Impact of granulocyte colony-stimulating factor (G-CSF) and epoetin (EPO) on hematological toxicities and quality of life in patients during adjuvant chemotherapy in early breast cancer - Results from the multi-center randomized ADEBAR trial

Abstract Background Hematological toxicities are one of the greatest challenges in adjuvant chemotherapy for breast cancer. This analysis of the ADEBAR trial aims to evaluate application and effect of granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO) on hematological parameters and fatigue in breast cancer patients during chemotherapy. Patients and Methods In the ADEBAR trial, 1493 patients with node-positive primary breast cancer were randomized to either 6 x 5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or 4 x epirubicin and cyclophosphamide followed by 4 x docetaxel (EC-DOC). Co-medication with G-CSF or EPO was applied to treat chemotherapy-induced leukopenia or anemia. Fatigue was assessed at baseline and after half of the chemotherapy. Results In total, 899 patients could be included in the analysis. There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively. Hemoglobin levels (B = -0.41, p Conclusion 0.0.0.1. We showed that fatigue during adjuvant chemotherapy was mostly affected by the level of fatigue present before the start of chemotherapy. This result suggests that the level of fatigue before the start of treatment should be included as an important factor when deciding on type and toxicity of chemotherapy in early breast cancer.