”


FDA Gives Radium-223 Priority Review Status

Radium Ra 223 Dichloride will be considered as a treatment for patients who have castration-resistant prostate cancer with bone metastases under the FDA’s priority review program. The filing is based on the 922 patient phase III ALSYMPCA trial, of radium-223 plus current standard of care, or placebo plus current standard of care.


ASCO GU 2013: C-11 Choline PET for Biochemical Recurrence in Prostate Cancer: Answer or Just Catalyst for Change?

The recent approval by the U.S. Food and Drug Administration (FDA) for the production of C-11 choline at Mayo Clinic for PET imaging in patients with biochemical recurrence (BCR) of prostate cancer has generated intense interest in the biomedical molecular imaging community. The main reason for this enthusiasm is that this is the first approval of a PET agent specifically for detecting sites of recurrence in prostate cancer, a highly prevalent disease for which conventional imaging tools have proven inadequate.