Antroula Papakonstantinou1,2, Elham Hedayati1,2, Mats Hellström3, Hemming Johansson3, Michael Gnant4,5, Günther Steger5,6,7, Richard Greil5,8, Michael Untch9, Volker Moebus10, Sibylle Loibl11, Theodoros Foukakis1,2, Jonas Bergh1,2, Alexios Matikas1,2. 1. Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. 2. Breast Cancer, Endocrine Tumours and Sarcoma Section, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden. 3. CKC, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden. 4. Department of Surgery, Medical University of Vienna, Vienna, Austria. 5. Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria. 6. Department of Medical Oncology, Medical University, Vienna, Austria. 7. Gaston H. Glock Research Center, Medical University, Vienna, Austria. 8. IIIrd Medical Department, Cancer Cluster Salzburg, Salzburg Cancer Research Institute, Paracelsus Medical University Salzburg, Salzburg, Austria. 9. Department of Obstetrics and Gynecology, Helios Klinikum Berlin-Buch, Berlin, Germany. 10. Department of Gynecology and Obstetrics, Klinikum Frankfurt Höchst, Academic Hospital of the Goethe University, Frankfurt, Germany. 11. German Breast Group, Neu-Isenburg, Germany.
Abstract
Introduction: Myelosuppresion is a common side effect of chemotherapy and granulocyte-colony stimulating factor (G-CSF) is often used to reduce the risk of neutropenic events. The purpose of this exploratory analysis was to investigate neutropenic complications in the phase III PANTHER trial of standard 3-weekly chemotherapy with 5-fluorouracil, epirubicin and cyclophosphamide plus docetaxel (FEC/D) versus bi-weekly tailored dose-dense EC/D adjuvant chemotherapy in breast cancer.Patients and methods: Febrile neutropenia, neutropenic infection and infection grade 3-4 according to CTC AE 3.0, were explored in relation to G-CSF use. Per cycle analysis was performed concerning dose reduction and dose delays in conjunction with G-CSF administration. Results: In the experimental group, 98.9% of patients received primary G-CSF support during EC and 97.4% during docetaxel, compared with 49.7% during FEC and 63.88% during docetaxel in the standard group. Overall, the use of G-CSF was associated with a lower risk for developing neutropenic events (OR 0.44, 95% CI 0.35-0.55, p < .001). Chemotherapy delays due to neutropenia and leukopenia were significantly decreased among patients that received G-CSF (OR 0.098, 95% CI 0.06-0.15 and OR 0.32, 95% CI 0.18-0.58, respectively).Discussion: In conclusion, G-CSF support reduces neutropenic events and permits increased relative dose intensity, which is essential for improved survival outcomes.
RCT Entities:
Introduction: Myelosuppresion is a common side effect of chemotherapy and granulocyte-colony stimulating factor (G-CSF) is often used to reduce the risk of neutropenic events. The purpose of this exploratory analysis was to investigate neutropenic complications in the phase III PANTHER trial of standard 3-weekly chemotherapy with 5-fluorouracil, epirubicin and cyclophosphamide plus docetaxel (FEC/D) versus bi-weekly tailored dose-dense EC/D adjuvant chemotherapy in breast cancer.Patients and methods: Febrile neutropenia, neutropenic infection and infection grade 3-4 according to CTC AE 3.0, were explored in relation to G-CSF use. Per cycle analysis was performed concerning dose reduction and dose delays in conjunction with G-CSF administration. Results: In the experimental group, 98.9% of patients received primary G-CSF support during EC and 97.4% during docetaxel, compared with 49.7% during FEC and 63.88% during docetaxel in the standard group. Overall, the use of G-CSF was associated with a lower risk for developing neutropenic events (OR 0.44, 95% CI 0.35-0.55, p < .001). Chemotherapy delays due to neutropenia and leukopenia were significantly decreased among patients that received G-CSF (OR 0.098, 95% CI 0.06-0.15 and OR 0.32, 95% CI 0.18-0.58, respectively).Discussion: In conclusion, G-CSF support reduces neutropenic events and permits increased relative dose intensity, which is essential for improved survival outcomes.
Authors: Ioannis Zerdes; Michele Simonetti; Alexios Matikas; Luuk Harbers; Balazs Acs; Ceren Boyaci; Ning Zhang; Dimitrios Salgkamis; Susanne Agartz; Pablo Moreno-Ruiz; Yalai Bai; David L Rimm; Johan Hartman; Artur Mezheyeuski; Jonas Bergh; Nicola Crosetto; Theodoros Foukakis Journal: NPJ Breast Cancer Date: 2021-11-19