Safety Of Pegfilgrastim Research Articles

Safety of pegfilgrastim in patients with metastatic germ-cell tumor receiving combination chemotherapy containing bleomycin.

Safety of pegfilgrastim in patients with metastatic germ-cell tumor receiving combination chemotherapy containing bleomycin.

Pegfilgrastim Versus Filgrastim in the Supportive Care of Heavily Pretreated Multiple Myeloma in Treatment with Pomalidomide-Dexamethasone

The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by heavily pretreated MM, treated with pomalidomide-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. 57 patients (31 M and 26 F) were enrolled, median age at diagnosis 69 years (r. 52-84), and median age at start of treatment 76 years (r.56-90) treated with several lines of treatments (median 7, r. 2-12), every refractory to all the drugs previously received, received Pomalidomide-Dexamethasone (P 4 mg for 21 days, D 40 mg days 1,8,15,22, pegfilgrastim day +8) every 28 days, until progression. Since first course, received in domestic setting, with a very good compliance, patients performed blood counts once weekly and received, from day +8 to day +19, prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle, 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 4.6 (r. 3-6); nadir neutropenia was registered after a median of 10.4 days (r. 7-14); median of nadir neutrophil count was 1.13 x 10^9 cells/L (r.0.3 - 1.5), with maximum duration of 14 days. From the second course, all patients switched to prophylaxis with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. 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 1.28 (r.0.9-2.2). Only 4 patients needed a supplement of 3 administrations of filgrastim. Pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain (21.2%). In patients affected by heavily pretreated MM treated with pomalidomide-dexamethasone, pegfilgrastim seems to reduce the incidence of severe neutropenia and infections and may increase the possibility to maintain the scheduled time of treatment.

MM-499 Pegfilgrastim Versus Filgrastim in the Supportive Care of Heavily Pretreated Multiple Myeloma in Treatment With Pomalidomide-Dexamethasone

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. The objective was to compare the efficacy and safety of pegfilgrastim in heavily pretreated MM, treated with pomalidomide-dexamethasone, in order to determine whether a single subcutaneous injection of pegfilgrastim is as effective as daily filgrastim. 57 patients (31 M and 26 F) were enrolled, median age at diagnosis 69 years (r. 52-84), and median age at start of treatment 76 years (r. 56-90) treated with several lines of treatments (median 7, r. 2-12), refractory to all drugs previously received. They received pomalidomide-dexamethasone (P 4 mg for 21 days, D 40 mg days 1, 8, 15, 22, pegfilgrastim day +8) every 28 days, until progression. In the first course in domestic setting, patients' blood counts were drawn once weekly and they received, from day +8 to day +19, prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle, filgrastim (5 µgr/kg/day for 3 days) was given if neutrophils count was <1500 × 109 cells/L. Median number of filgrastim administrations was 4.6 (r. 3-6); nadir neutropenia was registered after a median of 10.4 days (r. 7-14); median of nadir neutrophil count was 1.13 × 109 cells/L (r.0.3 - 1.5), with maximum duration of 14 days. For the second course, all patients switched to prophylaxis with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. During treatment with pegfilgrastim, neutropenia was never longer than 8 days, with a consequent reduction of neutropenia-related infections. Median nadir neutrophil count, evaluated for every patient for at least three courses of therapy (r. 3-6) registered at day + 11, was 1.28 (r.0.9-2.2). Only 4 patients needed a supplement of 3 administrations of filgrastim. Pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain (21.2%). In MM treated with pomalidomide-dexamethasone, pegfilgrastim seems to reduce the incidence of severe neutropenia and infections and may increase the possibility to maintain the scheduled time of treatment.

