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Article ; Online: Testing considerations for phosphatidylinositol-3-kinase catalytic subunit alpha as an emerging biomarker in advanced breast cancer.

Toppmeyer, Deborah L / Press, Michael F

Cancer medicine

2020 Volume 9, Issue 18, Page(s) 6463–6472

Abstract: Breast cancer is the most common cancer in women, and approximately 71% of carcinomas are hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-not-amplified (HER2-negative). Pathogenesis of breast cancer is associated with ... ...

Abstract	Breast cancer is the most common cancer in women, and approximately 71% of carcinomas are hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-not-amplified (HER2-negative). Pathogenesis of breast cancer is associated with dysregulation of several signaling pathways, including the phosphatidylinositol-3-kinase (PI3K) pathway. PIK3CA, the gene encoding PI3K catalytic subunit p110α, is mutated in 20%-40% of breast cancer patients. Several PI3K inhibitors have been developed and one, alpelisib, was recently approved for use in PIK3CA-mutated, HR+, HER2-negative advanced breast cancer. There are numerous types of assays and methods used in clinical studies to determine PIK3CA status in cancers. Additionally, there are several factors to consider for PIK3CA testing in clinical practice, including choice of assay, source of sample, and test timing. In this review, we discuss the use of PIK3CA as a biomarker to guide treatment decisions in patients with HR+, HER2-negative advanced breast cancer, as well as practical considerations and recommendations for testing.
MeSH term(s)	Antineoplastic Agents/therapeutic use ; Biomarkers, Tumor/antagonists & inhibitors ; Biomarkers, Tumor/genetics ; Biomarkers, Tumor/metabolism ; Breast Neoplasms/drug therapy ; Breast Neoplasms/enzymology ; Breast Neoplasms/genetics ; Breast Neoplasms/pathology ; Class I Phosphatidylinositol 3-Kinases/antagonists & inhibitors ; Class I Phosphatidylinositol 3-Kinases/genetics ; Class I Phosphatidylinositol 3-Kinases/metabolism ; Clinical Decision-Making ; DNA Mutational Analysis ; Female ; Humans ; Mutation ; Phosphoinositide-3 Kinase Inhibitors/therapeutic use ; Precision Medicine ; Predictive Value of Tests ; Prognosis ; Signal Transduction
Chemical Substances	Antineoplastic Agents ; Biomarkers, Tumor ; Phosphoinositide-3 Kinase Inhibitors ; Class I Phosphatidylinositol 3-Kinases (EC 2.7.1.137) ; PIK3CA protein, human (EC 2.7.1.137)
Language	English
Publishing date	2020-07-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ISSN	2045-7634
ISSN (online)	2045-7634
DOI	10.1002/cam4.3278
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: A Systematic Review and Meta-Analysis of Smoking and Circulating Sex Hormone Levels Among Premenopausal Women.

Ihenacho, Ugonna / Sriprasert, Intira / Mack, Wendy J / Hamilton, Ann S / Unger, Jennifer B / Press, Michael F / Wu, Anna H

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco

2022 Volume 24, Issue 11, Page(s) 1705–1713

Abstract: Introduction: It is established that higher prediagnostic circulating androgen and estrogen levels are associated with increased breast cancer risk in premenopausal and postmenopausal women. Pooled analyses in postmenopausal women report higher androgen ...

