When Gene Tests for Breast Cancer Reveal Grim Data but No Guidance

“At a time when genetic testing and genetically personalized treatments for cancer are proliferating, buoyed by new resources like President Obama’s $215 million personalized medicine initiative, women with breast cancer are facing a frustrating reality: The genetic data is there, but in many cases, doctors do not know what to do with it.

“That was the situation Angie Watts, 44, faced after she walked into a radiation oncologist’s office last June expecting to discuss the radiation therapy she was about to begin after a lumpectomy for breast cancer. Instead, Dr. Timothy M. Zagar of the University of North Carolina looked down at a sheet of test results and delivered some shocking news.

“A genetic test showed she had inherited an alteration in a gene needed to repair DNA. Radiation breaks DNA, so the treatment might actually spur the growth of her cancer, he said. He urged her not to take the risk and to have a double mastectomy instead.”


Lung-MAP Precision Medicine Trial Makes Exciting Changes

“The team behind the Lung Cancer Master Protocol (Lung-MAP), a groundbreaking clinical trial for patients with advanced squamous cell lung cancer, is announcing exciting new changes and enrolling more patients as it adapts to the latest science and treatments. The nation-wide precision medicine trial now includes nivolumab, the immunotherapy treatment recently approved by the U.S. Food and Drug Administration

“Lung-MAP tests several new treatments for patients with advanced stage squamous cell . In advanced stage squamous patients, cancer has usually spread from the lungs to other organs. The trial is for these patients, whose cancer has continued to grow – even after being treated with standard therapy.

“Lung-MAP gives these patients access to innovative therapies. The trial design allows several drugs to be tested simultaneously. Currently, the trial has four trial options for patients. Here’s how it works. All qualifying patients enrolled in Lung-MAP get free genomic profiling. Based on results of that DNA tumor tissue test, patients can be assigned to one of three biomarker-driven sub-studies, each evaluating a promising new drug. If there is no genomic match, patients can enroll in a fourth sub-study, which is testing the FDA-approved nivolumab, an immunotherapy made by Bristol Myers Squibb, against a nivolumab combination therapy. Regardless of their genomic profile, all Lung-MAP patients receive a treatment – not a placebo.”


Precision Medicine on the Horizon for Prostate Cancer

“While still in its early stages, integrative genomic testing could be the future for personalizing therapy for patients with castration-resistant prostate cancer (CRPC), according to Tomasz M. Beer, MD, FACP.

“In an interview with Targeted Oncology, Beer, deputy director, Knight Cancer Institute, Oregon Health and Science University, explained that understanding the genetic makeup of CRPC could lead to new treatments, both single-agents and combinations. One of the most recent examples was the discovery of BRCA genetic mutations within CRPC, he said. While BRCA mutations are mostly associated with breast and ovarian cancers, this discovery could provide a new avenue for treating men with CRPC.

“In the interview, Beer discussed the current state of genetic testing for prostate cancer and changes on the horizon that are currently being explored in clinical trials.”


Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting

“Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

“The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

“ ‘We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,’ said Patrick J. Mahaffy, President and CEO of Clovis Oncology. ‘New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.’ “


Testing for BRCA Mutations Reaches High Levels Among Young Women With Breast Cancer, Study Finds

“The vast majority of young women with breast cancer are being tested for mutations in the cancer-susceptibility genes BRCA1 and BRCA2, a new study led by Dana-Farber Cancer Institute investigators suggests, and many of them are using the results of those tests to guide their treatment.

“The study, published in the Journal of the American Medical Association Oncology, provides encouraging evidence that patients are largely following National Comprehensive Cancer Network guidelines that women diagnosed with breast cancer at age 50 or younger undergo genetic testing. At the same time, however, the researchers found that many patients who don’t carry BRCA1 or 2 mutations are choosing to have both breasts removed, even though their risk of cancer in the unaffected breast is no higher than average.”


ASCO Issues New Guideline on Use of Biomarkers to Guide Early Breast Cancer Therapy Decisions

“The American Society of Clinical Oncology (ASCO) today issued a new clinical practice guideline for women with early-stage invasive breast cancer and known hormone receptor and human epidermal growth factor 2 (HER2) receptor status. The guideline includes evidence-based recommendations on the appropriate use of breast tumor biomarker tests to guide decisions on adjuvant systemic therapy.

” ‘In the era of precision medicine, the role of biomarkers in guiding clinical care is greater than in the past. An extensive number of new tests have come out in the last 5-10 years, but not all have sufficient evidence of clinical utility,’ said Lyndsay N. Harris, MD, co-chair of the ASCO expert panel that developed the guideline. ‘These latest recommendations truly inform physicians about which tests need to be performed. But this is not all that goes into patient care—doctors need to continue discussions with patients to develop individualized treatment plans.’ “


Shoddy Biopsies Deny Cancer Patients a Shot at Personalized Treatment

“A huge federal trial of personalized cancer medicine has run into an unexpected roadblock: Many of the tumor samples aren’t robust enough to be put through genetic analysis.

“The samples, taken from patients with advanced cancer, were collected by doctors in hundreds of clinics nationwide. When researchers checked them, they found as many as 1 in 5 didn’t have enough malignant cells to analyze, in most cases because the biopsy had been poorly done.

“The glitch raises troubling questions about the new era of precision medicine.”


Impact of Recurrence Score Assay Varies With Patient Age

“For women with early-stage breast cancer, the impact of receipt of the 21-gene recurrence score (RS) assay varies with patient age, according to a study published online Nov. 23 in the Journal of Clinical Oncology.

“Andrew J. Epstein, Ph.D., from the Philadelphia Veterans Affairs Medical Center, and colleagues used data from the Pennsylvania Cancer Registry to examine the correlations between RS assay receipt, subsequent chemotherapy use, and medical expenditures. Data were included for 7,287 women with early-stage breast cancer who underwent initial surgical treatment.”


Study Supports Prognostic Potential of Genomic Health's Oncotype DX in Breast Cancer

“In a study published in the latest issue of the New England Journal of Medicine, an international team led by investigators in the US validated Genomic Health’s Oncotype DX as a means to stratify treatment in a prospective trial of women with a relatively low risk breast cancer subtype.”