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  • 1
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2022
    In:  Breast Cancer Research and Treatment Vol. 196, No. 3 ( 2022-12), p. 441-451
    In: Breast Cancer Research and Treatment, Springer Science and Business Media LLC, Vol. 196, No. 3 ( 2022-12), p. 441-451
    Type of Medium: Online Resource
    ISSN: 0167-6806 , 1573-7217
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2004077-5
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  • 2
    In: Pharmaceuticals, MDPI AG, Vol. 8, No. 1 ( 2015-03-17), p. 107-122
    Abstract: To assess clinical utility of the 21-gene assay (Oncotype DX® Recurrence Score®), we determined whether women with HER2(−)/ER+ pN1mi breast cancer with low ( 〈 18) Recurrence Scores results are given adjuvant chemotherapy in a lower proportion than those with high scores (≥31). This was a multicenter chart review of ≥18 year old women with pN1mi breast cancer, HER2(−)/ER+ tumors, ductal/lobular/mixed histology, with the assay ordered on or after 1 January 2007. One hundred and eighty one patients had a mean age of 60.7 years; 82.9% had ECOG performance status 0; 33.7% had hypertension, 22.7% had osteoporosis, 18.8% had osteoarthritis, and 8.8% had type-2 diabetes. Mean Recurrence Score was 17.8 (range: 0–50). 48.6% had a mastectomy; 55.8% had a lumpectomy. 19.8% of low-risk group patients were recommended chemotherapy vs. 57.9% in the intermediate-risk group and 100% in the high-risk group (p 〈 0.001). A total of 80.2% of the low-risk group were recommended endocrine therapy alone, while 77.8% of the high-risk group were recommended both endocrine and chemotherapy (p 〈 0.001). The Oncotype DX Recurrence Score result provides actionable information that can be incorporated into treatment planning for women with HER2(−)/ER+ pN1mi breast cancer. The Recurrence Score result has clinical utility in treatment planning for HER2(−)/ER+ pN1mi breast cancer patients.
    Type of Medium: Online Resource
    ISSN: 1424-8247
    Language: English
    Publisher: MDPI AG
    Publication Date: 2015
    detail.hit.zdb_id: 2193542-7
    SSG: 15,3
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  • 3
    In: Modern Pathology, Elsevier BV, Vol. 25, No. 4 ( 2012-04), p. 556-566
    Type of Medium: Online Resource
    ISSN: 0893-3952
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2012
    detail.hit.zdb_id: 2041318-X
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  • 4
    In: Modern Pathology, Elsevier BV, Vol. 26, No. 11 ( 2013-11), p. 1451-1460
    Type of Medium: Online Resource
    ISSN: 0893-3952
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2013
    detail.hit.zdb_id: 2041318-X
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  • 5
    Online Resource
    Online Resource
    American Medical Association (AMA) ; 2009
    In:  JAMA Vol. 302, No. 18 ( 2009-11-11), p. 2034-
    In: JAMA, American Medical Association (AMA), Vol. 302, No. 18 ( 2009-11-11), p. 2034-
    Type of Medium: Online Resource
    ISSN: 0098-7484
    RVK:
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2009
    detail.hit.zdb_id: 2958-0
    detail.hit.zdb_id: 2018410-4
    SSG: 5,21
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  • 6
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 26_suppl ( 2013-09-10), p. 27-27
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 26_suppl ( 2013-09-10), p. 27-27
    Abstract: 27 Background: Treatment planning for early-stage estrogen receptor (ER) positive, lymph node negative breast cancer was based on prognostic factors with limited predictive power such as age. The Recurrence Score (RS) from the Oncotype DX assay (ODX) provides predictive power transcending age but is rarely applied to the elderly or young patients (pts). We examined our experience with RS along the age continuum. Methods: Retrospective review was conducted of prospectively gathered breast cancer pts having a RS obtained as part of their cancer care. Eligibility for performance of the ODX was based on NCCN guidelines or physician discretion. Comparisons on RS were made by age groups (young: 〈 45yrs; middle: 〉 45yrs - 〈 70yrs: elderly: 〉 70yrs) using general linear regression model and the exact Wilcoxon Rank Sum Test. Results: 677pts had 681 tumors with RS available (89 young, 476 middle and 112 elderly pts). Median RS for the study pts was 17 (range 0-85) and 16, 17, and 15 for the young, middle, and elderly respectively. Median age was 58yrs (range: 27-95); young, middle, and elderly was 42, 58, and 74yrs respectively. Age as a continuous or categorical variable was not predictive of RS (p value = 0.38, 0.58 respectively). No significant differences were seen between age cohorts for histology, mitotic rate, lymphovascular invasion (LVI), grade, nodal status, stage, or strength of ER positivity. Mastectomy rates were higher in the young (57.5%), compared to the middle (42.5%) and elderly (39.6%) (p=0.02). Median invasive tumor size was 1.6, 1.5, and 1.5cm for young, middle, and elderly. Larger tumor size, as a continuous variable, equaled higher RS (p=0.046). Other significant factors predicting higher RS were increased mitosis (p 〈 0.001), LVI (p=0.013), high grade (p 〈 0.001), and weak ( 〈 10%) ER positivity (p 〈 0.001). Nodal status, stage, and histology did not affect RS. Conclusions: Age has limited predictive power for treatment planning for breast cancer. Age alone should not preclude recommendations for performance of ODX in estrogen receptor positive lymph node negative early stage breast cancer as the RS distribution across the spectrum of age is well matched.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 26_suppl ( 2013-09-10), p. 101-101
