Adherence to anti-estrogen therapy in women with hormone receptor-positive breast cancer utilizing bubble packaging: a pilot study.

PURPOSE: This pilot study evaluated adherence to anti-estrogen therapy in women with hormone receptor-positive breast cancer utilizing bubble packaging. METHODS: This was a single-arm prospective investigational pilot study that enrolled 86 patients between August 2012 and April 2014. Descriptive statistics for patient age, race, insurance, stage, duration of treatment, and comorbidities were computed. All patients received routine prescriptions in a "bubble" pack or daily blister pack dispensed by one pharmacy. Participants were considered adherent if they had taken ≥ 80% of the dispensed drug. Disease-free survival (DFS) and overall survival (OS) data were obtained at 78 months. RESULTS: Fifty patients were included in the analysis. The overall adherence rate was 97%. None of the variables examined (race, age, insurance status, and stage) had an impact on adherence rate. Only duration of endocrine therapy had a marginal effect on adherence (p value = 0.06). The late cohort (duration of therapy 37-60 months) was least likely to be compliant at 89.53%. Our 5-year DFS was 94% and 5-year OS was 96%. There was no statistically significant difference in DFS and OS between patients with adherence rate > 90% and < 90%. CONCLUSION: Adherence rate to bubble packaging was higher than that in historical studies. Although this is a single-arm pilot study, these data suggest bubble packaging of anti-estrogen may be a reasonable option to improve adherence in hormone receptor-positive breast cancer patients.

Liquid biopsy using the nanotube-CTC-chip: capture of invasive CTCs with high purity using preferential adherence in breast cancer patients.

In this paper, we report the development of the nanotube-CTC-chip for isolation of tumor-derived epithelial cells (circulating tumor cells, CTCs) from peripheral blood, with high purity, by exploiting the physical mechanisms of preferential adherence of CTCs on a nanotube surface. The nanotube-CTC-chip is a new 76-element microarray technology that combines carbon nanotube surfaces with microarray batch manufacturing techniques for the capture and isolation of tumor-derived epithelial cells. Using a combination of red blood cell (RBC) lysis and preferential adherence, we demonstrate the capture and enrichment of CTCs with a 5-log reduction of contaminating WBCs. EpCAM negative MDA-MB-231/luciferase-2A-green fluorescent protein (GFP) cells were spiked in the blood of wild mice and enriched using an RBC lysis protocol. The enriched samples were then processed using the nanotube-CTC-chip for preferential CTC adherence on the nanosurface and counting the GFP cells yielded anywhere from 89% to 100% capture from the droplets. Electron microscopy (EM) studies showed focal adhesion with filaments from the cell body to the nanotube surface. We compared the nanotube preferential adherence to collagen adhesion matrix (CAM) scaffolding, reported as a viable strategy for CTC capture in patients. The CAM scaffolding on the device surface yielded 50% adherence with 100% tracking of cancer cells (adhered vs. non-adhered) versus carbon nanotubes with >90% adherence and 100% tracking for the same protocol. The nanotube-CTC-chip successfully captured CTCs in the peripheral blood of breast cancer patients (stage 1-4) with a range of 4-238 CTCs per 8.5 ml blood or 0.5-28 CTCs per ml. CTCs (based on CK8/18, Her2, EGFR) were successfully identified in 7/7 breast cancer patients, and no CTCs were captured in healthy controls (n = 2). CTC enumeration based on multiple markers using the nanotube-CTC-chip enables dynamic views of metastatic progression and could potentially have predictive capabilities for diagnosis and treatment response.

Impact of 21-Gene Expression Assay on Staging Estrogen Receptor-Positive HER2-Negative Breast Cancer.

PURPOSE: The 8th edition of the American Joint Committee on Cancer (AJCC) breast cancer staging system requires histologic grade (GR), estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and stage (assessed by the tumor, node, metastasis classification system). For T1-2 N0, ER+/HER2- tumors, if the 21-gene expression assay is ordered and Oncotype DX (ODX) recurrence score (RS) is 0 to 10, the stage is IA. The purpose of this study was to determine the impact of the ODXRS on staging ER+/HER2- tumors. MATERIALS AND METHODS: This is a retrospective review of ER+/HER2- invasive breast cancer (BC) with ODXRS results from 2 institutions (n = 816) between 2006 and 2018. Stage based on the AJCC 7th and 8th editions, and stage using the 8th edition with and without ODXRS were compared. Significant associations among pathologic parameters and ODX risk groups were determined. Clinical histories were reviewed. RESULTS: Nearly half of the patients (43%) had a change in BC stage using the new staging system. Only 4 patients changed stage as a direct result of ODXRS. Influence of ODXRS on staging is limited to T2N0 tumors that are either GR 3 and strongly ER+ and PR+ or GR 1-2 and ER+/PR-. Sixty-one percent of cases of recurrence (11/18) were downstaged using the new staging system. CONCLUSION: ODXRS has little influence on staging, thus supporting the view of the AJCC 8th edition expert panel that ODX is not required for staging. Downstaging of more than half of cases of recurrence suggests that continued refinement of the staging system, as proposed by the expert panel, could be beneficial in this subgroup of patients.