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  1. Article ; Online: Feasibility of Long-term Proteasome Inhibition in Multiple Myeloma by in-class Transition From Bortezomib to Ixazomib.

    Manda, Sudhir / Yimer, Habte A / Noga, Stephen J / Girnius, Saulius / Yasenchak, Christopher A / Charu, Veena / Lyons, Roger / Aiello, Jack / Bogard, Kimberly / Ferrari, Renda H / Cherepanov, Dasha / Demers, Brittany / Lu, Vickie / Whidden, Presley / Kambhampati, Suman / Birhiray, Ruemu E / Jhangiani, Haresh S / Boccia, Ralph / Rifkin, Robert M

    Clinical lymphoma, myeloma & leukemia

    2020  Volume 20, Issue 11, Page(s) e910–e925

    Abstract: Background: The ongoing US MM-6 study is investigating in-class transition (iCT) from parenteral bortezomib-based induction to all-oral IRd (ixazomib-lenalidomide-dexamethasone) with the aim of increasing proteasome inhibitor (PI)-based treatment ... ...

    Abstract Background: The ongoing US MM-6 study is investigating in-class transition (iCT) from parenteral bortezomib-based induction to all-oral IRd (ixazomib-lenalidomide-dexamethasone) with the aim of increasing proteasome inhibitor (PI)-based treatment adherence and duration while maintaining patients' health-related quality of life (HRQoL) and improving outcomes.
    Patients and methods: US community sites are enrolling non-transplant-eligible patients with newly diagnosed multiple myeloma (MM) with no evidence of progressive disease after 3 cycles of bortezomib-based therapy to receive IRd (up to 39 cycles or until progression or toxicity). The patients use mobile or wearable digital devices to collect actigraphy (activity and sleep) data and electronically complete HRQoL, treatment satisfaction and medication adherence questionnaires. The primary endpoint is progression-free survival. The key secondary endpoints include response rates and therapy duration.
    Results: At the data cutoff, 84 patients had been treated (median age 73 years; 44% aged ≥ 75 years; 49% men; 15% Black or African American; and 10% Hispanic or Latino). Of the 84 patients, 62% were continuing therapy. The mean duration of total PI therapy was 10.1 months and for the IRd regimen was 7.3 months. With an 8-month median follow-up, the 12-month progression-free survival rate was 86% (95% confidence interval, 73%-93%) from both the start of bortezomib-based treatment and the start of IRd. The overall response rate was 62% (complete response, 4%; very good partial response, 25%; partial response, 33%) after bortezomib-based induction and 70% (complete response, 26%; very good partial response, 29%; partial response, 15%) after iCT. The IRd safety profile was consistent with previous clinical trial data, and HRQoL and treatment satisfaction were maintained.
    Conclusion: The patients included in the US MM-6 study are representative of the real-world US MM population. The use of iCT might permit prolonged PI-based therapy with promising efficacy, without impacting patients' HRQoL or treatment satisfaction.
    MeSH term(s) Aged ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Boron Compounds/pharmacology ; Boron Compounds/therapeutic use ; Bortezomib/pharmacology ; Bortezomib/therapeutic use ; Female ; Glycine/analogs & derivatives ; Glycine/pharmacology ; Glycine/therapeutic use ; Humans ; Male ; Multiple Myeloma/drug therapy ; Multiple Myeloma/mortality ; Multiple Myeloma/pathology ; Progression-Free Survival ; Proteasome Inhibitors/pharmacology ; Proteasome Inhibitors/therapeutic use ; Survival Analysis ; Treatment Outcome
    Chemical Substances Boron Compounds ; Proteasome Inhibitors ; Bortezomib (69G8BD63PP) ; ixazomib (71050168A2) ; Glycine (TE7660XO1C)
    Keywords covid19
    Language English
    Publishing date 2020-07-06
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2540992-X
    ISSN 2152-2669 ; 2152-2650
    ISSN (online) 2152-2669
    ISSN 2152-2650
    DOI 10.1016/j.clml.2020.06.024
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    Zs.A 5903: Show issues Location:
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  2. Article: Feasibility of Long-term Proteasome Inhibition in Multiple Myeloma by in-class Transition From Bortezomib to Ixazomib

