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Thomas J. Walsh - One of the best experts on this subject based on the ideXlab platform.

Tempe K Chen - One of the best experts on this subject based on the ideXlab platform.

Ch Weaver - One of the best experts on this subject based on the ideXlab platform.

  • Economic evaluation of filgrastim, Sargramostim, and sequential Sargramostim and filgrastim after myelosuppressive chemotherapy.
    Bone marrow transplantation, 2002
    Co-Authors: Ch Weaver, C D Buckner, Lesley H. Curtis, K Bajwa, Kevin P. Weinfurt, Barbara Wilson-relyea, Kevin A. Schulman
    Abstract:

    Filgrastim alone and sequential Sargramostim and filgrastim have been shown to be more effective than Sargramostim alone in the mobilization of CD34(+) cells after myelosuppressive chemotherapy (MC). We sought to compare costs and resource use associated with these regimens. Data were collected prospectively alongside a multicenter, randomized trial of filgrastim, Sargramostim, and sequential Sargramostim and filgrastim. Direct medical costs were calculated for inpatient and outpatient visits and procedures, including administration of growth factors and MC. We followed 156 patients for 30 days or until initiation of high-dose chemotherapy. The main outcome measures were resource use and costs of inpatient and outpatient visits, platelet and red blood cell transfusions, antibiotic use, and apheresis procedures. Hospital admissions, red blood cell transfusions, and use of i.v. antibiotics were significantly more common in the Sargramostim group than in the other treatment arms. In univariate and multivariable analyses, total costs were higher for patients receiving Sargramostim alone than for patients in the other groups. Mean costs in multivariable analysis for the filgrastim and sequential Sargramostim and filgrastim arms were not significantly different. Filgrastim alone and sequential Sargramostim and filgrastim are less costly than Sargramostim alone after MC, as well as therapeutically more beneficial.

  • Mobilization of peripheral blood stem cells following myelosuppressive chemotherapy: a randomized comparison of filgrastim, Sargramostim, or sequential Sargramostim and filgrastim.
    Bone Marrow Transplantation, 2001
    Co-Authors: Ch Weaver, Kevin A. Schulman, C D Buckner
    Abstract:

    Mobilization of peripheral blood stem cells following myelosuppressive chemotherapy: a randomized comparison of filgrastim, Sargramostim, or sequential Sargramostim and filgrastim

  • Mobilization of peripheral blood stem cells following myelosuppressive chemotherapy: a randomized comparison of filgrastim, Sargramostim, or sequential Sargramostim and filgrastim
    Bone Marrow Transplantation, 2001
    Co-Authors: Ch Weaver, Ka Schulman, Cd Buckner
    Abstract:

    Myelosuppressive chemotherapy is frequently used for mobilization of autologous CD34^+ progenitor cells into the peripheral blood for subsequent collection and support of high-dose chemotherapy. The administration of myelosuppressive chemotherapy is typically followed by a myeloid growth factor and is associated with variable CD34 cell yields and morbidity. The two most commonly used myeloid growth factors for facilitation of CD34 cell harvests are granulocyte colony-stimulating factor (G-CSF) and granulocyte–macrophage colony-stimulating factor (GM-CSF). We performed a randomized phase III clinical trial comparing G-CSF, GM-CSF, and sequential administration of GM-CSF and G-CSF following administration of myelosuppressive chemotherapy. We evaluated CD34 yields, morbidity, and cost-effectiveness of the three cytokine schedules. One hundred and fifty-six patients with multiple myeloma, breast cancer, or lymphoma received cyclophosphamide with either paclitaxel or etoposide and were randomized to receive G-CSF 6 μg/kg/day s.c., GM-CSF 250 μg/m^2/day s.c., or GM-CSF for 6 days followed by G-CSF until completion of the stem cell harvest. Compared with patients who received GM-CSF, patients who received G-CSF had faster recovery of absolute neutrophil count to 0.5 × 10^9 per liter (median of 11 vs 14 days, P = 0.0001) with fewer patients requiring red blood cell transfusions ( P = 0.008); fewer patients with fever (18% vs 52%, P = 0.001); fewer hospital admissions (20% vs 42%, P = 0.13); and less intravenous antibiotic therapy (24% vs 59%, P = 0.001). Patients who received G-CSF also yielded more CD34 cells (median 7.1 vs 2.0 × 10^6 kg per apheresis, P = 0.0001) and a higher percentage achieved 2.5 × 10^6 CD34 cells per kilogram (94% vs 78%, P = 0.21) and 5 × 10^6 CD34 cells per kilogram (88% vs 53%, P = 0.01) or more CD34 cells per kilogram with fewer aphereses (median 2 vs 3, P = 0.002) and fewer days of growth factor treatment (median 12 vs 14, P = 0.0001). There were no significant differences in outcomes between groups receiving G-CSF alone and the sequential regimen. After high-dose chemotherapy, patients who had peripheral blood stem cells mobilized with G-CSF or the sequential regimen received higher numbers of CD34 cells and had faster platelet recovery with fewer patients requiring platelet transfusions than patients receiving peripheral blood stem cells mobilized by GM-CSF. In summary, G-CSF alone is superior to GM-CSF alone for the mobilization of CD34^+ cells and reduction of toxicities following myelosuppressive chemotherapy. An economic analysis evaluating the cost-effectiveness of these three effective schedules is ongoing at the time of this writing. Bone Marrow Transplantation (2001) 27, Suppl. 2 , S23–S29.

  • Mobilization of peripheral blood stem cells following myelosuppressive chemotherapy: a randomized comparison of filgrastim, Sargramostim, or sequential Sargramostim and filgrastim.
    Bone marrow transplantation, 2001
    Co-Authors: Ch Weaver, Ka Schulman, Cd Buckner
    Abstract:

    Myelosuppressive chemotherapy is frequently used for mobilization of autologous CD34(+) progenitor cells into the peripheral blood for subsequent collection and support of high-dose chemotherapy. The administration of myelosuppressive chemotherapy is typically followed by a myeloid growth factor and is associated with variable CD34 cell yields and morbidity. The two most commonly used myeloid growth factors for facilitation of CD34 cell harvests are granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF). We performed a randomized phase III clinical trial comparing G-CSF, GM-CSF, and sequential administration of GM-CSF and G-CSF following administration of myelosuppressive chemotherapy. We evaluated CD34 yields, morbidity, and cost-effectiveness of the three cytokine schedules. One hundred and fifty-six patients with multiple myeloma, breast cancer, or lymphoma received cyclophosphamide with either paclitaxel or etoposide and were randomized to receive G-CSF 6 microg/kg/day s.c., GM-CSF 250 microg/m(2)/day s.c., or GM-CSF for 6 days followed by G-CSF until completion of the stem cell harvest. Compared with patients who received GM-CSF, patients who received G-CSF had faster recovery of absolute neutrophil count to 0.5 x 10(9) per liter (median of 11 vs14 days, P = 0.0001) with fewer patients requiring red blood cell transfusions (P= 0.008); fewer patients with fever (18% vs 52%, P = 0.001); fewer hospital admissions (20% vs 42%, P = 0.13); and less intravenous antibiotic therapy (24% vs 59%, P = 0.001). Patients who received G-CSF also yielded more CD34 cells (median 7.1 vs 2.0 x 10(6) kg per apheresis, P = 0.0001) and a higher percentage achieved 2.5 x 10(6) CD34 cells per kilogram (94% vs 78%, P = 0.21) and 5 x 10(6) CD34 cells per kilogram (88% vs 53%, P = 0.01) or more CD34 cells per kilogram with fewer aphereses (median 2 vs 3, P = 0.002) and fewer days of growth factor treatment (median 12 vs 14, P = 0.0001). There were no significant differences in outcomes between groups receiving G-CSF alone and the sequential regimen. After high-dose chemotherapy, patients who had peripheral blood stem cells mobilized with G-CSF or the sequential regimen received higher numbers of CD34 cells and had faster platelet recovery with fewer patients requiring platelet transfusions than patients receiving peripheral blood stem cells mobilized by GM-CSF. In summary, G-CSF alone is superior to GM-CSF alone for the mobilization of CD34(+) cells and reduction of toxicities following myelosuppressive chemotherapy. An economic analysis evaluating the cost-effectiveness of these three effective schedules is ongoing at the time of this writing.

