Single Dose Pegfilgrastin (SD/01) Is as Effective as Daily Filgrastim Following ESHAP Chemotherapy for Subjects wtih Non-Hodgkin's Lymphoma or Hodgkin's Disease: Results of a Randomized, Open-Label Study

Reviewer: Mary Kara Bucci, MD
The Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 11 de diciembre del 2001

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Presenter: Julie M. Vose
Presenter's Affiliation: University of Nebraska Medical Center, Omaha, NE
Type of Session: Scientific

Background
Pegfilgrastim is a pegylated form of filgrastim that has previously been shown to safely and effictively improve neutrophil counts and decrease neutropenia-related complications in patients receiving chemotherapy. In this randomized, open-label Phase II study, single dose pegfilgrastin is directly compared to daily injections of filgrastim to evaluate safety and efficacy following ESHAP chemotherapy in patients with non-Hodgkin's lymphoma (NHL) and Hodgkin's Disease (HD).

Materials and Methods

  • 60 patients with relapsed or refractory NHL or HD were randomized to received a single sub-cutaneous injection of pegfilfrastim (100 ug/kg)or daily sub-cutaneous injections of filgrastim (5ug/kg/day).
  • The primary endpoint of this study was the duration of severe neutropenia (DSN) curing cycle 1, with severe neutropenia defined as Grade 4 neutropenia, absolute neutrophil count < 500 x 10 6 cells/L.

    Results

  • Patient characteristics including age, ECOG performance status, and prior chemotherapy or radiotherapy were similar between the two groups. 87% of filgrastin patients and 66% of pegfilgrastin patients had Stage III-IV disease.
  • Pegfilgrastim patients received a median of 1 injection vs 11 injections for filgrastim patients.
  • Grade IV neutropenia occurred in 68% of the filgrastim patients and 69% of the pegfilgrastim patients (no significant difference)
  • The duration of the severe neutropenia was (mean) 2.4 days for filgrastim patients vs. 2.8 days for pegfilgrastim (no significant difference)
  • Absolute neutrophil count (ANC) nadir was 161 for Pegfilgrastim patients, with a median time to recovery (ANC>2.0 x 10 9/L) of 13 days. ANC nadir for filgrastim patients was 208, with a median 14 days to recovery.
  • Chemotherapy dose reductions were necessary for 4 pegfilgrastim patients during the first cycle and 4 during the second cycle, and for 2 filgrastim patients during the first and 2 during the second cycles.
  • There was no difference in cytokine-related bone pain between the two groups.
  • Late adverse effects such as neuropathy and tinnitis were related to chemotherapy, not pegfilgrastim or filgrastim, and did not differ significantly between the two groups.

    Author's Conclusions

  • The authors conclude that a single subcutaneous injection of pegfilgrastim is as safe and as effective as multiple doses of filgrastim for chemotherapy induced neutropenia.

    Clinical/Scientific Implications
    The possibility of a single injection per chemotherapy cycle as opposed to multiple injections is advantageous for many reasons, including compliance and quality of life. Large, Phase III studies are needed to verify the findings from this study.

    Oncolink's ASH Coverage made possible by an unrestricted Educational Grant from Amgen.


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