    Manda, Sudhir / Yimer, Habte A / Noga, Stephen J / Girnius, Saulius / Yasenchak, Christopher A / Charu, Veena / Lyons, Roger / Aiello, Jack / Bogard, Kimberly / Ferrari, Renda H / Cherepanov, Dasha / Demers, Brittany / Lu, Vickie / Whidden, Presley / Kambhampati, Suman / Birhiray, Ruemu E / Jhangiani, Haresh S / Boccia, Ralph / Rifkin, Robert M

    Clin. lymphoma myeloma leuk. (Online)

    Abstract: BACKGROUND: The ongoing US MM-6 study is investigating in-class transition (iCT) from parenteral bortezomib-based induction to all-oral IRd (ixazomib-lenalidomide-dexamethasone) with the aim of increasing proteasome inhibitor (PI)-based treatment ... ...

    Abstract BACKGROUND: The ongoing US MM-6 study is investigating in-class transition (iCT) from parenteral bortezomib-based induction to all-oral IRd (ixazomib-lenalidomide-dexamethasone) with the aim of increasing proteasome inhibitor (PI)-based treatment adherence and duration while maintaining patients' health-related quality of life (HRQoL) and improving outcomes. PATIENTS AND METHODS: US community sites are enrolling non-transplant-eligible patients with newly diagnosed multiple myeloma (MM) with no evidence of progressive disease after 3 cycles of bortezomib-based therapy to receive IRd (up to 39 cycles or until progression or toxicity). The patients use mobile or wearable digital devices to collect actigraphy (activity and sleep) data and electronically complete HRQoL, treatment satisfaction and medication adherence questionnaires. The primary endpoint is progression-free survival. The key secondary endpoints include response rates and therapy duration. RESULTS: At the data cutoff, 84 patients had been treated (median age 73 years; 44% aged ≥ 75 years; 49% men; 15% Black or African American; and 10% Hispanic or Latino). Of the 84 patients, 62% were continuing therapy. The mean duration of total PI therapy was 10.1 months and for the IRd regimen was 7.3 months. With an 8-month median follow-up, the 12-month progression-free survival rate was 86% (95% confidence interval, 73%-93%) from both the start of bortezomib-based treatment and the start of IRd. The overall response rate was 62% (complete response, 4%; very good partial response, 25%; partial response, 33%) after bortezomib-based induction and 70% (complete response, 26%; very good partial response, 29%; partial response, 15%) after iCT. The IRd safety profile was consistent with previous clinical trial data, and HRQoL and treatment satisfaction were maintained. CONCLUSION: The patients included in the US MM-6 study are representative of the real-world US MM population. The use of iCT might permit prolonged PI-based therapy with promising efficacy, without impacting patients' HRQoL or treatment satisfaction.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #633899
    Database COVID19

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  3. Article ; Online: Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia.

    Hernandez, Enrique / Ganly, Peter / Charu, Veena / Dibenedetto, Joseph / Tomita, Dianne / Lillie, Tom / Taylor, Kerry

    Current medical research and opinion

    2009  Volume 25, Issue 9, Page(s) 2109–2120

    Abstract: Objective: Darbepoetin alfa is effective in treating chemotherapy-induced anemia (CIA). Administration of subcutaneous darbepoetin alfa every 3 weeks (Q3W) could simplify treatment through synchronization with common Q3W chemotherapy regimens. We report ...

