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  1. Article: Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy

    Slamon, Dennis J / Fasching, Peter A / Hurvitz, Sara / Chia, Stephen / Crown, John / Martín, Miguel / Barrios, Carlos H / Bardia, Aditya / Im, Seock-Ah / Yardley, Denise A / Untch, Michael / Huang, Chiun-Sheng / Stroyakovskiy, Daniil / Xu, Binghe / Moroose, Rebecca L / Loi, Sherene / Visco, Frances / Bee-Munteanu, Valerie / Afenjar, Karen /
    Fresco, Rodrigo / Taran, Tetiana / Chakravartty, Arunava / Zarate, Juan Pablo / Lteif, Agnes / Hortobagyi, Gabriel N

    Therapeutic advances in medical oncology

    2023  Volume 15, Page(s) 17588359231178125

    Abstract: Background: Ribociclib has demonstrated a statistically significant overall survival benefit in pre- and postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer. New ... ...

    Abstract Background: Ribociclib has demonstrated a statistically significant overall survival benefit in pre- and postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer. New Adjuvant Trial with Ribociclib [LEE011] (NATALEE) is a trial evaluating the efficacy and safety of adjuvant ribociclib plus endocrine therapy (ET)
    Methods/design: NATALEE is a multicenter, randomized, open-label, Phase III trial in patients with HR+/HER2- EBC. Eligible patients include women, regardless of menopausal status, and men aged ⩾18 years. Select patients with stage IIA, stage IIB, or stage III disease (per the anatomic classification in the
    Discussion: The 36-month treatment duration of ribociclib in NATALEE is extended compared with that in other adjuvant cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor trials and is intended to maximize efficacy due to longer duration of CDK4/6 inhibition. Compared with the 600-mg/day dose used in advanced breast cancer, the reduced ribociclib dose used in NATALEE may improve tolerability while maintaining efficacy. NATALEE includes the broadest population of patients with HR+/HER2- EBC of any Phase III trial currently evaluating adjuvant CDK4/6 inhibitor treatment.
    Trial registration: ClinicalTrials.gov identifier: NCT03701334 (https://clinicaltrials.gov/ct2/show/NCT03701334).
    Language English
    Publishing date 2023-05-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 2503443-1
    ISSN 1758-8359 ; 1758-8340
    ISSN (online) 1758-8359
    ISSN 1758-8340
    DOI 10.1177/17588359231178125
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer.

    Bardia, Aditya / Mayer, Ingrid A / Vahdat, Linda T / Tolaney, Sara M / Isakoff, Steven J / Diamond, Jennifer R / O'Shaughnessy, Joyce / Moroose, Rebecca L / Santin, Alessandro D / Abramson, Vandana G / Shah, Nikita C / Rugo, Hope S / Goldenberg, David M / Sweidan, Ala M / Iannone, Robert / Washkowitz, Sarah / Sharkey, Robert M / Wegener, William A / Kalinsky, Kevin

    The New England journal of medicine

    2019  Volume 380, Issue 8, Page(s) 741–751

    Abstract: Background: Standard chemotherapy is associated with low response rates and short progression-free survival among patients with pretreated metastatic triple-negative breast cancer. Sacituzumab govitecan-hziy is an antibody-drug conjugate that combines a ...

    Abstract Background: Standard chemotherapy is associated with low response rates and short progression-free survival among patients with pretreated metastatic triple-negative breast cancer. Sacituzumab govitecan-hziy is an antibody-drug conjugate that combines a humanized monoclonal antibody, which targets the human trophoblast cell-surface antigen 2 (Trop-2), with SN-38, which is conjugated to the antibody by a cleavable linker. Sacituzumab govitecan-hziy enables delivery of high concentrations of SN-38 to tumors.
    Methods: We conducted a phase 1/2 single-group, multicenter trial involving patients with advanced epithelial cancers who received sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxic effects. A total of 108 patients received sacituzumab govitecan-hziy at a dose of 10 mg per kilogram of body weight after receiving at least two previous anticancer therapies for metastatic triple-negative breast cancer. The end points included safety; the objective response rate (according to Response Evaluation Criteria in Solid Tumors, version 1.1), which was assessed locally; the duration of response; the clinical benefit rate (defined as a complete or partial response or stable disease for at least 6 months); progression-free survival; and overall survival. Post hoc analyses determined the response rate and duration, which were assessed by blinded independent central review.
    Results: The 108 patients with triple-negative breast cancer had received a median of 3 previous therapies (range, 2 to 10). Four deaths occurred during treatment; 3 patients (2.8%) discontinued treatment because of adverse events. Grade 3 or 4 adverse events (in ≥10% of the patients) included anemia and neutropenia; 10 patients (9.3%) had febrile neutropenia. The response rate (3 complete and 33 partial responses) was 33.3% (95% confidence interval [CI], 24.6 to 43.1), and the median duration of response was 7.7 months (95% CI, 4.9 to 10.8); as assessed by independent central review, these values were 34.3% and 9.1 months, respectively. The clinical benefit rate was 45.4%. Median progression-free survival was 5.5 months (95% CI, 4.1 to 6.3), and overall survival was 13.0 months (95% CI, 11.2 to 13.7).
    Conclusions: Sacituzumab govitecan-hziy was associated with durable objective responses in patients with heavily pretreated metastatic triple-negative breast cancer. Myelotoxic effects were the main adverse reactions. (Funded by Immunomedics; IMMU-132-01 ClinicalTrials.gov number, NCT01631552.).
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Anemia/chemically induced ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antigens, Neoplasm ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Camptothecin/adverse effects ; Camptothecin/analogs & derivatives ; Camptothecin/therapeutic use ; Cell Adhesion Molecules/antagonists & inhibitors ; Diarrhea/chemically induced ; Dose-Response Relationship, Drug ; Female ; Humans ; Immunoconjugates/adverse effects ; Immunoconjugates/therapeutic use ; Infusions, Intravenous ; Irinotecan/administration & dosage ; Irinotecan/adverse effects ; Male ; Middle Aged ; Neutropenia/chemically induced ; Progression-Free Survival ; Survival Rate ; Triple Negative Breast Neoplasms/drug therapy ; Triple Negative Breast Neoplasms/mortality
    Chemical Substances Antibodies, Monoclonal, Humanized ; Antigens, Neoplasm ; Antineoplastic Agents ; Cell Adhesion Molecules ; Immunoconjugates ; TACSTD2 protein, human ; Irinotecan (7673326042) ; sacituzumab govitecan (M9BYU8XDQ6) ; Camptothecin (XT3Z54Z28A)
    Language English
    Publishing date 2019-02-20
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa1814213
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ua VI Zs.34: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  3. Article ; Online: Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer.