Abstract	Introduction: It is established that higher prediagnostic circulating androgen and estrogen levels are associated with increased breast cancer risk in premenopausal and postmenopausal women. Pooled analyses in postmenopausal women report higher androgen and estrogen levels in current heavy cigarette smokers compared to nonsmokers. However, evidence among premenopausal women has been inconsistent. Aims and methods: We conducted a systematic review and meta-analysis to estimate differences in standardized mean hormone levels among current premenopausal smokers compared to nonsmokers. We reviewed and collated publications with sex hormone levels by smoking status among healthy, premenopausal women who were nonusers of exogenous hormones, including oral contraceptives, using PubMed through December 2019. A random effects meta-analysis was conducted to combine the standardized mean differences (SMD) and 95% confidence intervals (CIs) for estradiol, progesterone, testosterone, dehydroepiandrosterone, dehydroepiandrosterone-sulfate, and sex hormone-binding globulin by smoking status. Findings were summarized by menstrual cycle phase and overall. Results: Nineteen published peer-reviewed articles were included. Significantly increased testosterone levels among smokers compared to nonsmokers were identified from cross-sectional studies with varied menstrual phase timing (SMD 0.14; 95% CI 0.0005, 0.29) and significantly increased dehydroepiandrosterone-sulfate levels were found over all phases (SMD 0.12; 95% CI 0.01, 0.22). However, substantial heterogeneity existed in these studies. Conclusions: This meta-analysis suggests that smoking may increase blood androgen levels in healthy premenopausal women which may increase breast cancer risk; however, the differences were modest. Larger and covariate-adjusted studies with standardized collection over the menstrual cycle are needed to better understand this relationship and to reduce heterogeneity. Implications: Existing research has described associations between high prediagnostic estradiol and androgen levels with breast cancer risk among premenopausal women and has established active smoking as a breast cancer risk factor. However, the smoking and circulating sex hormone associations among premenopausal women remain inadequately studied. In this meta-analysis, we identified an association between smoking and higher mean testosterone and dehydroepiandrosterone-sulfate levels with consideration of menstrual phase, providing additional information on smoking's potential pathway to premenopausal breast cancer.
MeSH term(s)	Female ; Humans ; Sex Hormone-Binding Globulin/analysis ; Sex Hormone-Binding Globulin/metabolism ; Androgens ; Progesterone ; Cross-Sectional Studies ; Gonadal Steroid Hormones ; Estradiol ; Testosterone ; Breast Neoplasms/epidemiology ; Breast Neoplasms/etiology ; Estrogens ; Smoking ; Dehydroepiandrosterone ; Contraceptives, Oral ; Sulfates/metabolism
Chemical Substances	Sex Hormone-Binding Globulin ; Androgens ; Progesterone (4G7DS2Q64Y) ; Gonadal Steroid Hormones ; Estradiol (4TI98Z838E) ; Testosterone (3XMK78S47O) ; Estrogens ; Dehydroepiandrosterone (459AG36T1B) ; Contraceptives, Oral ; Sulfates
Language	English
Publishing date	2022-03-15
Publishing country	England
Document type	Meta-Analysis ; Systematic Review ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1452315-2
ISSN	1469-994X ; 1462-2203
ISSN (online)	1469-994X
ISSN	1462-2203
DOI	10.1093/ntr/ntac066
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Zs.A 5789: Show issues

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Article ; Online: Tumor biomarkers and efficacy in patients treated with trastuzumab emtansine + pertuzumab versus standard of care in HER2-positive early breast cancer: an open-label, phase III study (KRISTINE).

de Haas, Sanne L / Slamon, Dennis J / Martin, Miguel / Press, Michael F / Lewis, Gail D / Lambertini, Chiara / Prat, Aleix / Lopez-Valverde, Vanesa / Boulet, Thomas / Hurvitz, Sara A

Breast cancer research : BCR

2023 Volume 25, Issue 1, Page(s) 2

Abstract: Background: KRISTINE is an open-label, phase III study of trastuzumab emtansine + pertuzumab (T-DM1 + P) versus docetaxel + carboplatin + trastuzumab + pertuzumab (TCH + P) in patients with HER2-positive, stage II-III breast cancer. We investigated the ... ...

