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Annals of Hematology Dec 2023A single injection of 12 mg pegfilgrastim was used to mobilize peripheral blood progenitor cells (PBPCs) from healthy donors in some studies. The purpose of this study...
A single injection of 12 mg pegfilgrastim was used to mobilize peripheral blood progenitor cells (PBPCs) from healthy donors in some studies. The purpose of this study was to determine if 6 mg of pegfilgrastim was effective and safe for mobilizing CD34+ cells in donors for allogeneic hematopoietic stem cell transplantation. We conducted a retrospective case-matched design. A single dosage of 6 mg pegfilgrastim was used to mobilize PBPCs from 60 healthy donors. Granulocyte colony-stimulating factor (G-CSF, 10 μg/kg) was administered daily to the matched donors. Leukapheresis was scheduled to commence on day 4 of the mobilization regimen. The median yielded CD34+ cell in the pegfilgrastim group was higher than those in the G-CSF group, at 5.06 × 10/kg recipient weight. The 73.3% of donors mobilized with pegfilgrastim yielded >4 × 10 cells/kg CD34+ cells in a single apheresis procedure when compared to the 33.3% of donors mobilized with G-CSF (P < 0.001). The myeloid-derived suppressor cells (MDSC) proportion in the pegfilgrastim group was significantly higher than that in the G-CSF group (P < 0.001). The cumulative incidence of grade II-IV acute graft-versus-host disease (aGVHD) was higher in the G-CSF group than that in the pegfilgrastim group (26.7% vs. 11.7%), without statistical difference. In comparison to the G-CSF group, the pegfilgrastim group had a reduced median pain intensity numerical rating scale score (1 vs. 2). A single 6 mg dosage of pegfilgrastim is effective and safe for allogeneic PBPCs collection from healthy donors. Pegfilgrastim may decrease the incidence of aGVHD by boosting MDSCs, which need further investigation.
Topics: Humans; Peripheral Blood Stem Cells; Retrospective Studies; Hematopoietic Stem Cell Mobilization; Hematopoietic Stem Cell Transplantation; Granulocyte Colony-Stimulating Factor; Antigens, CD34; Peripheral Blood Stem Cell Transplantation; Blood Donors
PubMed: 37773294
DOI: 10.1007/s00277-023-05469-y -
Supportive Care in Cancer : Official... Sep 2023Clinical practice guidelines recommend the use of all approved granulocyte colony-stimulating factors (G-CSFs), including filgrastim and pegfilgrastim, as primary...
PURPOSE
Clinical practice guidelines recommend the use of all approved granulocyte colony-stimulating factors (G-CSFs), including filgrastim and pegfilgrastim, as primary febrile neutropenia (FN) prophylaxis in patients receiving high- or intermediate-risk regimens (in those with additional patient risk factors). Previous studies have examined G-CSF cost-effectiveness by cancer type in patients with a high baseline risk of FN. This study evaluated patients with breast cancer (BC), non-small cell lung cancer (NSCLC), or non-Hodgkin's lymphoma (NHL) receiving therapy who were at intermediate risk for FN and compared primary prophylaxis (PP) and secondary prophylaxis (SP) using biosimilar filgrastim or biosimilar pegfilgrastim in Austria, France, and Germany.
METHODS
A Markov cycle tree-based model was constructed to evaluate PP versus SP in patients with BC, NSCLC, or NHL receiving therapy over a lifetime horizon. Cost-effectiveness was evaluated over a range of willingness-to-pay (WTP) thresholds for incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analyses evaluated uncertainty.
RESULTS
Results demonstrated that using biosimilar filgrastim as PP compared to SP resulted in incremental cost-effectiveness ratios (ICERs) well below the most commonly accepted WTP threshold of €30,000. Across all three countries, PP in NSCLC had the lowest cost per QALY, and in France, PP was both cheaper and more effective than SP. Similar results were found using biosimilar pegfilgrastim, with ICERs generally higher than those for filgrastim.
