1494P - Safety and tolerability of lipegfilgrastim (Lipeg) and pegfilgrastim (Peg) in breast cancer patients receiving chemotherapy (CTx): an integrated an...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Supportive Care
Breast Cancer
Presenter Igor Bondarenko
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors I. Bondarenko1, P. Bias2, U. Müller3, A. Buchner2
  • 1City Clinical Hospital N 4, Dnepropetrovsk Medical Academy, 49102 - Dnepropetrovsk/UA
  • 2Clinical Research, Teva ratiopharm, Ulm/DE
  • 3Biosimilars Global Medical Directors Group - Global Medical Affairs, Teva Pharmaceuticals, 89079 - Ulm/DE

Abstract

Aim

This analysis presents the combined tolerability data from 2 studies (phase II and III) of Lipeg and Peg in CTx-naïve breast cancer patients.

Methods

Patients who received 4 cycles of CTx (doxorubicin 60 mg/m2+docetaxel 75 mg/m2) and a single 6-mg subcutaneous injection of Lipeg or Peg were included. The analysis included incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to death across all 4 cycles of CTx stratified by age groups (≤55 and >55 years of age [y]) and compared within each treatment group.

Results

A total of 151 patients treated with Lipeg (n = 106 ≤55 y and n = 45 >55 y) and 155 patients treated with Peg (n = 104 ≤55 y and n = 51 >55 y) were included. The percentage of patient experiencing AEs was similar regardless of age within each treatment group: 96.2% (≤55 y) vs 91.1% (>55 y) in Lipeg patients and 89.4% (≤55 y) vs 88.2% (>55 y) in Peg patients. The incidence of the most commonly occurring AEs stratified by age group within each treatment were: alopecia, 77.4% vs 84.4% and 71.2% vs 70.6%; nausea, 57.5% vs 48.9% and 51.0% vs 49.0%; asthenia, 29.2% vs 24.4% and 22.1% vs 29.4%; neutropenia, 21.7% vs 15.6% and 24.0% vs 19.6%; and bone pain, 18.9% vs 8.9% and 14.4% vs 13.7% for Lipeg patients ≤55 y vs >55 y and Peg patients ≤55 y vs >55 y, respectively. The most commonly occurring SAE was febrile neutropenia (2.7% [≤55 y] vs 3.1% [>55 y] for Lipeg and 4.1% [≤55 y] vs 2.9% [>55 y] for Peg). Additional SAEs included 1 event each of: leukocytosis, stomatitis, and asthenia, Lipeg ≤55 y; epistaxis and enterocolitis, Lipeg >55 y; uterine leiomyoma, anemia, tachycardia paroxysmal, deep vein thrombosis, enterocolitis, metrorrhagia, and pyrexia, Peg ≤55 y; and bronchitis, Peg >55 y. One AE resulted in death, entercolitis in a Lipeg patient >55 y.

Conclusions

The incidence of nausea, neutropenia, and bone pain in the Lipeg group was lower in patients >55 y vs those ≤55 y and the incidence of alopecia was greater in patients >55 y vs those ≤55 y. The incidence of asthenia in the Peg group was greater in patients >55 y vs those ≤55 y. SAEs were greater in Lipeg patients >55 y vs those ≤55 y, whereas Peg patients >55 y had fewer SAEs vs those ≤55 y.

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.