Biosimilar Retacrit® (epoetin zeta) in the treatment of chemotherapy-induced symptomatic anemia in hematology and oncology in Germany (ORHEO) - non-interventional study.

ABSTRACT

BACKGROUND: Symptomatic anemia is a frequent and severe complication of chemotherapy that is commonly treated with erythropoiesis-stimulating agents. The primary objective of this study was to assess the change in hemoglobin levels in patients with chemotherapy-induced anemia (CIA) following treatment with biosimilar Retacrit® (epoetin zeta). Secondary objectives included changes in hematologic parameters and tolerability. METHODS: This was a non-interventional, multicenter, long-term observational study that is part of an ongoing surveillance program for epoetin zeta. Adult patients (N=291) with solid tumors, malignant lymphomas or multiple myeloma, and chemotherapy-induced symptomatic anemia, who were eligible for treatment with biosimilar epoetin zeta, were enrolled. Patients were evaluated at enrollment, 3 months, and 6 months. RESULTS: Evaluable patients had lymphoma or myeloma (n=30) or solid tumors (n=260). At 3 months, patients with lymphoma and myeloma showed the greatest increase in mean (SD) hemoglobin from 9.2 (0.9) to 11.0 (1.8) g/dL, whereas patients with breast cancer showed the smallest increase from 10.0 (1.0) to 11.1 (1.2) g/dL. At 6 months, the greatest mean increase occurred in patients with lymphoma or myeloma from 11.0 (1.8) to 11.7 (2.3) g/dL, and the smallest in patients with other solid tumors from 10.9 (1.4) to 11.1 (1.5) g/dL. Patient evaluation of epoetin zeta therapy was positive, as most patients expressed satisfaction with epoetin zeta treatment during the study, compliance with treatment was high, and most indicated their willingness to be retreated if necessary. Epoetin zeta was also well tolerated; overall, in 25 patients (8.6%), there were 31 adverse events. CONCLUSION: Despite variability among different disease groups, epoetin zeta was effective and well tolerated in patients with different types of solid tumors and hematologic malignancies.