  • Randomized Trial of Filgrastim, Sargramostim, or Sequential Sargramostim and Filgrastim After Myelosuppressive Chemotherapy for the Harvesting of Peripheral-Blood Stem Cells
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2000
    Co-Authors: Ch Weaver, Barbara Wilson-relyea, Kevin A. Schulman, Robert Birch, William H. West, C D Buckner
    Abstract:

    PURPOSE: The purpose of this study was to compare the effects of filgrastim, Sargramostim, or sequential Sargramostim and filgrastim on CD34+ cell yields and morbidity after myelosuppressive mobilization chemotherapy (MC). PATIENTS AND METHODS: One hundred fifty-six patients were randomized to receive filgrastim (n = 51), Sargramostim (n = 52), or Sargramostim for 5 days followed by filgrastim (n = 53) after MC with either cyclophosphamide and etoposide (n = 75) or paclitaxel and cyclophosphamide (n = 81). RESULTS: Compared with those who received Sargramostim, patients who received filgrastim had faster recovery of an absolute neutrophil count of 0.5 × 109/L or greater (a median of 11 v 14 days; P = .0001), with fewer patients requiring RBC transfusions (P = .008), fewer patients with fever (18% v 52%; P = 0.001), fewer hospital admissions (20% v 42%; P = .013), and less intravenous antibiotic therapy (24% v 69%; P = .001). Patients who received filgrastim yielded more CD34+ cells (median, 7.1 v 2.0 × 10...

Nilesh Chande - One of the best experts on this subject based on the ideXlab platform.

  • Sargramostim (GM-CSF) for induction of remission in crohn's disease: A cochrane inflammatory bowel disease and functional bowel disorders systematic review of randomized trials†
    Inflammatory bowel diseases, 2012
    Co-Authors: Lee Roth, John K Macdonald, John Wd Mcdonald, Nilesh Chande
    Abstract:

    Background: We planned to systematically review the efficacy of Sargramostim (granulocyte colony stimulating factor [GM-CSF]) for remission induction in patients with Crohn's disease (CD). Methods: A literature search to April 2011 was performed to identify all randomized trials studying Sargramostim in patients with CD. The Cochrane risk of bias tool was used to evaluate study quality and the GRADE criteria were utilized to assess the overall quality of the evidence. Results: Three randomized studies (total 537 patients) were identified. The risk of bias was low for the three included studies. There was no statistically significant difference in the proportion of patients who achieved clinical remission (GM-CSF 25.3%; placebo 17.5%; relative risk [RR] 1.67; 95% confidence interval [CI] 0.80–3.50; P = 0.17), or 100-point clinical response (GM-CSF 38.3%; placebo 24.8%; RR 1.71 95% CI 0.98–2.97; P = 0.06). There was no statistically significant difference in the proportion of patients (GM-CSF 95.8%; placebo 89.3%) who experienced adverse events (RR 1.07; 95% CI 0.99–1.16; P = 0.08), or serious adverse events (GM-CSF 12.0% vs. placebo 4.8%; RR 2.21; 95% CI 0.84–5.81; P = 0.11). Conclusions: Sargramostim does not appear to be more effective than placebo for induction of clinical remission or improvement in active CD. However, the GRADE analysis indicates that the overall quality of the evidence for the primary and secondary outcomes was low due to sparse data and heterogeneity, indicating that further research likely would have a significant impact on the effect estimates. (Inflamm Bowel Dis 2012;)

