Pegfilgrastim and daily granulocyte colony-stimulating factor: patterns of use and neutropenia-related outcomes in cancer patients in Spain - results of the LEARN Study

Abstract

Daily granulocyte colony-stimulating factors [(G-CSFs); e.g. filgrastim, lenograstim] are frequently used to reduce the duration of chemotherapy-induced neutropenia (CIN) and the incidence of febrile neutropenia (FN) in cancer patients. A pegylated formulation of filgrastim, pegfilgrastim, which is administered once per cycle, was introduced in Spain in 2003. LEARN was a multi-centre, retrospective, observational study in Spain comparing patterns of use of daily G-CSF and pegfilgrastim, and CIN-related outcomes in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy. Outcome measures were the percentage of patients receiving G-CSF for primary prophylaxis versus secondary prophylaxis/treatment, duration of treatment with G-CSF and incidence of CIN-related complications. Medical records from consecutive patients with documented pegfilgrastim (n = 75) or daily G-CSF (n = 111) use during 2003 were included. The proportion of patients receiving primary or secondary prophylaxis was comparable between the pegfilgrastim (39 and 48% respectively) and daily G-CSF (40 and 48% respectively) groups. However, there was a trend towards less frequent use to treat a neutropenic event such as FN or neutropenia in the pegfilgrastim group (17 versus 30% with daily G-CSF). Chemotherapy-induced neutropenia-related complications were less frequent in patients receiving pegfilgrastim (e.g. FN 11 versus 24% with daily G-CSF). This is the first study to show the potential benefits of pegfilgrastim over daily G-CSF in Spanish clinical practice.

Prevention and Treatment of Chemotherapy-Induced Neutropenia with the Biosimilar Filgrastim: A Non-Interventional Observational Study of Clinical Practice Patterns

“…However, the type of patients (i.e. predominantly breast cancer) and usage observed are largely consistent with those of other observational studies, and there is no evidence to suggest a widely divergent use of G-CSFs between countries [2,8,9,10,11]. …”

“…This is likely to be most important in patients where dose-dense or dose-intense chemotherapy strategies have survival benefits. However, as others have shown, data on adherence to guidelines in clinical practice are often lacking [2,8,9,10]. The cost of G-CSF treatment may be a contributory factor here and increased availability of more affordable biosimilars may help to achieve optimal use of G-CSFs.…”

“…age ≥ 65 years, advanced disease, history of previous febrile neutropenia) [1,6,7]. However, data from real-world practice settings have indicated that administration of filgrastim does not always concur with guidelines, with patients either not treated or given shortened courses [2,8,9,10,11]. Such suboptimal use of filgrastim is associated with poorer outcomes; for example, the risk of hospitalization for neutropenia or infection has been reported to decline with each additional day of G-CSF prophylaxis in patients with various types of cancer [12].…”

Chemotherapy treatment patterns and neutropenia management in gastric cancer

“…In addition, patients given G-CSF primary prophylaxis were more frequently given pegfilgrastim than filgrastim or lenograstim. Of those given daily G-CSF, the mean length of administration was only 5.2 days, which has previously been established to provide lower protection than one dose of pegfilgrastim [24][25][26][27]. Of those who received the DCF regimen, the use of G-CSF primary prophylaxis was higher, though a full 30 % of patients were not administered protection against neutropenia.…”

Prevention of neutropenia during chemotherapy by prolonged myelostimulatory preparations

“…Частота развития ФН у пациентов, получавших пэгфилграстим с ципрофлоксацином или без него (5 и 7 % соответственно), оказалась статистически зна-чимо меньше (р < 0,01), чем у больных, получавших ципрофлоксацин (22 %) или непегилированные Г-КСФ (18 %). Схожие результаты (снижение частоты ФН с 24 % в группе непегилированного Г-КСФ до 11 % в группе пэгфилграстима) были получены и в другом ретроспективном исследовании, включившем 186 больных с различными солидными опухолями и не-миелоидными гематологическими новообразования-ми [34].…”