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4. MRS of the Breast

Author

Allouche-Arnon, H., primary, Arazi-Kleinman, T., additional, Fraifeld, S., additional, Uziely, B., additional, and Katz-Brull, R., additional

Published
2014
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9. Ten-year clinical outcomes in >1000 node-negative (N0) Estrogen Receptor (ER)+ breast cancer (BC) patients (Pts) where treatment decisions incorporated the Recurrence Score Results: a registry analysis using TAILORx categorization

Author

Stemmer, S.M., primary, Leviov, M., additional, Tokar, M., additional, Ben-Baruch, N., additional, Uziely, B., additional, Fried, G., additional, Rosengarten, O., additional, Itay, A., additional, Nisenbaum, B., additional, and Shak, S., additional

Published
2019
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10. Autoimmunity and benefit from trastuzumab treatment in breast cancer: Results from the HERA phase III trial

Author

Sonnenblick, A., primary, Bailey, A., additional, Uziely, B., additional, Untch, M., additional, Smith, I., additional, Gianni, L., additional, Baselga, J., additional, Jackisch, C., additional, Cameron, D., additional, Bell, R., additional, Zardavas, D., additional, Al-Sakaff, N., additional, Gelber, R., additional, Dowsett, M., additional, Leyland-jones, B., additional, Piccart, M., additional, and de Azambuja, E., additional

Published
2018
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12. Treatment inferred from mutations identified using massive parallel sequencing leads to clinical benefit in some heavily pretreated cancer patients

Author

Zick, A., primary, Peretz, T., additional, Lotem, M., additional, Hubert, A., additional, Katz, D., additional, Temper, M., additional, Rottenberg, Y., additional, Uziely, B., additional, Nechushtan, H., additional, Meirovitz, A., additional, Sonnenblick, A., additional, Sapir, E., additional, Edelman, D., additional, Goldberg, Y., additional, Lossos, A., additional, Rosenberg, S., additional, Fried, I., additional, Finklstein, R., additional, Pikarsky, E., additional, and Goldshmidt, H., additional

Published
2016
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15. Abstract P5-08-02: Real-life analysis evaluating 1594 N0/Nmic breast cancer patients for whom treatment decisions incorporated the 21-gene recurrence score result: 5-year KM estimate for breast cancer specific survival with recurrence score results ≤30 is >98%

Author

Stemmer, SM, primary, Steiner, M, additional, Rizel, S, additional, Soussan-Gutman, L, additional, Geffen, DB, additional, Nisenbaum, B, additional, Ben-Baruch, N, additional, Isaacs, K, additional, Fried, G, additional, Rosengarten, O, additional, Uziely, B, additional, Svedman, C, additional, Rothney, M, additional, Klang, SH, additional, Ryvo, L, additional, Kaufman, B, additional, Evron, E, additional, Zidan, J, additional, Shak, S, additional, and Liebermann, N, additional

Published
2016
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17. A preliminary report of a pilot randomized trial comparing cyclophosphamide, methotrexate and 5-fluorouracil with cyclophosphamide, mitoxantrone and 5-fluorouracil in the adjuvant therapy of stage II breast cancer with four or more positive axillary nodes

Author

Isacson R, Safra T, Brufman G, Ben-Dor Cg, and Uziely B

Subjects
Adult, Oncology, Cancer Research, medicine.medical_specialty, Axillary lymph nodes, Cyclophosphamide, Breast Neoplasms, Pilot Projects, Gastroenterology, law.invention, Leukocyte Count, Randomized controlled trial, law, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Adjuvant therapy, Humans, Medicine, Pharmacology (medical), Prospective Studies, Prospective cohort study, Pharmacology, Mitoxantrone, business.industry, Middle Aged, Methotrexate, medicine.anatomical_structure, Doxorubicin, Fluorouracil, Lymphatic Metastasis, Female, Lymph Nodes, business, medicine.drug
Abstract

Thirty-eight patients with stage II breast cancer with four or more positive axillary lymph nodes were randomized to receive CMF (cyclophosphamide, methotrexate and 5-fluorouracil, every 3 weeks) or CXF (cyclophosphamide, mitoxantrone and 5-fluorouracil, every 3 weeks). Pretreatment characteristics were similar for both groups. The actuarial 5 year disease-free survival (DFS) was 36% for the CMF group and 23% for the CXF group. The actuarial 5 year survival was 60% for the CMF arm and 66% for the CXF arm. These differences were not statistically significant. Partial alopecia was observed in 42% of patients in the CMF arm and in 100% of those receiving CXF (p = 0.0002). No episodes of leucopenic fever were observed in patients receiving CMF, while they were present in 53% of patients treated with CXF (p = 0.0006). No stomatitis occurred in the CMF group, but it was observed in 90% of patients who received CXF (p < 0.0001). Treatment with CXF had to be discontinued in two patients because of toxicity. In this small group of patients with poor prognosis, it seems that CXF at the doses given here is more toxic but not more effective than CMF, as represented by a similar DFS and survival.