    Abstract Objective: Darbepoetin alfa is effective in treating chemotherapy-induced anemia (CIA). Administration of subcutaneous darbepoetin alfa every 3 weeks (Q3W) could simplify treatment through synchronization with common Q3W chemotherapy regimens. We report results from a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of fixed-dose Q3W darbepoetin alfa in patients with a wide variety of tumor types who experienced CIA.
    Research design and methods: Patients aged > or = 18 years with anemia (hemoglobin <11 g/dL) being treated for nonmyeloid malignancy were randomized 1:1 to receive darbepoetin alfa 300 microg (n = 193) or placebo (n = 193) subcutaneously Q3W from weeks 1 to 13 in this 16-week study. Doses could be adjusted per prespecified rules.
    Main outcome measures: The primary endpoint was the proportion of patients who received > or =1 red blood cell (RBC) transfusion between week 5 and the end of the treatment period (EOTP). The study also analyzed the proportions of patients achieving a hemoglobin concentration > or =11 g/dL and subsequently maintaining hemoglobin levels above 11 g/dL, and the change in hemoglobin concentration over time.
    Results: The proportion of patients requiring RBC transfusions between week 5 and EOTP was significantly lower in the darbepoetin alfa-treated group than in the placebo-treated group (24 vs. 41% of patients, a 16.3% difference, p < 0.001). There were no differences between the two treatment arms in quality-of-life measures. Cardiovascular/thromboembolic adverse events were uncommon and were not associated with increases in hemoglobin levels. Study limitations suggest caution in the interpretation of these results: transfusions, the primary endpoint, were recommended but not required if hemoglobin concentrations were < or =8.0 g/dL, and protocol deviations (primarily dosing errors) occurred in approximately one-half of the patients in both treatment groups.
    Conclusions: In this study, fixed-dose Q3W darbepoetin alfa appeared to be well-tolerated and effective for the treatment of CIA.
    Trial registration: Study 20030232; ClinicalTrials.Gov Identifier: NCT00110955.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Algorithms ; Anemia/drug therapy ; Anemia/etiology ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Darbepoetin alfa ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Erythropoietin/administration & dosage ; Erythropoietin/analogs & derivatives ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/drug therapy ; Placebos ; Young Adult
    Chemical Substances Placebos ; Erythropoietin (11096-26-7) ; Darbepoetin alfa (15UQ94PT4P)
    Language English
    Publishing date 2009-09
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 80296-7
    ISSN 1473-4877 ; 0300-7995
    ISSN (online) 1473-4877
    ISSN 0300-7995
    DOI 10.1185/03007990903084164
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    Zs.A 955: Show issues Location:
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  4. Article: Initiation of epoetin-alpha therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy: an open-label, multicenter study with randomized and nonrandomized treatment arms.

    Glaspy, John A / Charu, Veena / Luo, Donghan / Moyo, Victor / Kamin, Marc / Wilhelm, Francois E

    Cancer

    2009  Volume 115, Issue 5, Page(s) 1121–1131

    Abstract: Background: Epoetin-alpha initiated once weekly, followed by once-every-3-weeks maintenance, was effective and well tolerated for chemotherapy-induced anemia. This study evaluated a starting dose of epoetin-alpha 120,000 U once every 3 weeks for ... ...

    Abstract Background: Epoetin-alpha initiated once weekly, followed by once-every-3-weeks maintenance, was effective and well tolerated for chemotherapy-induced anemia. This study evaluated a starting dose of epoetin-alpha 120,000 U once every 3 weeks for chemotherapy-induced anemia using early and late initiation regimens.
    Methods: Patients with baseline hemoglobin 11.0-12.0 g/dL were randomly assigned to early intervention with immediate epoetin-alpha (n = 68) or to standard intervention with epoetin-alpha when hemoglobin decreased to <11 g/dL (n = 68). A third group of patients with baseline hemoglobin <11 g/dL (n = 50) were enrolled but not randomized; epoetin-alpha was initiated immediately. The primary endpoint was mean proportion of hemoglobin values within the target range (11.0-13.0 g/dL) among randomized patients.
    Results: The mean proportion of hemoglobin values in range through week 16 was 60% in each randomized group. Mean hemoglobin by week showed similar increases over the study. Blood transfusions were administered in 9%, 8%, and 24% of patients in the early, standard, and nonrandomized groups. Mean epoetin-alpha doses were similar between treatment groups. Dose reductions and withholds were more common in the early intervention group. Adverse events (eg, diarrhea, fatigue, nausea) were consistent with the safety profile for epoetin-alpha . Clinically relevant thrombotic vascular events (regardless of relationship to study treatment) were reported for 9%, 12%, and 12% of patients in the early, standard, and nonrandomized groups.
    Conclusions: Early and standard intervention with epoetin-alpha, administered once every 3 weeks, increased and maintained hemoglobin levels within 11.0-13.0 g/dL in patients with chemotherapy-induced anemia.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Anemia/chemically induced ; Anemia/drug therapy ; Antineoplastic Agents/adverse effects ; Blood Transfusion ; Epoetin Alfa ; Erythropoietin/administration & dosage ; Erythropoietin/adverse effects ; Female ; Hemoglobins/analysis ; Humans ; Male ; Middle Aged ; Neoplasms/complications ; Neoplasms/drug therapy ; Recombinant Proteins
    Chemical Substances Antineoplastic Agents ; Hemoglobins ; Recombinant Proteins ; Erythropoietin (11096-26-7) ; Epoetin Alfa (64FS3BFH5W)
    Language English
    Publishing date 2009-03-01
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1429-1
    ISSN 1097-0142 ; 0008-543X ; 1934-662X
    ISSN (online) 1097-0142
    ISSN 0008-543X ; 1934-662X
    DOI 10.1002/cncr.24127
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  5. Article ; 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  Volume 33, Issue 33, Page(s) 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 term(s) 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
    Chemical Substances Adrenal Cortex Hormones ; Thalidomide (4Z8R6ORS6L) ; Bortezomib (69G8BD63PP)
    Language English
    Publishing date 2015-11-20
    Publishing country United States
    Document type 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
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    Zs.A 1847: Show issues Location:
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  6. Article ; Online: A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma.