Abstract	Background: KRISTINE is an open-label, phase III study of trastuzumab emtansine + pertuzumab (T-DM1 + P) versus docetaxel + carboplatin + trastuzumab + pertuzumab (TCH + P) in patients with HER2-positive, stage II-III breast cancer. We investigated the association of biomarkers with clinical outcomes in KRISTINE. Methods: Patients were randomized to receive neoadjuvant T-DM1 + P or TCH + P and assessed for pathologic complete response (pCR; ypT0/is, ypN0). HER2 status (per central assessment), hormone receptor status, PIK3CA mutation status, HER2/HER3 mRNA levels, tumor-infiltrating lymphocyte levels, PD-L1 status, and NanoString data were analyzed. pCR rates by treatment arm were compared across biomarker subgroups. Analyses were descriptive. Results: Biomarker analyses included data from all 444 patients (T-DM1 + P, n = 223; TCH + P, n = 221) enrolled in KRISTINE. Biomarker distribution was balanced across treatment arms. All subgroups with higher HER2 amplification/expression and immune marker levels showed numerically higher pCR rates in both arms. Mutated versus non-mutated PIK3CA tumors were associated with numerically lower pCR rates in the T-DM1 + P arm but not in the TCH + P arm. In a multivariate analysis, Prediction Analysis of Microarray with the 50-gene classifier (PAM50) HER2-enriched subtype, HER2 gene ratio ≥ 4, and PD-L1-positive status positively influenced the pCR rate. Biomarkers associated with lower pCR rates (e.g., low HER2 levels, positive hormone receptor status, mutated PIK3CA) were more likely to co-occur. Dynamic on-treatment biomarker changes were observed. Differences in the treatment effects for T-DM1 + P versus TCH + P were similar to those observed in the intent-to-treat population for the majority of the biomarker subgroups. Conclusions: Although our biomarker analysis did not identify a subgroup of patients that benefited from neoadjuvant T-DM1 + P versus TCH + P, the data revealed that patients with higher HER2 amplification/expression and immune marker levels had improved response irrespective of treatment arm. These analyses confirm the role of HER2 tumor biology and the immune microenvironment in influencing pCR in the neoadjuvant setting and reaffirm the molecular diversity of HER2-positive breast cancer. Trial registration: ClinicalTrials.gov NCT02131064. Registered 06 May 2014.
MeSH term(s)	Female ; Humans ; Ado-Trastuzumab Emtansine/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; B7-H1 Antigen ; Biomarkers, Tumor/genetics ; Biomarkers, Tumor/analysis ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Class I Phosphatidylinositol 3-Kinases/genetics ; Neoadjuvant Therapy ; Receptor, ErbB-2/genetics ; Standard of Care ; Trastuzumab/therapeutic use ; Tumor Microenvironment/immunology
Chemical Substances	Ado-Trastuzumab Emtansine (SE2KH7T06F) ; B7-H1 Antigen ; Biomarkers, Tumor ; Class I Phosphatidylinositol 3-Kinases (EC 2.7.1.137) ; pertuzumab (K16AIQ8CTM) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK)
Language	English
Publishing date	2023-01-11
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2015059-3
ISSN	1465-542X ; 1465-5411
ISSN (online)	1465-542X
ISSN	1465-5411
DOI	10.1186/s13058-022-01587-z
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Zs.A 5494: Show issues

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Article ; Online: Discordance of HER2 Expression and/or Amplification on Repeat Testing.

DiPeri, Timothy P / Kong, Kathleen / Varadarajan, Kaushik / Karp, Daniel D / Ajani, Jaffer A / Pant, Shubham / Press, Michael F / Piha-Paul, Sarina A / Dumbrava, Ecaterina E / Meric-Bernstam, Funda

Molecular cancer therapeutics

2023 Volume 22, Issue 8, Page(s) 976–984

Abstract: We sought to assess discordance of HER2 status in patients with HER2-amplified/expressing solid tumors who underwent reevaluation of HER2 status. Patients with metastatic solid tumors and HER2 expression by IHC or amplification by FISH/next-generation ... ...

