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Prophylactic long-acting granulocyte-colony stimulating factors (G-CSF) in gynecologic malignancies: an oncologic expert statement

Prophylaxe mit langwirksamen Granulozyten-Kolonie-stimulierenden Faktoren (G-CSF) bei gynäkologischen Malignomen

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Summary

We reviewed the status of the use of the prophylactic long-acting granulocyte colony-stimulating factors (G-CSFs) pegfilgrastim and lipegfilgrastim in gynecologic malignancies. Long-acting G-CSFs should not be used in weekly regimens. Filgrastim is not indicated in patients with febrile and/or severe neutropenia after administration of long-acting G-CSF in the same cycle. One study has shown a moderate effect on febrile neutropenia of ciprofloxacin when co-administered with pegfilgrastim. There is broad evidence from meta-analyses that pegfilgrastim effectively reduces severe neutropenia. In parallel, its adverse effects have been studied extensively. All-cause mortality was significantly reduced by pegfilgrastim. The glycopegylated long-acting G-CSF, lipegfilgrastim has demonstrated antineutropenic efficacy similar to that of pegfilgrastimin in one breast cancer study. In another pivitol non-small cell lung cancer study, impaired survival was observed in the lipegfilgrastim group during the first 30 days of study. The European Medicines Agency claimed more profound safety data to be provided for lipegfilgrastim by 2017.

Zusammenfassung

Der aktuelle Status der prophylaktischen langwirksamen Granulozyten Kolonie-stimulierender Faktoren (G-CSFs) Pegfilgrastim and Lipegfilgrastim bei gynäkologischen Malignomen wurde zusammengefasst. Langwirksame G-CSFs sollten nicht bei wöchentlichen Chemotherapien angewendet werden. Konventionelles Filgrastim ist bei Patienten mit febriler und/oder schwerer Neutropenie nach Anwendung langwirksamer G-CSF im gleichen Zyklus nicht indiziert. Eine Studie hat einen moderaten Effekt der Begleittherapie von Ciprofloxacin zusätzlich zu Pegfilgrastim auf die febrile Neutropenie gezeigt. Es existiert breite Evidenz auf der Basis großer Studien und Metaanalysen, dass Pegfilgrastim die schwere Neutropenie signifikant reduziert. Parallel wurden seine Nebenwirkungen wie Knochenschmerzen im Detail untersucht. Die Gesamtmortalität wird durch Pegfilgrastim signifikant reduziert. Das andere glykopegylierte langwirksame G-CSF, Lipegfilgrastim, hat eine Pegfilgrastim vergleichbare antineutropenische Effektivität in einer Brustkrebsstudie gezeigt. In der anderen Zulassungsstudie beim nichtkleinzelligen Bronchuskarzinom wurde während der ersten 30 Tage der Studie gegenüber Plazebo ein schlechteres Überleben in der Lipegfilgrastimgruppe beobachtet. Die Europäische Medizinagentur fordert daher vertiefte Sicherheitsdaten für Lipegfilgrastim bis 2017.

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Authors and Affiliations

  1. Division of Gynecology, Department of Obstetrics and Gynecology, Medical University of Graz, Auenbruggerplatz 14, 8036, Graz, Austria

    Edgar Petru & Christoph Benedicic MD

  2. Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria

    Christian F. Singer MD, Stephan Polterauer MD, Michael Seifert MD & Alexander Reinthaller MD

  3. Department of Obstetrics and Gynecology, Hanuschkrankenhaus, Vienna, Austria

    Arik Galid MD

  4. Department of Gynecology, Hospital Barmherzige Brüder Graz, Graz, Austria

    Christian Schauer MD

  5. Department of Internal Medicine, Klinikum Klagenfurt, Klagenfurt, Austria

    Johann Klocker MD

  6. Department of Obstetrics and Gynecology, Medical University of Innsbruck, Innsbruck, Austria

    Michael Hubalek MD, Christian Marth MD & Alain-Gustave Zeimet MD

  7. Department of Gynecology, Hospital Barmherzige Schwestern, Linz, Austria

    Lukas Hefler MD

  8. Department of Obstetrics and Gynecology, Wilhelminenspital, Vienna, Austria

    Tonja Scholl-Firon MD

  9. Department of Obstetrics and Gynecology, Paracelsus University of Salzburg, Salzburg, Austria

    Gerhard Bogner MD

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  1. Edgar Petru
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Petru, E., Singer, C., Polterauer, S. et al. Prophylactic long-acting granulocyte-colony stimulating factors (G-CSF) in gynecologic malignancies: an oncologic expert statement. Wien Med Wochenschr 165, 387–394 (2015). https://doi.org/10.1007/s10354-015-0392-3

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