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A test that changes prostate cancer treatment recommendations — but does it improve outcomes?

GenomeDx Biosciences today announced that a study featured on the cover of Urology demonstrates that Decipher® Prostate Cancer Classifier significantly influenced treatment recommendations following prostate surgery, reducing disagreement between urologists and radiation oncologists, and has the potential to enhance personalization of patient care. Decipher is a Medicare-covered genomic test capable of predicting tumor aggressiveness in men following prostate surgery. The study, titled “Impact of a Genomic Classifier of Metastatic Risk on Postprostatectomy Treatment Recommendations by Radiation Oncologists and Urologists,” was published in this month’s issue of Urology.

“Conflicting treatment recommendations by different specialists looking at the same disease can be highly confusing for patients and is a problem for the health care system in general,” said Paul Nguyen, M.D., of Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School. “The Decipher test’s tendency to make the two specialties more concordant in their treatment recommendations provides significant value toward standardizing care for patients.”

The study was designed to evaluate how the Decipher Prostate Cancer Classifier, which predicts the risk of metastasis after prostatectomy, would impact adjuvant treatment recommendations made by urologists and radiation oncologists. These two specialties often disagree on which patients should receive radiation therapy following surgery and when.

Using clinical information alone, observation rather than adjuvant radiation therapy was recommended in 42% of decisions made by urologists and 23% of decisions by radiation oncologists (P < .0001). The Decipher test results altered 45% and 35% of treatment recommendations made by urologists and radiation oncologists, respectively. Decipher results indicating genomic high risk resulted in intensification of treatment, whereas genomic low risk resulted in less aggressive recommendations. The Decipher results increased agreement in treatment recommendations between urologists and radiation oncologists, as the odds of a recommendation for adjuvant treatment by urologists vs radiation oncologists increased from 0.27 (95% CI, 0.17-0.44) to 0.46 (95% CI, 0.29-0.75) after results of the Decipher test were made available.

“It is notable that while the Decipher test significantly influenced treatment decisions, it did not increase the total number of people receiving adjuvant therapy, suggesting that it helped ensure that the ones selected for adjuvant therapy are the ones most likely to benefit from it,” said Doug Dolginow, M.D., chief executive officer of GenomeDx. “As genomic tests like Decipher become used more routinely in urologic cancer patient care, they will have a greater impact on treatment recommendations in clinical practice and allow for better personalization of therapy.”

The Decipher test used in this study has been previously described in multiple blinded independent validation studies in men at high risk of recurrence at the time of prostatectomy. Researchers found that 60% of the clinically high-risk men would be reclassified as low risk based on the Decipher test and have only a 2.4% risk of metastasis at 5 years after surgery. In addition, the 19% of the patients with the highest risk based on Decipher had a nearly 10-fold higher risk of distant metastases by 5 years. The test provided a more accurate and precise estimate of a patient’s risk of recurrence. Use of this test therefore has the potential to assist clinicians to better direct utilization of secondary therapy after surgery.

About Decipher®

The Decipher® Prostate Cancer Classifier is a highly validated and commercially available genomic test for men with intermediate and high risk prostate cancer. Decipher predicts cancer aggressiveness by looking for a unique genomic signature comprised of a validated series of biomarkers associated with metastatic disease. Adding truly unique information to the treatment decision-making process, Decipher generates a risk result that is completely independent and distinct from PSA, Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease, which men may benefit from radiation therapy following prostate surgery, and can lead to significant cost-savings for healthcare systems. Decipher was developed in partnership with the Mayo Clinic.

Decipher is covered by Medicare and multiple private insurance plans in the US.
Learn more at: www.DecipherTest.com and follow Decipher on Twitter @DecipherTest and on Facebook.

About GenomeDx Biosciences

GenomeDx Biosciences is focused on transforming cancer patient care by putting usable genomic information in the hands of patients and their physicians. GenomeDx is developing and commercializing Decipher®, a highly validated genomic test for predicting metastatic disease in men with prostate cancer. In partnership with leading medical centers, the company has assembled the largest genomic catalogue of prostate cancer tumors in the world, representing billions of data points and more than 20 years of prostate cancer research expertise. Using advanced cloud-based bioinformatics, GenomeDx mines the genomic data to develop proprietary tests that address key clinical questions in cancer patient management. GenomeDx has partnered to share genomic data with leading clinician-scientists worldwide to collaboratively enrich the knowledge and understanding of urologic cancers for the goal of improving global cancer patient care. GenomeDx is based in San Diego, California and Vancouver, British Columbia.

Learn more at www.genomedx.com and follow us on Twitter at Twitter @GenomeDx, Facebook, LinkedIn and YouTube.

Media Contact for GenomeDx Biosciences:
Ian Stone
Canale Communications
619-849-5388
ian@canalecomm.com

 

SOURCE GenomeDx Biosciences

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http://genomedx.com

Rating

3 Star

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New Study Published on Cover of Urology Finds that Decipher® Prostate Cancer Classifier Reduces Conflicting Treatment Recommendations between Urologists and Radiation Oncologists

Our Review Summary

prostate cancerIn this news release, we’re introduced to a world of confusion among doctors about what to do with a man after they remove his cancerous, walnut-sized prostate gland. And the release offers something that can allegedly reduce that confusion: GenomeDx Biosciences’ Decipher, a test that sniffs out 22 different genetic signals of how a cancer case might play out.

