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Randomized Controlled Trial
. 2012 Mar;138(3):513-7.
doi: 10.1007/s00432-011-1116-8. Epub 2011 Dec 25.

Early versus late administration of pegfilgrastim after high-dose chemotherapy and autologous hematopoietic stem cell transplantation

C Kahl  1 , H G Sayer, A Hinke, M Freund, J Casper
Affiliations
Randomized Controlled Trial

Early versus late administration of pegfilgrastim after high-dose chemotherapy and autologous hematopoietic stem cell transplantation

C Kahl et al. J Cancer Res Clin Oncol. 2012 Mar.

Abstract

Purpose: Single-dose pegylated filgrastim (pegfilgrastim) after autologous hematopoietic stem cell transplantation (AHSCT) showed similar efficacy compared to daily lenograstim. To address the question of the optimal application time, we randomly assigned patients (pts) to pegfilgrastim on day + 1 (Peg1) or day + 4 (Peg4) after AHSCT.

Method: Fifty-three pts with different hematological malignancies were included in this prospective randomized multicenter study. Primary endpoint of this study was time to neutrophil recovery (>500 Gpt/l), and secondary endpoint was time to neutrophil recovery (>1,000 Gpt/l), platelet recovery (>20,000 Gpt/l), number and duration of febrile episodes, i.v. antibiotics, and number of transfusions. Time to engraftment endpoints were estimated according to Kaplan-Meier.

Results: Median time to neutrophil recovery (>500 Gpt/l) was 10 days (95% CI: 10-11) in Peg1 versus 10 days (95% CI: 10-11) in Peg4 (P = 0.68, logrank test; hazard ratio: 0.93). The corresponding mean values were 10.2 and 10.4 days. Median time to platelet recovery (>20,000 Gpt/l) was 10 (95% CI: 10-11) in Peg1 versus 10 (95% CI: 9-11) in Peg4, again not significantly different (P = 0.54). There was no difference regarding the incidence (67% vs. 60%, P = 0.77, Fisher's exact test) or duration of febrile neutropenia episodes in both groups (median: 1 vs. 1; mean: 2.8 vs. 2.4 days; P = 0.73, Wilcoxon test).

Conclusion: In terms of neutrophil or platelet recovery after AHSCT, number and duration of febrile episodes, the use of i.v. antibiotics, early and late administration of pegfilgrastim are equally effective.

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Figures

Fig. 1
Fig. 1
Days to granulocyte engraftment >500/μl (fat line: Peg1, median 10 days, fine line: Peg 4, median 10 days, logrank test P = 0.68)
Fig. 2
Fig. 2
Days to granulocyte engraftment >1,000/μl (fat line: Peg1, median 10 days, fine line: Peg 4, median 11 days, logrank test P = 0.74)
Fig. 3
Fig. 3
Days to platelet engraftment >20,000 Gpt/l (fat line: Peg1, median 10 days, fine line: Peg 4, median 10 days, logrank test P = 0.54)
Fig. 4
Fig. 4
Days to platelet engraftment >50,000 Gpt/l (fat line: Peg1, median 16 days, fine line: Peg 4, median 17 days, logrank test P = 0.63)
See this image and copyright information in PMC

References

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