  • The Cochrane Library - Sargramostim (GM‐CSF) for induction of remission in Crohn's disease
    The Cochrane database of systematic reviews, 2011
    Co-Authors: Lee Roth, John K Macdonald, John Wd Mcdonald, Nilesh Chande
    Abstract:

    BACKGROUND Crohn's disease is an inflammatory condition of the gut, thought to involve an overactive immune response to gut flora. A novel theory postulates possible immunodeficiency as a cause, and aims to use Sargramostim (granulocyte macrophage colony stimulating factor, GM-CSF) to boost the immune system in an effort to test this hypothesis. OBJECTIVES The primary objectives were to determine the efficacy and safety of Sargramostim for induction of remission in patients with clinically active Crohn's disease. SEARCH METHODS A systematic search of MEDLINE, EMBASE, and CENTRAL was conducted from inception to April 2011. Reference lists of relevant review articles were also searched. Trial registries and abstract databases including Digestive Diseases Week (1980-2010) and United European Gastroenterology Week (2005-2009) were searched to identify studies published in abstract form. SELECTION CRITERIA Randomized controlled trials of Sargramostim for the treatment of patients with active Crohn's disease were considered for inclusion. DATA COLLECTION AND ANALYSIS Data from selected articles were extracted and the Cochrane Risk of Bias tool applied independently by two authors. The primary outcome was induction of clinical remission as defined by a Crohn's Disease Activity Index (CDAI) of < 150 at the end of treatment. Secondary outcomes included clinical responses measures on the CDAI and safety outcomes. Pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes, in most cases using a random effects model due to high heterogeneity. MAIN RESULTS Three studies were identified, 2 published as full papers and one in abstract form (537 patients). The risk of bias was low for the 3 included studies. There was no statistically significant difference in the proportion of patients (GM-CSF 25.3% versus placebo 17.5%) who achieved clinical remission (RR 1.67; 95% CI 0.80 to 3.50; P = 0.17; 3 studies; 537 patients). There was no statistically significant difference in the proportion of patients (GM-CSF 38.3% versus placebo 24.8%) who achieved a 100-point clinical response (RR 1.71 95% CI 0.98 to 2.97; P = 0.06; 3 studies; 537 patients). There was no statistically significant difference in the proportion of patients (GM-CSF 54.3% versus placebo 44.2%) who achieved a 70 point clinical response (RR 1.23; 95% CI 0.83 to 1.82; P = 0.30; 1 study; 124 patients). There was no statistically significant difference in the proportion of patients (GM-CSF 95.8% versus placebo 89.3%) who experienced at least one adverse event (RR 1.07; 95% CI 0.99 to 1.16; P = 0.08; 2 studies; 251 patients), or serious adverse events (GM-CSF 12.0% versus placebo 4.8%; RR 2.21; 95% CI 0.84 to 5.81; P = 0.11; 2 studies; 251 patients). The incidence of bone pain, musculoskeletal chest pain, and dyspnea were higher in patients treated with Sargramostim compared to placebo. Other adverse events commonly associated with Sargramostim such as pulmonary capillary leak syndrome, pulmonary edema, heart failure, fever, and neurotoxicity were not reported in these studies. AUTHORS' CONCLUSIONS Sargramostim does not appear to be more effective than placebo for induction of clinical remission or clinical improvement in patients with active Crohn's disease. However, the GRADE analysis indicates that the overall quality of the evidence for the primary (clinical remission) and secondary outcomes (clinical response) was low indicating that further research is likely to have an impact on the effect estimates.