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 26_suppl ( 2013-09-10), p. 101-101
    Abstract: 101 Background: The Oncotype Dx (ODX) Recurrence Score (RS) stratifies breast cancer patients (pts) by risk of recurrence and potential benefit of adjuvant chemotherapy. Pts with early stage, estrogen receptor (ER) positive, lymph node-negative breast cancer were included in the initial validation studies. Limited data exists on the application of ODX in node positive pts. We review our experience with RS along the continuum of nodal burden. Methods: A prospective database of pts with breast cancer for whom ODX RS was obtained for treatment planning was reviewed by final surgical pathology. Patients were grouped into four pathologic categories: negative sentinel lymph node [N0(i-)], isolated tumor cells [N0(i+)] , micro-metastasis [N1mic] and macro-macrometastasis [N1, 1-3 + nodes] . P values were calculated using the exact Wilcoxon Rank Sum Test. Results: 637 pts were identified in the study period: 521 (81.8%) pts had negative sentinel lymph nodes; 54 (8.5%) pts had isolated tumor cells (N0(i+)); 29 (4.6%) pts had N1mic, and 33 (5.2%) had N1 disease (Table). Median age overall was 58yrs, median invasive tumor size was 1.5cm; 475 (91.2%) had ductal histology. Median RS for the study pts was 17 (range 0-85), and increasing RS had no correlation to increasing nodal burden (p=0.23). Pathologic factors associated with nodal status were lymphovascular invasion (LVI) and histology. The frequency of LVI was higher with increasing nodal burden (p 〈 0.0001). Ductal histology was significantly associated with abnormal nodal findings. (p = 0.002). Age, mitotic rate, grade and degree of ER-positive staining on IHC were not significantly associated with sentinel lymph node status (p 〉 0.05). Conclusions: Tumor size, histology and LVI were significant predictors of increased nodal burden. However, ODX RS was neither predictive nor reflective of increasing nodal disease. RS is a potentially useful tool in adjuvant systemic treatment decisions in patients with positive lymph nodes but should not impact decisions regarding local-regional therapy. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 8
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 27_suppl ( 2012-09-20), p. 84-84
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 27_suppl ( 2012-09-20), p. 84-84
    Abstract: 84 Background: In 2006, the FIQCC (comprised of 11 practice sites) initiated a comprehensive review of quality of care specific to breast cancer based on QOPI/NCCN/ACOS and panel consensus quality indicators. Feedback on indicator performance was provided to participating practices in 2007 to encourage quality improvement efforts. Re-assessment of adherence to the same performance indicators was conducted in 2009. Methods: Chart reviews were conducted for breast cancer patients (pts) seen by a medical oncologist at FIQCC sites in 2006(n=602) and 2009(n=636) Quality indicators included: 1) presence/completeness of pathology report; 2) documentation of surgery type; 3) documentation of sentinel lymph node biopsy (SLNB) and if SLNB positive documentation of a complete axillary node dissection; and 4) mammogram usage post surgery. Statistical comparisons of 2006 and 2009 data were performed using the Pearson chi-square exact test based on Monte Carlo estimation. Results: The median age of pts (99% female) was 60 years (range 24-94). Compared to 2006 data, improvements were made in specimen orientation (69%-2006, 78%-2009; p=0.001) and inking of margins (89%-2006, 96%-2009; p= 〈 0.001). In clinical node negative N 0 pts, SLNB was performed in 87%, up from 82%-2006 (p=0.035). Of the pts with a metastatic SLNB, 86% went on to have a complete axillary node dissection, but not statistically significant compared to 79% in 2006 (p=0.10). Compliance continues to be highly variable across practice sites with obtaining a mammogram within 14 months of surgery (79%) (p=0.002); but the range narrowed: 26%-98% (2006) and 56%-92% (2009). Significant variances also continued in 2009 across practice sites for margin orientation (p 〈 0.001), inking of the margins (p=0.04), and performance of SLNB (p 〈 0.001). Conclusions: The FIQCC identified quality improvement needs in multiple aspects of breast cancer care. Improvements in margin orientation/inking, use of SLNB and follow-up mammograms after definitive surgery made over the course of this initiative speak to the benefits of continual re-assessment of adherence to performance indicators to guide quality improvement.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS629-TPS629
