Lonquex (lipegfilgrastim) / Teva - LARVOL DELTA

An open-label, randomized study comparing lipegfilgrastim with filgrastim in pediatric patients receiving chemotherapy for Ewing sarcoma or rhabdomyosarcoma. (PubMed, Sci Rep) - "Lipegfilgrastim demonstrated comparable efficacy and tolerability to filgrastim in reducing duration and incidence of neutropenia. A reduced dosing frequency of once per cycle could be particularly beneficial for children, enhancing convenience and improving adherence."

Journal • Ewing Sarcoma • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

GCSF-PAIN: G-CSF-Induced Bone Pain and Supportive Care Approaches (clinicaltrials.gov) - P=N/A | N=128 | Recruiting | Sponsor: Ankara Etlik City Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Chemotherapy-Induced Neutropenia • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Pain • Solid Tumor

GCSF-PAIN: G-CSF-Induced Bone Pain and Supportive Care Approaches (clinicaltrials.gov) - P=N/A | N=128 | Not yet recruiting | Sponsor: Ankara Etlik City Hospital

New trial • Chemotherapy-Induced Neutropenia • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Pain • Solid Tumor

Risks of haematological malignancies in patients treated for solid tumours associated with the use of pegylated granulocyte colony-stimulating factors: A single centre study since 2005. (PubMed, Oncol Lett) - "The use of pegylated granulocyte colony-stimulating factors (PGCSFs), specifically pegfilgrastim and lipegfilgrastim, has been widely adopted to reduce the incidence of febrile neutropenia in patients undergoing chemotherapy...The present study findings demonstrated that the long-term use of PGCSFs in patients treated for solid tumours does not substantially increase the risk of secondary haematological malignancies, which supports their safety profile in clinical practice. However, a longer follow-up is necessary to further evaluate the safety of PGCSFs, particularly for biosimilars."

Journal • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Long-acting lipegfilgrastim and antimicrobials as vigorous primary prophylaxis in bendamustine-treated patients with indolent B cell non-Hodgkin lymphoma: a multicentric real-life experience. (PubMed, Support Care Cancer) - "Febrile neutropenia (FN) is one of the most important clinical signs of infection, especially for older patients with indolent B cell non-Hodgkin lymphomas (iBC-NHLs) receiving frontline immune-chemotherapy with bendamustine-rituximab (BR). Data on the optimal strategy for infection prophylaxis from the start of chemotherapy until 1 month after the last cycle is scanty in this setting of patients, and for this reason, we carried out a multicentric retrospective study on vigorous primary anti-infectious prophylaxis consisting of lipegfilgrastim, trimethoprim-sulfamethoxazole, and acyclovir...Prophylaxis was well tolerated with grade 3 toxicity (bone pain) in only 10% of patients and was successfully managed with paracetamol or tramadol. Systematic, prompt, and sustained use of vigorous primary anti-infectious prophylaxis was able to reduce the rate of fever episodes, thus averting parenteral antimicrobial administrations, hospitalizations, and immune-chemotherapy..."

Journal • Retrospective data • B Cell Non-Hodgkin Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Musculoskeletal Pain • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pain

Trends of the use of pegylated granulopoiesis growth factors in clinical practice - single oncology centre experience since 2005. (PubMed, Klin Onkol) - "In 2019, compared to 2005-2010, we show an increase in the use of PGCSF with a shift to palliative CHT protocols and generally less risky for the development of FN. The efficacy and safety of PGCSF were consistent with the conclusions of published studies. More detailed analyses of indications for Q2W protocols, generally low-risk or infrequent non-standard situations can bring other important insights and are topics for ideally multicenter cooperation."

Journal • Retrospective data • Allergy • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Immunology • Leukopenia • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor • EGFR

Strategies for premedication and neutropenia prophylaxis in sacituzumab govitecan treatment of patients with triple-negative breast cancer: multicenter insights (SABCS 2024) - "We evaluated the use of drugs such as acetaminophen, corticosteroids, atropine, H1/H2 blockers, 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, neurokinin-1 (NK1) receptor antagonists, filgrastim, and pegfilgrastim/lipegfilgrastim...All patients received steroids (typically 8 milligrams of iv dexamethasone) and 5-HT3 antagonists (usually 8 milligrams of iv ondansetron)...The use of steroids as secondary prophylaxis for neutropenia remains controversial and should be avoided. Only a few patients required atropine as secondary diarrhea prophylaxis."

Clinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

LIPOSOMAL DOXORUBICIN, VINBLASTINE AND DACARBAZINE PLUS CONSOLIDATION RADIOTHERAPY OF RESIDUAL NODAL MASSES FOR FRONTLINE TREATMENT IN OLDER ADULTS WITH ADVANCED STAGE CLASSIC HODGKIN LYMPHOMA (C-HL): IMPROVED OUTCOME IN A SINGLE-CENTER REAL-LIFE STUDY (SIE 2024) - "Patients received primary anti-infectious prophylaxis with lipegfilgrastim s.c. on days 4, 18 of every cycle; trimethropin-sulfamethoxazole at 960 mg orally every 12h for 2 days a week and acyclovir at 800 mg orally daily from the start of chemotherapy until 1 month; allopurinol at 300 mg orally in every course; FDG-PET with Deauville score (DS) at staging, EoT and every 3-6 months and 2D echocardiography and speckle tracking echocardiography at baseline, interim, EoT and within six months from EoT. Our data suggest that in older adults with high-risk c-HL, NPLD-driven strategy (without bleomycin) plus consolidation radiotherapy (if needed) may be a promising up-front option, to test in phase II clinical trials for improving survival incidence. Figure 1."

Clinical • Metastases • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • Novel Coronavirus Disease • Oncology

PEGFILGRASTIM FOR STEM CELL MOBILIZATION FOLLOWED BY FRESH STEM CELL INFUSION IN MULTIPLE MYELOMA (EBMT 2024) - "Of those 156 received initial filgrastim and 150 received pegfilgrastim, 6 patients received different mobilization regimens (lipegfilgrastim and chemo-mobilization) and were excluded from the present analysis. Peg-filgrastim provided adequate stem cell yield however required a higher usage of plerixafor rescue compared to FILG and this might have an impact on the number of apheresis session. Health resource utilization reduced modestly with PEG during mobilization. Transplant short term outcomes were comparable without the requirement of GCSF to hasten neutrophil engraftment, and with a reduction in the transfusion requirements needs in the PEG group."

Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Transplantation • CD34

PEGFILGRASTIM FOR STEM CELL MOBILIZATION FOLLOWED BY FRESH STEM CELL INFUSION IN MULTIPLE MYELOMA (EBMT 2024) - "Of those 156 received initial filgrastim and 150 received pegfilgrastim, 6 patients received different mobilization regimens (lipegfilgrastim and chemo-mobilization) and were excluded from the present analysis. Peg-filgrastim provided adequate stem cell yield however required a higher usage of plerixafor rescue compared to FILG and this might have an impact on the number of apheresis session. Health resource utilization reduced modestly with PEG during mobilization. Transplant short term outcomes were comparable without the requirement of GCSF to hasten neutrophil engraftment, and with a reduction in the transfusion requirements needs in the PEG group."

Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Transplantation • CD34

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. (PubMed, Clin Lymphoma Myeloma Leuk) - "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."

Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD34

Incidence of Febrile Neutropenia and Time to Count Recovery in Patients with Acute Myeloid Leukaemia receiving Pegylated G-CSF following High-Dose Cytarabine (HiDAC) Consolidation (COSA 2023) - "Aims : To investigate the incidence of febrile neutropenia (FN) and time to count recovery (TTCR) between varying pegylated granulocyte-colony stimulating factor (G-CSF) in patients with Acute Myeloid Leukaemia (AML) during High-Dose Cytarabine (HiDAC) consolidation chemotherapy. Pegfilgrastim appears as effective as lipegfilgrastim from this audit despite what the theoretical difference in drug pharmacokinetic properties would infer. Therefore, a greater sample size is required for more robust data."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Analyzing Flow Cytometry or Targeted Gene Expression Data Influences Clinical Discoveries-Profiling Blood Samples of Pancreatic Ductal Adenocarcinoma Patients. (PubMed, Cancers (Basel)) - "Targeted gene expression complements flow cytometry analysis to provide a comprehensive understanding of the effects of FFX-Lipeg. Flow cytometry and targeted gene expression showed increases in neutrophils and monocytes after FFX-Lipeg. The number of lymphocytes is increased after treatment; nevertheless, their cell-specific gene expression levels are downregulated. This highlights that different techniques influence clinical discoveries. Therefore, it is important to carefully select the measurement technique used to study the effect of a treatment."