    Berenson, James R / Yellin, Ori / Shamasunder, Hesaraghatta K / Chen, Chien-Shing / Charu, Veena / Woliver, Thomas B / Sanani, Shamel / Schlutz, Michael / Nassir, Youram / Swift, Regina A / Andreu-Vieyra, Claudia / Vescio, Robert

    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

    2014  Volume 23, Issue 6, Page(s) 1503–1512

    Abstract: Purpose: Fatigue is a common problem among multiple myeloma (MM) patients. Armodafinil is a drug known to promote wakefulness, which is related to modafinil, a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents. ... ...

    Abstract Purpose: Fatigue is a common problem among multiple myeloma (MM) patients. Armodafinil is a drug known to promote wakefulness, which is related to modafinil, a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents. We investigated whether armodafinil could reduce cancer-related fatigue in MM patients.
    Methods: This double-blind, placebo-controlled phase 3 trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue. Patients were randomized to one of two arms: treatment-only, with armodafinil given at 150 mg/daily for 56 days, or placebo-first, with placebo given on days 1-28, followed by armodafinil administered at 150 mg daily on days 29-56. Fatigue was measured on days 1 (pre-dose: baseline), 15, 28, 43, and 56 using seven separate assessments, including four patient-reported outcomes of fatigue and related quality of life measures, as well as three objective measures of cognitive function.
    Results: Overall toxicities were similar between treatment groups. No significant differences were observed between the placebo-first and the treatment-only arms after 28 days. Treatment with armodafinil for 28 additional days did not produce responses. Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day 28 compared to baseline. Placebo-first patients improved on eight additional measures (one patient-reported measure, six subscales, and one objective task), suggesting a strong placebo effect in this patient population.
    Conclusions: Evaluation and treatment of cancer-related fatigue continues to be challenging; a clear definition of this symptom and better assessment tools are needed.
    MeSH term(s) Adult ; Aged ; Benzhydryl Compounds/adverse effects ; Benzhydryl Compounds/therapeutic use ; Cross-Over Studies ; Double-Blind Method ; Fatigue/drug therapy ; Fatigue/etiology ; Female ; Humans ; Male ; Middle Aged ; Modafinil ; Multiple Myeloma/complications ; Multiple Myeloma/drug therapy ; Placebo Effect ; Quality of Life ; Wakefulness/drug effects ; Wakefulness-Promoting Agents/therapeutic use
    Chemical Substances Benzhydryl Compounds ; Wakefulness-Promoting Agents ; Modafinil (R3UK8X3U3D)
    Language English
    Publishing date 2014-11-05
    Publishing country Germany
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1134446-5
    ISSN 1433-7339 ; 0941-4355
    ISSN (online) 1433-7339
    ISSN 0941-4355
    DOI 10.1007/s00520-014-2486-7
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  7. Article ; Online: TROPICS 1: a phase III, randomized, double-blind, placebo-controlled study of tenecteplase for restoration of function in dysfunctional central venous catheters.

