NEULASTA SUMMARY
Neulasta®
(pegfilgrastim)
Neulasta™ (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxypolyethylene glycol.
Neulasta™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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NEWS HIGHLIGHTS
Published Studies Related to Neulasta (Pegfilgrastim)
Mobilization of peripheral blood stem cells in myeloma with either pegfilgrastim or filgrastim following chemotherapy. [2008.11]
Quality and quantity of mobilized peripheral blood stem cells determine the safety of tandem autologous transplants in myeloma. Using the same mobilization chemotherapy with DT-PACE in two consecutive protocols, robustness of stem cell collection and rapidity of engraftment after transplantation were assessed...
Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: a meta-analysis of randomized controlled trials. [2007.09]
CONCLUSION: A single dose of pegfilgrastim performed better than a median of 10-14 days of filgrastim in reducing FN rates for patients undergoing myelosuppressive chemotherapy.
Pegfilgrastim as hematopoietic support for dose-dense chemoimmunotherapy with R-CHOP-14 as first-line therapy in elderly patients with diffuse large B cell lymphoma. [2007.07]
GOALS OF WORK: Recently, 6 cycles of R-CHOP-14 have been recommended as the reference standard regimen for the treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL). Pegfilgrastim has been shown to facilitate dose-dense chemotherapy schedules with a single administration per chemotherapy cycle. The aims of this study were to evaluate the use of pegfilgrastim in combination with the R-CHOP-14 regimen in a homogenous group of previously untreated elderly patients with DLBCL and to assess the pharmacokinetics of pegfilgrastim within this patient population... CONCLUSIONS: A single fixed dose of 6 mg of pegfilgrastim given once per cycle of R-CHOP-14 is effective in supporting neutrophil recovery to allow two-weekly drug administration in previously untreated elderly patients with DLBCL. However, close monitoring for infectious complications is mandatory in this patient population.
Pegfilgrastim compared with filgrastim after high-dose melphalan and autologous hematopoietic peripheral blood stem cell transplantation in multiple myeloma patients. [2006.11]
We undertook a comparative study of Pegfilgrastim vs.This study shows that a single injection Pegfilgrastim can be used with safety and efficacy similar to those provided by daily injections of Filgrastim and it is associated with a decrease incidence of infectious events after APBSCT in MM patients.
Pegfilgrastim support for full delivery of BEACOPP-14 chemotherapy for patients with high-risk Hodgkin's lymphoma: results of a phase II study. [2006.04]
The primary endpoint of this feasibility study was to determine whether pegfilgrastim support could enable the delivery of the full dose of BEACOPP chemotherapy every 14 days on schedule. Forty-one patients with high-risk Hodgkin's lymphoma were randomized to receive pegfilgrastim (6 mg) on day 4 or 8 of each cycle...
Clinical Trials Related to Neulasta (Pegfilgrastim)
Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma [Completed]
In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for
autologous transplantation. One of the cited advantages of this procedure is the avoidance of
bone marrow harvest, which frequently requires general anesthesia. Other advantages include
faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the
amount of tumor contamination and technical ability to obtain stem cells from patients
previously considered unharvestable because of marrow fibrosis or because of prior
radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell
mobilization based on its safety profile and the positive experience in granulocyte donors
however, the number of circulating CD34+ cells does not occur until the third day after
starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of
neutrophil precursors and enhances the functions of mature neutrophils in the same manner as
filgrastim. Data form normal volunteers and in studies of patients with cancer have shown
prolonged serum levels of the cytokine, with "self-regulation" of pegfilgrastim levels as a
function of the neutrophil count. This confers a therapeutic advantage in clinical settings
by allowing a less frequent dosing.
Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer [Active, not recruiting]
The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in
supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell
growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in
chemotherapy recipients.
Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy [Completed]
The purpose of this study is to estimate the relationship between patient reported outcomes
(PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with
or without Neulasta® (pegfilgrastim).
Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim (Neulasta) in Subjects With Advanced Colon Cancer [Active, not recruiting]
The purpose of this research study is to evaluate the safety and effectiveness of
pegfilgrastim in reducing infection when given after one of three chemotherapy regimens
(FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer.
This study is considered to be "investigational" because the time between receiving
pegfilgrastim and the next cycle of chemotherapy is only 11 days.
Pegfilgrastim PBPC Mobilization Study [Completed]
This is a randomized, double-blind, multi-center study to assess the safety and effectiveness
of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily
subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation
in patients with Hodgkin's or non-Hodgkin's lymphoma.
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