Abstract	We sought to assess discordance of HER2 status in patients with HER2-amplified/expressing solid tumors who underwent reevaluation of HER2 status. Patients with metastatic solid tumors and HER2 expression by IHC or amplification by FISH/next-generation sequencing on local testing underwent central HER2 IHC/FISH testing with either archival or fresh biopsies and were evaluated for discordance in HER2 status. 70 patients (12 cancer types) underwent central HER2 reevaluation, including 57 (81.4%) with a new biopsy. In 30 patients with HER2 3+ on local IHC, 21 (70.0%) were 3+, 5 (16.7%) were 2+, 2 (6.7%) were 1+, and 2 (6.7%) had 0 HER2 expression on central IHC. In 15 patients whose cancers were 2+ on local IHC, 2 (13.3%) were 3+, 5 (33.3%) were 2+, 7 (46.7%) were 1+, and 1 (6.7%) had 0 HER2 expression on central IHC. HER2 discordance was seen in 16 of 52 (30.8%) of patients with HER2 overexpression/amplification who underwent a new image-guided biopsy. Discordance was observed in 10 (33.3%) of 30 patients who received intervening HER2-targeted therapy and in 6 (23.8%) of 22 patients who did not. In the 8 patients who had central HER2 assessment from the same archival block used for local testing, none were discordant. Discordance of HER2 status is common in patients with tumors previously identified as HER2-expressing, especially in patients with HER2 2+ tumors. Repeat biomarker evaluation may have value when considering HER2-targeted therapies.
MeSH term(s)	Humans ; Receptor, ErbB-2/genetics ; Receptor, ErbB-2/metabolism ; In Situ Hybridization, Fluorescence ; Immunohistochemistry ; Biomarkers, Tumor/genetics ; Stomach Neoplasms/pathology
Chemical Substances	Receptor, ErbB-2 (EC 2.7.10.1) ; Biomarkers, Tumor
Language	English
Publishing date	2023-06-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	2063563-1
ISSN	1538-8514 ; 1535-7163
ISSN (online)	1538-8514
ISSN	1535-7163
DOI	10.1158/1535-7163.MCT-22-0630
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 5750: Show issues

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Article ; Online: Clinical evaluation of BCL-2/XL levels pre- and post- HER2-targeted therapy.

Zoeller, Jason J / Press, Michael F / Selfors, Laura M / Dering, Judy / Slamon, Dennis J / Hurvitz, Sara A / Brugge, Joan S

PloS one

2021 Volume 16, Issue 5, Page(s) e0251163

Abstract: Our previous pre-clinical work defined BCL-2 induction as a critical component of the adaptive response to lapatinib-mediated inhibition of HER2. To determine whether a similar BCL-2 upregulation occurs in lapatinib-treated patients, we evaluated gene ... ...

Abstract	Our previous pre-clinical work defined BCL-2 induction as a critical component of the adaptive response to lapatinib-mediated inhibition of HER2. To determine whether a similar BCL-2 upregulation occurs in lapatinib-treated patients, we evaluated gene expression within tumor biopsies, collected before and after lapatinib or trastuzumab treatment, from the TRIO-B-07 clinical trial (NCT#00769470). We detected BCL2 mRNA upregulation in both HER2+/ER- as well as HER2+/ER+ patient tumors treated with lapatinib or trastuzumab. To address whether mRNA expression correlated with protein expression, we evaluated pre- and post-treatment tumors for BCL-2 via immunohistochemistry. Despite BCL2 mRNA upregulation within HER2+/ER- tumors, BCL-2 protein levels were undetectable in most of the lapatinib- or trastuzumab-treated HER2+/ER- tumors. BCL-2 upregulation was evident within the majority of lapatinib-treated HER2+/ER+ tumors and was often coupled with increased ER expression and decreased proliferation. Comparable BCL-2 upregulation was not observed within the trastuzumab-treated HER2+/ER+ tumors. Together, these results provide clinical validation of the BCL-2 induction associated with the adaptive response to lapatinib and support evaluation of BCL-2 inhibitors within the context of lapatinib and other HER2-targeted receptor tyrosine kinase inhibitors.
MeSH term(s)	Adult ; Aged ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Biomarkers, Tumor/metabolism ; Breast Neoplasms/drug therapy ; Breast Neoplasms/metabolism ; Cell Proliferation/drug effects ; Female ; Gene Expression Regulation, Neoplastic/drug effects ; Humans ; Lapatinib/therapeutic use ; Middle Aged ; Neoadjuvant Therapy/methods ; Protein Kinase Inhibitors/therapeutic use ; Proto-Oncogene Proteins c-bcl-2/metabolism ; Quinazolines/therapeutic use ; RNA, Messenger/metabolism ; Receptor, ErbB-2/metabolism ; Trastuzumab/therapeutic use ; Up-Regulation/drug effects
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antineoplastic Agents ; BCL2 protein, human ; Biomarkers, Tumor ; Protein Kinase Inhibitors ; Proto-Oncogene Proteins c-bcl-2 ; Quinazolines ; RNA, Messenger ; Lapatinib (0VUA21238F) ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK)
Language	English
Publishing date	2021-05-05
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0251163
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: How is Her-2/neu status established when Her-2/neu and chromosome 17 centromere are both amplified?