MM-418: Pegfilgrastim in the Supportive Care of Heavily Pretreated Multiple Myeloma in Pomalidomide-Based Treatment

Objective The objective of this study was to compare the efficacy and safety of pegfilgrastim in heavily pretreated MM treated with pomalidomide-dexamethasone in order to determine whether a single subcutaneous injection of pegfilgrastim is as effective as daily injections of standard filgrastim. Design 57 patients (31 M/26 F), median age at diagnosis 69 years (range: 52–84), and median age at the start of treatment 76 years (range: 56–90), who were treated with several lines of treatments (median 7, range: 2–12) and were refractory to all drugs previously received, received pomalidomide-dexamethasone (P: 4 mg for 21 days, D: 40 mg days 1, 8, 15, and 22, pegfilgrastim day +8) every 28 days, until progression. Starting with the first course, patients performed blood counts once weekly and received, from day +8 to day +19, prophylactic oral chinolonic antibiotics and anti-fungal drugs. Main Outcome Measures During neutropenia after the first cycle, filgrastim (5 µg/kg/day for 3 days) was given if the neutrophil count was Results During pegfilgrastim, neutropenia never lasted longer than 8 days, with a consequent reduction of neutropenia-related infections. Median nadir neutrophil count, evaluated for every patient for at least three courses of therapy (range: 3–6) and registered at day +11, was 1.28 (range: 0.9–2.2). Only 4 patients needed a supplement of 3 administrations of filgrastim. Pegfilgrastim was well tolerated in all patients; the main side effects in our patients were mild fever and bone pain (21.2%). Conclusions In patients affected by heavily pretreated MM treated with pomalidomide-dexamethasone, pegfilgrastim seems to reduce the incidence of severe neutropenia and infections and may increase the possibility to maintain the scheduled time of treatment.

Pegfilgrastim Versus Filgrastim in the Supportive Care of Heavily Pretreated Multiple Myeloma in Treatment with Pomalidomide-Dexamethasone

Background 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. Aims The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by heavily pretreated MM, treated with pomalidomide-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 57 patients (31 M and 26 F) were enrolled, median age at diagnosis 69 years (r. 52-84), and median age at start of treatment 76 years (r.56-90) treated with several lines of treatments (median 7, r. 2-12), every refractory to all the drugs previously received, received Pomalidomide-Dexamethasone (P 4 mg for 21 days, D 40 mg days 1,8,15,22, pegfilgrastim day +8) every 28 days, until progression. Results Since first course, received in domestic setting, with a very good compliance, patients performed blood counts once weekly and received, from day +8 to day +19, prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle, Filgrastim (5 μgr/kg/day for 3 days) was given if neutrophils count was &amp;lt;1500 x 10^9 cells/L. Median number of filgrastim administrations was 4.6 (r. 3-6); nadir neutropenia was registered after a median of 10.4 days (r. 7-14); median of nadir neutrophil count was 1.13 x 10^9 cells/L (r.0.3 - 1.5), with maximum duration of 14 days. From the second course, all patients switched to prophylaxis with pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. 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 1.28 (r.0.9-2.2). Only 4 patients needed a supplement of 3 administrations of filgrastim. Pegfilgrastim was well tolerated in all patients: main side effects in our patients were mild fever and bone pain (21.2%). Conclusions In patients affected by heavily pretreated MM treated with pomalidomide-dexamethasone, pegfilgrastim seems to reduce the incidence of severe neutropenia and infections and may increase the possibility to maintain the scheduled time of treatment. Disclosures Lucchesi: Novartis: Honoraria; Incyte: Honoraria; Pfizer: Honoraria.

Is It Better to Mobilize Hematopoietic Stem Cells With Pegfilgrastim in Healthy Donors During Allogeneic Hematopoietic Stem Cell Transplantation?