    Gabrail, Nashat / Sandler, Eric / Charu, Veena / Anas, Nick / Lim, Eduardo / Blaney, Martha / Ashby, Mark / Gillespie, Barbara S / Begelman, Susan M

    Journal of vascular and interventional radiology : JVIR

    2010  Volume 21, Issue 12, Page(s) 1852–1858

    Abstract: Purpose: To evaluate the efficacy and safety of the thrombolytic tenecteplase, a fibrin-specific recombinant tissue plasminogen activator, for restoring function to dysfunctional central venous catheters (CVCs).: Materials and methods: In this double- ...

    Abstract Purpose: To evaluate the efficacy and safety of the thrombolytic tenecteplase, a fibrin-specific recombinant tissue plasminogen activator, for restoring function to dysfunctional central venous catheters (CVCs).
    Materials and methods: In this double-blind, placebo-controlled study, eligible patients with dysfunctional nonhemodialysis CVCs were randomly assigned to two treatment arms. In the first arm (TNK-TNK-PBO), patients received an initial dose of intraluminal tenecteplase (TNK) (up to 2 mg), a second dose of tenecteplase if indicated, and a third placebo (PBO) dose. In the PBO-TNK-TNK arm, placebo was instilled first followed by up to two doses of tenecteplase, if needed, for restoration of catheter function. After administration of each dose, CVC function was assessed at 15, 30, and 120 minutes.
    Results: There were 97 patients who received either TNK-TNK-PBO (n = 50) or PBO-TNK-TNK (n = 47). Within 120 minutes of initial study drug instillation, catheter function was restored to 30 patients (60%) in the TNK-TNK-PBO arm and 11 patients (23%) in the PBO-TNK-TNK arm, for a treatment difference of 37 percentage points (95% confidence interval 18-55; P = .0002). Cumulative restoration rates for CVC function increased to 87% after the second dose of tenecteplase in both study arms combined. Two patients developed a deep vein thrombosis (DVT) after exposure to tenecteplase; one DVT was considered to be drug related. No cases of intracranial hemorrhage, major bleeding, embolic events, catheter-related bloodstream infections, or catheter-related complications were reported.
    Conclusions: Tenecteplase was efficacious for restoration of catheter function in these study patients with dysfunctional CVCs.
    MeSH term(s) Adolescent ; Adult ; Aged ; Catheterization, Central Venous/adverse effects ; Catheterization, Central Venous/instrumentation ; Catheters, Indwelling/adverse effects ; Chi-Square Distribution ; Double-Blind Method ; Female ; Fibrinolytic Agents/administration & dosage ; Fibrinolytic Agents/adverse effects ; Humans ; Male ; Middle Aged ; Placebo Effect ; Regional Blood Flow ; Thrombolytic Therapy/adverse effects ; Thrombosis/drug therapy ; Thrombosis/etiology ; Thrombosis/physiopathology ; Time Factors ; Tissue Plasminogen Activator/administration & dosage ; Tissue Plasminogen Activator/adverse effects ; Treatment Outcome ; United States ; Young Adult
    Chemical Substances Fibrinolytic Agents ; Tissue Plasminogen Activator (EC 3.4.21.68) ; tenecteplase (WGD229O42W)
    Language English
    Publishing date 2010-12
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1137756-2
    ISSN 1535-7732 ; 1051-0443
    ISSN (online) 1535-7732
    ISSN 1051-0443
    DOI 10.1016/j.jvir.2010.09.002
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  8. Article: Combination therapy for chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy: palonosetron, dexamethasone, and aprepitant.

    Grote, Thomas / Hajdenberg, Julio / Cartmell, Alan / Ferguson, Susan / Ginkel, Angela / Charu, Veena

    The journal of supportive oncology

    2006  Volume 4, Issue 8, Page(s) 403–408

    Abstract: The objective of this multicenter, phase II, open-label study was to evaluate the safety and efficacy of the newest 5-hydroxytryptamine3 (5-HT3) receptor antagonist, palonosetron, plus dexamethasone and aprepitant in preventing nausea and vomiting in ... ...