  • Sargramostim gm csf for induction of remission in crohn s disease
    Cochrane Database of Systematic Reviews, 2011
    Co-Authors: Lee Roth, John K Macdonald, John Wd Mcdonald, Nilesh Chande
    Abstract:

    BACKGROUND Crohn's disease is an inflammatory condition of the gut, thought to involve an overactive immune response to gut flora. A novel theory postulates possible immunodeficiency as a cause, and aims to use Sargramostim (granulocyte macrophage colony stimulating factor, GM-CSF) to boost the immune system in an effort to test this hypothesis. OBJECTIVES The primary objectives were to determine the efficacy and safety of Sargramostim for induction of remission in patients with clinically active Crohn's disease. SEARCH METHODS A systematic search of MEDLINE, EMBASE, and CENTRAL was conducted from inception to April 2011. Reference lists of relevant review articles were also searched. Trial registries and abstract databases including Digestive Diseases Week (1980-2010) and United European Gastroenterology Week (2005-2009) were searched to identify studies published in abstract form. SELECTION CRITERIA Randomized controlled trials of Sargramostim for the treatment of patients with active Crohn's disease were considered for inclusion. DATA COLLECTION AND ANALYSIS Data from selected articles were extracted and the Cochrane Risk of Bias tool applied independently by two authors. The primary outcome was induction of clinical remission as defined by a Crohn's Disease Activity Index (CDAI) of < 150 at the end of treatment. Secondary outcomes included clinical responses measures on the CDAI and safety outcomes. Pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes, in most cases using a random effects model due to high heterogeneity. MAIN RESULTS Three studies were identified, 2 published as full papers and one in abstract form (537 patients). The risk of bias was low for the 3 included studies. There was no statistically significant difference in the proportion of patients (GM-CSF 25.3% versus placebo 17.5%) who achieved clinical remission (RR 1.67; 95% CI 0.80 to 3.50; P = 0.17; 3 studies; 537 patients). There was no statistically significant difference in the proportion of patients (GM-CSF 38.3% versus placebo 24.8%) who achieved a 100-point clinical response (RR 1.71 95% CI 0.98 to 2.97; P = 0.06; 3 studies; 537 patients). There was no statistically significant difference in the proportion of patients (GM-CSF 54.3% versus placebo 44.2%) who achieved a 70 point clinical response (RR 1.23; 95% CI 0.83 to 1.82; P = 0.30; 1 study; 124 patients). There was no statistically significant difference in the proportion of patients (GM-CSF 95.8% versus placebo 89.3%) who experienced at least one adverse event (RR 1.07; 95% CI 0.99 to 1.16; P = 0.08; 2 studies; 251 patients), or serious adverse events (GM-CSF 12.0% versus placebo 4.8%; RR 2.21; 95% CI 0.84 to 5.81; P = 0.11; 2 studies; 251 patients). The incidence of bone pain, musculoskeletal chest pain, and dyspnea were higher in patients treated with Sargramostim compared to placebo. Other adverse events commonly associated with Sargramostim such as pulmonary capillary leak syndrome, pulmonary edema, heart failure, fever, and neurotoxicity were not reported in these studies. AUTHORS' CONCLUSIONS Sargramostim does not appear to be more effective than placebo for induction of clinical remission or clinical improvement in patients with active Crohn's disease. However, the GRADE analysis indicates that the overall quality of the evidence for the primary (clinical remission) and secondary outcomes (clinical response) was low indicating that further research is likely to have an impact on the effect estimates.

Roy A. Beveridge - One of the best experts on this subject based on the ideXlab platform.

  • Impact of Long‐Acting Growth Factors on Practice Dynamics and Patient Satisfaction
    Pharmacotherapy, 2003
    Co-Authors: Roy A. Beveridge, Gary Milkovich, Ronald J Moleski, John Reitan, Thomas A Paivanas, Robert M. Rifkin, R. Jake Jacobs
    Abstract:

    Objective. To quantify time expended, patient satisfaction, and econometrics associated with short-acting (Sargramostim, epoetin alfa) and long-acting (darbepoetin alfa, pegfilgrastim) growth factors. Design. Retrospective resource utilization and prospective two-phase observational study. Methods. During week 1, time-motion measurements related to patient treatment and drug preparation were collected for scheduling; check-in; phlebotomy; laboratory; and drug preparation, administration, and recording. Drug utilization for one chemotherapy cycle during weeks 2 and 3 was assessed for Sargramostim, pegfilgrastim, epoetin alfa, darbepoetin alfa, Sargramostim plus epoetin alfa, and pegfilgrastim plus darbepoetin alfa. Patients completed a satisfaction survey. Results. Among 140 patients (mean age 58 yrs), mean chemotherapy cycle duration was 19 days. A total of 268 events were observed. Mean total staff time/patient visit for drug administration was 22.1 minutes, with most time spent on scheduling (5.5 min) and drug preparation, administration, recording (5.2 min). For Sargramostim only versus pegfilgrastim only, pegfilgrastim resulted in a 37% reduction (p

  • a comparison of efficacy of Sargramostim yeast derived rhugm csf and filgrastim bacteria derived rhug csf in the therapeutic setting of chemotherapy induced myelosuppression
    Cancer Investigation, 1998
    Co-Authors: Roy A. Beveridge, John A. Miller, Arthur N. Kales, Richard A. Binder, Nicholas J. Robert, Jimmie Harvey, Kevin Windsor, Ira Gore, James Cantrell, Keith A Thompson
    Abstract:

    A randomized, double-blind, multicenter study in 181 afebrile cancer patients with ANC levels <500/μL receiving myelosuppressive chemotherapy was undertaken to compare Sargramostim (yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor, RhuGM-CSF) and filgrastim (bacteria-derived recombinant human granulocyte colony-stimulating factor, RhuG-CSF) in the treatment of chemotherapy-induced myelosuppression. Patients received daily subcutaneous (SC) injections of either agent until ANC levels reached at least 1500/μL. There was no statistical difference between treatment groups in the mean number of days to reach an ANC of500/μL, but the mean number of days to reach ANC levels of 1000/μL and 1500/μ L was approximately one day less in patients receiving filgrastim. Fewer patients in the Sargramostim arm were hospitalized, and they had a shorter mean length of hospitalization, mean duration of fever, and mean duration of IV antibiotic therapy compared with patients who received filgras...

  • Randomized trial comparing the tolerability of Sargramostim (yeast-derived RhuGM-CSF) and filgrastim (bacteria-derived RhuG-CSF) in cancer patients receiving myelosuppressive chemotherapy.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 1997
    Co-Authors: Roy A. Beveridge, John A. Miller, Arthur N. Kales, Richard A. Binder, Nicholas J. Robert, Janet Heisrath-evans, Kathy Koczyk-scripka, Steven Pashko, Michael J. Norgard, Harry M. Barnes
    Abstract:

    A prospective, randomized, double-blind, multicenter study in cancer patients receiving myelosuppressive chemotherapy was undertaken to evaluate and compare the tolerability of Sargramostim (yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor, RhuGM-CSF) and filgrastim (bacteria-derived recombinant human granulocyte colony-stimulating factor, RhuG-CSF) in the prophylaxis or treatment of chemotherapy-induced neutropenia. In all, 137 evaluable patients received Sargramostim (300 μg; 193 mg/m2) or filgrastim (481 mg; 7 mg/kg) once daily by self-administered s.c. injection, usually beginning within 48 h after completion of chemotherapy. With the exception of a slightly higher incidence of grade 1 fever (/38.1 °C) with Sargramostim, there were no statistically significant differences in the incidence or severity of local or systemic adverse events possibly related to the growth factors. Although the study was not designed to evaluate efficacy directly, there also were no statistically significant differences between treatment groups in total days of growth factor therapy, days of hospitalization, or days of i.v. antibiotic therapy during the treatment period. Both Sargramostim and filgrastim were comparably well tolerated when given by s.c. injection in this group of patients, and no clinically significant differences between the growth factors were demonstrated.