    Bardia, Aditya / Mayer, Ingrid A / Diamond, Jennifer R / Moroose, Rebecca L / Isakoff, Steven J / Starodub, Alexander N / Shah, Nikita C / O'Shaughnessy, Joyce / Kalinsky, Kevin / Guarino, Michael / Abramson, Vandana / Juric, Dejan / Tolaney, Sara M / Berlin, Jordan / Messersmith, Wells A / Ocean, Allyson J / Wegener, William A / Maliakal, Pius / Sharkey, Robert M /
    Govindan, Serengulam V / Goldenberg, David M / Vahdat, Linda T

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2017  Volume 35, Issue 19, Page(s) 2141–2148

    Abstract: Purpose Trop-2, expressed in most triple-negative breast cancers (TNBCs), may be a potential target for antibody-drug conjugates. Sacituzumab govitecan, an antibody-drug conjugate, targets Trop-2 for the selective delivery of SN-38, the active metabolite ...

    Abstract Purpose Trop-2, expressed in most triple-negative breast cancers (TNBCs), may be a potential target for antibody-drug conjugates. Sacituzumab govitecan, an antibody-drug conjugate, targets Trop-2 for the selective delivery of SN-38, the active metabolite of irinotecan. Patients and Methods We evaluated sacituzumab govitecan in a single-arm, multicenter trial in patients with relapsed/refractory metastatic TNBC who received a 10 mg/kg starting dose on days 1 and 8 of 21-day repeated cycles. The primary end points were safety and objective response rate; secondary end points were progression-free survival and overall survival. Results In 69 patients who received a median of five prior therapies (range, one to 12) since diagnosis, the confirmed objective response rate was 30% (partial response, n = 19; complete response, n = 2), the median response duration was 8.9 (95% CI, 6.1 to 11.3) months, and the clinical benefit rate (complete response + partial response + stable disease ≥ 6 months) was 46%. These responses occurred early, with a median onset of 1.9 months. Median progression-free survival was 6.0 (95% CI, 5.0 to 7.3) months, and median overall survival was 16.6 (95% CI, 11.1 to 20.6) months. Grade ≥ 3 adverse events included neutropenia (39%), leukopenia (16%), anemia (14%), and diarrhea (13%); the incidence of febrile neutropenia was 7%. The majority of archival tumor specimens (88%) were moderately to strongly positive for Trop-2 by immunohistochemistry. No neutralizing antibodies to the ADC or antibody were detected, despite repeated cycles developed. Conclusion Sacituzumab govitecan was well tolerated and induced early and durable responses in heavily pretreated patients with metastatic TNBC. As a therapeutic target and predictive biomarker, Trop-2 warrants further research.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antigens, Neoplasm/biosynthesis ; Antigens, Neoplasm/immunology ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Breast Neoplasms, Male/drug therapy ; Breast Neoplasms, Male/immunology ; Breast Neoplasms, Male/metabolism ; Camptothecin/administration & dosage ; Camptothecin/adverse effects ; Camptothecin/analogs & derivatives ; Cell Adhesion Molecules/biosynthesis ; Cell Adhesion Molecules/immunology ; Female ; Humans ; Immunoconjugates/administration & dosage ; Immunoconjugates/adverse effects ; Male ; Middle Aged ; Neoplasm Metastasis ; Triple Negative Breast Neoplasms/drug therapy ; Triple Negative Breast Neoplasms/immunology ; Triple Negative Breast Neoplasms/metabolism
    Chemical Substances Antibodies, Monoclonal, Humanized ; Antigens, Neoplasm ; Antineoplastic Agents ; Cell Adhesion Molecules ; Immunoconjugates ; TACSTD2 protein, human ; sacituzumab govitecan (M9BYU8XDQ6) ; Camptothecin (XT3Z54Z28A)
    Language English
    Publishing date 2017-03-14
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.2016.70.8297
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1847: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 650: Show issues

