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  1. AU="Clowney, Billy"
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  1. Artikel ; Online: Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens.

    Niesvizky, Ruben / Flinn, Ian W / Rifkin, Robert / Gabrail, Nashat / Charu, Veena / Clowney, Billy / Essell, James / Gaffar, Yousuf / Warr, Thomas / Neuwirth, Rachel / Zhu, Yanyan / Elliott, Jennifer / Esseltine, Dixie-Lee / Niculescu, Liviu / Reeves, James

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

    2015  Band 33, Heft 33, Seite(n) 3921–3929

    Abstract: Purpose: The US community-based, phase IIIB UPFRONT trial was designed to compare three frontline bortezomib-based regimens in transplantation-ineligible patients with myeloma.: Patients and methods: Patients (N = 502) were randomly assigned 1:1:1 to ...

    Abstract Purpose: The US community-based, phase IIIB UPFRONT trial was designed to compare three frontline bortezomib-based regimens in transplantation-ineligible patients with myeloma.
    Patients and methods: Patients (N = 502) were randomly assigned 1:1:1 to 24 weeks (eight 21-day cycles) of induction with bortezomib-dexamethasone (VD; n = 168; intravenous bortezomib 1.3 mg/m(2), days 1, 4, 8, and 11 plus oral dexamethasone 20 mg, days 1, 2, 4, 5, 8, 9, 11, and 12 [cycles 1 to 4], or 1, 2, 4, and 5 [cycles 5 to 8]), bortezomib-thalidomide-dexamethasone (VTD; n = 167; bortezomib and dexamethasone as before plus oral thalidomide 100 mg, days 1 to 21), or bortezomib-melphalan-prednisone (VMP; n = 167; bortezomib as before plus oral melphalan 9 mg/m(2) and oral prednisone 60 mg/m(2), days 1 to 4, every other cycle), followed by 25 weeks (five 35-day cycles) of bortezomib maintenance (1.6 mg/m(2), days 1, 8, 15, and 22). The primary end point was progression-free survival.
    Results: After 42.7 months' median follow-up, median progression-free survival with VD, VTD, and VMP was 14.7, 15.4, and 17.3 months, respectively; median overall survival was 49.8, 51.5, and 53.1 months, with no significant differences among treatments for either end point (global P = .46 and P = .79, respectively, Wald test). Overall response rates were 73% (VD), 80% (VTD), and 70% (VMP). Adverse events were more common with VTD than VD or VMP. Bortezomib maintenance was feasible without producing cumulative toxicity.
    Conclusion: Although all bortezomib-containing regimens produced good outcomes, VTD and VMP did not appear to offer an advantage over VD in transplantation-ineligible patients with myeloma treated in US community practice.
    Mesh-Begriff(e) Adrenal Cortex Hormones/administration & dosage ; Adrenal Cortex Hormones/adverse effects ; Aged ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bortezomib/administration & dosage ; Bortezomib/adverse effects ; Community Health Services ; Disease-Free Survival ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Multiple Myeloma/drug therapy ; Multiple Myeloma/mortality ; Multiple Myeloma/pathology ; Multivariate Analysis ; Prognosis ; Proportional Hazards Models ; Prospective Studies ; Risk Assessment ; Severity of Illness Index ; Survival Analysis ; Thalidomide/administration & dosage ; Thalidomide/adverse effects ; Treatment Outcome
    Chemische Substanzen Adrenal Cortex Hormones ; Thalidomide (4Z8R6ORS6L) ; Bortezomib (69G8BD63PP)
    Sprache Englisch
    Erscheinungsdatum 2015-11-20
    Erscheinungsland United States
    Dokumenttyp Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.2014.58.7618
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel: Darbepoetin alfa administered every three weeks is effective for the treatment of chemotherapy-induced anemia.

    Boccia, Ralph / Malik, Imtiaz A / Raja, Vinay / Kahanic, Stephen / Liu, Randall / Lillie, Tom / Tomita, Dianne / Clowney, Billy / Silberstein, Peter

    The oncologist

    2006  Band 11, Heft 4, Seite(n) 409–417

    Abstract: Patients with cancer receiving chemotherapy often have chemotherapy-induced anemia (CIA) and reduced quality of life. Darbepoetin alfa can effectively treat CIA when administered at an extended dosing interval of once every 3 weeks (Q3W). Darbepoetin ... ...

    Abstract Patients with cancer receiving chemotherapy often have chemotherapy-induced anemia (CIA) and reduced quality of life. Darbepoetin alfa can effectively treat CIA when administered at an extended dosing interval of once every 3 weeks (Q3W). Darbepoetin alfa administered Q3W may allow synchronization of darbepoetin alfa therapy with chemotherapy administered Q3W. This multicenter, open-label, 16-week study evaluated the effectiveness and safety of darbepoetin alfa administered as a fixed dose (300 mug) Q3W in patients with CIA. Eligible patients (> or =18 years) were anemic (hemoglobin <11g/dl), had a nonmyeloid malignancy, and were receiving multicycle chemotherapy. This analysis includes 1,493 patients who received at least one dose of darbepoetin alfa. The effect of baseline hemoglobin (<10 or > or =10 g/dl) on clinical outcomes was evaluated. Patients in the > or =10-g/dl stratum achieved the hemoglobin target range (11-13 g/dl)in less time than patients in the <10-g/dlstratum (3 weeks vs. 9 weeks). More patients in the > or =10-g/dl stratum achieved the hemoglobin target range (87% vs. 66%); however, similar proportions of patients in both strata maintained hemoglobin within the target range (73% vs. 71%). Fewer patients in the > or =10-g/dl stratum received RBC transfusions from week 5 to the end of the study (12% vs. 28%). Over 50% of patients in both strata reported clinically significant improvements (> or =3-point increase) in Functional Assessment of Cancer Therapy-Fatigue score. Twenty-eight percent of patients reported serious adverse events; 3% of all patients had a venous or arterial thrombotic event. This study demonstrates that darbepoetin alfa Q3W is well tolerated and effective for treating CIA.
    Mesh-Begriff(e) Adult ; Aged ; Aged, 80 and over ; Anemia/blood ; Anemia/chemically induced ; Anemia/drug therapy ; Antineoplastic Agents/adverse effects ; Darbepoetin alfa ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Therapy, Combination ; Endpoint Determination ; Erythropoietin/administration & dosage ; Erythropoietin/adverse effects ; Erythropoietin/analogs & derivatives ; Female ; Follow-Up Studies ; Hemoglobins/drug effects ; Hemoglobins/metabolism ; Humans ; Male ; Middle Aged ; Predictive Value of Tests ; Quality of Life ; Time Factors ; Treatment Outcome
    Chemische Substanzen Antineoplastic Agents ; Hemoglobins ; Erythropoietin (11096-26-7) ; Darbepoetin alfa (15UQ94PT4P)
    Sprache Englisch
    Erscheinungsdatum 2006-04
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 1409038-7
    ISSN 1083-7159
    ISSN 1083-7159
    DOI 10.1634/theoncologist.11-4-409
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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