The mobilization of hematopoietic stem cells (HSCs) using granulocyte colony-stimulating factor is a classic method. Recently, a single injection of pegfilgrastim was used to mobilize CD34+ cells in some small-sample studies. To confirm the efficacy and safety of pegfilgrastim in the mobilization of CD34+ cells from healthy donors, we conducted a retrospective multicenter study. A total of 146 healthy donors who all received subcutaneous pegfilgrastim (12 mg) on day 1 were enrolled in our study. Donor HSC apheresis was conducted on day 5. The primary endpoint was the percentage of donors from whom ≥4 × 106 CD34+ cells/kg were collected in a single apheresis session. The median number of CD34+ cells in donors was significantly higher on day 5 than that on day 4 (82.26 μL vs. 51.65 μL, P ¡ 0.001). In 111 of the 146 donors, an optimal number of CD34+ cells (≥4 × 106 kg) were collected in a single apheresis procedure. Bone pain and headache were the main adverse events, but the side effects did not require treatment. The number of white blood cells in most donors dropped to normal levels within 1 week after apheresis. Nearly 97% of patients achieved neutrophil and platelet engraftment. Pegfilgrastim for mobilization could be used to obtain an optimal number of CD34+ cells in a single session. Pegfilgrastim-induced mobilization not only was effective and safe but also avoided the pain of multiple injections and apheresis procedures in donors. However, prospective randomized controlled trials should be conducted in the future.

MM-390: Pegfilgrastim vs. Filgrastim in the Supportive Care of Heavily Pre-Treated Multiple Myeloma in Treatment with Pomalidomide-Dexamethasone

Context: Pegfilgrastim is a pegylated long-acting recombinant form of G-CSF that extends its half-life and allows for once-per-cycle dosing, requiring less frequent dosing than non-pegylated G-CSF. Objective: The objective of this study was to compare the efficacy and safety of pegfilgrastim in heavily pre-treated MM treated with pomalidomide-dexamethasone. Design: Real-world analysis. Setting: Supportive care in rrMM. Patients: We enrolled 57 patients (31 M and 26 F) with a median age at diagnosis of 69 years (r. 52–84) and a median age at start of treatment of 76 years (r.56–90) who were treated with several lines of treatments (median 7, r. 2–12), were refractory to all drugs previously received, and had received Pomalidomide-Dexamethasone (P 4 mg for 21 days, D 40 mg on days 1, 8, 15, 22, pegfilgrastim day +8) every 28 days until progression. Interventions: Pegfilgrastim in rrMM. Main outcome measures: Results were evaluated according to IMWG criteria. Results: Since first course, which was received in domestic setting, patients had blood counts performed once weekly and received, from day +8 to day +19, prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after the first cycle, filgrastim (5 μg/kg/day for 3 days) was given if the neutrophil count was Conclusions: In patients affected by heavily pre-treated MM treated with pomalidomide-dexamethasone, pegfilgrastim seems to reduce the incidence of severe neutropenia and infections and may increase the possibility of maintaining the scheduled time of treatment.

Efficacy and safety of pegfilgrastim in prophylaxis of chemotherapy-induced neutropenia in breast cancer patients.

e12511 Background: The role of secondary prophylaxis with pegfilgrastim (brand name: Jinyouli) in Chinese breast cancer patients has not been fully evaluated. We assessed the efficacy and safety of pegfilgrastim in secondary prophylaxis of chemotherapy-induced neutropenia in breast cancer patients. Methods: In the open-label, single-arm, multicenter trail, 319 patients were enrolled. Breast cancer patients who developed grades 3/4 neutropenia in the previous chemotherapy cycle were given a fixed dose of subcutaneous pegfilgrastim, 24-48 hours after receiving the same chemotherapy regimen in the subsequent cycle. A dose of 6mg/cycle was given to patients weighed ≥45kg, and a dose of 3mg/cycle was given to patients weighed &lt;45kg. The primary end point was the incidence of grade 3/4 neutropenia and secondary end point was the incidence of febrile neutropenia (FN). Results: In patients who received prophylactic pegfilgrastim, the incidence of grade 3/4 neutropenia was reduced to 12.53% (95% CI, 9.1 to 16.7) and the incidence of FN was reduced from 6.58% (95% CI, 4.1 to 9.9) in the screening cycle to 0.94% (95% CI, 0.2 to 2.7)(Table). Among the 40 patients who still developed grades 3/4 neutropenia after receiving pegfilgrastim, the absolute neutrophil count (ANC) was not significantly different between patients with (n=10) or without (n=30) additional filgrastim treatment. The most common adverse events (AEs) associated with pegfilgrastim were bone pain and myalgia, which were prevalent in 10% to 15% of the patients. However, both AEs were mild or moderate (grades 1/2). Conclusions: Prophylactic administration of pegfilgrastim is effective and safe in reducing the risk of grades 3/4 neutropenia and FN in breast cancer patients after receiving chemotherapy. [Table: see text]