CONCLUSIONS
Biosimilar filgrastim and pegfilgrastim as primary prophylaxis are cost-effective approaches to avoid FN events in patients with BC, NSCLC, or NHL at intermediate risk for FN in Austria, France, and Germany.
Topics: Humans; Female; Filgrastim; Carcinoma, Non-Small-Cell Lung; Cost-Benefit Analysis; Biosimilar Pharmaceuticals; Lung Neoplasms; Granulocyte Colony-Stimulating Factor; Breast Neoplasms; Lymphoma, Non-Hodgkin; Febrile Neutropenia; Granulocytes
PubMed: 37728795
DOI: 10.1007/s00520-023-08043-4 -
Federal Practitioner : For the Health... May 2023Granulocyte colony-stimulating factor prophylaxis has been shown to reduce the risk and duration of chemotherapy-induced neutropenia and febrile neutropenia and is...
BACKGROUND
Granulocyte colony-stimulating factor prophylaxis has been shown to reduce the risk and duration of chemotherapy-induced neutropenia and febrile neutropenia and is recommended for at-risk patients receiving chemotherapy. Within the South Texas Veterans Health Care System, daily filgrastim injections remain the preferred formulation of granulocyte colony-stimulating factor for primary prophylaxis of febrile neutropenia.
METHODS
This retrospective, single-center cohort study included 59 patients who received daily filgrastim as primary prophylaxis with a curative cancer diagnosis and a chemotherapy regimen at the South Texas Veterans Health Care System from September 1, 2015 to September 24, 2020. Patients had either a high risk for febrile neutropenia or a chemotherapy regimen with an intermediate risk for febrile neutropenia and additional risk factors. The primary outcome was the incidence of neutropenia/febrile neutropenia leading to treatment delays. Secondary outcomes included chemotherapy dose decreases or discontinuations, hospitalizations, days of hospitalization, infections, extended duration of filgrastim, and transitions to pegfilgrastim due to neutropenia/febrile neutropenia.
RESULTS
Patients received a median (IQR) of 7 (5-10) doses of filgrastim for primary prophylaxis. Overall, 10 patients (17%) experienced treatment delays due to neutropenia/febrile neutropenia. Fifteen patients (25%) were hospitalized with a median (IQR) length of stay of 5 (4-7) days, 9 patients (15%) had documented infections, and 2 patients (3%) required a chemotherapy dose reduction. Additionally, 9 patients (15%) required an additional median (IQR) of 2 (2-5) doses of filgrastim, and 9 (15%) patients were transitioned to pegfilgrastim.
CONCLUSIONS
These results suggest that additional measures such as tracking postnadir absolute neutrophil counts should be performed to ensure patients receive an appropriate number of filgrastim doses to prevent complications associated with neutropenia/febrile neutropenia.
PubMed: 37727832
DOI: 10.12788/fp.0327 -
Advances in Therapy Nov 2023Pegfilgrastim-cbqv (UDENYCA; Coherus BioSciences, Redwood City, CA, USA) is a pegfilgrastim (Neulasta; Amgen, Thousand Oaks, CA, USA) biosimilar approved for... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Pegfilgrastim-cbqv (UDENYCA; Coherus BioSciences, Redwood City, CA, USA) is a pegfilgrastim (Neulasta; Amgen, Thousand Oaks, CA, USA) biosimilar approved for administration by prefilled syringe (PFS). The recently approved pegfilgrastim-cbqv prefilled autoinjector (AI) was developed as another method of self-administration and to aid in-office use, providing flexibility in drug delivery. The objectives of the study were to assess the pharmacokinetics (PK) and pharmacodynamics (PD) to determine bioequivalence of the prefilled AI and the PFS for administration of pegfilgrastim-cbqv and to assess the safety profile of the prefilled AI.
