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P. Rubin - One of the best experts on this subject based on the ideXlab platform.

  • Effects of granulocyte‐macrophage colony stimulating factor produced in Chinese hamster ovary cells (regramostim), Escherichia coli (Molgramostim) and yeast (sargramostim) on priming peripheral blood progenitor cells for use with autologous bone marr
    European Journal of Haematology, 2009
    Co-Authors: A. El-hussein, Colleen Gilbert, Maureen Ross, James J Vredenburgh, Barry Meisenberg, Vera Hars, William P Peters, David Coniglio, Joanne Kurtzberg, P. Rubin
    Abstract:

    Peripheral blood progenitor cells (PBPCs) were collected without prior association with chemotherapy but after the administration of granulocyte-macrophage colony-stimulating factor (GM-CSF) produced in Chinese hamster ovary cells (CHO-GM, regramostim), Escherichia coli (E. coli-GM, Molgramostim), or yeast (Yeast-GM, sargramostim) and used in conjunction with autologous bone marrow after high-dose chemotherapy in 69 patients with breast cancer or melanoma. The mean peripheral white blood cell (WBC) counts increased by 2.2 to 2.7-fold after regramostim, 4.5 to 7.3-fold after Molgramostim and 4.3-fold after sargramostim. All patients underwent three leukaphereses. The mean (+/- standard error) total nucleated pheresed cells per kg x 10(8) were 4.15 +/- 0.56, 15.10 +/- 1.77 and 7.24 +/- 1.00 for patients receiving regramostim, Molgramostim or sargramostim respectively. The mean (+/- standard error) granulocyte-macrophage colony-forming units per kg x 10(4) mobilized into the PB were 8.75 +/- 3.63, 71.03 +/- 17.85, and 65.11 +/- 18.74 for patients receiving regramostim, Molgramostim, or sargramostim respectively. The total mean (+/- standard error) CD34+ cells per kg x 10(7) collected by three leukaphereses were 3.28 +/- 1.62, 1.34 +/- 0.51 and 2.57 +/- 1.93, for patients receiving regramostim, Molgramostim or sargramostim respectively. The use of either Molgramostim- or sargramostim-primed PBPCs led to complete elimination of absolute leukopenia with a WBC count under 100/mm3 in 64% and 77% of patients treated, respectively. Patients receiving Molgramostim-primed PBPCs required fewer red blood cells transfusions than patients receiving regramostim-primed PBPCs (p = 0.0062). Our data indicate that PBPCs collected without prior association with chemotherapy but after either Molgramostim or sargramostim with autologous bone marrow support and GM-CSF shorten the hematopoietic recovery after myeloablative chemotherapy in patients with breast cancer or melanoma.

  • effects of granulocyte macrophage colony stimulating factor produced in chinese hamster ovary cells regramostim escherichia coli Molgramostim and yeast sargramostim on priming peripheral blood progenitor cells for use with autologous bone marrow afte
    European Journal of Haematology, 2009
    Co-Authors: A. El-hussein, Colleen Gilbert, Maureen Ross, James J Vredenburgh, Barry Meisenberg, Vera Hars, William P Peters, David Coniglio, Joanne Kurtzberg, P. Rubin
    Abstract:

