Background: OncoBOS is a national, prospective, non-interventional, longitudinal, observational study describing biosimilar epoetin alfa (Binocrit®) use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma or myeloma. This sub-analysis focuses on the management of CIA in patients with MM.
Patients and methods: Patients ≥18 years with MM, CIA and eligible for treatment with Binocrit® were included in this analysis. Patients characteristics, data on CIA and its management and predominant factors considered by the physician in prescribing Binocrit® were recorded at baseline, 3-4 weeks and 12 (± 1) weeks later. Hemoglobin (Hb) outcomes assessed included the proportion of patients achieving a Hb increase ≥1 and ≥2 g/dL, and the mean Hb change from baseline.
Results: 99 patients with MM (mean age 71.1 years) from 20 sites were recruited from September 2011 to April 2014. 54.5% of subjects were male. Mean and median baseline Hb levels were 9.4 g/dL and 10 g/dL, respectively. The mean increase in Hb level was 1.1 g/dL after 1 month and 2.2 g/dL after 3 months (p<0.001 vs baseline) of Binocrit® treatment. A Hb increase ≥1 g/dL was achieved by 57.6% of patients at week 3-4 and 78.0% at week 12; a Hb increase ≥2 g/dL was achieved by 22.2% and 60.4% of patients at the same time points. Patients received a median dose of 30,000 IU Binocrit® once weekly. Four of the 99 patients (4.0%) required a dose increase; 3 of these patients had their dose doubled during the treatment period. Transfusion rates remained stable at 12.1% and 9.6% at week 3-4 and week 12, respectively. Oral and intravenous (IV) iron supplementation rates were low: oral iron was received by 1.0% and 2.2% of patients at week 3-4 and week 12, respectively; 1.0% and 1.1% of patients received IV supplementation at the same time points. Of note, these low rates could be explained by the fact that iron status (serum ferritin and transferrin saturation coefficient) was assessed in only 32.3% of subjects at baseline. Physicians considered quality of life (59.6%), fatigue (20.2%) and avoidance of blood transfusion (13.1%) as predominant factors in the rationale for anemia management and treatment. Over the treatment period, one treatment-related adverse reaction was recorded, which was not considered serious.
Conclusion: This sub-analysis indicates that Binocrit®, used in routine practice, is effective and well tolerated for the treatment of CIA in patients with MM receiving CT.
Voronina:Sandoz: Investigator Other. Ojeda-Urib:Sandoz: Honoraria. Dauriac:Sandoz: Investigator Other. Voillat:Sandoz: Investigator Other. Aubron-Olivier:Sandoz: Employment. Fernet:Sandoz: Employment. Karlin:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sandoz: Honoraria, Membership on an entity's Board of Directors or advisory committees. Fitoussi:Sandoz: Honoraria.
Asterisk with author names denotes non-ASH members.