METHODS
During this open-label, two-period crossover study, healthy adult males (N = 155) were randomly assigned (1:1 ratio) to receive a subcutaneous injection of pegfilgrastim-cbqv using a prefilled AI (n = 76) or a PFS (n = 79) in period 1. During period 2, participants received an injection using the other method. Primary PK and secondary PD parameters were calculated to assess the bioequivalence of the treatment as administered by the two delivery methods. Safety and immunogenicity were also assessed.
RESULTS
The 90% CIs of the geometric mean ratios for the PK and PD parameters were within the required range (80-125%), demonstrating bioequivalence between the pegfilgrastim-cbqv prefilled AI and PFS. Treatment-emergent adverse events (TEAEs) were reported by 75% and 74.1% of participants in the prefilled AI and PFS groups, respectively. The most common TEAEs in both treatment groups were myalgia, bone pain, and headache. AI-device-related TEAEs were injection site pain (1.4%) and injection site bruising (0.7%). The incidence of antidrug antibodies and neutralizing antibodies was low and was similar in both treatment sequences.
CONCLUSIONS
The bioequivalence of pegfilgrastim-cbqv administered using a prefilled AI and a PFS was established. The safety, including immunogenicity profiles, of pegfilgrastim-cbqv administered using the prefilled AI and the PFS were similar, with no new safety findings.
Topics: Adult; Humans; Male; Therapeutic Equivalency; Syringes; Cross-Over Studies; Injections, Subcutaneous; Healthy Volunteers; Biosimilar Pharmaceuticals; Injection Site Reaction; Pain
PubMed: 37707674
DOI: 10.1007/s12325-023-02636-5 -
Clinical Nuclear Medicine Dec 2023To elucidate the PET/CT findings of pegfilgrastim-induced aortitis (PFIA) and compare them with those of other large-vessel vasculitis. (Observational Study)
Observational Study
PURPOSE OF THE REPORT
To elucidate the PET/CT findings of pegfilgrastim-induced aortitis (PFIA) and compare them with those of other large-vessel vasculitis.
METHODS
We enrolled 45 patients diagnosed with the following: PFIA, n = 8; Takayasu arteritis (TA), n = 12; giant cell arteritis (GCA), n = 6; and immunoglobulin G4-related aortitis (IgG4-A), n = 19. Records of PET/CT performed before treatment initiation were collected. The aorta and its branches were divided into 16 anatomic regions. Presence of abnormal 18 F-FDG uptake in each region was determined and measured.
RESULTS
The 18 F-FDG-positive areas of PFIA were distributed in the regions of the ascending aorta to the suprarenal abdominal aorta, cervical branches of the aorta, and external iliac arteries, similar to those of TA. However, TA had a higher proportion of 18 F-FDG-positive areas than PFIA in almost all anatomic regions. These areas of GCA were widespread throughout the entire aorta and the upper and lower limbs, whereas those of IgG4-A were observed from the abdominal aorta to iliac arteries. SUV max , SUV peak , metabolic volume, and total lesion glycolysis were higher in GCA than in PFIA, TA, and IgG4-A.
CONCLUSIONS
Pegfilgrastim-induced aortitis distribution on PET/CT was frequently observed in the aorta, cervical branches, and extra iliac arteries. The low proportion of 18 F-FDG-positive areas in PFIA was different from that of TA, GCA, and IgG4-A. These findings may help identify and differentiate various aortitis types in clinical practice.
Topics: Humans; Aortitis; Fluorodeoxyglucose F18; Positron Emission Tomography Computed Tomography; Radiopharmaceuticals; Giant Cell Arteritis; Takayasu Arteritis; Aorta, Abdominal; Immunoglobulin G
PubMed: 37703494
DOI: 10.1097/RLU.0000000000004847 -
Clinical Lymphoma, Myeloma & Leukemia Nov 2023This post-hoc study aimed to find out factors affecting graft viable CD34 cell loss during processing and cryopreservation in 129 non-Hodgkin lymphoma (NHL) patients...
