FDA Approves First-of-a-Kind Test for Cancer-Gene Profiling

Excerpt:

“U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.

“The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

“The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now and will lead more insurers to cover it.”

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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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Blood Tumor Markers May Warn When Lung Cancer Patients Are Progressing on Targeted Treatments

Excerpt:

“For many years, oncologists have known that cancers can secrete complex molecules into the blood and that levels of these molecules can be easily measured. These so-called ‘tumor markers’ are traditionally associated with a single dominant cancer type, for example Prostate Specific Antigen (PSA) linked to prostate cancer, Carcinoembryonic antigen (CEA) to colorectal cancer, CA125 to ovarian cancer, CA19.9 to pancreatic cancer and CA27.29 to breast cancer. However, the real challenge has been to determine a practical use for these markers. They don’t appear to be useful as a means of screening otherwise healthy people for evidence of underlying cancers.”

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Testing for Immune ‘Hotspots’ Can Predict Risk That Breast Cancer Will Return

Excerpt:

“Scientists have developed a new test that can pick out women at high risk of relapsing from breast cancer within 10 years of diagnosis.

“Their study looked for immune cell ‘hotspots’ in and around tumours, and found that women who had a high number of hotspots were more likely to relapse than those with lower numbers.

“The new test could help more accurately assess the risk of cancer returning in individual patients, and offer them monitoring or preventative treatment.”

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Blood-Based Assays Are Addition, But Not Replacement for Lung Tissue Biopsies

Excerpt:

“The boom of blood-based biomarkers has led to a turning point in clinical practice for physicians treating patients with non–small cell lung cancer (NSCLC). While tissue biopsies remain the standard approach, plasma assays—if positive—can direct patients to a first-line targeted treatment quicker.

” ‘Blood-based testing does have a role in patients with NSCLC,’ said Leora Horn, MD, MSc. ‘The blood can be potentially used as a surrogate for markers for directing for therapy. But if blood testing is negative, it is not enough to say that a patient is not positive. Those patients do need to go on to get a biopsy.’ ”

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First-Line Immunotherapy Treatment Can Improve Survival for Subset of Lung Cancer Patients

Excerpt:

“Findings from a phase III clinical trial for advanced lung cancer patients could help oncologists better predict which patients are likely to receive the most benefit from immunotherapy as a first-line treatment based on the unique molecular characteristics of their tumor, according to a new study reported by a global team led by David Carbone, MD, PhD, of The Ohio State University Comprehensive Cancer – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

“In this study, researchers compared the effectiveness of the immunotherapy drug nivolumab (pronounced ‘nye VOL ue mab,’ marketed at Opdivo), with standard-of-care chemotherapy in 541 patients with previously untreated or recurrent non-small cell lung cancer (NSCLC) that expressed PDL-1 antibodies.”

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Updates to NSCLC Guidelines Make Testing at Diagnosis, Resistance Essential

Excerpt:

“Updates to the National Comprehensive Cancer Network (NCCN) guidelines for the management of advanced non–small cell lung cancer (NSCLC) stress the importance of multiplexed biomarker testing at diagnosis to aid in the selection of appropriate first-line and subsequent lines of therapy, said presenters at the 2017 NCCN Annual Conference.

“The latest version of the guidelines recommends that PD-L1, in addition to molecular analysis, be employed as a biomarker to direct initial therapy, with ≥50% expression established as the threshold for a positive result. The PD-L1 test ‘decides whether a patient has enough of the marker to warrant initial immunotherapy,’ said presenter Gregory J. Riely, MD, PhD.”

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Physicians’ Misunderstanding of Genetic Test Results May Hamper Mastectomy Decisions

Excerpt:

“A recent survey of over 2,000 women newly diagnosed with breast cancer found that half of those who undergo bilateral mastectomy after genetic testing don’t actually have mutations known to confer increased risk of additional cancers, according to a study by researchers at the Stanford University School of Medicine and four other U.S. medical centers.

“Instead the women had what are known as variants of uncertain significance, or VUS, that are often eventually found to be harmless. A bilateral mastectomy is a surgical procedure in which both of a woman’s breasts are removed after a diagnosis of in one breast.”

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Expert Tackles Efficacy of PD-L1 Testing for NSCLC in 2017

Excerpt:

“In 2017, a lung cancer diagnosis must be accompanied by biomarker testing, whether it be for a genomic alteration, such as EGFR, ALK, or ROS1, or the immune marker PD-L1, according to Daniel B. Costa, MD, PhD, MMSc.

“Moreover, even with FDA-approved agents designed to target these abnormalities or expression levels, researchers are still hoping to uncover additional markers and match novel therapies to them.”

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