Next we’re told about the struggle between urologists and radiation oncologists. The former group is less likely than the latter to prescribe “adjuvant therapy,” typically radiation, after removing a prostate gland. Missing high-risk cancer cases and not treating them is a problem, of course, but so is treating men who probably don’t need it. (Although we’re never really told why that’s an issue.)

According to the release, Decipher has the ability to change the minds of both urologists (45%) and radiation oncologists (35%), and get more of them to agree what or what not to do with a patient after removal of his cancerous prostate gland. That’s potentially an important advance, but we aren’t provided with crucial context — notably that it’s unclear if the decisions made because of Decipher were actually better decisions that would lead to a reduction in prostate cancer deaths. We’re also never cautioned about the small size of the study, given cost information about the test, or told about potential harms.

 

Why This Matters

Among cancers in men, prostate cancer is the second-most common – about 1 in 5 men in the U.S. will get a diagnosis in their lifetimes. It’s also the second-most deadly: Of the more than 200,000 men diagnosed each year in the U.S., nearly 30,000 die. (At least twice as many more black men succumb to prostate cancer as other ethnic groups.)

Testing prostate cancer for how likely it is to grow quickly and migrate (metastasize) might save a lot of men from unnecessary follow-up treatments and unwanted side effects. So, a reliable tool to help clinicians make informed choices – and with a consensus of opinion among the doctors a patient sees – stands to help everyone while reducing costs associated with prostate cancer.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There isn’t a dollar sign in this release, and we could find no reliable figure for how much each Decipher test costs. (A New York Times article suggests similar genomic tests for prostate cancer cost roughly $3,000, if not more.) We’ve reached out to the company’s PR agency for an average per-test cost, but haven’t received a response in time for the publication of this review.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The release states that, according to the latest study, Decipher has the ability to change the minds of both urologists (45%) and radiation oncologists (35%), and get more of them to agree what or what not to do with a patient after removal of his cancerous prostate gland.

We’ll give the release credit here for quantifying the main findings of the study. But we’d note that there was potential to go deeper. We’re never told how many patients have issues with recurrent cancer or metastasis. (The Centers for Medicare and Medicaid Services suggests about 40,000 men each year face a high risk.) We also aren’t told how effective radiation or other therapies are after a prostatectomy, nor how effective Decipher might be in saving lives. Most of the clinical trials cited in the article mention only reductions in biochemical progression–a surrogate endpoint.

Most of what’s found in the release are rather general statements from doctors who have financial relationships with GenomeDx Biosciences, e.g. “it helped ensure that the ones selected for adjuvant therapy are the ones most likely to benefit from it.”

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release doesn’t explain what sorts of risks a patient faces from radiation, hormone, and other “adjuvant” therapies after surgery, and avoiding these seems to be a key point of the Decipher test. We also don’t get any words on how reliable the test actually test is and how often it might return inaccurate results, which is its own kind of risk.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release lacked context on important study limitations, particularly the small sample size of clinicians (only 20 urologists and 26 radiation oncologists) and the small number of patient cases (only 11). We also don’t know how experienced/representative the clinicians are in their specialties, or whether results among academics differed from community practices.

The study comments on some of this in its conclusion section, and it would have helped to see something like it in the release: “The sample size of this study is modest, and so additional validation studies are needed to determine the generalizability of the results over a wide range of patient cases and clinicians with varying degrees of expertise.”

Does the news release commit disease-mongering?

Satisfactory

There’s nothing dramatic or overblown in this release.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

GenomeDx Biosciences funded the research. The company’s name appears 14 times in the release and its product shows up 29 times.

But while the study itself makes detailed and explicit disclosures about funding and potential conflicts of interest (some of the researchers are employees of the company), the news release doesn’t. That’s unfortunate. Prostate cancer is very prevalent, Medicare can cover the cost of a Decipher test, and about half of men who get prostate cancer are covered by Medicare — so GenomeDx Biosciences has a lot to gain from more widespread use of its product.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

We’re not told if there are any alternatives. Even if Decipher stands alone as a post-operative test, that’s critical information.

In the study itself, the authors did provide clinicians with information about risk groups, PSA, and extensive information about the pathology of the cancer. Studies (and guidelines) have used these parameters to guide treatment–it would be useful to know whether the initial decisions followed accepted practice. If not, then clinician education might be a more (cost) effective intervention than providing results from an expensive test.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

We’re told Decipher is commercially available and that Medicare can pay for the test.

Does the news release establish the true novelty of the approach?

Satisfactory

A bit of boilerplate text toward the end of the release gets at novelty with this statement: “Decipher generates a risk result that is completely independent and distinct from PSA, Gleason score and other clinical risk factors. Clinical studies from leading cancer centers published in over a dozen medical journals demonstrate that Decipher can accurately predict metastatic disease, which men may benefit from radiation therapy following prostate surgery, and can lead to significant cost-savings for healthcare systems.” That’s good enough for Satisfactory rating, although we caution again that the amount of independent value added from Decipher is unclear.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

We found no charged or dramatic language. On the contrary, the entire release is pretty staid.

Total Score: 5 of 10 Satisfactory

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