Humana Issues Positive Coverage Decision for NanoString’s Prosigna® Breast Cancer Assay

Excerpt:

“NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Humana has issued a positive coverage decision for the Prosigna® Breast Cancer Gene Signature Assay. Humana and its more than 13 million members join other payors now covering Prosigna, collectively representing more than 175 million covered lives throughout the United States.

“This positive coverage decision is in line with updated ASCO guidelines released in February of 2016, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients, when adjuvant chemotherapy is not precluded due to any other factor.”

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Low Axillary Recurrence/Mortality Among Older Women With Node-Negative Breast Cancer Undergoing Breast-Conserving Surgery Without Sentinel Node Biopsy

“In a single institution study reported in JAMA Surgery, Chung et al found a low axillary recurrence rate and low mortality among women with clinical T1–2N0 breast cancer aged ≥ 70 years who underwent breast-conserving surgery without sentinel node biopsy.

“The study involved 140 women treated at Cedars-Sinai Medical Center between January 2000 and December 2011. Patients had a median age of 83 years (range = 70–97 years); 74% had T1 tumors; 27% had grade 1, 44% grade 2, and 29% grade 3 tumors; 86% were estrogen receptor–positive; 73% were progesterone receptor–positive; 92% were HER2-negative; and 65% had ductal histology. Overall, 98% received chemotherapy, 76% radiotherapy, and 59% hormonal therapy…

“The investigators concluded: ‘Our study demonstrated low axillary recurrence and low mortality for patients with clinical T1–2N0 breast cancer who were 70 years of age or older and who underwent breast-conserving surgery without a sentinel node biopsy.’ “


Risks, Benefits Must Be Balanced When Choosing Optimal Therapy for Node-Negative, HER-2–Positive Breast Cancer

“On May 16, 2005, at about 1:30 p.m. local time, I was one of several hundred fortunate persons crowded into a conference hall at the ASCO Annual Meeting when the wide separation of the DFS curves in the joint analysis of NCCTG 9831 and NSABP B-31 was first shown.

“The benefit of adjuvant trastuzumab was dramatic, and the results changed clinical practice that very next Monday morning.

“Because there was a known cardiac risk of trastuzumab, patients with smaller lymph node-negative breast cancers either were excluded or underrepresented in the initial adjuvant trastuzumab studies, thus making extrapolation of these impressive results somewhat problematic for patients at lower risk for invasive recurrence.”


Four Cycles of FEC Chemotherapy Are as Good as Six Cycles in Node-Negative Breast Cancer

The gist: A recent clinical trial showed that people with node-negative breast cancer did just as well on a shorter, four-week chemotherapy treatment as people who took a longer, six-week one. The shorter treatment consisted of four cycles of doxorubicin and cyclophosphamide. The longer one involved six cycles of 5-fluorouracil, epirubicin and cyclophosphamide. Patients in both groups had similar survival rates, and people in the longer treatment group had worse side effects.

“Patients with node-negative breast cancer who received six cycles of 5-fluorouracil, epirubicin and cyclophosphamide experienced similar DFS and OS as patients who received four cycles of doxorubicin and cyclophosphamide, according to results of a phase 3 study presented at the San Antonio Breast Cancer Symposium.

“ ‘[In the MA-5 trial, the NCIC Clinical Trials Group] administered a dose-intensified epirubicin program, and the RFS and OS results were encouraging,’ Charles Edward Geyer, Jr., MD, FACP, associate director for clinical research at Virginia Commonwealth University Massey Cancer Center, said during his presentation. ‘Additionally, the French Adjuvant Study Group around that time had also evaluated their standard adjuvant regimen of FEC-50 and had shown that six cycles of therapy were more effective than three. So, at that time, we had two separate trials looking at different epirubicin schedules, both of which had seemed to be positive. It seemed reasonable at that time to compare [doxorubicin and cyclophosphamide] with one of those regimens. Since we were going to conclude the study in node-negative patients and include post-menopausal women, we chose the FEC-100 [chemotherapy regimen] because of its improved toxicity profile…’

“ ‘[Six cycles of] FEC-100 did not improve the primary endpoint of DFS or our secondary endpoint of OS relative to [four cycles of] AC,’ Geyer said. ‘Toxicities were increased with the FEC-100, which wasn’t unexpected because it did administer additional cycles of therapy compared with AC. Overall, the results do not support the use of six cycles of anthracycline-based regimens in node-negative breast cancer.’ “


Study Shows that Prosigna Test Influences Docs' Chemo Recommendations for Women with ER+, Node-Negative Breast Cancer

The gist: A recent study showed that a test called Prosigna affects whether oncologists recommend chemotherapy to women with estrogen receptor (ER)-positive, node-negative breast cancer.

“NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that the results of the first Prosigna® Assay decision impact study presented at the 37th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) showed that the use of the test significantly changed oncologists’ treatment recommendations. Conducted in collaboration with Grupo Español de Investigación del Cáncer de Mama (GEICAM), a Spanish breast cancer research group, this prospective study of the Prosigna Assay and its impact on the treatment of women with Estrogen Receptor-Positive (ER+), HER2-negative, node-negative breast cancer showed that the use of the test informed the oncologists’ recommendation whether or not to treat with adjuvant chemotherapy in addition to adjuvant endocrine therapy.

“ ‘We are very pleased to see that in this study, Prosigna was used by oncologists to make more informed decisions regarding the administration of adjuvant chemotherapy for early-stage breast cancer patients,’ stated Brad Gray, President and Chief Executive Officer of NanoString. ‘Also, we were pleased to recapitulate the results of our earlier analytical validation study, which showed that Prosigna can be run at multiple sites and generate high-quality, consistent results…’ ”

“Overall, the investigators concluded that Prosigna can be reliably performed in hospital laboratories to provide useful information beyond standard clinicopathological variables that oncologists can use to inform adjuvant treatment recommendations in clinical practice, and that this study provides additional evidence that Prosigna has analytical validity and clinical utility in real-world settings.”


70-Gene Signature Not Cost-Effective in Breast Cancer

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.


Patient-Reported Data Indicates That Radiation Therapy Does Not Increase Risk of Lymphedema in Node-Negative Breast Cancer Patients

“A secondary analysis of the National Surgical Adjuvant Breast and Bowel Project B-32 trial (Krag 2010) indicates that radiation therapy (RT) does not increase the incidence of lymphedema in patients with node-negative breast cancer, according to research presented today at the American Society for Radiation Oncology’s (ASTRO’s) 56th Annual Meeting.

“The original NSABP B-32 study was a randomized trial of sentinel node biopsy (SNB) versus SNB + axillary lymph node dissection (ALND) in 5,611 women with clinically node-negative breast cancer. The study was initiated to determine if SNB was as effective as ALND with fewer side effects.

“Although designed to assess the impact of type of axillary surgery specifically on lymphedema risk, the NSABP B-32 trial also provided the opportunity to evaluate the impact of radiation therapy (RT) on lymphedema risk. Lymphedema, swelling of the arm commonly caused by the removal of or damage to lymph nodes, is a significant concern for women undergoing breast cancer treatment.”