Randomized, Multicenter, Open-Label Study of Pegfilgrastim Compared With Daily Filgrastim After Chemotherapy for Lymphoma

Vose, Julie M.; Crump, Michael; Lazarus, Hillard M.; Emmanouilides, C.; Schenkein, David P.; Moore, Joseph O.; Frankel, S. R.; Flinn, Ian W.; Lovelace, Wade; Hackett, James; Liang, Bertrand C.

doi:10.1200/jco.2003.03.040

Cited by 167 publications

(110 citation statements)

References 22 publications

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“…As observed in previous studies, 5,17,18 adverse events associated with bone pain were most common, occurring in approximately 20% of patients in all three treatment groups.…”

Section: Discussionsupporting

confidence: 84%

A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin's lymphoma receiving chemotherapy

Russell¹,

Mesters²,

Schubert³

et al. 2008

Haematologica

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“…As observed in previous studies, 5,17,18 adverse events associated with bone pain were most common, occurring in approximately 20% of patients in all three treatment groups.…”

Section: Discussionsupporting

confidence: 84%

A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin's lymphoma receiving chemotherapy

Russell¹,

Mesters²,

Schubert³

et al. 2008

Haematologica

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“…Pegfilgrastim is a 20-kilodalton polyethylene glycol carrier of filgrastim that is covalently bound at the N-terminal residue. Randomized trials have demonstrated that a single dose of pegfilgrastim offers neutrophil support comparable to multiple once-daily doses of filgrastim (1, 2). G-CSF and pegfilgrastim are used to reduce infection risk associated with neutropenia and febrile neutropenia in patients receiving myelosuppressive chemotherapy (3).…”

Section: Introductionmentioning

confidence: 99%

Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim

Moukharskaya¹,

Abrams

Ashikaga

et al. 2016

Support Care Cancer

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Purpose Bone pain is a common side-effect of pegfilgrastim and can interfere with quality of life and treatment adherence. This study i nvestigated the impact of antihistamine prophylaxis on pegfilgrastim-induced bone pain. Methods This is a two stage enrichment trial design. Patients receiving an initial dose of pegfilgrastim after chemotherapy were enrolled into the observation stage (OBS). Those who developed significant back or leg bone pain (SP) were enrolled into the treatment stage (TRT) and randomized to daily loratadine 10 mg or placebo for 7 days. SP was defined by Brief Pain Inventory as back or leg pain score ≥ 5 and a 2 point increase after pegfilgrastim. The primary end-point of TRT was reduction of worst back or leg bone pain with loratadine, defined as 2 point decrease after treatment compared to OBS. Results 213 patients were included in the final analysis. Incidence of SP was 30.5%. The SP subset had a worse overall Functional Assessment of Cancer Therapy – Bone Pain score (33.9 vs. 51.7, p < 0.001) and a higher mean white blood cell count (15.4 vs. 8.4 K/cm3, p = 0.013) following pegfilgrastim than those without SP. 46 patients were randomized in the TRT. Benefit was 77.3% with loratadine and 62.5% with placebo (p = 0.35). Baseline NSAID use was documented in 4 patients (18.2%) in loratadine arm and 2 patients (8.3%) in placebo arm, with baseline non-NSAID use documented in 5 (22.7%) and 6 (25%) patients respectively. Eight additional patients used NSAIDS by day 8 compared to day 1 (6 in the loratadine and 2 in the placebo arm). A total of 6 additional patients used non-NSAIDS by day 8 compared to day 1 (4 in the loratadine and 2 in the placebo arm). Conclusions Administration of prophylactic loratadine does not decrease the incidence of severe bone pain or improve quality of life in a high-risk patient population.

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“…It has a prolonged terminal elimination half-life of 33 h and self-regulating serum levels as a result of neutrophil-mediated clearance [4,5]. A single dose of PEGFIL has been shown to be as effective as multiple doses of daily FIL in the management of chemotherapy-induced neutropenia [6][7][8]. There are also some reports on the use of PEGFIL for the mobilization of stem cells into peripheral blood [9][10][11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies

Putkonen

Rauhala

Pelliniemi³

et al. 2009

Ann Hematol

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To cite this version:Mervi Putkonen, Auvo Rauhala, Tarja-Terttu Pelliniemi, Kari Remes. Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies. Annals of Hematology, Springer Verlag, 2009, 88 Abstract Pegfilgrastim (PEGFIL) has been found to be comparable to daily filgrastim (FIL) in managing chemotherapy-induced neutropenia. In the present study, we evaluated the ability of PEGFIL to mobilize stem cells in 38 consecutive patients with lymphoproliferative diseases (multiple myeloma, n=18; lymphomas, n=15; chronic lymphocytic leukemia, n=5). Patients were mobilized using PEGFIL (6-18 mg as a single dose) during [2005][2006]; 32 then received high-dose chemotherapy followed by autologous stem cell transplantation. PEGFIL-mobilized patients were matched by age, disease, and treatment line at a ratio of 1:2 to historical FIL-mobilized controls. The primary study endpoint was the blood CD34 + concentration at onset of leukapheresis. Leukapheresis began a median of 10 days from the beginning of mobilization chemotherapy in both groups. At the onset of leukapheresis, median blood CD34 + cell counts did not differ significantly in the FIL group compared with the PEGFIL group (79×10 6 /L vs 64×10 6 /L, respectively; p=0.44). In the different disease categories, the respective CD34 + cell counts after FIL and PEGFIL mobilization were 72×10 6 /L vs 123×10 6 /L (p=0.08) in myeloma, 51×10 6 /L vs 62×10 6 /L (p=0.6) in lymphomas, and 27×10 6 /L vs 30×10 6 /L (p=0.62) in CLL, respectively.The target CD34 + cell yield was harvested with one leukapheresis in 53% of PEGFIL-mobilized patients. Engraftment after autografting did not differ significantly in the two groups. Stem cell mobilization with a single dose of PEGFIL was, therefore, comparable to that achieved using daily FIL in patients with lymphoproliferative diseases. PEGFIL is a more practical way to mobilize stem cells than daily FIL.

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Randomized, Multicenter, Open-Label Study of Pegfilgrastim Compared With Daily Filgrastim After Chemotherapy for Lymphoma

Cited by 167 publications

References 22 publications

A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin's lymphoma receiving chemotherapy

A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin's lymphoma receiving chemotherapy

Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim

Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies

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