1548PD - Absolute neutrophil counts in a study of lipegfilgrastim compared with pegfilgrastim in patients with breast cancer who are receiving chemotherapy

Date 30 September 2012
Event ESMO Congress 2012
Session Supportive and palliative care: Controlling disease and treatment side-effects
Topics Supportive Care
Breast Cancer
Presenter Oleg Gladkov
Authors O.A. Gladkov1, I. Bondarenko2, R. Elsaesser3, A. Buchner4, P. Bias4
  • 1Chemotherapy, Regional Oncology Center, 454004 - Chelyabinsk/RU
  • 2Oncology, Dnipropetrovsk State Medical Academy, Dnipropetrovsk/UA
  • 3Biostatistics, Teva ratiopharm, Ulm/DE
  • 4Clinical Research, Teva ratiopharm, Ulm/DE

Abstract

Background

Cancer chemotherapy frequently causes neutropenia, leading to an increased risk of infections and delays in subsequent chemotherapy treatments. In a randomized, double-blind, phase 3, active-controlled, noninferiority trial, the efficacy and safety of lipegfilgrastim, a glycosylated and pegylated recombinant granulocyte colony stimulating factor (G-CSF), was compared with pegfilgrastim, a pegylated recombinant G-CSF. Here we report the results of the absolute neutrophil counts (ANC) from this study.

Methods

Patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5x109 cells/L were randomly assigned to lipegfilgrastim 6 mg (n = 101) or pegfilgrastim 6 mg (n = 101). Study medication was injected subcutaneously on day 2 of the chemotherapy cycle (4 cycles maximum). The primary efficacy endpoint, the duration of severe neutropenia, was reported previously. Secondary endpoints included ANC nadir and time to ANC recovery and were analyzed using a Poisson regression. The intent-to-treat (ITT) analysis population included all randomized patients.

Results

ANC nadir and time to ANC recovery for cycle 1 (ITT population) are summarized in the table.

Measurement Lipegfilgrastim(n = 101) Pegfilgrastim(n = 101) LS Mean Difference(95% CI), p value
Depth of ANC nadir (109/L)
Mean (SD) 1.2 (1.3) 1.0 (1.2) 0.146 (-0.169 to 0.461)
Median (range) 0.6 (0.0 to 5.5) 0.4 (0.0 to 5.2) p = 0.3610
Time to ANC recovery (days)
Mean (SD) 5.8 (3.3) 7.4 (3.6) −1.570 (-2.547 to −0.592)
Median (range) 7.0 (0.0 to 12.0) 8.0 (0.0 to 21.0) p = 0.0018

Conclusions

Patients who received lipegfilgrastim had significantly faster time to ANC recovery than those who received pegfilgrastim.

Disclosure

O.A. Gladkov: Investigator in Teva-sponsored studies,

I.M. Bondarenko: Investigator in Teva-sponsored studies

R. Elsaesser: Employee of Teva Pharmaceuticals and own Teva Pharmaceuticals stock,

A. Buchner: Employee of Teva Pharmaceuticals and own Teva Pharmaceuticals stock,

P. Bias: Employee of Teva Pharmaceuticals and own Teva Pharmaceuticals stock.