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Gene-expression-based Biomarker Predicts Long-term Risk of Breast Cancer Recurrence

A comparison of three methods of predicting the risk of recurrence in women treated for estrogen-receptor (ER)-positive breast cancer finds that only the breast cancer index (BCI) – a biomarker based on the expression levels of seven tumor-specific genes – accurately identifies patients who continue to be at risk after five years of treatment with either tamoxifen or the aromatase inhibitor anastrozole. The study comparing the BCI with two other prognostic tests has been published online in Lancet Oncology.

Lifestyle, Age Linked to Diabetes-related Protein

Over the last decade researchers have amassed increasing evidence that relatively low levels of a protein called sex hormone binding globulin (SHBG) can indicate an elevated risk of type 2 diabetes and metabolic syndrome years in advance.

bioTheranostics’ Breast Cancer IndexSM Molecular Test Identifies Risk for Early and Late Breast Cancer Recurrence, Lancet Oncology Study Finds

A study published online in The Lancet Oncology found that in a comparison of three methods of predicting the risk of recurrence of estrogen-receptor (ER)-positive breast cancer, only the Breast Cancer IndexSM (BCI) from bioTheranostics predicts risk for both early (0-5 years) and late (5-10 years) recurrence. The study provides important new information to guide patient treatment decisions at diagnosis and after several years of therapy.

Study Published Showing Advantages of the PAM50 Gene Signature, the Basis for Prosigna, in Helping to Estimate Risk of Late Distant Recurrence in Postmenopausal Estrogen Receptor Positive Breast Cancer Patients

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that a study published online in the Journal of the National Cancer Institute demonstrated that the PAM50 gene signature, which is the basis for the Prosigna™ Breast Cancer Prognostic Gene Signature Assay, provides important information to help estimate the risk of late distant recurrence in postmenopausal women with estrogen receptor positive (ER+) early-stage breast cancer. After comparing the PAM50 gene signature, the Oncotype DX® Breast Cancer Assay and the IHC4 score, the authors concluded that the PAM50 gene signature provided the strongest prognostic information regarding risk of distant recurrence five to 10 years following diagnosis in postmenopausal ER+ early-stage breast cancer patients treated with five years of endocrine therapy.

NICE Recommends Genomic Health’s Oncotype DX® Test To Guide Chemotherapy Treatment Decisions For Qualified Early-Stage Invasive Breast Cancer Patients

Genomic Health, Inc. recently announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its final guidance recommending Oncotype DX® as the only multi-gene breast cancer test for use in clinical practice to guide chemotherapy treatment decisions for patients with early-stage, hormone receptor-positive, invasive breast cancer. Consistent with leading international breast cancer treatment guidelines, including ASCO®, NCCN®, ESMO® and St. Gallen, NICE’s recommendation recognizes the unparalleled evidence of the clinical validity of the Oncotype DX test and its ability to enable physicians and their patients to make more informed, individualized decisions.

“It is encouraging to see growing recognition of the value of genomic testing. Its provision has enhanced the care of breast cancer patients around the world and it will now be available as an option in the UK,” said David Miles, M.D., medical oncologist at Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom. “NICE’s recommendation for the use of Oncotype DX in the UK is an important step forward, enabling physicians and patients to make better-informed treatment decisions based on the biology of an individual patient’s breast cancer.”

To date, more than 1,500 women in the UK have utilized the Oncotype DX test to help guide their treatment decisions. Breast cancer is the most commonly diagnosed cancer in women, with almost 50,000 people diagnosed each year in the UK. Most of these patients are diagnosed with early-stage, invasive breast cancer and a significant number of them could benefit from this test under the NICE recommendation.

“The decision of whether or not to undergo chemotherapy is an extremely important and difficult one for patients, not only due to the many side effects associated with treatment, but also due to the hardship for the patient and her family and the loss of income due to days off work. Allowing patients and their physicians to make more personalized treatment decisions can help improve outcomes for the rising number of early-stage breast cancer patients in Europe,” said Kathi Apostolidis, vice president, European Cancer Patient Coalition, Brussels, Belgium, and a two-time breast cancer survivor, commenting on the NICE announcement. “We hope NICE’s decision will also inspire other European countries to provide broader access to novel diagnostics such as Oncotype DX, which allows informed decision making for sparing the burden of chemotherapy from those who do not need it.”

With data showing that only four out of 100 early-stage invasive breast cancer patients benefit from chemotherapy, the Oncotype DX test helps improve patient outcomes by personalizing treatment decisions through assessment of the risk of cancer recurrence and chemotherapy benefit.

“Given NICE’s rigorous review process and its influence throughout the region, we believe this decision brings us an important step closer to achieving our mission to improve the quality of treatment decisions for cancer patients across Europe and around the world,” said Steven Shak, M.D., executive vice president of research and development, Genomic Health. “Our extensive body of clinical evidence highlights the unique ability of our test to play a critical role in breast cancer treatment, while providing a positive impact on health systems worldwide. Based on NICE’s recommendation, we will work with NHS healthcare providers and commissioners to provide broad access to the Oncotype DX test for UK patients.”

The robust body of evidence supporting Oncotype DX includes 15 clinical studies in more than 6,000 patients; 18 decision impact studies from 10 countries, which consistently demonstrate an approximate 30 percent change in treatment recommendations; and more than 20 studies from nine countries, showing that the use of the test is cost-effective in all health systems analyzed.

Source: PR Newswire