    Abstract The objective of this multicenter, phase II, open-label study was to evaluate the safety and efficacy of the newest 5-hydroxytryptamine3 (5-HT3) receptor antagonist, palonosetron, plus dexamethasone and aprepitant in preventing nausea and vomiting in patients receiving moderately emetogenic chemotherapy. Eligible patients received a single intravenous dose of palonosetron (0.25 mg on day 1 of chemotherapy), along with 3 daily oral doses of aprepitant (125 mg on day 1,80 mg on days 2 and 3) and dexamethasone (12 mg on day 1,8 mg on days 2 and 3). Efficacy and safety data were obtained from patient diaries and adverse event reporting. Fifty-eight patients were evaluable; 47% were women with breast cancer and 52% received cyclophosphamide-based chemotherapy. The proportion of patients with complete response (no emesis and no rescue medication) was 88% during the acute (0-24 hours) interval, 78% during the delayed (> 24-120 hours) interval, and 78% during the overall (0-120 hours post chemotherapy) interval. More than 90% of patients during all time intervals had no emetic episodes, and between 57% and 71% of patients reported no nausea during each of the 5 days post chemotherapy. Treatment was well tolerated, with no unexpected adverse events. These data demonstrate that palonosetron in combination with dexamethasone and aprepitant is safe and highly effective in preventing chemotherapy-induced nausea and vomiting in the days following administration of moderately emetogenic chemotherapy.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Antiemetics/adverse effects ; Antiemetics/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Dexamethasone/adverse effects ; Dexamethasone/therapeutic use ; Female ; Humans ; Isoquinolines/adverse effects ; Isoquinolines/therapeutic use ; Male ; Middle Aged ; Morpholines/adverse effects ; Morpholines/therapeutic use ; Nausea/chemically induced ; Nausea/prevention & control ; Neoplasms/drug therapy ; Quinuclidines/adverse effects ; Quinuclidines/therapeutic use ; Serotonin Antagonists/adverse effects ; Serotonin Antagonists/therapeutic use ; Vomiting/chemically induced ; Vomiting/prevention & control
    Chemical Substances Antiemetics ; Isoquinolines ; Morpholines ; Quinuclidines ; Serotonin Antagonists ; aprepitant (1NF15YR6UY) ; palonosetron (5D06587D6R) ; Dexamethasone (7S5I7G3JQL)
    Language English
    Publishing date 2006-09
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Multicenter Study
    ZDB-ID 2394158-3
    ISSN 1879-596X ; 1544-6794
    ISSN (online) 1879-596X
    ISSN 1544-6794
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Randomized comparison of epoetin alfa (40,000 U weekly) and darbepoetin alfa (200 microg every 2 weeks) in anemic patients with cancer receiving chemotherapy.

    Waltzman, Roger / Croot, Christopher / Justice, Glen R / Fesen, Mark R / Charu, Veena / Williams, Denise

    The oncologist

    2005  Volume 10, Issue 8, Page(s) 642–650

    Abstract: This is the first randomized, open-label, multicenter trial designed and powered to directly compare the hemoglobin (Hb) response to epoetin alfa (EPO), 40,000 U once weekly (QW), with that to darbepoetin alfa (DARB), 200 microg every 2 weeks (Q2W), in ... ...

    Abstract This is the first randomized, open-label, multicenter trial designed and powered to directly compare the hemoglobin (Hb) response to epoetin alfa (EPO), 40,000 U once weekly (QW), with that to darbepoetin alfa (DARB), 200 microg every 2 weeks (Q2W), in anemic patients with cancer receiving chemotherapy (CT). Transfusion requirements, quality of life (QOL), and safety also were evaluated. Adults with solid tumors scheduled to receive CT for > or =12 weeks and with baseline Hb < or =11 g/dl were randomized to receive either EPO 40,000 U QW (n = 178) or DARB 200 microg Q2W (n = 180) s.c. for up to 16 weeks. Doses were increased for nonresponders (Hb increase <1 g/dl) after 4 (EPO) or 6 (DARB) weeks, as per National Comprehensive Cancer Network guidelines, and were reduced for a rapid rise in Hb (>1.3 g/dl [EPO] or >1.0 g/dl [DARB] within any 2-week period) or for an Hb level >13 g/dl. The proportion of patients achieving a > or =1-g/dl Hb rise by week 5, the primary end point, was significantly higher with EPO (47.0%) than with DARB (32.5%), and EPO-treated patients achieved a > or =1-g/dl Hb increase significantly earlier than those receiving DARB (median, 35 days versus 46 days). The mean increase in Hb from baseline was significantly higher at weeks 5, 9, 13, and the end of the study with EPO than with DARB. The number of units transfused per patient was significantly lower for the EPO group than for the DARB group. The proportions of patients requiring transfusions, mean QOL improvements, and tolerability profiles were similar in the two groups.
    MeSH term(s) Aged ; Anemia/chemically induced ; Anemia/drug therapy ; Anemia/etiology ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Darbepoetin alfa ; Epoetin Alfa ; Erythropoietin/administration & dosage ; Erythropoietin/analogs & derivatives ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/blood ; Neoplasms/drug therapy ; Quality of Life ; Recombinant Proteins
    Chemical Substances Recombinant Proteins ; Erythropoietin (11096-26-7) ; Darbepoetin alfa (15UQ94PT4P) ; Epoetin Alfa (64FS3BFH5W)
    Language English
    Publishing date 2005-09
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1409038-7
    ISSN 1083-7159
    ISSN 1083-7159
    DOI 10.1634/theoncologist.10-8-642
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim.