Pegfilgrastim versus filgrastim in the supportive care of heavily pretreated multiple myeloma in treatment with pomalidomide-dexamethasone.

e20514 Background: 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. The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by heavily pretreated MM, treated with pomalidomide-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: We enrolled 57 patients (31 M, 26 F) median age at diagnosis 69 years (r. 52-84), and median age at start of treatment 76 years (r.56-90) treated with several lines of treatments (median 7, r. 2-12), every refractory to all the drugs previously received, received Pomalidomide-Dexamethasone (P 4 mg for 21 days, D 40 mg days 1,8,15,22, pegfilgrastim day +8) every 28 days, until progression. Results: Since first course, received in domestic setting, with a very good compliance, patients performed blood counts once weekly and received, day +8 to day +19, prophylactic oral chinolonic antibiotics and anti-fungal drugs. During neutropenia after first cycle, Filgrastim (5 μgr/kg/day for 3 d) was given if neutrophils count was &lt; 1500 x 10^9 cells/L. Median number of filgrastim administrations was 4.6 (r. 3-6); nadir neutropenia was registered after a median of 10.4 days (r. 7-14); median of nadir neutrophil count was 1.13 x 10^9 cells/L (r.0.3–1.5), with maximum duration of 14 days. From the second course, all patients switched to pegfilgrastim (6 mg), injected subcutaneously with a single administration on day +3 independently from the neutrophil count at that time. 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 1.28 (r.0.9-2.2). Only 4 patients needed a supplement of 3 administrations of filgrastim. Pegfilgrastim was well tolerated in all patients: main side effects were mild fever and bone pain (21.2%). Conclusions: In conclusions, in patients affected by heavily pretreated MM treated with pomalidomide-dexamethasone, pegfilgrastim seems to reduce the incidence of severe neutropenia and infections and may increase the possibility to maintain the scheduled time of treatment.

Pegfilgrastim Versus Filgrastim in the Supportive Care of Heavily Pretreated Multiple Myeloma in Treatment With Pomalidomide-Dexamethasone

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. The objective of this study was to compare the efficacy and safety of pegfilgrastim in patients affected by heavily pretreated MM, treated with pomalidomide-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.

PS1546 IS IT BETTER TO MOBILIZE HEMATOPOIETIC STEM CELLS FROM HEALTHY DONORS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH PEGFILGRASTIM?

Background: Granulocyte colony-stimulating factor (G-CSF) has been established for mobilizing allogeneic hematopoietic stem cells from healthy donors as the standard regimen. It has a short elimination half-life and daily subcutaneous injection. The pegylated form of filgrastim (pegfilgrastim) has a longer elimination half-life because of decreased serum clearance and might be a convenient alternative for allogeneic hematopoietic stem cell mobilization. Aims: To observe the efficacy and safety of pegfilgrastim in mobilization of donor stem cells compared with rhG-CSF. Methods: This study was a prospective randomize control single-center trial. 47 normal related donors received pegfilgrastim 12 mg subcutaneously to mobilize peripheral blood stem cells (PBSC) for allogeneic stem cell transplantation. 36 donors received 10 ug/kg granulocyte colony-stimulating factor (G-CSF) for mobilization in conventional filgrastim group. Pegfilgrastim group with inadequate mobilization (blood CD34+ cells 20/uL on day 4) were given additional daily doses of 10 ug/kg conventional filgrastim. Leukapheresis was planned to start 5 days after injection. Results: There were 40/47 donors in pegfilgrastim group who only required single leukapheresis, 29/36 in conventional filgrastim group. These indicated no statistical difference. The maximum concentration of white blood cells (WBC) and circulating CD34 cells occurred 5 days after egfilgrastim injection in two groups had significant statistical difference(P = 0.039,P = 0.02,respectively), median WBC in case group is 511836/ul vs.42.6884/ul in control group; CD34:median 128.33/ul vs.73.68/ul). In 44 out of 47 achieved neutrophil and platelet engraftment in pegfilgrastim group after transplantation,34/36 in conventional filgrastim group, respectively. Median neutrophil and platelet engraftments in the recipients in pegfilgrastim group occurred on day 14 and day 16, day 15 and day 17 in conventional filgrastim group. Pegfilgrastim group was associated with lower incidences of acute graft-versus-host disease(GVHD) (14.9% vs. 30.5%, p < 0.05) compared with conventional filgrastim. The main adverse events were bone pain and headache, the incidence ratio is 14.9% in pegfilgrastim group, 22.2% in conventional filgrastim group. Summary/Conclusion: PBSC mobilization in normal donor with single injection of pegfilgrastim is feasible. Further comparisons to standard G-CSF for allogeneic stem cell mobilization should be conducted in future.