Published
1993

19. 1963 First prospective outcome data in 930 patients with more than 5 year median follow up in whom treatment decisions in clinical practice have been made incorporating the 21-Gene Recurrence Score

Author

Stemmer, S., primary, Steiner, M., additional, Rizel, S., additional, Ben-Baruch, N., additional, Soussan-Gutman, L., additional, Rosengarten, O., additional, Geffen, D., additional, Nisenbaum, B., additional, Ryvo, L., additional, Uziely, B., additional, Fried, G., additional, Svedman, C., additional, Rothney, M., additional, Klang, S., additional, Kaufman, B., additional, Isaacs, K., additional, Evron, E., additional, Zidan, J., additional, Shak, S., additional, and Liebermann, N., additional

Published
2015
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22. Abstract P2-16-06: Final Overall Survival Results, Including Analysis of Patients with Triple-Negative Disease and Aged ≥70 Years, from the ATHENA Study Evaluating First-Line Bevacizumab-Containing Therapy for Locally Recurrent/Metastatic Breast Cancer

Author

Pritchard, KI, primary, Thomssen, C, additional, Pierga, J-Y, additional, Cortes-Funes, H, additional, Biganzoli, L, additional, Guan, Z, additional, Manikhas, G, additional, Jendiroba, D, additional, Uziely, B, additional, Boyle, F, additional, Jagiello-Gruszfeld, A, additional, Van Arkel, C, additional, Tung, Y, additional, Dunne, A-A, additional, and Smith, IE., additional

Published
2010
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43. Successful Administration of Low Molecular Weight Heparin in a Patient with Heparin-lnduced Thrombocytopenia and Coumarin-lnduced Skin Necrosis

Author

Drakos, P., Uziely, B., Nagler, A., Gillis, S., and Eldor, A.

Abstract

A case of heparin-induced thrombocytopenia and skin necrosis induced by coumarin is reported in a 58-year-old female patient suffering from metastatic breast adenocarcinoma and deep vein thrombosis. The thrombosis resolved after treatment with low molecular weight heparin and the thrombocytopenia recovered within a few days. The occurrence of both these rare complications in the same patient has not been previously reported in the literature. We present a review of these complications and their current treatment.

Published
1993
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45. The effect of tamoxifen on the endometrium

Author

Uziely, B., Dorembus, D., Brufman, G., Lewin, A., Catane, R., and Mor-Yosef, S.

Subjects
Tamoxifen -- Physiological aspects, Endometrium, Health, Science and technology
Abstract

AUTHORS: B. Uziely, D. Dorembus, G. Brufman, A. Lewin, R. Catane and S. Mor-Yosef. Hadassah Hospital, Jerusalem, Israel. According to the authors' abstract of a poster presentation to the 83rd [...]

Published
1992

48. Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA.

Author

Hiayev S, Shacham-Shmueli E, Berkovitch M, Weiss I, Ashkenazi S, Vexberg MH, Hershkowitz R, Gorelik E, Mayan H, Steinmetz Y, Yanai NB, Schlissel O, Azem M, Gutgold N, Shulman K, Divinsky M, Yarom N, Vishkautzan A, Ganzel C, Gatt ME, Arcavi L, Marom E, Uziely B, Zevin S, Meirow H, Luxenburg O, and Ainbinder D

Subjects
United States, Humans, Pharmaceutical Preparations, United States Food and Drug Administration, Israel, Cohort Studies, Retrospective Studies, Drug Approval
Abstract

