PEGFILGRASTIM VERSUS FILGRASTIM IN THE MANAGEMENT OF POST-CHEMOTHERAPY NEUTROPENIA IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA IN TREATMENT WITH BVD (BENDAMUSTINE-BORTEZOMIB-DEXAMETHASONE)
(Abstract release date: 05/19/16)
EHA Library. Cerchione C. 06/09/16; 132879; E1330
Dr. Claudio Cerchione
Contributions
Contributions
Abstract
Abstract: E1330
Type: Eposter Presentation
Background
Patients receiving cancer chemotherapy are at increased risk of neutropenia, leading to increased risk of infections and delay in subsequent chemotherapy treatments. Recombinant granulocyte colony stimulating factors (G-CSFs) have been developed to stimulate proliferation and differentiation of neutrophils in patients receiving chemotherapy. Pegfilgrastim is a pegylated long-acting recombinant form of G-CSF that extends the half-life and allows for once-per-cycle dosing, requiring less frequent dosing than nonpegylated G-CSF. Multiple Myeloma (MM) in advanced phases of disease may be managed by regimens combining agents not frequently employed in early phases of treatment (e.g. Anthracyclines, Alkylating agents, etc), but myelotoxicity is the main expected side effect. In this context, G-CSFs are often necessary to counteract the risks of febrile neutropenia: their use is bound to frequent evaluation of neutrophil counts that may not be easy for patients in home-care. Avoiding severe neutropenia by prophylactic pegfilgrastim seems particularly useful in these cases.
Aims
The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by Multiple Myeloma in advanced phase of disease. treated with BVD (Bendamustine, Bortezomib, Dexamethasone), in order to determine whether a single subcutaneous injection of pegfilgrastim is as effective as daily injections of standard filgrastim, in terms of haematological toxicity, febrile neutropenic episodes, antibiotic usage and hospedalization duration.
Methods
47 patients (25 male and 22 female) with a median age of 58.4 years (range 36-82) affected by multiple myeloma, all relapsed and refractory to a median of 6 lines of therapy (range 2-11), all previously exposed to Bortezomib, Lenalidomide, Melphalan and all relapsed after at least one autologous bone marrow transplantation, had been enrolled.
Results
Since first course, received in our out-patient department, patients performed blood counts twice weekly and received, from day +8 to day +19 (considering “day + 1” the day in which the chemotherapy protocol starts), prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle of chemotherapy, Filgrastim (5 μgr/kg/day for 3 days) was given if neutrophils count was <1500 x 10^9 cells/L. Median number of filgrastim administrations was 4.1 (r. 3-6); nadir neutropenia was registered after a median of 11.6 days (r. 8-14); median of nadir neutrophil count was 1.22 x 10^9 cells/L (range 0.4 – 1.5 x 10^9 cells/L), with maximum duration of 13 days. From the second course of chemotherapy, all patients switched to prophylactic therapy with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. Primary endpoint of this study was the duration of neutropenia (neutrophil count < 1.5 x 10^9 cells/L), comparing pegfilgrastim and filgrastim. During pegfilgrastim, neutropenia was never longer than 8 days, with a consequent reduction of neutropenia-related infections. Median nadir neutrophil count, evaluated for every patients for at least three courses of therapy (r. 3-6) registered at day +11, was 1.484 (range 1.04-2.33 x 10^9 cells/L); only six patients (12.7%) needed, one week after pegfilgrastim administration, a supplement of 3 administrations of filgrastim. During pegfilgrastim prophylaxis, neutropenia was shorter than during Filgrastim treatment. Besides the mono-administration, pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain, (9/47 patients,19.1%).
Conclusion
In conclusions, in patients affected by MM exposed to myelosuppressive agents in advanced phases of myeloma disease, pegfilgrastim seems to reduce the incidence of neutropenia and may increase the possibility to maintain the scheduled time of treatment.
Session topic: E-poster
Keyword(s): Bendamustine, Myeloma, Pegfilgrastim
Type: Eposter Presentation
Background
Patients receiving cancer chemotherapy are at increased risk of neutropenia, leading to increased risk of infections and delay in subsequent chemotherapy treatments. Recombinant granulocyte colony stimulating factors (G-CSFs) have been developed to stimulate proliferation and differentiation of neutrophils in patients receiving chemotherapy. Pegfilgrastim is a pegylated long-acting recombinant form of G-CSF that extends the half-life and allows for once-per-cycle dosing, requiring less frequent dosing than nonpegylated G-CSF. Multiple Myeloma (MM) in advanced phases of disease may be managed by regimens combining agents not frequently employed in early phases of treatment (e.g. Anthracyclines, Alkylating agents, etc), but myelotoxicity is the main expected side effect. In this context, G-CSFs are often necessary to counteract the risks of febrile neutropenia: their use is bound to frequent evaluation of neutrophil counts that may not be easy for patients in home-care. Avoiding severe neutropenia by prophylactic pegfilgrastim seems particularly useful in these cases.