A randomized, multicenter clinical trial to determine the efficacy and safety of pegfilgrastim (GEMA BIOTECH) compared to pegfilgrastim (Roche) for prevention of chemotherapy induced neutropenia in patients with breast cancer.

3113 Background: Peg-Neutropine, GEMA BIOTECH SAU biosimilar Peg-Filgrastim, is the first Peg-Filgrastim approved in LATAM for prevention of febrile neutropenia in patients treated with myelosuppressive chemotherapy. Methods: Study population: women with stage 2, 3 or 4 of breast cancer scheduled to receive 4 or 6 cycles of chemotherapy (with Taxane) at 3 weeks interval. Stratification was based on breast cancer stage. Study drug was administered subcutaneously in a 6 mg dose. The study was blind to the assessors. The primary endpoint was Duration of Severe Neutropenia (DSN, Absolute Neutrophil Count-ANC &lt; 500/mm3) in the first cycle of chemotherapy. Secondary endpoints were incidence of severe neutropenia (SN), other efficacy measures, and incidence of ADRs. The non-inferiority margin for DSN was estimated in less than 1 day. Results: A total of 120 subjects were randomized 1:1, 58 were treated with Peg-Neutropine and 62 with Peg-Filgrastim (Roche). Efficacy: SN was developed in 52/283 (18,4%) cycles with Peg-Neutropine in 27 patients and 48/297 (16,2%) cycles with Peg-Filgrastim (Roche) in 20 patients (p=0,4836). In the first cycle, 16 patients with Peg-Neutropine and 11 patients with Peg-Filgrastim (Roche) developed SN. In per protocol analysis mean DNS in the first cycle was 0,78 ± 1,53 days for Peg-Neutropine group and 0,53±1,25 for Peg-Filgrastim (Roche) group (95% IC for the difference -0,26; 0,76). Per ITT analysis the mean DSN was 0,90±1,79 for Peg- Neutropine group and 0,50±1,21 for Peg-Filgrastim (Roche) group , (95% IC for the difference -0,15; 0,95). For all the efficacy secondary endpoints the differences were not statistically significant. Safety: 7 ADRs were developed by 3 subjects with Peg-Neutropine and 31 ADRs were developed by 10 subjects with Peg-Filgrastim (Roche). The most common reaction was myalgia, and other ADRs were arthralgia, asthenia, bone pain and acid sensitive syndrome. Conclusions: Based on the non-inferiority margin established we conclude that Peg-Neutropine is biosimilar to Peg-Filgrastim (Roche). Clinical trial information: NCT03404752.

Efficacy of pegfilgrastim administration in patients with esophageal cancer treated with docetaxel, cisplatin, and 5-fluorouracil.