Press, Michael F

American journal of clinical pathology

2006 Volume 126, Issue 5, Page(s) 673–674

MeSH term(s)	Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Breast Neoplasms/pathology ; Centromere/genetics ; Chromosome Aberrations ; Chromosomes, Human, Pair 17/genetics ; Female ; Gene Amplification ; Humans ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Ovarian Neoplasms/genetics ; Ovarian Neoplasms/metabolism ; Ovarian Neoplasms/pathology ; Receptor, ErbB-2/analysis ; Receptor, ErbB-2/genetics
Chemical Substances	Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2006-11
Publishing country	England
Document type	Comment ; Editorial
ZDB-ID	2944-0
ISSN	1943-7722 ; 0002-9173
ISSN (online)	1943-7722
ISSN	0002-9173
DOI	10.1309/GM16-C018-06EF-URX7
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Article: RANK and RANKL Expression in Tumors of Patients with Early Breast Cancer.

Behrens, Annika / Wurmthaler, Lena / Heindl, Felix / Gass, Paul / Häberle, Lothar / Volz, Bernhard / Hack, Carolin C / Emons, Julius / Erber, Ramona / Hartmann, Arndt / Beckmann, Matthias W / Ruebner, Matthias / Dougall, William C / Press, Michael F / Fasching, Peter A / Huebner, Hanna

Geburtshilfe und Frauenheilkunde

2023 Volume 84, Issue 1, Page(s) 77–85

Abstract: Introduction: The receptor activator of nuclear factor-κB (RANK) pathway was associated with the pathogenesis of breast cancer. Several studies attempted to link the RANK/RANKL pathway to prognosis; however, with inconsistent outcomes. We aimed to ... ...

Abstract	Introduction: The receptor activator of nuclear factor-κB (RANK) pathway was associated with the pathogenesis of breast cancer. Several studies attempted to link the RANK/RANKL pathway to prognosis; however, with inconsistent outcomes. We aimed to further contribute to the knowledge about RANK/RANKL as prognostic factors in breast cancer. Within this study, protein expression of RANK and its ligand, RANKL, in the tumor tissue was analyzed in association with disease-free survival (DFS) and overall survival (OS) in a study cohort of patients with early breast cancer. Patients and methods: 607 samples of female primary and early breast cancer patients from the Bavarian Breast Cancer Cases and Controls Study were analyzed to correlate the RANK and RANKL expression with DFS and OS. Therefore, expression was quantified using immunohistochemical staining of a tissue microarray. H-scores were determined with the cut-off value of 8.5 for RANK and 0 for RANKL expression, respectively. Results: RANK and RANKL immunohistochemistry were assessed by H-score. Both biomarkers did not correlate (ρ = -0.04). According to molecular subtypes, triple-negative tumors and HER2-positive tumors showed a higher number of RANK-positive tumors (H-score ≥ 8.5), however, no subtype-specific expression of RANKL could be detected. Higher RANKL expression tended to correlate with a better prognosis. However, RANK and RANKL expression could not be identified as statistically significant prognostic factors within the study cohort. Conclusions: Tumor-specific RANK and RANKL expressions are not applicable as prognostic factors for DFS and OS, but might be associated with subtype-specific breast cancer progression.
Language	English
Publishing date	2023-11-22
Publishing country	Germany
Document type	Journal Article
ZDB-ID	80111-2
ISSN	1438-8804 ; 0016-5751 ; 1615-3359
ISSN (online)	1438-8804
ISSN	0016-5751 ; 1615-3359
DOI	10.1055/a-2192-2998
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Um I Zs.190: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 655: Show issues

