Protroca: a non-interventional study on prophylaxis of chemotherapy induced neutropenia using Lipegfilgrastim in non-selected breast cancer patients

R Wuerstlein; N Harbeck; EM Grischke; D Forstmeyer; R von Schumann; P Krabisch; K Lüdtke-Heckenkamp; A Stefek; O Stoetzer; A Grafe; U Nitz; O Gluz; M Rahbari; R Kates; M Graeser

doi:10.1055/s-0039-1688077

Senologie - Zeitschrift für Mammadiagnostik und -therapie, Table of Contents

Senologie - Zeitschrift für Mammadiagnostik und -therapie 2019; 16(02): e46-e47
DOI: 10.1055/s-0039-1688077

Abstracts

Georg Thieme Verlag KG Stuttgart · New York

Protroca: a non-interventional study on prophylaxis of chemotherapy induced neutropenia using Lipegfilgrastim in non-selected breast cancer patients

Authors

R Wuerstlein

¹Breast Center and CCC Munich, Department OB & GYN, Munich, Deutschland

²West German Study Group, Moenchengladbach, Deutschland
N Harbeck

²West German Study Group, Moenchengladbach, Deutschland

³Breast Center and CCC Munich, Dept. OB&GYN, Munich, Deutschland
EM Grischke

⁴University Clinic Tuebingen, Women's Clinic, Tuebingen, Deutschland
D Forstmeyer

⁵University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig, Deutschland
R von Schumann

⁶Evangelical Hospital Bethesda, Breast Center Niederrhein, Moenchengladbach, Deutschland
P Krabisch

⁷Clinic Chemnitz, Breast Center, Chemnitz, Deutschland
K Lüdtke-Heckenkamp

⁸Niels-Stensen Clinics, Franziskus Hospital Harderberg, Georgsmarienhuette, Deutschland
A Stefek

⁹Johanniter Clinics Stendal, Breast Center Altmark, Stendal, Deutschland
O Stoetzer

¹⁰Medical Center for Hematology and Oncology Munich, Munich, Deutschland
A Grafe

¹¹MVZ Nordhausen, Nordhausen, Deutschland
U Nitz

²West German Study Group, Moenchengladbach, Deutschland

⁶Evangelical Hospital Bethesda, Breast Center Niederrhein, Moenchengladbach, Deutschland
O Gluz

¹²West German Study Group, Breast Center Niederrhein, Moenchengladbach, Deutschland

¹³Evangelical Hospital Bethesda, Moenchengladbach, Deutschland

¹⁴University Hospital Cologne, Cologne, Deutschland
M Rahbari

²West German Study Group, Moenchengladbach, Deutschland
R Kates

²West German Study Group, Moenchengladbach, Deutschland
M Graeser

²West German Study Group, Moenchengladbach, Deutschland

⁶Evangelical Hospital Bethesda, Breast Center Niederrhein, Moenchengladbach, Deutschland

Abstract

Full Text

Background:

WSG (West German Study Group)-Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer (BC) patients receiving neo-adjuvant or adjuvant treatment in routine praxis.

Methods:

Eligibility: histologically confirmed BC patients, age ≥18 years, prior or concurrent neo-adjuvant or adjuvant treatment with dose-dense chemotherapy, or moderate risk chemotherapy with risk factors (age > 65 years, severe co-morbidities). Primary endpoint: occurrence rate of febrile neutropenia (FN) and/or severe infection (SI) (grade 3 – 4). Secondary endpoints: i.a., adverse events (AEs) and serious adverse events (SAEs) related to Lonquex®.

Results:

Of the 255 enrolled patients (2015 – 2017), 248 patients were evaluable for the intent to treat (ITT) set (222 and 26 patients with primary and secondary prophylaxis, respectively). 5 patients of the ITT set receiving Lonquex® as primary prophylaxis had FN grade 3 – 4 (2.3%). Regarding SI, 5 patients of the ITT population (2.0%) had an infection of grade 3 – 4; 4 patients got primary prophylaxis (1.8%) and one received secondary prophylaxis (3.9%). 67.6% (84.6%) and 6.3% (11.5%) of ITT patients with primary (secondary) prophylaxis exhibited AEs and SAEs, respectively. 10.8% (92/851 AEs) and 8% (2/25 SAEs of 851 AEs) of documented AEs and SAEs, respectively, were related to Lonquex®.

Conclusions:

The application of Lonquex® was effective as primary and secondary prophylaxis in the prevention of chemotherapy-induced neutropenia. Adverse drug reactions and AEs were in line with the Lonquex® summary of product characteristics and chemotherapy, respectively; no new toxicities were identified.