Chemotherapy is among the standard treatments for esophageal cancer. The docetaxel, 5-fluorouracil, and cisplatin (DCF) protocol yields a better response rate than 5-fluorouracil plus cisplatin. However, the incidence of side effects, such as febrile neutropenia and hematologic toxicity, is also significantly high with the DCF protocol. The granulocyte colony-stimulating factor and pegfilgrastim are prophylactically administered to prevent febrile neutropenia. This retrospective study evaluated the efficacy and safety of pegfilgrastim in patients receiving DCF therapy. Of the 65 patients who were administered DCF therapy in our hospital from 2011 through 2016, 21 received pegfilgrastim 24 hours or more after the end of chemotherapy. The protocol comprised 70 mg/m2 each of docetaxel and cisplatin on day 1 and 700 mg/m2 5-fluorouracil on days 1 to 5 via intravenous injection in a 3-week cycle. The primary endpoint was the rate of grade 3-4 neutropenia and febrile neutropenia. The mean patient age was 66.4 years. The incidence of grade 3 and 4 neutropenia was 14.2 % and 11.4 %, respectively, in the pegfilgrastim group and 31.9 % and 37.8 %, respectively, in the non-pegfilgrastim group. The incidence of febrile neutropenia in the pegfilgrastim group and non-pegfilgrastim group was 11.4 % and 40.3 %, respectively. Statistical analysis showed that the incidence of neutropenia and febrile neutropenia was significantly different (p<0.05) between the two groups. Pegfilgrastim prevents severe neutropenia and febrile neutropenia in patients with esophageal cancer who are treated according to the DCF protocol.

Effectiveness and Safety of Pegfilgrastim in BEP Treatment for Patients with Germ Cell Tumor.

The effectiveness and safety of pegfilgrastim during bleomycin, etoposide and cisplatin (BEP) chemotherapy have not yet been investigated. Patients with germ cell tumors (GCTs) who received pegfilgrastim during BEP at the Kanazawa University Hospital between January 2014 and December 2016 were retrospectively analyzed. The frequency of adverse events and effectiveness in inhibiting neutropenia were compared between cycles using pegfilgrastim and those using filgrastim. Pegfilgrastim and filgrastim were administered in 13 and 22 cycles, respectively. The absolute neutrophil count at the nadir was significantly lower in patients receiving pegfilgrastim than in those receiving filgrastim (p=0.003). The duration of grade 2-4 neutropenia in cycles using filgrastim was significantly longer than that in those pegfilgrastim (p=0.01). No significant differences in the incidence of febrile neutropenia and serious adverse events were observed. Pegfilgrastim can be safely and effectively administrated during BEP for patients with GCT.

Safety and Efficacy of Pegfilgrastim When Given Less Than 14 Days Before the Next Chemotherapy Cycle: Review of Every 14-Day Chemotherapy Regimen Containing 5-FU Continuous Infusion.

Pegfilgrastim should not be given <14 days from the next chemotherapy because of concerns for cytopenias. Some clinicians are prescribing pegfilgrastim to be given <14 days in patients receiving 5-fluorouracil continuous infusion (5-FUCI) regimens. To determine the effectiveness and safety of pegfilgrastim administered <14 days from the next chemotherapy in patients receiving 5-FUCI administered >46 hours. Single-institution retrospective cohort study of patients who received 5-FUCI administered >46 hours from June 2013 to December 2015. The unit of measurement was chemotherapy cycles. End points included the safety and efficacy of giving pegfilgrastim <14 days from the next chemotherapy (Pegfilgrastim-Less-Than-14-Days-Group) and comparing that to pegfilgrastim given ≥14 days (Pegfilgrastim-More-Than-14-Days-Group), filgrastim only (Filgrastim-Group), and no colony stimulating factors (No-CSF-Group). Generalized estimating equations (GEEs) were used to compare mean absolute neutrophil count (ANC) and white blood cell count (WBC). Poisson regression models with GEE were used to estimate relative risk (RR) for neutropenia. There were no incidences of neutropenia, febrile neutropenia (FN), or hospitalizations for FN with the Pegfilgrastim-Less-Than-14-Days-Group. There was also a high mean ANC of 9.9 (5.7) × 109/L. Mean ANC and WBC were statistically significantly less with the Filgrastim-Group, No-CSF-Group, and Pegfilgrastim-More-Than-14-Days-Group compared with the Pegfilgrastim-Less-Than-14-Days-Group. The Filgrastim-Group and the No-CSF-Group had a 32% (1.10-1.56, P = 0.002) and 8% (1.04-1.12, P < 0.001) increased risk of incidence of neutropenia, respectively, compared with the Pegfilgrastim-Less-Than-14-Days-Group. The risk of incidence of neutropenia was the same with the Pegfilgrastim-More-Than-14-Days-Group and Pegfilgrastim-Less-Than-14-Days-Group (0.95-1.04, P = 0.821). This study shows a promising possibility that administering pegfilgrastim <14 days from the next chemotherapy cycle could be a safe and effective practice. However, better controlled clinical trials are needed.