Objectives: US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Medicines Agency (EMA), clinical data are reviewed independently by the Advisory Committee of Drug Registration (ACDR). In this study, the correlation between the number of discussions at the ACDR and major postapproval variations is examined., Design: This is an observational retrospective comparative cohort study., Setting: Applications with FDA and/or EMA approval at time of assessment in Israel were included. The timeframe was chosen to allow a minimum of 3 years of postmarketing approval experience for potential major label variations. Data regarding the number of discussions at ACDR were extracted from protocols. Data on postapproval major variations were extracted from the FDA and EMA websites., Results: Between 2014 and 2016, 226 (176 drugs) applications, met the study criteria. 198 (87.6%) and 28 (12.4%) were approved following single and multiple discussions, respectively. A major postapproval variation was recorded in 129 (65.2%) compared with 23 (82.1%) applications approved following single and multiple discussions, respectively (p=0.002). Increased risk for major variation was found for medicines approved following multiple discussions (HR=1.98, 95% CI: 1.26 to 3.09) with a median time of 1.2 years, applications approved based on phase II trials (HR=2.58, 95% CI: 1.72 to 3.87), surrogate endpoints (HR=1.99, 95% CI: 1.44 to 2.74) and oncologic indications (HR=2.48, 95% CI: 1.78 to 3.45)., Conclusions: Multiple ACDR discussions associated with limited supportive data are predictive for major postapproval variations. Moreover, our findings demonstrate that approval by the FDA and/or EMA does not pave the way to automatic approval in Israel. In a substantial per cent of the cases, submission of the same clinical data resulted in different safety and efficacy considerations, requiring additional supporting data in some cases or even rejection of the application in others., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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49. PH-Binding Motif in PAR4 Oncogene: From Molecular Mechanism to Drug Design.

Author

Nag JK, Malka H, Sedley S, Appasamy P, Rudina T, Levi T, Hoffman A, Gilon C, Uziely B, and Bar-Shavit R

Subjects
Blood Proteins, Drug Design, ErbB Receptors genetics, Humans, Oncogenes, Phosphoproteins, Proto-Oncogene Proteins c-akt metabolism, Colonic Neoplasms drug therapy, Colonic Neoplasms genetics, Receptors, Thrombin genetics, Receptors, Thrombin metabolism
Abstract

While the role of G-protein-coupled receptors (GPCR) in cancer is acknowledged, their underlying signaling pathways are understudied. Protease-activated receptors (PAR), a subgroup of GPCRs, form a family of four members (PAR1-4) centrally involved in epithelial malignancies. PAR4 emerges as a potent oncogene, capable of inducing tumor generation. Here, we demonstrate identification of a pleckstrin-homology (PH)-binding motif within PAR4, critical for colon cancer growth. In addition to PH-Akt/PKB association, other PH-containing signal proteins such as Gab1 and Sos1 also associate with PAR4. Point mutations are in the C-tail of PAR4 PH-binding domain; F347 L and D349A, but not E346A, abrogate these associations. Pc(4-4), a lead backbone cyclic peptide, was selected out of a mini-library, directed toward PAR2&4 PH-binding motifs. It effectively attenuates PAR2&4-Akt/PKB associations; PAR4 instigated Matrigel invasion and migration in vitro and tumor development in vivo. EGFR/erbB is among the most prominent cancer targets. AYPGKF peptide ligand activation of PAR4 induces EGF receptor (EGFR) Tyr-phosphorylation, effectively inhibited by Pc(4-4). The presence of PAR2 and PAR4 in biopsies of aggressive breast and colon cancer tissue specimens is demonstrated. We propose that Pc(4-4) may serve as a powerful drug not only toward PAR-expressing tumors but also for treating EGFR/erbB-expressing tumors in cases of resistance to traditional therapies. Overall, our studies are expected to allocate new targets for cancer therapy. Pc(4-4) may become a promising candidate for future therapeutic cancer treatment., (©2022 American Association for Cancer Research.)

Published
2022
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50. [THE LIQUID BIOPSY REVOLUTION IN BREAST CANCER - APPLICATIONS AND POSSIBILITIES].

Author

Tunik M, Cohen Y, Uziely B, and Grinshpun A

Subjects
Biomarkers, Tumor, Female, Humans, Liquid Biopsy methods, Breast Neoplasms diagnosis, Circulating Tumor DNA, Neoplastic Cells, Circulating pathology
Abstract

Introduction: Over the past two decades there have been significant developments in the fields of laboratory technology, genetics and bioinformatics. These developments have raised the attractiveness of liquid biopsy - a test aimed to detect tumor markers in body fluids. One of the liquid biopsy methods is based on identification of circulating tumor DNA - fragments of DNA originating from the tumor which are evident in the bloodstream - revealing the various tumor characteristics via simple blood tests. This novel approach has several advantages over the traditional biopsy: it is noninvasive and thus more convenient and safer for the patient; it reflects the characteristics of the entire tumor tissue present in the patient's body in a single test; it is performed quickly and safely by a phlebotomist and does not rely on the subjective interpretation of the pathologist. The liquid biopsy is a highly valuable tool for the diagnosis and monitoring of cancer, which can be recruited for the clinical management of breast cancer - the most common malignancy in females which is estimated to affect one in every eight women. In this review we will present the existing and the potential applications of the liquid biopsy in breast cancer patients, regarding the various settings of patient care - diagnosis, treatment and follow-up.

Published
2022

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