Journal • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Assessing the Optimal Regimen: A Systematic Review and Network Meta-Analysis of the Efficacy and Safety of Long-Acting Granulocyte Colony-Stimulating Factors in Patients with Breast Cancer. (PubMed, Cancers (Basel)) - "For patients with breast cancer, lipegfilgrastim 6 mg and eflapegrastim 13.2 mg might be the most effective regimen among LA-G-CSFs. Higher doses of LA-G-CSF may enhance efficacy without causing additional SAEs."

Journal • Retrospective data • Review • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Pure Intralymphatic Breast Carcinoma Following Neoadjuvant Treatment: Clinicopathologic Features and Outcome of a Rare Pattern of Residual Disease (USCAP 2023) - "Results Table: Age at diagnosis (years old) 42 47 24 51 38 45 50 Imaging Pattern Non-mass enhancement; nipple thickening PET-scan SUV max up to 13.4 Irregular nodule with heterogeneous enhancement Non-mass enhancement Non-mass enhancement; skin thickening Irregular nodule with heterogeneous enhancement Irregular nodule with peripheral enhancement Clinical Tumor Size (cm) 13.0 1.3 5.4 0.8 1.6 3.5 4.5 Core Needle Biopsy (CNB) Diagnosis PILC Nottingham grade II Invasive carcinoma with apocrine differentiation Nottingham grade II Invasive carcinoma with apocrine differentiation Nottingham grade III Invasive micropapillary carcinoma Nottingham grade II Invasive breast carcinoma of no-special type Nottingham grade II Invasive breast carcinoma of no-special type Nottingham grade III Invasive breast carcinoma of no-special type Nottingham grade II Lymphovascular Invasion on CNB No Yes No Yes No No No Pre-NAST Axillary LN Status Positive FNA Positive FNA Positive FNA Suspicious..."

Clinical • Residual disease • Breast Cancer • HER2 Breast Cancer • Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • PGR

An observational study of dose dense chemotherapy with lipegfilgrastim support in early breast cancer. (PubMed, BMC Cancer) - "Lipegfilgrastim is an effective option in the prophylaxis of chemotherapy-induced neutropenia, and its use in everyday anti-cancer treatment can be considered."

Journal • Observational data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Mucositis • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

Prophylaxis of Neutropenia with Lipegfilgrastim in Breast Cancer Patients with Dose-Dense Chemotherapy: Results of a Noninterventional Study on Therapeutic Routine in Germany (NADENS). (PubMed, Breast Care (Basel)) - "Overall, 314 adverse events (AEs) were reported from 107 patients and 27 serious AEs from 21 patients. None of the SAEs was "fatal," and CTCAE grade was mostly (89.6%) assessed as "1" or "2." According to the treating physicians, 99.3% of all patients benefitted from lipegfilgrastim prophylaxis, and tolerability was mostly rated "very good" or "good." These results suggest that primary lipegfilgrastim prophylaxis is effective and safe in clinical routine and is beneficial in primary breast cancer patients undergoing dd/idd-ETC CTx."

Journal • Observational data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF3 • HER-2

A comparative assessment of neutropenia events, healthcare resource use, and costs among cancer patients treated with lipegfilgrastim compared with pegfilgrastim in Germany. (PubMed, Support Care Cancer) - "Overall, patients treated with pegfilgrastim and lipegfilgrastim were comparable in terms of neutropenia occurrences in the 1-year follow-up. In patients with lymphoma, neutropenia event-related healthcare costs and all-cause hospitalizations were significantly higher with pegfilgrastim compared with lipegfilgrastim in this study; however, this should be interpreted with caution in light of the limited sample size and the absence of clinical information."

Journal • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology • Solid Tumor

Prophylaxis of chemotherapy-induced neutropenia with lipegfilgrastim in patients with lung cancer: final results from the non-interventional study NADIR. (PubMed, Curr Med Res Opin) - "Interestingly, in older patients severe neutropenia was reported less frequently. While most patients with high FN risk received lipegfilgrastim for primary prophylaxis as recommended, there are still 20-30% of patients at high FN risk without primary prophylaxis who could benefit from better adherence to guidelines."