P1-260 - Pegfilgrastim for patients with malignant lymphoma in our hospital

Background: Pegfilgrastim is a drug for the prevention of febrile neutropenia in chemotherapy. We evaluated the efficacy and safety of pegfilgrastim in patients with malignant lymphoma. Methods: We retrospectively analyzed the data of 44 patients with malignant lymphoma who received pegfilgrastim in our hospital from January to December 2015. We used pegfilgrastim for patients who experienced Grade 3-4 neutropenia (neutrophil counts < 1000/µl). We generally administered pegfilgrastim 1-3 days after anti-tumor drugs. For bendamustine therapy, we administered pegfilgrastim on day 8 because we experienced a delayed decrease in neutrophil count compared to other chemotherapies. We assessed adverse events according to Common Terminology Criteria for Adverse Events version 4.0. Results: The median age was 68 years old (range: 54-85). There were 27 patients with aggressive B-cell lymphoma, 11 with indolent B-cell lymphoma and 6 with T-cell lymphoma, respectively. Bone marrow involvement was detected in 18 patients. The number of patients who received CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) therapy, DeVIC (dexamethasone, etoposide, ifosfamide and carboplatine) therapy, bendamustine therapy and the other therapies were 16, 13, 5 and 10, respectively. Eighteen patients experienced febrile neutropenia before using pegfilgrastim, and 2 patients experienced febrile neutropenia after using pegfilgrastim. The median minimum neutrophil count before and after using pegfilgrastim was 96/µl (range: 0-640) and 1980/µl (range: 6-6840), respectively. Five patients required intravenous antibacterial drugs and hospitalizations. Three patients required a reduction in chemotherapy dose. Grade 1 bone pain was detected in 5 patients, with no other adverse events being detected. Conclusion: Pegfilgrastim may reduce febrile neutropenia, necessity of intravenous antibacterial drugs, and enable us to maintain the intensity of the chemotherapy.

Randomized double-blind controlled trial (RCT) of pegfilgrastim as prophylactic therapy in pediatric patients with solid tumors during myelosuppressive chemotherapy.

9565 Background: The objective of this study was to evaluate the effectiveness and safety of pegfilgrastim in pediatric patients with solid tumor as prophylactic therapy during dose-intensive combination chemotherapy, in comparison to filgrastim. Methods: Thirty-two cancer patients older than 2 years-old previously untreated with chemotherapy, and with Lansky scale > 50 were randomly assigned to receive a single pegfilgrastim dose of 100 mcgr/kg (n=16) or daily (during five days) filgrastim doses of 10 mcgr/kg (n=16) after chemotherapy. Outcome measures included: duration and incidence of neutropenia (<1,000 cel./mm3) and febrile neutropenia, time to neutrophil recovery, and adverse events (AE). Statistical analysis: Chi-square and Mann-Whitney U test were used. Results: One-hundred thirty-two cycles were evaluated; 66 from pegfilgrastim group (PG) and 66 from filgrastim group (FG). Their age varied from 2- to 16 years-old. Between groups, there were no differences in age, sex and type of neoplasm. Central nervous system tumors and osteosarcoma were the most frequent tumors (n=6 and n=5 in each group, respectively). Ifosfamide-carboplatin-etoposide (ICE) and cisplatin-epirubicin (CDDP/EPI) were the most common chemotherapy used (n=7 and n=4 vs. n=6 and n=5, respectively). There were 10 episodes (15.1%) of neutropenia in FG vs. 9 (13.6%) in PG; prolonged neutropenia was seen in 2 (3%) and 1 (1.5%), respectively (p>0.05). Incidence of febrile neutropenia was more frequent in FG (6 cycles, 9% vs. 1, 1.5% p=0.057). One chemotherapy cycle in each group was deferred. Regarding of AE, pain at the application site was more frequent in FG (20 cycles, 30.3% vs. 1, 1.5%; p<0.001), but bone pain was only observed in PG (10 cycles, 15.1%, p<0.01). Frequency of hyperleukocytosis (>11,000 cel./mm3) was lower in FG (5 cycles, 7.5% vs. 20 cycles, 30.3%, p=0.001). Conclusions: In children with solid tumors the effectiveness and safety of pegfilgrastim as prophylactic therapy during chemotherapy is similar to filgrastim. These results warrant a pharmacoeconomic evaluation.

