Efficacy of Lipegfilgrastim (Lipeg) and Pegfilgrastim (Peg) in Breast Cancer Patients Receiving Chemotherapy (Ctx) Stratified By Status, Age, and Disease Stageby Status, Age, and Disease Stage

Abstract

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