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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Tailored, Dense-Dose Chemotherapy for Early Breast Cancer Does Not Result in Significant Improvement

Excerpt:

“Among women with high-risk early breast cancer, the use of tailored dose-dense chemotherapy compared with standard adjuvant chemotherapy did not result in a statistically significant improvement in breast cancer recurrence-free survival, and nonhematologic toxic effects were more frequent in the tailored dose-dense group, according to a study appearing in the November 8 issue of JAMA.

“Dose-dense therapy, defined as delivery of chemotherapy at shorter intervals without increasing the cumulative dose, has been suggested as a means to improve efficacy of chemotherapy for early . Dosing of most is calculated based on body surface area, which leads to large interpatient variability in toxic effects and efficacy. Whether tailored dosing can improve outcomes is unknown, as is the role of dose-dense adjuvant chemotherapy.”

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Adjuvant Chemotherapy Extends OS in Early-Stage NSCLC

Excerpt:

“Adjuvant chemotherapy following complete surgical resection improved OS among patients with early-stage non–small cell lung cancer, according to a study published in Journal of Thoracic Oncology.

“Patients diagnosed with medically operable, early-stage non–small cell lung cancer typically undergo complete resection.

“However, 5-year OS is ‘suboptimal, ranging from 73% in patients with pathologic stage IA to 24% in those with stage IIIA,’ Daniel Morgensztern, MD, associate professor at Washington University School of Medicine in St. Louis and member of the International Association for the Study of Lung Cancer, and colleagues wrote.”

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Adjuvant Chemotherapy Improves Overall Survival in Patients With Stage IB Non-Small Cell Lung Cancer

Excerpt:

“The use of adjuvant chemotherapy in early-stage non-small cell lung cancer (NSCLC) patients improves overall survival (OS) and 5-year OS in patients with tumor sizes ranging from 3 – 7 cm.

“Stage I , the earliest stage at which clinicians diagnose lung cancer, is identified in approximately 16% of all lung cancer cases in the U.S. For early-stage  with medically operable clinical NSCLC, surgery is the treatment of choice. Several studies have found that patients with stage II and III NSCLC that had adjuvant chemotherapy following complete surgical resection lived longer than those that had surgery without chemotherapy. However, in early-stage NSCLC patients there currently is not enough evidence to support the use of chemotherapy following complete resection, even though stage I lung cancer recurs either locally or at distant sites in roughly a third of early-stage patients. Exploratory analysis of the use of adjuvant chemotherapy in early-stage patients showed improved overall survival for patients whose tumors were ? 4 cm. Consequently, a thorough investigation of the clinical benefits and survival of the use of adjuvant chemotherapy in early-stage patients is warranted in order to improve the current treatment recommendations.”

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MammaPrint Genetic Test Can Reduce Use of Post-surgery Chemotherapy Among Early-stage Breast Cancer Patients

Excerpt:

“Among patients with early-stage breast cancer who were considered at high risk for disease recurrence based on clinical and biological criteria, the MammaPrint genetic test identified a large group of patients for whom five-year distant metastasis–free survival was equally good whether or not they received adjuvant chemotherapy (chemotherapy given post-surgery), according to results from the randomized, phase III microarray in node negative disease may avoid chemotherapy (MINDACT) clinical trial to be presented here at the AACR Annual Meeting 2016, April 16-20.”

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Oncotype Dx Gene Test Has a Big Impact on Oncologists' Chemo Recommendations

Excerpt:

“The 21-gene Recurrence Score (RS) assay significantly influenced clinicians’ decisions to recommend breast cancer patients for adjuvant chemotherapy, analysis of a population-based dataset showed.

“Used to predict disease recurrence and benefit of chemotherapy in estrogen receptor-positive, lymph node-negative early-stage breast cancer (EBC), the assay had the strongest association with recommendation for chemotherapy, with an adjusted odds ratio (aOR) of 83 for high assay scores and 12 for intermediate scores, both relative to low scores.

“Test use was significantly associated with younger age, white race, academic centers, private insurance, and pT2/pN0(i+) grade 2 to 3 disease, Peter Kabos, MD, of the University of Denver, Aurora, CO, and colleagues reported online in the Journal of Clinical Oncology.”

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EBCC-10 NEWS: Chemotherapy Every Two Weeks for Premenopausal Breast Cancer Patients Improves Survival and Does Not Increase Risk of Early Menopause

“Amsterdam, The Netherlands: Premenopausal women with breast cancer have a better chance of survival if they are given cycles of adjuvant chemotherapy closer together, every two weeks rather than every three weeks. Furthermore, this regimen, known as “dose-dense” adjuvant chemotherapy, does not seem to be associated with an increased risk of treatment induced early menopause.

“The findings will be presented today (Thursday) at the 10th European Breast Cancer Conference (EBCC-10) and the researchers say they are important for helping younger breast cancer patients and their doctors to make better-informed decisions about the choice of chemotherapy regimens that are given in addition to other treatments such as surgery, hormone therapy and radiotherapy.

“Dr Matteo Lambertini, MD, a medical oncologist at IRCCS AOU San Martino-IST, National Institute for Cancer Research, Genoa, Italy [1], and at the Institut Jules Bordet, Brussels, Belgium, will tell the conference: ‘Our results confirm the superiority of dose-dense chemotherapy as compared to standard interval regimens in premenopausal patients at higher risk of relapse, and its use should be implemented in Europe, as it is in the United States.’ ”


Women with Luminal A Subtype of Breast Cancer Did Not Benefit from Adjuvant Chemotherapy

“Premenopausal women whose invasive breast cancers were of the luminal A subtype had comparable 10-year disease-free survival rates regardless of whether or not they received adjuvant chemotherapy, according to data from the phase III DBCG77B clinical trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8-12.

” ‘Luminal A is a relatively common subtype of breast cancer, and is defined by high expression of hormone receptors [estrogen receptor (ER) and progesterone receptor (PR)], and low expression of the cell-growth marker Ki67 and the oncoprotein HER2. It is the form of breast cancer with the best prognosis,’ said Torsten Nielsen, MD, PhD, professor of pathology at the University of British Columbia in Vancouver, Canada.

” ‘We wanted to address the clinical question of whether or not women with molecularly low-risk luminal A breast cancer actually benefit from chemotherapy,’ added Nielsen. ‘Instead of starting a new trial and waiting for 10 years to find answers, we used an older, completed trial that had saved tissue samples for future studies.’ “


Sequential Anthracycline-Cyclophosphamide, Taxane Regimen 'Most Effective' Adjuvant Therapy for Early-Stage Breast Cancer

“Sequential anthracycline-cyclophosphamide and taxane may serve as the best available adjuvant therapy regimen for early-stage breast cancer regardless of hormone receptor status, according to the results of a systemic review and network meta-analysis.

“Many different adjuvant chemotherapy regimens exist for early-stage breast cancer; however, a conventional meta-analysis would not allow for comparison of all of these regimens, according to researchers.

“ ‘It is well established that adjuvant chemotherapy plays an important role in reducing the risk for recurrence and improving the survival of patients with breast cancer,’ Naoto T. Ueno, MD, PhD, chief of the section of translational breast cancer research at The University of Texas MD Anderson Cancer Center, and colleagues wrote. ‘The National Comprehensive Cancer Network guidelines for the treatment of breast cancer describe numerous recommended adjuvant chemotherapy regimens … of them, sequential anthracycline-cyclophosphamide and taxane (AC-T) is the most commonly accepted standard regimen. However, two types of regimens without anthracyclines may have efficacy similar to or greater than that of sequential AC-T.’ “