    Abstract: TPS629 Background: Patients with breast cancers (BCs) harboring low expression of hormone receptors (HRs) and human epidermal growth factor receptor-2 (HER2) have poor outcomes. Results from the KEYNOTE-522 trial showed that activation of the immune system using a PD1/PD-L1-targeted approach improves outcomes of patients with these high-risk tumors. Antigen-presenting cells (eg, dendritic cells [DCs]) are pivotal for robust cytotoxic responses due to broader activation of the adaptive immune system (ie, CD4 + and CD8 + Th1) against tumor-associated antigens (ie, HER2 or HER3) expressed by high-risk BCs. Methods: DecipHER is a dose-escalation, dose-expansion phase 1 trial designed to assess the safety and the preliminary efficacy of autologous, HER2- and HER3-primed DCs in combination with KEYNOTE 522 regimen in 30 patients. Patients with clinical stage cT1cN1/2 or cT2-4cN0-2, HR 20, HER2-negative BCs are eligible. Patients with inflammatory BC cancer and uncontrolled immune mediated diseases are excluded. After collection through aphaeresis, autologous DCs will be primed ex vivo against 6 HER2 and 8 HER3 immunogenic peptides. Participants will receive alternating ultrasound-guided intratumoral HER2 and HER3 DC injections administered twice a week for 8 doses in total starting 2 weeks prior to neoadjuvant therapy with KEYNOTE 522 regimen. The dose-escalation phase of the study has 3 planned cohorts (10-20, 30-50, 80-100 million DCs) and follows a 3+3 design (maximum n=18). The 12 additional patients enrolled will be treated at the maximum tolerated dose (MTD) in the dose-expansion cohort. The MTD will be defined as the highest dose level at which 〈 2 of 6 patients experience dose-limiting toxicities (grade ≥ 3 non-hematologic, ; grade ≥ 3 hematologic toxicity thought be at least possibly related to DCs ; any grade 4 nausea, vomiting, or diarrhea [or grade 3 if duration 〉 3 days]) during the 5 weeks following treatment initiation with DCs. Secondary endpoints include the absolute risk of adverse events, clinical and pathological responses, and recurrence free survival. Tumor tissue, blood and stool samples will be collected for correlative analyses. The study is open at H. Lee Moffitt Cancer Center. Clinical trial information: NCT05504707 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 10
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 598-598
    Abstract: 598 Background: TVEC is an engineered oncolytic virus (OVs) approved for the treatment of melanoma. We published a phase 1/2 trial combining TVEC with NACT in early stage TNBC demonstrating increased pathologic complete response (pCR) compared to expected rates with NACT. RNAseq was performed on 37 pretreatment samples from enrolled patients to identify potential predictive genomic alterations. Methods: Transcriptomic RNA sequencing analysis was performed on macrodissected tumor tissue through the Moffitt Molecular Genomics core using Illumina Truseq RNA exome kits. Read adapters were detected using BBMerge (v37.88) and removed with cutadapt (v1.8.1). For gene expression analysis, processed raw reads were aligned to human genome HG19 using STAR (v2.5.3a). Gene expression was evaluated as read count at gene level with HTSeq (v0.6.1) and Gencode gene model v19. Gene expression data were normalized and differential expression between experimental groups were evaluated using DEseq2 (v 1.38.2). Ensembl was used for SNP data search. Results: Tumor mutation burden was not significantly different between pCR and non-pCR samples (median 227 vs 222 mut/MB, p = .11). Top 5 upregulated non-immunoglobulin genes associated with pCR in baseline samples were MYBL1, DNAH8, NR2E1, FGFR2, and SLC12A1 (FDR 〈 1%). A single nucleotide polymorphism (SNP) of the EIF2A gene (c.C290G, p.T97S) was the top variant associated with response present in 21/37 samples (non-pCR = 17/21 vs. pCR = 4/21, FDR = 〈 1%). This exon 4 coding region SNP is present in 17% of Black, 35% of White, and 46% of Asian individuals but its biologic or clinical significance is unknown. Lower EIF2A pathway activation was associated with inferior response to therapy. Additional data will be presented at the meeting. Conclusions: Genomic alterations including a EIF2A SNP were correlated with response to OV plus NAC in TNBC. EIF2A is an important mediator of cellular responses to OV and may play a role in susceptibility to oncolysis. Additional investigation and validation of these variations in experimental models of OV susceptibility may provide predictive biomarkers for TNBC patients treated with OV plus NAC therapy. Clinical trial information: NCT02779855 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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