Aims
The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by Multiple Myeloma in advanced phase of disease. treated with BVD (Bendamustine, Bortezomib, Dexamethasone), in order to determine whether a single subcutaneous injection of pegfilgrastim is as effective as daily injections of standard filgrastim, in terms of haematological toxicity, febrile neutropenic episodes, antibiotic usage and hospedalization duration.
Methods
47 patients (25 male and 22 female) with a median age of 58.4 years (range 36-82) affected by multiple myeloma, all relapsed and refractory to a median of 6 lines of therapy (range 2-11), all previously exposed to Bortezomib, Lenalidomide, Melphalan and all relapsed after at least one autologous bone marrow transplantation, had been enrolled.
Results
Since first course, received in our out-patient department, patients performed blood counts twice weekly and received, from day +8 to day +19 (considering “day + 1” the day in which the chemotherapy protocol starts), prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle of chemotherapy, Filgrastim (5 μgr/kg/day for 3 days) was given if neutrophils count was <1500 x 10^9 cells/L. Median number of filgrastim administrations was 4.1 (r. 3-6); nadir neutropenia was registered after a median of 11.6 days (r. 8-14); median of nadir neutrophil count was 1.22 x 10^9 cells/L (range 0.4 – 1.5 x 10^9 cells/L), with maximum duration of 13 days. From the second course of chemotherapy, all patients switched to prophylactic therapy with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. Primary endpoint of this study was the duration of neutropenia (neutrophil count < 1.5 x 10^9 cells/L), comparing pegfilgrastim and filgrastim. During pegfilgrastim, neutropenia was never longer than 8 days, with a consequent reduction of neutropenia-related infections. Median nadir neutrophil count, evaluated for every patients for at least three courses of therapy (r. 3-6) registered at day +11, was 1.484 (range 1.04-2.33 x 10^9 cells/L); only six patients (12.7%) needed, one week after pegfilgrastim administration, a supplement of 3 administrations of filgrastim. During pegfilgrastim prophylaxis, neutropenia was shorter than during Filgrastim treatment. Besides the mono-administration, pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain, (9/47 patients,19.1%).
Conclusion
In conclusions, in patients affected by MM exposed to myelosuppressive agents in advanced phases of myeloma disease, pegfilgrastim seems to reduce the incidence of neutropenia and may increase the possibility to maintain the scheduled time of treatment.
Session topic: E-poster
Keyword(s): Bendamustine, Myeloma, Pegfilgrastim
Abstract: E1330
Type: Eposter Presentation
Background
Patients receiving cancer chemotherapy are at increased risk of neutropenia, leading to increased risk of infections and delay in subsequent chemotherapy treatments. Recombinant granulocyte colony stimulating factors (G-CSFs) have been developed to stimulate proliferation and differentiation of neutrophils in patients receiving chemotherapy. Pegfilgrastim is a pegylated long-acting recombinant form of G-CSF that extends the half-life and allows for once-per-cycle dosing, requiring less frequent dosing than nonpegylated G-CSF. Multiple Myeloma (MM) in advanced phases of disease may be managed by regimens combining agents not frequently employed in early phases of treatment (e.g. Anthracyclines, Alkylating agents, etc), but myelotoxicity is the main expected side effect. In this context, G-CSFs are often necessary to counteract the risks of febrile neutropenia: their use is bound to frequent evaluation of neutrophil counts that may not be easy for patients in home-care. Avoiding severe neutropenia by prophylactic pegfilgrastim seems particularly useful in these cases.
Aims
The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by Multiple Myeloma in advanced phase of disease. treated with BVD (Bendamustine, Bortezomib, Dexamethasone), in order to determine whether a single subcutaneous injection of pegfilgrastim is as effective as daily injections of standard filgrastim, in terms of haematological toxicity, febrile neutropenic episodes, antibiotic usage and hospedalization duration.
Methods
47 patients (25 male and 22 female) with a median age of 58.4 years (range 36-82) affected by multiple myeloma, all relapsed and refractory to a median of 6 lines of therapy (range 2-11), all previously exposed to Bortezomib, Lenalidomide, Melphalan and all relapsed after at least one autologous bone marrow transplantation, had been enrolled.