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Article: RANK and RANKL Expression in Tumors of Patients with Early Breast Cancer

Behrens, Annika / Wurmthaler, Lena / Heindl, Felix / Gass, Paul / Häberle, Lothar / Volz, Bernhard / Hack, Carolin C. / Emons, Julius / Erber, Ramona / Hartmann, Arndt / Beckmann, Matthias W. / Ruebner, Matthias / Dougall, William C. / Fasching, Peter A. / Huebner, Hanna / Press, Michael F.

TumorDiagnostik & Therapie

2024 Volume 45, Issue 02, Page(s) 112–119

Abstract: The receptor activator of nuclear factor-κB (RANK) pathway was associated with the pathogenesis of breast cancer. Several studies attempted to link the RANK/RANKL pathway to prognosis; however, with inconsistent outcomes. We aimed to further ... ...

Abstract	The receptor activator of nuclear factor-κB (RANK) pathway was associated with the pathogenesis of breast cancer. Several studies attempted to link the RANK/RANKL pathway to prognosis; however, with inconsistent outcomes. We aimed to further contribute to the knowledge about RANK/RANKL as prognostic factors in breast cancer. Within this study, protein expression of RANK and its ligand, RANKL, in the tumor tissue was analyzed in association with disease-free survival (DFS) and overall survival (OS) in a study cohort of patients with early breast cancer. 607 samples of female primary and early breast cancer patients from the Bavarian Breast Cancer Cases and Controls Study were analyzed to correlate the RANK and RANKL expression with DFS and OS. Therefore, expression was quantified using immunohistochemical staining of a tissue microarray. H-scores were determined with the cut-off value of 8.5 for RANK and 0 for RANKL expression, respectively. RANK and RANKL immunohistochemistry were assessed by H-score. Both biomarkers did not correlate (ρ = −0.04). According to molecular subtypes, triple-negative tumors and HER2-positive tumors showed a higher number of RANK-positive tumors (H-score ≥ 8.5), however, no subtype-specific expression of RANKL could be detected. Higher RANKL expression tended to correlate with a better prognosis. However, RANK and RANKL expression could not be identified as statistically significant prognostic factors within the study cohort. Tumor-specific RANK and RANKL expressions are not applicable as prognostic factors for DFS and OS, but might be associated with subtype-specific breast cancer progression.
Keywords	breast cancer ; RANK ; RANKL ; prognosis ; immunohistochemistry ; Brustkrebs ; RANK ; RANKL ; Prognose ; Immunohistochemie
Language	English
Publishing date	2024-03-01
Publisher	Georg Thieme Verlag KG
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	2072365-9
ISSN	1439-1279 ; 0722-219X
ISSN (online)	1439-1279
ISSN	0722-219X
DOI	10.1055/a-2257-9565
Database	Thieme publisher's database

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Article: Molecular Assessment of HER2 to Identify Signatures Associated with Therapy Response in HER2-Positive Breast Cancer.

Maddox, Adam L / Brehove, Matthew S / Eliato, Kiarash R / Saftics, Andras / Romano, Eugenia / Press, Michael F / Mortimer, Joanne / Jones, Veronica / Schmolze, Daniel / Seewaldt, Victoria L / Jovanovic-Talisman, Tijana

Cancers

2022 Volume 14, Issue 11

Abstract: Trastuzumab, the prototype HER2-directed therapy, has markedly improved survival for women with HER2-positive breast cancers. However, only 40-60% of women with HER2-positive breast cancers achieve a complete pathological response to chemotherapy ... ...