Is pegfilgrastim safe and effective in congenital neutropenia? An analysis of the French Severe Chronic Neutropenia registry

To examine the efficacy and safety of pegfilgrastim in patients with congenital neutropenia (CN). Seventeen patients enrolled in the French Severe CN Register received pegfilgrastim. Median age at pegfilgrastim introduction was 19.1 years (range 3.9-52.3 years). In 14 cases pegfilgrastim replaced GCSF (filgrastim or lenograstim), after a median of 6.9 years of GCSF therapy. The dose of pegfilgrastim was usually one full vial per injection (except in five children, who received 1/6 to 1/2 a vial), resulting in a dose of between 50 and 286 microg/kg. The pegfilgrastim schedule ranged from two injections every 7 days to one injection every 30 days, with treatment-free periods. The median interval between the first and last dose of pegfilgrastim was 0.8 years (0.01-4.1 years). The absolute neutrophil count tended to increase more strongly on pegfilgrastim than on GCSF, but the difference was not statistically significant. During pegfilgrastim therapy, a severe infection occurred in two patients and recurrent ENT infections in two other patients. Bone pain was reported by nine patients, anemia and thrombocytopenia occurred in one patient (WHO grade III), chronic urticaria occurred in one patient (WHO grade III), and a single pegfilgrastim injection was followed by respiratory distress and death 15 days later in a patient with GDSIb. At the last update, 10 patients had stopped receiving pegfilgrastim and seven patients were still receiving pegfilgrastim. Compared to conventional GCSF, pegfilgrastim is more difficult to use in congenital neutropenia, with more frequent adverse events and sometimes poor efficacy.

Fixed-dose Pegfilgrastim is Safe and Allows Neutrophil Recovery in Patients with Non-Hodgkin's Lymphoma

Twenty-nine patients with non-Hodgkin's lymphoma received a single subcutaneous injection of 6 mg pegfilgrastim approximately 24 h after the start of CHOP chemotherapy. The safety of pegfilgrastim in this patient population was determined by reports of adverse events. The pharmacokinetics of pegfilgrastim were characterized and the duration of grade 4 neutropenia, time to absolute neutrophil count (ANC) recovery to ≥ 2.0 x 109/l, neutrophil nadir, and incidence of febrile neutropenia were determined in the first 21-day chemotherapy cycle. The incidence of grade 4 neutropenia in cycle 1 was 43% with a mean (SD) duration of grade 4 neutropenia value of 1.0 (1.4) day. No apparent relationship between the duration of grade 4 neutropenia and body weight was observed. The median [quartiles] time to ANC recovery was 10 [9, 11] days. The incidence of febrile neutropenia was 11%. No unexpected adverse events were reported and no patient developed antibodies to pegfilgrastim. Serum concentration of pegfilgrastim reached a maximum (median [quartiles]) of 128 [58, 159] ng/ml at approximately 24 h after administration, and was followed by a second smaller peak (median [quartiles]) of 10.6 [3.0, 20.5] ng/ml at the time of the neutrophil nadir. After the second peak, concentration of pegfilgrastim declined linearly with a median terminal half-life of approximately 42 h.