Cancer Mutation Gains Ground as Test for Immunotherapy Drugs

Excerpt:

“Scientists are stepping up the hunt for better diagnostic tests to predict if cancer patients will benefit from costly modern immunotherapy drugs, which are transforming cancer care but remain a hit-and-miss affair.

“Research presented at Europe’s biggest oncology congress in Madrid adds to evidence that patients with an above average number of genetic mutations in their tumors have a better chance of responding to the new treatments, and drugmakers are racing to confirm the idea.”

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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.”


New Test to Aid Melanoma Diagnosis: Ready for Clinical Use?

“Differentiating between malignant melanoma and benign skin moles can be difficult in about 15% of cases, where histopathologic analysis is not straightforward because of ambiguous findings.

“A new 23-gene signature test (myPath Melanoma, Myriad Genetics) could be helpful in these instances, researchers working with the company suggest.

“The test was developed with a training set and then validated in an independent cohort. The results were published online March 2 in the Journal of Cutaneous Pathology.

” ‘myPath Melanoma is a powerful new molecular diagnostic test that analyzes genetic information inside skin cells to help us understand the biology of a patient’s skin lesion and objectively differentiate benign moles from potentially lethal melanomas,’ researcher Loren Clarke, MD, medical director for dermatology at Myriad, said in a company press release.”


Myriad myPath(TM) Melanoma Improves Diagnosis and Treatment Plans

The gist: It can be difficult for doctors to tell whether a patient has malignant melanoma or simply a benign mole. A test called myPath Melanoma uses molecular testing to help clarify whether or not a person has melanoma. Researchers recently finished a study to look at the effectiveness of the test. They found that doctors who used MyPath Melanoma had 43% fewer cases of indecision, and changed their mind about treatment recommendations 49% of the time.

“Myriad Genetics, Inc. (Nasdaq:MYGN) today presented results from a prospective clinical utility study of its Myriad myPath Melanoma test at the 2014 American Society of Dermatopathology (ASDP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a genetic test that differentiates malignant melanoma from benign skin lesions across all major melanoma subtypes. Key findings of this clinical utility study included a 43 percent reduction in indeterminate diagnoses and a 49 percent change in physicians’ treatment recommendations for patients.

” ‘These findings demonstrate the power of Myriad myPath Melanoma to improve patient care through more definitive diagnoses of skin lesions, particularly in these difficult-to-call cases,’ said Loren Clarke, M.D., vice president of Medical Affairs at Myriad Genetic Laboratories. ‘Importantly, the number of indeterminate cases was significantly reduced, which means less uncertainty for more patients and physicians, and may lead to less overtreatment in these cases.’ ”

“The study evaluated the impact of the Myriad myPath Melanoma diagnostic test on dermatopathologists’ diagnoses and intended treatment recommendations for 218 patients with pigmented skin lesions that were considered difficult to diagnose. The dermatopathologists recorded their diagnoses and treatment plans before and after receiving the myPath Melanoma test results.”


The Cancer Biomarker Problem


In 2008, Dr. Charles Sawyers, currently the president of American Association for Cancer Research, wrote an article for the journal Nature entitled: ‘The Cancer Biomarker Problem.’ This excellent paper clearly explains what cancer biomarkers are, outlines the different categories of biomarkers, and emphasizes how important biomarkers are in the field of targeted therapies. Predictive biomarkers are indispensable tools that should direct the rational use of targeted drugs in cancer patients. There are additional types of biomarkers, including some that could help evaluate the course of cancer progression or help determine the effective dose of an investigational drug. But this post focuses on predictive biomarkers. Continue reading…


2 Skin Cancer Drugs Win FDA Approval

“Two new drugs for metastatic or inoperable melanoma, dabrafenib (Tafinlar) and trametinib (Mekinist), were approved by the FDA on Wednesday.The agency also approved a companion diagnostic test for both agents to detect certain mutations in the BRAF gene that render melanoma cells susceptible to the drugs.”