The gist: A new study has confirmed that a test called Oncotype DX is a reliable way to predict how likely it is that a woman’s cancer will come back (recur) after she undergoes surgery for ductal carcinoma in situ (DCIS). If a patient’s cancer is more likely to recur, she may decide on additional aggressive treatment to prevent it. Patients with DCIS that is unlikely to return after surgery may choose to forgo unnecessary treatments.
“Ductal carcinoma in situ (DCIS), which accounts for 30% of all newly diagnosed breast cancer, is actually a precancerous lesion. A proportion of patients will have progression to invasive breast cancer, but up until recently, it has not been possible to identify which patients require further treatment to prevent recurrence.
“Oncotype DX DCIS is a 12-panel gene test with a scoring system that categorizes cancers as low, intermediate, or high risk for local recurrence over 10 years following treatment with breast-conserving surgery alone. A large population-based study presented at the 2014 San Antonio Breast Cancer Symposium validated Oncotype DX DCIS in a diverse population of women with DCIS (Abstract S5-04)…
“The current study is important because the ECOG E5914 study that showed Oncotype DX DCIS was predictive of local recurrence was based on only a select population of women. ‘Our results confirm the ECOG E5914 results in a more diverse population,’ explained lead author Eileen Rakovitch, MD,Sunnybrook Health Sciences Centre, University of Toronto, Canada.”
The gist: A new drug called PLX3397 will now be available through the innovative I-SPY 2clinical trial, which uses molecular testing to match breast cancer patients to the pre-surgery treatments most likely to work for them. The trial is open for participation by women with newly diagnosed, locally advanced breast cancer.
“Plexxikon Inc., a member of Daiichi Sankyo Group, and QuantumLeap Healthcare Collaborative today announced that Plexxikon’s drug candidate, PLX3397, has been selected for study in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2). I-SPY 2 is a standing phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (minimum of Stage 2) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (prior to surgery).
“I-SPY 2 is conducted by a consortium that brings together the Food and Drug Administration (FDA), National Cancer Institute (NCI), pharmaceutical companies, leading academic medical centers, and patient advocacy groups under its umbrella. The trial is sponsored by QuantumLeap Healthcare Collaborative (QLHC), a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions.
“The I-SPY 2 TRIAL employs a unique adaptive trial design to match experimental therapies with patients. Genetic or biological markers (‘biomarkers’) from individual patients’ tumors are used to screen promising new treatments, identifying which therapies are most effective in specific patient subgroups. Regimens that have a high Bayesian predictive probability of showing superiority in a 300 patient phase 3 confirmatory trial in at least one of 10 predefined signatures may ‘graduate’ from I-SPY. This high efficacy bar and rapid turnaround time allows the trial to identify the right drug for the right patient in the most expeditious fashion.”
The gist: New research shows interesting results for a test that’s used to determine whether early-stage breast cancer patients need chemotherapy after tumor-removal surgery. The test, called Oncotype DX, is linked with lower chemotherapy use in younger patients, but not in patients 66 years old or older. The test is used for patients with lymph node-negative, hormone receptor (HR)-positive and HER2-negative breast cancer. It looks at a patient’s tumor genes to determine how likely a return of cancer later on (recurrence) might be.
“In what’s believed to be one of the largest population-based studies of Oncotype DX ever conducted, researchers at The University of Texas MD Anderson Cancer Center have found that the commercial diagnostic tool, Oncotype DX, was associated with a decrease in chemotherapy use in younger patients, but not in those over 66 years of age.
“Mariana Chavez Mac Gregor, M.D., assistant professor, health services research and breast medical oncology, will present the findings at a poster session of the 2014 San Antonio Breast Cancer Symposium.
“Oncotype DX is a 21-gene assay used to help estimate the likelihood of recurrence in women with early-stage breast cancer and, thus, determine those who may or may not benefit from adjuvant chemotherapy. The National Comprehensive Cancer Network includes its use for women with lymph node-negative, hormone receptor (HR)-positive and HER2-negative disease…
” ‘In the younger group of breast cancer patients for whom the test is appropriate, and when used in this setting, we’re finding an important reduction in chemotherapy use. The contrast between older and younger patients’ results did surprise us. However, generally, older breast cancer patients receive much less chemotherapy because of their age and because they often have additional co-morbidities. Perhaps we will see that impact with time,’ said Chavez Mac Gregor.”
The gist: Doctors sometimes use molecular tests to help make treatment decisions. These tests give information about the genetics of a patient’s tumor. Different companies make different kinds of molecular tests for patients with node-negative breast cancer (NNBC). These tests help with decision-making for adjuvant chemotherapy—chemotherapy after tumor-removal surgery to keep the cancer from returning. Recently, scientists found that one of these tests was not cost-effective when compared to other options.
“For patients with node-negative breast cancer (NNBC), the 70-gene signature is unlikely to be cost-effective for guiding adjuvant chemotherapy decision making, according to a study published online Oct. 6 in the Journal of Clinical Oncology.
“Julia Bonastre, Ph.D., from Gustave Roussy in Villejuif, France, and colleagues conducted an economic analysis of the 70-gene signature used to guide adjuvant chemotherapy decision making in patients with NNBC. The 70-gene signature was compared with Adjuvant! Online and chemotherapy in all patients as a basis for the decision to administer adjuvant chemotherapy. Costs, life-years (LYs), and quality-adjusted life-years (QALYs) were compared over a 10-year period.
“The researchers observed similar mean differences in LYs and QALYs for the three strategies. Higher cost was seen in association with the 70-gene strategy, with a mean difference of €2,037 and €657 compared with Adjuvant! Online and systematic chemotherapy, respectively. The probability of being the most cost-effective strategy was 92 percent for Adjuvant! Online, 6 percent for systematic chemotherapy, and 2 percent for the 70-gene signature, for a €50,000 per QALY willingness-to-pay threshold.
” ‘Optimizing adjuvant chemotherapy decision making based on the 70-gene signature is unlikely to be cost-effective in patients with NNBC,’ the authors write.
Editor’s note: Testing a patient’s tumors for mutated genes can give doctors important information about that patient’s outlook and appropriate treatments. This article discusses two predictive mutations that doctors can test for in the tumors of people with anaplastic large-cell lymphoma (ALCL) who have already been found not to have a mutation in the ALK gene.
“A Mayo Clinic-led group of researchers has discovered three subgroups of a single type of non-Hodgkin lymphoma that have markedly different survival rates. These subgroups could not be differentiated by routine pathology but only with the aid of novel genetic tests, which the research team recommends giving to all patients with ALK-negative anaplastic large-cell lymphoma (ALCL). Findings are published in the journal Blood.
“Patients whose lymphomas had TP63 rearrangements had only a 17 percent chance of living five years beyond diagnosis, compared to 90 percent of patients whose tumors had DUSP22 rearrangements. A third group of tumors, those with neither rearrangement, was associated with an intermediate survival rate.
“ ‘This is the first study to demonstrate unequivocal genetic and clinical heterogeneity among systemic ALK-negative anaplastic large-cell lymphomas,’ says Andrew L. Feldman, M.D., a Mayo Clinic pathologist and senior author on the multi-institutional study. ‘Most strikingly, patients with DUSP22-rearranged ALCL had excellent overall survival rates, while patients with TP63-rearranged ALCL had dismal outcomes and nearly always failed standard therapy.’ Dr. Feldman also is a Damon Runyon Clinical Investigator.”
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