Abstract	Trastuzumab, the prototype HER2-directed therapy, has markedly improved survival for women with HER2-positive breast cancers. However, only 40-60% of women with HER2-positive breast cancers achieve a complete pathological response to chemotherapy combined with HER2-directed therapy. The current diagnostic assays have poor positive-predictive accuracy in identifying therapy-responsive breast cancers. Here, we deployed quantitative single molecule localization microscopy to assess the molecular features of HER2 in a therapy-responsive setting. Using fluorescently labeled trastuzumab as a probe, we first compared the molecular features of HER2 in trastuzumab-sensitive (BT-474 and SK-BR-3) and trastuzumab-resistant (BT-474
Language	English
Publishing date	2022-06-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14112795
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Article ; Online: A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone.

Polewski, Monika D / Nielsen, Gitte B / Gu, Ying / Weaver, Aaron T / Gegg, Gavin / Tabuena-Frolli, Siena / Cajaiba, Mariana / Hanks, Debra / Method, Michael / Press, Michael F / Gottstein, Claudia / Gruver, Aaron M

Applied immunohistochemistry & molecular morphology : AIMM

2022 Volume 30, Issue 4, Page(s) 237–245

Abstract: The objectives were to develop a standardized Ki-67 immunohistochemistry (IHC) method for precise, robust, and reproducible assessment of patients with early breast cancer, and utilize this assay to evaluate patients participating in the monarchE study ( ... ...

Abstract	The objectives were to develop a standardized Ki-67 immunohistochemistry (IHC) method for precise, robust, and reproducible assessment of patients with early breast cancer, and utilize this assay to evaluate patients participating in the monarchE study (NCT03155997). The Ki-67 assay was developed and validated for sensitivity, specificity, repeatability, precision, and robustness using a predefined ≥20% cutoff. Reproducibility studies (intersite and intrasite, interobserver and intraobserver) were conducted at 3 external laboratories using detailed scoring instructions designed for monarchE. Using the assay, patient tumors were classified as displaying high (≥20%) or low (<20%) Ki-67 expression; Kaplan-Meier methods evaluated 2-year invasive disease-free survival rates for these 2 groups among patients treated with endocrine therapy (ET) alone. All analytical validation and reproducibility studies achieved point estimates of >90% for negative, positive, and overall percent agreement. Intersite reproducibility produced point estimate values of 94.7%, 100.0%, and 97.3%. External interobserver reproducibility produced point estimate values of 98.9%, 97.8%, and 98.3%. Among 1954 patients receiving ET alone, 986 (50.5%) had high and 968 (49.5%) had low Ki-67 expression. Patients with high Ki-67 had a clinically meaningful increased risk of developing invasive disease within 2 years compared with those with low Ki-67 [2-y invasive disease-free survival rate: 86.1% (95% confidence interval: 83.1%-88.7%) vs. 92.0% (95% confidence interval: 89.7%-93.9%), respectively]. This standardized Ki-67 methodology resulted in high concordance across multiple laboratories, and its use in the monarchE study prospectively demonstrated the prognostic value of Ki-67 IHC in HR+, HER2- early breast cancer with high-risk clinicopathologic features.
MeSH term(s)	Biomarkers, Tumor/metabolism ; Breast Neoplasms/pathology ; Female ; Humans ; Immunohistochemistry ; Ki-67 Antigen/metabolism ; Neoplasm Recurrence, Local ; Receptor, ErbB-2/metabolism ; Reproducibility of Results
Chemical Substances	Biomarkers, Tumor ; Ki-67 Antigen ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2022-04-07
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1473273-7
ISSN	1533-4058 ; 1062-3345 ; 1541-2016
ISSN (online)	1533-4058
ISSN	1062-3345 ; 1541-2016
DOI	10.1097/PAI.0000000000001009
Database	MEDical Literature Analysis and Retrieval System OnLINE

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