Loss of CD34 Cells and Effect of the Number of Viable Cryopreserved CD34 Cells in the Infused Blood Grafts on Hematologic Recovery, Progression-Free Survival and Overall Survival in NHL Patients After Autologous Stem Cell Transplantation.
PATIENTS
This post-hoc study aimed to find out factors affecting graft viable CD34 cell loss during processing and cryopreservation in 129 non-Hodgkin lymphoma (NHL) patients receiving autologous stem cell transplantation (auto-SCT) and the impact of a low (< 2.0 × 10/kg, group A) and a decent number (≥ 2 × 10/kg, group B) of viable CD34 cells infused on the hematologic recovery, progression-free survival (PFS) and overall survival (OS) after auto-SCT.
RESULTS
The median loss of viable CD34 cells during cryopreservation was higher in group A (47% vs. 19%, p < .001). A higher yield of CD34 cells at the first apheresis in group B (p = .002) was linked with greater loss of viable graft CD34 cells after cryopreservation. Filgrastim (FIL) use for mobilization seemed to associate with higher viable CD34 cell loss compared to pegfilgrastim (PEG) or lipegfilgrastim (LIPEG) in both groups (in group A FIL 66 vs. PEG 35%, p = .006; in group B FIL 37 vs. PEG 15 vs. LIPEG 13%, p < .001). Hematologic recovery after auto-SCT was faster in group B. Neither viable CD34 cell loss during storage nor viable CD34 cell number < 2.0 × 10/kg infused affected on PFS or OS.
CONCLUSIONS
G-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34 cell loss during processing and storage. Most importantly, low infused viable CD34 cell count did not seem to impact on PFS or OS.
Topics: Humans; Hematopoietic Stem Cell Transplantation; Progression-Free Survival; Transplantation, Autologous; Lymphoma, Non-Hodgkin; Cryopreservation; Antigens, CD34; Hematopoietic Stem Cell Mobilization
PubMed: 37684185
DOI: 10.1016/j.clml.2023.08.009 -
Future Oncology (London, England) Jan 2024Biosimilars can provide choices for patients and may provide cost savings; however, their uptake has been slow in the USA, in part due to limited knowledge. To provide... (Review)
Review
Biosimilars can provide choices for patients and may provide cost savings; however, their uptake has been slow in the USA, in part due to limited knowledge. To provide additional confidence in US pegfilgrastim biosimilars, this narrative review compared the safety profiles of biosimilar pegfilgrastims, currently approved or filed for approval in the USA, with the EU- and US-approved reference pegfilgrastims. Headache and bone pain were common to biosimilars and reference products and occurred at a similar incidence. Clinical trial data on the safety profiles of biosimilar pegfilgrastims and reference products have demonstrated similarity and comparability, with no unexpected safety outcomes. Overall, the safety profiles of biosimilar pegfilgrastims and reference pegfilgrastims demonstrated a high degree of similarity and comparability.
Topics: Humans; Biosimilar Pharmaceuticals; Filgrastim; Polyethylene Glycols; Leukocytes
PubMed: 37609795
DOI: 10.2217/fon-2023-0026 -
Japanese Journal of Clinical Oncology Dec 2023Dose-dense chemotherapy has shown a better prognosis than standard interval chemotherapy in adjuvant settings for high-risk breast cancer. This study aimed to evaluate...
OBJECTIVE
Dose-dense chemotherapy has shown a better prognosis than standard interval chemotherapy in adjuvant settings for high-risk breast cancer. This study aimed to evaluate the efficacy and safety of dose-dense nanoparticle albumin-bound paclitaxel followed by dose-dense epirubicin and cyclophosphamide as neoadjuvant chemotherapy for human epidermal growth factor 2 (HER2)-negative operable breast cancer.