    : Peripheral blood progenitor cells (PBPCs) were collected without prior association with chemotherapy but after the administration of granulocyte-macrophage colony-stimulating factor (GM-CSF) produced in Chinese hamster ovary cells (CHO-GM, regramostim), Escherichia coli (E. coli-GM, Molgramostim), or yeast (Yeast-GM, sargramostim) and used in conjunction with autologous bone marrow after high-dose chemotherapy in 69 patients with breast cancer or melanoma. The mean peripheral white blood cell (WBC) counts increased by 2.2 to 2.7-fold after regramostim, 4.5 to 7.3-fold after Molgramostim and 4.3-fold after sargramostim. All patients underwent three leukaphereses. The mean (+/- standard error) total nucleated pheresed cells per kg x 10(8) were 4.15 +/- 0.56, 15.10 +/- 1.77 and 7.24 +/- 1.00 for patients receiving regramostim, Molgramostim or sargramostim respectively. The mean (+/- standard error) granulocyte-macrophage colony-forming units per kg x 10(4) mobilized into the PB were 8.75 +/- 3.63, 71.03 +/- 17.85, and 65.11 +/- 18.74 for patients receiving regramostim, Molgramostim, or sargramostim respectively. The total mean (+/- standard error) CD34+ cells per kg x 10(7) collected by three leukaphereses were 3.28 +/- 1.62, 1.34 +/- 0.51 and 2.57 +/- 1.93, for patients receiving regramostim, Molgramostim or sargramostim respectively. The use of either Molgramostim- or sargramostim-primed PBPCs led to complete elimination of absolute leukopenia with a WBC count under 100/mm3 in 64% and 77% of patients treated, respectively. Patients receiving Molgramostim-primed PBPCs required fewer red blood cells transfusions than patients receiving regramostim-primed PBPCs (p = 0.0062). Our data indicate that PBPCs collected without prior association with chemotherapy but after either Molgramostim or sargramostim with autologous bone marrow support and GM-CSF shorten the hematopoietic recovery after myeloablative chemotherapy in patients with breast cancer or melanoma.

  • Evaluation of GM-CSF mouthwash for prevention of chemotherapy-induced mucositis: a randomized, double-blind, dose-ranging study
    Cytokine, 1995
    Co-Authors: Leanne Cartee, Colleen Gilbert, Sarah G. Moore, Mary Lou Affronti, James A. Hoke, Maureen Ross, A. El-hussein, William P. Petros, Gary L. Rosner, P. Rubin
    Abstract:

    Abstract Uncontrolled clinical trials have shown that parenteral administration of GM-CSF reduces the frequency of chemotherapy-induced mucositis. The mechanism of this effect could be related to acceleration of haematopoiesis and/or increase in functional activation of WBC. We conducted a double-blind, placebo-controlled, dose ranging study of GM-CSF (Molgramostim) mouthwash in patients with breast cancer during the first treatment cycle of a combination chemotherapy regimen which has historically produced dose-limiting (grade ≥3) mucositis in approximately 39% of patients. Subjects were randomized to receive either placebo mouthwash (0.1 percent albumin) or one of four concentrations of GM-CSF mouthwash (0.01, 0.1, 1.0 or 10 mcg/ml). The primary endpoint was to evaluate the relationship between dose of GM-CSF mouthwash received and probability of grade ≥3 mucositis using a logistic model. Solutions were administered four times daily starting within 24 hours of chemotherapy initiation and continuing until the end of the cycle (day 21). Mucositis was assessed on days 1–6, 10, 15 and 21. Day 6 plasma samples were assayed for GM-CSF. Forty-five patients were evaluable for response (nine per dosing group). A 42% risk (15/36) of mucositis grade ≥3 was evident on day 15 in patients receiving GM-CSF compared to 2 of 9 patients on the placebo arm. No evidence of dose response was found by logistic regression. Five patients had a detectable plasma concentration of GM-CSF (56–209 pg/ml). A positive correlation between GM-CSF dose and leukocyte recovery was noted ( P =0.04).

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

  • A randomized study comparing filgrastim versus lenograstim versus Molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization
    Bone Marrow Transplantation, 2006
    Co-Authors: B Kopf, U De Giorgi, B Vertogen, G Monti, A Molinari, D Turci, C Dazzi, M Leoni, A Tienghi, A Cariello
    Abstract:

    We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and Molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or Molgramostim at 5  μ g/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1–3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 × 10^6/kg in the filgrastim arm versus 5.8 × 10^6/kg in the lenograstim arm versus 4.0 × 10^6/kg in the Molgramostim arm ( P =0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and Molgramostim (14 days) ( P

  • a randomized study comparing filgrastim versus lenograstim versus Molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization
    Bone Marrow Transplantation, 2006
    Co-Authors: B Kopf, U De Giorgi, B Vertogen, G Monti, A Molinari, D Turci, C Dazzi, M Leoni, A Tienghi, A Cariello
    Abstract:

    We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and Molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or Molgramostim at 5 μg/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1–3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 × 106/kg in the filgrastim arm versus 5.8 × 106/kg in the lenograstim arm versus 4.0 × 106/kg in the Molgramostim arm (P=0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and Molgramostim (14 days) (P<0.0001) and for the subgroup of chemonaive patients (12 days) versus pretreated patients (14 days) (P<0.001). In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34+ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.