Results
Since first course, received in our out-patient department, patients performed blood counts twice weekly and received, from day +8 to day +19 (considering “day + 1” the day in which the chemotherapy protocol starts), prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle of chemotherapy, Filgrastim (5 μgr/kg/day for 3 days) was given if neutrophils count was <1500 x 10^9 cells/L. Median number of filgrastim administrations was 4.1 (r. 3-6); nadir neutropenia was registered after a median of 11.6 days (r. 8-14); median of nadir neutrophil count was 1.22 x 10^9 cells/L (range 0.4 – 1.5 x 10^9 cells/L), with maximum duration of 13 days. From the second course of chemotherapy, all patients switched to prophylactic therapy with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. Primary endpoint of this study was the duration of neutropenia (neutrophil count < 1.5 x 10^9 cells/L), comparing pegfilgrastim and filgrastim. During pegfilgrastim, neutropenia was never longer than 8 days, with a consequent reduction of neutropenia-related infections. Median nadir neutrophil count, evaluated for every patients for at least three courses of therapy (r. 3-6) registered at day +11, was 1.484 (range 1.04-2.33 x 10^9 cells/L); only six patients (12.7%) needed, one week after pegfilgrastim administration, a supplement of 3 administrations of filgrastim. During pegfilgrastim prophylaxis, neutropenia was shorter than during Filgrastim treatment. Besides the mono-administration, pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain, (9/47 patients,19.1%).
Conclusion
In conclusions, in patients affected by MM exposed to myelosuppressive agents in advanced phases of myeloma disease, pegfilgrastim seems to reduce the incidence of neutropenia and may increase the possibility to maintain the scheduled time of treatment.
Session topic: E-poster
Keyword(s): Bendamustine, Myeloma, Pegfilgrastim
Type: Eposter Presentation
Background
Patients receiving cancer chemotherapy are at increased risk of neutropenia, leading to increased risk of infections and delay in subsequent chemotherapy treatments. Recombinant granulocyte colony stimulating factors (G-CSFs) have been developed to stimulate proliferation and differentiation of neutrophils in patients receiving chemotherapy. Pegfilgrastim is a pegylated long-acting recombinant form of G-CSF that extends the half-life and allows for once-per-cycle dosing, requiring less frequent dosing than nonpegylated G-CSF. Multiple Myeloma (MM) in advanced phases of disease may be managed by regimens combining agents not frequently employed in early phases of treatment (e.g. Anthracyclines, Alkylating agents, etc), but myelotoxicity is the main expected side effect. In this context, G-CSFs are often necessary to counteract the risks of febrile neutropenia: their use is bound to frequent evaluation of neutrophil counts that may not be easy for patients in home-care. Avoiding severe neutropenia by prophylactic pegfilgrastim seems particularly useful in these cases.
Aims
The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by Multiple Myeloma in advanced phase of disease. treated with BVD (Bendamustine, Bortezomib, Dexamethasone), in order to determine whether a single subcutaneous injection of pegfilgrastim is as effective as daily injections of standard filgrastim, in terms of haematological toxicity, febrile neutropenic episodes, antibiotic usage and hospedalization duration.
Methods
47 patients (25 male and 22 female) with a median age of 58.4 years (range 36-82) affected by multiple myeloma, all relapsed and refractory to a median of 6 lines of therapy (range 2-11), all previously exposed to Bortezomib, Lenalidomide, Melphalan and all relapsed after at least one autologous bone marrow transplantation, had been enrolled.
Results
Since first course, received in our out-patient department, patients performed blood counts twice weekly and received, from day +8 to day +19 (considering “day + 1” the day in which the chemotherapy protocol starts), prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle of chemotherapy, Filgrastim (5 μgr/kg/day for 3 days) was given if neutrophils count was <1500 x 10^9 cells/L. Median number of filgrastim administrations was 4.1 (r. 3-6); nadir neutropenia was registered after a median of 11.6 days (r. 8-14); median of nadir neutrophil count was 1.22 x 10^9 cells/L (range 0.4 – 1.5 x 10^9 cells/L), with maximum duration of 13 days. From the second course of chemotherapy, all patients switched to prophylactic therapy with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. Primary endpoint of this study was the duration of neutropenia (neutrophil count < 1.5 x 10^9 cells/L), comparing pegfilgrastim and filgrastim. During pegfilgrastim, neutropenia was never longer than 8 days, with a consequent reduction of neutropenia-related infections. Median nadir neutrophil count, evaluated for every patients for at least three courses of therapy (r. 3-6) registered at day +11, was 1.484 (range 1.04-2.33 x 10^9 cells/L); only six patients (12.7%) needed, one week after pegfilgrastim administration, a supplement of 3 administrations of filgrastim. During pegfilgrastim prophylaxis, neutropenia was shorter than during Filgrastim treatment. Besides the mono-administration, pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain, (9/47 patients,19.1%).
Conclusion
In conclusions, in patients affected by MM exposed to myelosuppressive agents in advanced phases of myeloma disease, pegfilgrastim seems to reduce the incidence of neutropenia and may increase the possibility to maintain the scheduled time of treatment.
Session topic: E-poster
Keyword(s): Bendamustine, Myeloma, Pegfilgrastim
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