METHODS
Patients with histologically confirmed stage I-III HER2-negative breast cancer were enrolled in this study. Patients received nanoparticle albumin-bound paclitaxel (260 mg/m2) followed by epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) every 2 weeks with pegfilgrastim. The primary endpoint was the pathological complete response rate. Patients also underwent prophylactic management for peripheral neuropathy, which involved a combination of cryotherapy, compression therapy using elastic stockings and medications including goshajinkigan.
RESULTS
Among the 55 patients enrolled in this study, 13 (23.6%) achieved pathological complete response, of whom 10/26 (38.5%) patients had triple-negative disease and 3/29 (10.3%) had luminal disease. The objective response was observed in 46 (83.6%) patients. Of the 36 patients who were initially planned for mastectomy, 11 (30.6%) underwent breast-conserving surgery after neoadjuvant chemotherapy. The most common grade 3-4 adverse events were myalgia (14.5%), fatigue (12.7%) and elevated transaminase levels (9.1%). No patients experienced febrile neutropenia. Eight (14.5%) patients discontinued treatments due to adverse events.
CONCLUSIONS
Neoadjuvant dose-dense biweekly nanoparticle albumin-bound paclitaxel followed by dose-dense epirubicin and cyclophosphamide was effective, especially in patients with triple-negative disease, and feasible with pegfilgrastim support.
Topics: Humans; Female; Breast Neoplasms; Epirubicin; Neoadjuvant Therapy; Albumin-Bound Paclitaxel; Antineoplastic Combined Chemotherapy Protocols; Mastectomy; Paclitaxel; Cyclophosphamide; Treatment Outcome
PubMed: 37609671
DOI: 10.1093/jjco/hyad112 -
Impact of primary prophylaxis by pegfilgrastim in diffuse large B-cell lymphoma treated with R-CHOP.Annals of Hematology Nov 2023Febrile neutropenia (FN) and chemotherapy-induced neutropenia (CIN) are common conditions that lead to dose reduction or delayed chemotherapy in patients with diffuse...
Febrile neutropenia (FN) and chemotherapy-induced neutropenia (CIN) are common conditions that lead to dose reduction or delayed chemotherapy in patients with diffuse large B-cell lymphoma (DLBCL). Primary prophylaxis (PP) with long-acting granulocyte colony-stimulating factor (G-CSF) was introduced in South Korea in 2014. We aimed to investigate the effects of PP on FN-related hospitalization and death in patients with DLBCL receiving rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Korean individuals (n = 11,491) with incident DLBCL and receiving R-CHOP during 2010-2016 were followed for FN-related hospitalization and mortality. The PP exposure group (patients during 2014-2015, n = 3599), patients during 2010-2016 (n = 11,491), and patients receiving PP during 2014-2016 (n = 4421) were compared with the non-exposure group (patients during July 2011-June 2013, n = 3017), patients in 2013 (n = 1596), and patients not receiving PP during 2014-2016 (n = 1289), respectively. Multivariable-adjusted hazard ratios (HRs) were calculated using the Cox model. The PP exposure group had 16% lower FN-related hospitalizations than the non-exposure group (HR = 0.84, P < 0.001). PP exposure had no beneficial effect on 1-year (HR = 0.98, P = 0.782) and 5-year mortality (HR = 0.97, P = 0.474). Patients in 2014 (HR = 0.85, P < 0.001), 2015 (HR = 0.88, P = 0.003), and 2016 (HR = 0.80, P < 0.001) had a decreased risk of FN-related hospitalizations compared with those in 2013. Among patients receiving their first R-CHOP cycle during 2014-2016, the HR for FN-related hospitalization was 0.90 (P = 0.014) in PP users compared with non-users. PP with a long-acting G-CSF lowered the FN-related hospitalization risk but did not benefit survival in patients with DLBCL receiving R-CHOP.
PubMed: 37599323
DOI: 10.1007/s00277-023-05411-2