1495P - Efficacy of lipegfilgrastim (Lipeg) and pegfilgrastim (Peg) in breast cancer patients receiving chemotherapy (CTx) stratified by status, age, and d...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Supportive Care
Presenter Constantin Volovat
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors C. Volovat1, P. Bias2, U. Müller3, A. Buchner2
  • 1Unknown, Centrul de Oncologie Medicala, 700106 - Iasi/RO
  • 2Clinical Research, Teva ratiopharm, Ulm/DE
  • 3Biosimilars Global Medical Directors Group - Global Medical Affairs, Teva Pharmaceuticals, 89079 - Ulm/DE

Abstract

Aim

Lipegfilgrastim is a once-per-cycle, glycoPEGylated recombinant human granulocyte colony-stimulating factor approved by the European Medicines Agency to reduce the duration of severe neutropenia (DSN) and incidence of febrile neutropenia in adult patients receiving CTx.

Methods

Breast cancer patients scheduled for CTx (doxorubicin 60 mg/m2+docetaxel 75 mg/m2 on Day 1 for up to 4 cycles) were randomized to 6-mg subcutaneous injections of Lipeg (n = 101) or Peg (n = 101) on Day 2 of each cycle. Post-hoc analyses compared efficacy outcomes during CTx cycle 1 within treatment groups stratified by Eastern Cooperative Oncology Group (ECOG) status, age (≤50 and >50 years of age [y]), and disease stage at baseline.

Results

The DSN within treatment groups was comparable regardless of ECOG status (0.7 vs 0.7 days [d] for Lipeg and 0.8 vs 0.9 d for Peg, status 0 vs 1, respectively) or age (0.6 vs 0.7 d for Lipeg and 0.8 vs 0.9 d for Peg, ages ≤50 y vs >50 y, respectively), but shorter in stage IV Lipeg-treated patients (0.7, 0.7, 0.4 d for Lipeg and 0.7, 0.9, 0.9 d for Peg, stages II, III, IV, respectively). The incidence of severe neutropenia (SN) was comparable regardless of ECOG status (45.5% vs 42.0% for Lipeg and 50.0% vs 52.1% for Peg, status 0 vs 1, respectively), higher in patients >50 y within both treatments (40.7% vs 47.5% for Lipeg and 47.7% vs 54.0% for Peg, ≤50 y vs >50 y, respectively), and lower within both treatment groups in stage IV patients (44.7%, 45.7%, 30.0% for Lipeg and 51.4%, 52.3%, 46.7% for Peg, stages II, III, IV, respectively). Time to ANC recovery was similar regardless of ECOG status (5.9 vs 5.8 d for Lipeg and 7.1 vs 7.7 d for Peg, status 0 vs 1, respectively), shorter in Lipeg patients ≤50 y (5.5 vs 6.4 d for Lipeg and 7.5 vs 7.3 d for Peg, ≤50 y vs >50 y, respectively), and similar regardless of disease stage (5.6, 6.0, 6.0 d for Lipeg and 7.0, 7.6, 7.7 d for Peg, stages II, III, IV, respectively).

Conclusions

Within treatment groups, ECOG status did not affect DSN, incidence of SN, or time to ANC recovery. Age did not influence DSN or time to ANC recovery; however, more patients >50 y had SN vs those ≤50 y. DSN was shorter and SN was lower in stage IV patients.

Disclosure

P. Bias: TEVA employee and receives stock options; U. Müller: TEVA employee and receives stock options; A. Buchner: TEVA employee and receives stock options. All other authors have declared no conflicts of interest.