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

Russell, Nigel H.; Mesters, Rolf M.; Schubert, Jöerg; Boogaerts, Marc; Johnsen, Hans Erik; Cañizo, Consuelo del; Baker, Nigel; Barker, Philippa; Skácel, Tomáš; Schmitz, Norbert

doi:10.3324/haematol.11287

Cited by 56 publications

(63 citation statements)

References 19 publications

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“…In this study, 24 of 25 patients achieved a target CD34 þ cell dose of 2.0 Â 10 6 /kg in a single apheresis procedure. Mobilization with both filgrastim and pegfilgrastim 6 or 12 mg has also been reported by Russell et al 21 following ifosfamide, carboplatin and etoposide chemotherapy. What remains unclear is whether the 14-day interval between the first and second mobilization attempts was insufficient to allow haematopoietic potential to have been restored.…”

Section: Discussionmentioning

confidence: 80%

Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours

Willis

Woll

Theti

et al. 2009

Bone Marrow Transplant

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The efficacy of pegfilgrastim±chemotherapy for mobilizing stem cells in patients with solid tumours was assessed. In cycle 0, a 14-day prechemotherapy cycle, patients (N ¼ 61) were randomized open-label to single doses of pegfilgrastim (6, 12 or 18 mg) on day 1, or daily filgrastim (10 lg/kg) for p7 days. Mean peak peripheral CD34 þ cell counts increased with pegfilgrastim dose, but were significantly higher than filgrastim only at the 18 mg dose (10.17 vs 4.96 Â 10 4 /ml; P ¼ 0.014). In the clinically relevant period of days 3-7, both 12 and 18 mg pegfilgrastim doses produced significantly higher peak CD34 þ counts (8.18 and 9.96 vs 4.51 Â 10 4 /ml for filgrastim; P ¼ 0.034 and 0.006). In cycle 1, patients received carboplatin/paclitaxel on day 1, followed from day 2 by pegfilgrastim 6-18 mg or daily filgrastim (5 lg/ kg/day for p14 days) as per randomization in cycle 0. There were no significant differences in mean peak CD34 þ count between pegfilgrastim and filgrastim, but there was an advantage for pegfilgrastim 18 mg in the relevant period of days 7-12 (3.14 vs 1.19 Â 10 4 /ml; P ¼ 0.043). A single pegfilgrastim dose (X6 mg) could be substituted for daily filgrastim in cytokine-only peripheral CD34 þ cell mobilization.

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Section: Discussionmentioning

confidence: 80%

Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours

Willis

Woll

Theti

et al. 2009

Bone Marrow Transplant

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“…In healthy volunteers and donors, in contrast to postchemotherapy mobilization, 12 pegfilgrastim efficacy is strongly dose-dependent in terms of CD34 þ cell mobilization. 5,21 In patients with malignancy, the drawback to increasing the dose of pegfilgrastim is that it leads to sustained BM stimulation, which could delay chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…As far as pegfilgrastim is concerned, after chemotherapy the dose of 100 mg/kg has been proposed on the basis of several studies showing that a dose of 100 mg/kg of pegfilgrastim is comparable to a daily administration of 5 mg/kg filgrastim in terms of neutrophil recovery. 12 Hence, in the steady state, there is a rationale for increasing this dose in order to target stem cell mobilization. In healthy volunteers, pharmacokinetic studies have shown that the dose of 300 mg/kg is well tolerated and more efficient than 100 mg/kg for CD34 þ cell mobilization.…”

Section: Mobilization and Collection Regimensmentioning

confidence: 99%

Hematopoietic progenitor cell mobilization and harvesting in children with malignancies: do the advantages of pegfilgrastim really translate into clinical benefit?

Merlin

Zohar

Jérome³

et al. 2008

Bone Marrow Transplant

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International audienceOur purpose was to assess success rates in children of achieving optimal hematopoietic progenitor cells (HPCs) harvest after mobilization with 300 microg/kg pegfilgrastim. Between January 2005 and January 2007, 26 children with solid malignancies who were referred for HPC collection were consecutively included. Hematopoietic progenitor cell mobilization consisted of one s.c. injection of 300 microg/kg body weight (BW) of pegfilgrastim. The success criterion was defined as at least 5 x 10(6) CD34+ cells/kg during the first standard apheresis (less than 3 blood volumes processed (BVP)). After 26 inclusions, the Bayesian analysis gave a mean estimated success rate of 60.7% (95% credibility interval: 42.0-78.0%). The first apheresis allowed the collection of 8.3 x 10(6) CD34+ cells/kg BW (range 0.6-37.8), with a median of 2.8 BVP (range 1.4-3.0). Overall, the median of CD34+ cells collected was 12.4 x 10(6)/kg (range 2.7-37.8). The cumulative dose of anthracyclin was the only variable associated with the total number of CD34+ collected cells (P<0.05). Mobilization was clinically well tolerated in 20 patients. No drug-related adverse events of grade > or =3 occurred. We conclude that a single injection of 300 microg/kg pegfilgrastim in the hematological steady state is an efficient and well-tolerated method of HPC mobilization in children with solid malignancies

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“…This finding is consistent with the results of a recently published, blinded, placebo-controlled multicentre study conducted in patients with malignant lymphoma. 20 These results can be explained by the observation that a single in vivo injection of 6 mg pegfilgrastim in neutropenic patients with multiple myeloma results in plasma concentrations of B100 ng/ml, which are maintained until the time of regeneration of the neutrophilic granulocytes. 21 The levels are thus about 1-log factor higher than those achieved after administration of conventional doses of non-pegylated G-CSF, which, in turn, are 2-log factors higher than the endogenous levels of G-CSF in neutropenic patients.…”

Section: Introductionmentioning

confidence: 98%