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  4. Book: Hemophilia

    Winters, Thomas F / Moroose, Rebecca L

    orthopaedic manifestations and treatment

    1985  

    Abstract: Producer) This program reviews the classification and pathophysiology of the major cause of morbidity in patients with hemophilia-hemophilic arthropathy. The medical and surgical treatment options are outlined and updated for the management of ... ...

    Institution American Academy of Orthopaedic Surgeons
    Author's details American Academy of Orthop[a]edic Surgeons
    Abstract (Producer) This program reviews the classification and pathophysiology of the major cause of morbidity in patients with hemophilia-hemophilic arthropathy. The medical and surgical treatment options are outlined and updated for the management of hemotherapy.
    MeSH term(s) Hemophilia A/complications ; Hemophilia A/therapy ; Orthopedics
    Language English
    Size 80 slides :, col. with b&w +
    Publisher AAOS
    Publishing place Park Ridge, Ill.
    Document type Book
    Note Sound accompaniment for manual operation.
    Accompanying material 1 sound cassette (1 7/8 ips).
    Database Catalogue of the US National Library of Medicine (NLM)

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  5. Article ; Online: A phase II trial of docetaxel with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (TORI B01).

    Hurvitz, Sara A / Allen, Heather J / Moroose, Rebecca L / Chan, David / Hagenstad, Christopher / Applebaum, Steven H / Patel, Giribala / Hu, Eddie H / Ryba, Nancy / Lin, Lii-Shin / Wang, Hejing / Glaspy, John / Slamon, Dennis J / Kabbinavar, Fairooz

    Clinical breast cancer

    2010  Volume 10, Issue 4, Page(s) 307–312

    Abstract: Introduction: Addition of the antiangiogenic agent bevacizumab to paclitaxel significantly improves response rates and progression-free survival for metastatic breast cancer (MBC). To assess the activity of docetaxel plus bevacizumab, a multicenter ... ...

    Abstract Introduction: Addition of the antiangiogenic agent bevacizumab to paclitaxel significantly improves response rates and progression-free survival for metastatic breast cancer (MBC). To assess the activity of docetaxel plus bevacizumab, a multicenter phase II trial was conducted.
    Patients and methods: Patients with measurable first-line HER2/neu-negative MBC were eligible. This trial began as a 2-arm study with a docetaxel-alone arm. When bevacizumab became widely available, it was converted to a 1-arm open-label trial of docetaxel/bevacizumab. Patients enrolled in the docetaxel-alone arm were permitted to cross over to docetaxel/bevacizumab. Patients received bevacizumab 15 mg/kg and docetaxel 75 mg/m2 intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.
    Results: From March 2005 to September 2006, 76 patients were enrolled. Of the 7 patients who were randomized to docetaxel alone, 6 crossed over to docetaxel/bevacizumab (included in the safety analysis only). Two patients were found to be ineligible before receiving drug. Efficacy data are based on the 67 patients who were originally enrolled in the docetaxel/bevacizumab arm and received at least 1 dose of study medication. The confirmed objective response rate is 51% (34 of 67) with 9% complete responses (6 of 67) and 42% partial responses (28 of 67). Nine additional patients (13%) had stable disease lasting >or= 6 months. With a median follow-up of 21.7 months, the median time to progression is 9.3 months, and median overall survival is 26.3 months. Common grade 3/4 adverse events included neutropenia (33%), leukopenia/lymphopenia (25%), fatigue (22%), infection (17%), pain (16%), and hypertension (9%).
    Conclusion: Docetaxel/bevacizumab was generally well tolerated with manageable toxicity and promising efficacy results.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bevacizumab ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Breast Neoplasms/pathology ; Cross-Over Studies ; Disease-Free Survival ; Female ; Humans ; Kaplan-Meier Estimate ; Middle Aged ; Neoplasm Staging ; Receptor, ErbB-2/genetics ; Taxoids/administration & dosage ; Taxoids/adverse effects
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Taxoids ; docetaxel (15H5577CQD) ; Bevacizumab (2S9ZZM9Q9V) ; Receptor, ErbB-2 (EC 2.7.10.1)
    Language English
    Publishing date 2010-08-01
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2106734-X
    ISSN 1938-0666 ; 1526-8209
    ISSN (online) 1938-0666
    ISSN 1526-8209
    DOI 10.3816/CBC.2010.n.040
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5800: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (2.OG)
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    Zs.MO 498: Show issues

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