    Balducci, Lodovico / Al-Halawani, Hafez / Charu, Veena / Tam, Jennifer / Shahin, Seta / Dreiling, Lyndah / Ershler, William B

    The oncologist

    2007  Volume 12, Issue 12, Page(s) 1416–1424

    Abstract: Background: There is a misconception that elderly cancer patients cannot tolerate standard doses of chemotherapy because of the frequency and severity of myelosuppressive complications. The reactive use of colony-stimulating factors (i.e., in response ... ...

    Abstract Background: There is a misconception that elderly cancer patients cannot tolerate standard doses of chemotherapy because of the frequency and severity of myelosuppressive complications. The reactive use of colony-stimulating factors (i.e., in response to severe neutropenia) commonly observed in this setting contributes to the frequency and severity of these complications. This study evaluated the incidence of febrile neutropenia and related events in elderly cancer patients receiving pegfilgrastim beginning with cycle 1 (proactive) in comparison with pegfilgrastim initiated after cycle 1 at the physician's discretion (reactive).
    Methods: Patients (> or = 65 years of age) with either solid tumors or non-Hodgkin's lymphoma (NHL) were randomly assigned to receive pegfilgrastim either proactively or reactively. The primary endpoint was the proportion of patients experiencing febrile neutropenia.
    Results: There were 852 patients enrolled (median age, 72 years). Proactive pegfilgrastim use resulted in a significantly lower incidence of febrile neutropenia for both solid tumor and NHL patients compared with reactive use. Proactive pegfilgrastim use also led to fewer hospitalizations resulting from neutropenia and febrile neutropenia by approximately 50%. Antibiotic use was lower for solid tumor patients receiving proactive pegfilgrastim and equivalent in the two NHL groups.
    Conclusions: This is the largest, randomized, prospective trial evaluating growth factor support in typical elderly cancer patients. Proactive pegfilgrastim use effectively produced a lower incidence of febrile neutropenia and related events in elderly patients with either solid tumors or NHL receiving an array of mild to moderately neutropenic chemotherapy regimens. Pegfilgrastim should be used proactively in elderly cancer patients to support the optimal delivery of standard chemotherapy.
    MeSH term(s) Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Drug-Related Side Effects and Adverse Reactions ; Female ; Filgrastim ; Granulocyte Colony-Stimulating Factor/administration & dosage ; Granulocyte Colony-Stimulating Factor/adverse effects ; Humans ; Male ; Neoplasms/drug therapy ; Neutropenia/drug therapy ; Neutropenia/prevention & control ; Polyethylene Glycols ; Recombinant Proteins
    Chemical Substances Recombinant Proteins ; Granulocyte Colony-Stimulating Factor (143011-72-7) ; Polyethylene Glycols (30IQX730WE) ; pegfilgrastim (3A58010674) ; Filgrastim (PVI5M0M1GW)
    Language English
    Publishing date 2007-12
    Publishing country United States
    Document type Clinical Trial, Phase IV ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 1409038-7
    ISSN 1083-7159
    ISSN 1083-7159
    DOI 10.1634/theoncologist.12-12-1416
    Database MEDical Literature Analysis and Retrieval System OnLINE

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