Journal • Observational data • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A multinational, drug utilization study of lipegfilgrastim use in real-world setting in Europe. (PubMed, Support Care Cancer) - "Using real-world data, these findings confirm the low rate of lipegfilgrastim off-label use as reported in a preceding feasibility study, indicating very high adherence to the approved indication."

Journal • Real-world evidence • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Real-world use of G-CSF in patients with breast cancer during first wave of COVID-19 in Germany (GSS 2022) - "A total of 2598 G-CSF prescriptions were reported (pegfilgrastim: 78%, lipegfilgrastim: 11%, filgrastim:11%). 19% of patients received PP with G-CSF during treatment. Majority of these patients were aged 41–60 (62%) and on average ~10 older than the non-PP group. 198 different protocols were reported: Most frequent were EC (38%) and pertuzumab+trastuzumab (10%) for regimes with and without PP, respectively."

Clinical • Real-world evidence • Breast Cancer • Oncology • Solid Tumor • CSF3

Lipegfilgrastim may cause hyperleukocytosis. (PubMed, J Oncol Pharm Pract) - "Although lipegfilgrastim-induced hyperleukocytosis has not been reported in the literature, it should be borne in mind that hyperleukocytosis and related complications may occur, as in our case."

Journal • Acute Respiratory Distress Syndrome • Anorexia • Chemotherapy-Induced Neutropenia • Glomerulonephritis • Hematological Disorders • Infectious Disease • Interstitial Lung Disease • Lupus Nephritis • Musculoskeletal Pain • Nephrology • Neutropenia • Oncology • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] A comparative assessment of neutropenia events, healthcare resource use, and costs among patients treated with long-acting granulocyte-colony stimulating factor in Germany (ESMO 2021) - "Background: We assessed the occurrence of febrile neutropenia (FN) events and the associated healthcare resource use and costs of cancer patients receiving myelosuppressive chemotherapy in combination with pegfilgrastim (PEG) versus lipegfilgrastim (LI-PEG). A retrospective analysis was conducted using a German insurance claims database. Unadjusted neutropenia-related healthcare costs and all-cause hospitalisations were significantly higher for lymphoma patients treated with PEG versus LI-PEG."

Breast Cancer • Colorectal Cancer • Hematological Malignancies • Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor

A randomized, open-label, non-inferiority study comparing the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B-cell Non-Hodgkin lymphomas (B-NHL) - AVOID Neutropenia. (ESMO 2018) - "EudraCT: 2013-001284-23.;Background: Lipegfilgrastim (LONQUEX®) has proven to be non-inferior to pegfilgrastim (NEULASTA®) in the reduction of the duration of severe neutropenia (DSN) in breast cancer patients. The efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with B-NHL at high risk for R-CHOP-21-induced neutropenia was investigated... Lipegfilgrastim was non-inferior to pegfilgrastim in the reduction of the DSN in elderly patients with B-NHL. The safety of lipegfilgrastim was comparable to pegfilgrastim."

Clinical • Head-to-Head • Breast Cancer • Non-Hodgkin’s Lymphoma

LONG-ACTING G-CSF (LIPEGFILGRASTIM, “LONQUEX”) FOR STEM CELL MOBILIZATION IN MULTIPLE MYELOMA PATIENTS UNDERGOING AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT) (EHA 2019) - P1/2; "...Lonquex has not previously been studied for stem cell mobilization in MM patients undergoing ASCT.Aims Evaluate the efficacy and tolerability of a single SC injection of Lonquex in mobilizing cells for ASCT in 24 patients with MM (ClinicalTrials.gov ID: NCT02488382).Methods 12 Males and 12 Females were enrolled after Bortezomib (13 pts) or Lenalidomide (11 pts)- baseline induction therapy...One patient failed to mobilize, and two patients mobilized < 6 x 106 cells/kg; these patients underwent successful mobilization with plerixafor...Twenty-one patients underwent ASCT following high-dose melphalan...Lonquex is administered only once, rather than over multiple days, increasing convenience and potentially improving both compliance and quality-of-life (QoL). Our findings may serve the basis for a well design 2-arm comparative study."

Clinical • Hematological Disorders • Hematological Malignancies • Immunology • Multiple Myeloma • Neutropenia • Oncology • Pain • Transplantation