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/Toxicities of treatment
Supportive measures
Breast Cancer
Therapy
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.