A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind, phase 2 trial
2008

Comparing Pegfilgrastim and Filgrastim for Neutrophil Recovery in AML

Sample size: 84 publication 10 minutes Evidence: moderate

Author Information

Author(s): Sierra Jorge, Szer Jeffrey, Kassis Jeannine, Herrmann Richard, Lazzarino Mario, Thomas Xavier, Noga Stephen J, Baker Nigel, Dansey Roger, Bosi Alberto

Primary Institution: Division of Clinical Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Hypothesis

Is a single dose of pegfilgrastim as effective as daily filgrastim for neutrophil recovery in patients with acute myeloid leukemia?

Conclusion

There is no clinically meaningful difference between a single dose of pegfilgrastim and multiple daily doses of filgrastim for shortening the duration of severe neutropenia following chemotherapy in AML patients.

Supporting Evidence

  • Both treatment groups had similar median times to recovery from severe neutropenia.
  • Pegfilgrastim was well tolerated with an adverse event profile similar to filgrastim.
  • The study included 84 patients from 27 sites across Australia, Europe, and North America.

Takeaway

This study looked at two medicines that help patients recover from low white blood cell counts after chemotherapy. It found that one dose of pegfilgrastim works just as well as taking filgrastim every day.

Methodology

Patients received standard induction chemotherapy followed by either pegfilgrastim or filgrastim to assist neutrophil recovery.

Potential Biases

Potential bias due to early termination of the study and patient withdrawals.

Limitations

The study was prematurely closed, which may have affected the power and generalizability of the results.

Participant Demographics

Patients aged 18 and older with de novo AML, with a median age of 51 years for pegfilgrastim and 54 years for filgrastim.

Statistical Information

P-Value

0.5

Confidence Interval

95% CI: -1.9 to 1.9

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-2407-8-195

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