The management of chemotherapy-induced anemia (CIA) by erythropoiesis-stimulating agents (ESA) is well established and recommendations are clear on their use. The SYNERGY study aimed to assess the effect of epoetin alfa biosimilar on CIA in current practice.
This observational, longitudinal, prospective, multicenter study was conducted in France, from a representative, random sample of oncologists and hematologists. The primary objective was response to epoetin alfa biosimilar (achieving target Hb level with increase of ≥1 g/dL versus baseline or increase of ≥2 g/dL in the absence of a transfusion in the 3 previous weeks). Data on patient characteristics, cancer diagnosis, methods of epoetin alfa biosimilar and iron use, anemia and iron status assessment were collected on enrollment. The study included patients aged ≥18 years with CIA, with solid tumors (ST), lymphoma or myeloma, eligible for treatment with epoetin alfa biosimilar, with follow-up at 12–16 weeks.
Oncologists and hematologists (n = 195) enrolled 2167 patients between June 2012 and December 2014; 2076 patients (49.4% male) were analyzed. Patient characteristics are shown in the table. Epoetin alfa biosimilar was administered subcutaneously (99.2% of patients) in a single weekly dose of 20,000–40,000 IU for a median duration of 11.0 weeks.
|ST (metastatic)||79.8 (72.3)|
|Mean Hb level, g/dL||9.6|
|Moderate anemia (8–9.5 g/dL)||37.2|
|Severe anemia (<8 g/dL)||1.2|
|Iron status assessment||51.7|
At follow-up, 71.9% of patients had a maximum Hb level above 11 g/dL. The mean change Â± SD in Hb level was 2.25 Â± 1.39 g/dL at its maximum and 1.67 Â± 1.55 g/dL at final visit. The overall response rate to epoetin alfa biosimilar was 70.4%; 68.6% for ST; 74.4% for lymphomas, and 81.3% for myelomas. Hb levels increased by ≥2 g/dL in 57.3% and by 1–2 g/dL in 26.4% of patients. Treatment-related adverse events occurred in 3.4% of patients, mainly thromboembolic events (2.0%). The rate of blood transfusions was 16.3%.
These results provide real-life evidence that epoetin alfa biosimilar was effective and well tolerated in treating CIA, and was used in accordance with recommendations.
Clinical trial identification
F. ScottÃ©, K. Laribi, D. Spaeth: grant and/or research support from Hospira SAS
DE. Kasdaghli, H. Albrand: employee of Hospira. E. Leutenegger: employee of GECEM. I. Ray-Coquard: grant and/or research support from Hospira SAS, consultancy fees from Amgen, PharmaMar, Roche, and paid instructor for Amgen, PharmaMar, and Roche. All other authors have declared no conflicts of interest.