A. El-hussein - One of the best experts on this subject based on the ideXlab platform.

  • Effects of granulocyte‐macrophage colony stimulating factor produced in Chinese hamster ovary cells (regramostim), Escherichia coli (Molgramostim) and yeast (sargramostim) on priming peripheral blood progenitor cells for use with autologous bone marr
    European Journal of Haematology, 2009
    Co-Authors: A. El-hussein, Colleen Gilbert, Maureen Ross, James J Vredenburgh, Barry Meisenberg, Vera Hars, William P Peters, David Coniglio, Joanne Kurtzberg, P. Rubin
    Abstract:

    Peripheral blood progenitor cells (PBPCs) were collected without prior association with chemotherapy but after the administration of granulocyte-macrophage colony-stimulating factor (GM-CSF) produced in Chinese hamster ovary cells (CHO-GM, regramostim), Escherichia coli (E. coli-GM, Molgramostim), or yeast (Yeast-GM, sargramostim) and used in conjunction with autologous bone marrow after high-dose chemotherapy in 69 patients with breast cancer or melanoma. The mean peripheral white blood cell (WBC) counts increased by 2.2 to 2.7-fold after regramostim, 4.5 to 7.3-fold after Molgramostim and 4.3-fold after sargramostim. All patients underwent three leukaphereses. The mean (+/- standard error) total nucleated pheresed cells per kg x 10(8) were 4.15 +/- 0.56, 15.10 +/- 1.77 and 7.24 +/- 1.00 for patients receiving regramostim, Molgramostim or sargramostim respectively. The mean (+/- standard error) granulocyte-macrophage colony-forming units per kg x 10(4) mobilized into the PB were 8.75 +/- 3.63, 71.03 +/- 17.85, and 65.11 +/- 18.74 for patients receiving regramostim, Molgramostim, or sargramostim respectively. The total mean (+/- standard error) CD34+ cells per kg x 10(7) collected by three leukaphereses were 3.28 +/- 1.62, 1.34 +/- 0.51 and 2.57 +/- 1.93, for patients receiving regramostim, Molgramostim or sargramostim respectively. The use of either Molgramostim- or sargramostim-primed PBPCs led to complete elimination of absolute leukopenia with a WBC count under 100/mm3 in 64% and 77% of patients treated, respectively. Patients receiving Molgramostim-primed PBPCs required fewer red blood cells transfusions than patients receiving regramostim-primed PBPCs (p = 0.0062). Our data indicate that PBPCs collected without prior association with chemotherapy but after either Molgramostim or sargramostim with autologous bone marrow support and GM-CSF shorten the hematopoietic recovery after myeloablative chemotherapy in patients with breast cancer or melanoma.

  • effects of granulocyte macrophage colony stimulating factor produced in chinese hamster ovary cells regramostim escherichia coli Molgramostim and yeast sargramostim on priming peripheral blood progenitor cells for use with autologous bone marrow afte
    European Journal of Haematology, 2009
    Co-Authors: A. El-hussein, Colleen Gilbert, Maureen Ross, James J Vredenburgh, Barry Meisenberg, Vera Hars, William P Peters, David Coniglio, Joanne Kurtzberg, P. Rubin
    Abstract:

    : Peripheral blood progenitor cells (PBPCs) were collected without prior association with chemotherapy but after the administration of granulocyte-macrophage colony-stimulating factor (GM-CSF) produced in Chinese hamster ovary cells (CHO-GM, regramostim), Escherichia coli (E. coli-GM, Molgramostim), or yeast (Yeast-GM, sargramostim) and used in conjunction with autologous bone marrow after high-dose chemotherapy in 69 patients with breast cancer or melanoma. The mean peripheral white blood cell (WBC) counts increased by 2.2 to 2.7-fold after regramostim, 4.5 to 7.3-fold after Molgramostim and 4.3-fold after sargramostim. All patients underwent three leukaphereses. The mean (+/- standard error) total nucleated pheresed cells per kg x 10(8) were 4.15 +/- 0.56, 15.10 +/- 1.77 and 7.24 +/- 1.00 for patients receiving regramostim, Molgramostim or sargramostim respectively. The mean (+/- standard error) granulocyte-macrophage colony-forming units per kg x 10(4) mobilized into the PB were 8.75 +/- 3.63, 71.03 +/- 17.85, and 65.11 +/- 18.74 for patients receiving regramostim, Molgramostim, or sargramostim respectively. The total mean (+/- standard error) CD34+ cells per kg x 10(7) collected by three leukaphereses were 3.28 +/- 1.62, 1.34 +/- 0.51 and 2.57 +/- 1.93, for patients receiving regramostim, Molgramostim or sargramostim respectively. The use of either Molgramostim- or sargramostim-primed PBPCs led to complete elimination of absolute leukopenia with a WBC count under 100/mm3 in 64% and 77% of patients treated, respectively. Patients receiving Molgramostim-primed PBPCs required fewer red blood cells transfusions than patients receiving regramostim-primed PBPCs (p = 0.0062). Our data indicate that PBPCs collected without prior association with chemotherapy but after either Molgramostim or sargramostim with autologous bone marrow support and GM-CSF shorten the hematopoietic recovery after myeloablative chemotherapy in patients with breast cancer or melanoma.

  • Evaluation of GM-CSF mouthwash for prevention of chemotherapy-induced mucositis: a randomized, double-blind, dose-ranging study
    Cytokine, 1995
    Co-Authors: Leanne Cartee, Colleen Gilbert, Sarah G. Moore, Mary Lou Affronti, James A. Hoke, Maureen Ross, A. El-hussein, William P. Petros, Gary L. Rosner, P. Rubin
    Abstract:

    Abstract Uncontrolled clinical trials have shown that parenteral administration of GM-CSF reduces the frequency of chemotherapy-induced mucositis. The mechanism of this effect could be related to acceleration of haematopoiesis and/or increase in functional activation of WBC. We conducted a double-blind, placebo-controlled, dose ranging study of GM-CSF (Molgramostim) mouthwash in patients with breast cancer during the first treatment cycle of a combination chemotherapy regimen which has historically produced dose-limiting (grade ≥3) mucositis in approximately 39% of patients. Subjects were randomized to receive either placebo mouthwash (0.1 percent albumin) or one of four concentrations of GM-CSF mouthwash (0.01, 0.1, 1.0 or 10 mcg/ml). The primary endpoint was to evaluate the relationship between dose of GM-CSF mouthwash received and probability of grade ≥3 mucositis using a logistic model. Solutions were administered four times daily starting within 24 hours of chemotherapy initiation and continuing until the end of the cycle (day 21). Mucositis was assessed on days 1–6, 10, 15 and 21. Day 6 plasma samples were assayed for GM-CSF. Forty-five patients were evaluable for response (nine per dosing group). A 42% risk (15/36) of mucositis grade ≥3 was evident on day 15 in patients receiving GM-CSF compared to 2 of 9 patients on the placebo arm. No evidence of dose response was found by logistic regression. Five patients had a detectable plasma concentration of GM-CSF (56–209 pg/ml). A positive correlation between GM-CSF dose and leukocyte recovery was noted ( P =0.04).

Damien Pouessel - One of the best experts on this subject based on the ideXlab platform.

  • low doses of gm csf Molgramostim and g csf filgrastim after cyclophosphamide 4 g m2 enhance the peripheral blood progenitor cell harvest results of two randomized studies including 120 patients
    Bone Marrow Transplantation, 2006
    Co-Authors: Philippe Quittet, Patrice Ceballos, Ernesto Lopez, Zhaoyang Lu, Pascal Latry, Catherine Becht, Eric Legouffe, Nathalie Fegueux, Carole Exbrayat, Damien Pouessel
    Abstract:

    The use of a combination of G-CSF and GM-CSF to G-CSF alone, after cyclophosphamide (4g/m2) was compared in 2 randomized phase III studies, including 120 patients. In study A, 60 patients received 5 × 2 μg/kg/day of G-CSF and GM-CSF compared to 5 μg/kg/day of G-CSF. In study B, 60 patients received 2.5 × 2 μg/kg/day G-CSF and GM-CSF compared to G-CSF alone (5 μg/kg/day). With the aim to collect at least 5 × 106/kg CD34 cells in a maximum of 3 large volume leukapherisis (LK), 123 LK were performed in study A, showing significant higher number of patients reaching 10 × 106/kg CD34 cells (21/29 in G+GM-CSF arm vs 11/27 in G-CSF arm, P= .00006). In study B, 109 LK were performed, with similar results (10/27 vs 15/26, P= .003). In both the study, the total harvest of CD34 cells/kg was 2-fold higher in G-CSF plus GM-CSF group (18.3 × 106 in study A and 15.85 × 106 in study B) than in G-CSF group (9 × 106 in study A and 8.1 × 106 in study B), a difference particularly seen in multiple myeloma, with no significant difference in terms of mobilized myeloma cells between G-CSF and GM-CSF groups.

  • Low doses of GM-CSF (Molgramostim) and G-CSF (filgrastim) after cyclophosphamide (4 g/m^2) enhance the peripheral blood progenitor cell harvest: results of two randomized studies including 120 patients
    Bone Marrow Transplantation, 2006
    Co-Authors: Philippe Quittet, Patrice Ceballos, Ernesto Lopez, Pascal Latry, Catherine Becht, Eric Legouffe, Nathalie Fegueux, Carole Exbrayat, Z Y Lu, Damien Pouessel
    Abstract:

    The use of a combination of G-CSF and GM-CSF versus G-CSF alone, after cyclophosphamide (4 g/m^2) was compared in two randomized phase III studies, including 120 patients. In study A, 60 patients received 5 × 2  μ g/kg/day of G-CSF and GM-CSF compared to 5  μ g/kg/day of G-CSF. In study B, 60 patients received 2.5 × 2  μ g/kg/day G-CSF and GM-CSF compared to G-CSF alone (5  μ g/kg/day). With the aim to collect at least 5 × 10^6/kg CD34 cells in a maximum of three large volume leukapherises (LK), 123 LK were performed in study A, showing a significantly higher number of patients reaching 10 × 10^6/kg CD34 cells (21/29 in G+GM-CSF arm vs 11/27 in G-CSF arm, P =0.00006). In study B, 109 LK were performed, with similar results (10/27 vs 15/26, P =0.003). In both the study, the total harvest of CD34 cells/kg was twofold higher in G-CSF plus GM-CSF group (18.3 × 10^6 in study A and 15.85 × 10^6 in study B) than in G-CSF group (9 × 10^6 in study A and 8.1 × 10^6 in study B), a significant difference only seen in multiple myeloma, with no significant difference in terms of mobilized myeloma cells between G-CSF and GM-CSF groups.

B Kopf - One of the best experts on this subject based on the ideXlab platform.

  • A randomized study comparing filgrastim versus lenograstim versus Molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization
    Bone Marrow Transplantation, 2006
    Co-Authors: B Kopf, U De Giorgi, B Vertogen, G Monti, A Molinari, D Turci, C Dazzi, M Leoni, A Tienghi, A Cariello
    Abstract:

    We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and Molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or Molgramostim at 5  μ g/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1–3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 × 10^6/kg in the filgrastim arm versus 5.8 × 10^6/kg in the lenograstim arm versus 4.0 × 10^6/kg in the Molgramostim arm ( P =0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and Molgramostim (14 days) ( P

  • a randomized study comparing filgrastim versus lenograstim versus Molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization
    Bone Marrow Transplantation, 2006
    Co-Authors: B Kopf, U De Giorgi, B Vertogen, G Monti, A Molinari, D Turci, C Dazzi, M Leoni, A Tienghi, A Cariello
    Abstract:

    We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, lenograstim and Molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or lenograstim or Molgramostim at 5 μg/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1–3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 × 106/kg in the filgrastim arm versus 5.8 × 106/kg in the lenograstim arm versus 4.0 × 106/kg in the Molgramostim arm (P=0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of lenograstim (12 days) versus filgrastim (13 days) and Molgramostim (14 days) (P<0.0001) and for the subgroup of chemonaive patients (12 days) versus pretreated patients (14 days) (P<0.001). In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34+ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.