San Francisco, CA — An interim subanalysis of an ongoing French national observational study (OncoBOS) demonstrated the real-life clinical efficacy and safety of the biosimilar epoetin alfa (HX575, Binocrit) for the treatment of chemotherapy-induced anemia (CIA) in patients with colorectal cancer receiving chemotherapy, according to data presented at the 2015 Gastrointestinal Cancers Symposium.
“These results demonstrate the ability of HX575 to safely correct anemia and maintain hemoglobin levels, in line with current recommendations, using a weekly dosing regimen,” noted the lead author of the study, Jean-Philippe Metges, MD, Institut de Cancérologie et d’Hématologie, CHU Morvan, Brest, France.
As Dr Metges observed, anemia is a common condition in patients with cancer receiving chemotherapy because of the cytotoxic effect of chemotherapy on erythroid precursors in bone marrow and cells in the kidney that are responsible for erythropoietin production. It also has a negative impact on recovery. Studies in patient populations with solid tumors and hematologic malignancies have shown that CIA symptoms, including extreme fatigue, reduced physical capacity, and impaired cognitive function, can negatively impact patients’ quality of life (QoL).
HX575—the first biosimilar recombinant human erythropoietin to be granted marketing authorization—has been licensed in 30 countries worldwide, not including the United States, since 2007. As of October 2014, the estimated exposure to HX575 was 300,000 patient-years.
“OncoBOS is an ongoing, national, prospective, non-interventional, longitudinal, observational study examining HX575 use in routine practice in France,” Dr Metges explained. “Its primary objective is to describe the conditions of use of HX575 for the correction of hemoglobin levels in patients receiving chemotherapy treatment for solid tumors, lymphoma, or myeloma. A key secondary objective is to describe the efficacy and safety of HX575 in real life clinical practice.”
The interim subanalysis included 96 patients with colorectal cancer, recruited from 28 French centers (university/academic hospitals, and public and private care units) between September 2011 and April 2014. Patient characteristics, data on CIA and CIA management, and the main factors considered by the clinician when prescribing HX575 were recorded at 3 different intervals: treatment initiation; 3 to 4 weeks; and 12 (±1) weeks posttreatment.
Assessed hemoglobin outcomes included the proportion of patients achieving hemoglobin increases of ≥1 g/dL and ≥2 g/dL, and mean hemoglobin changes from baseline.
“Clinicians considered QoL (n = 47, 49%), fatigue (n = 23, 24%), and avoidance of blood transfusion (n = 15, 15.6%) as the predominant factors influencing prescription of treatment for CIA,” Dr Metges elaborated on the results. “The 3 most common factors influencing prescription of treatment with HX575 were cost decrease (n = 59, 61.5%), product efficacy (n = 21, 21.9%), and maintenance of chemotherapy dose (n = 14, 14.6%).”
The mean and median range hemoglobin levels at baseline were 9.9 g/dL and 10 g/dL, respectively. The mean level increased to 11.0 g/dL at weeks 3 to 4, and 11.7 g/dL at week 12 (both P
A hemoglobin increase of ≥1 g/dL from baseline was achieved by 56.8% of patients at weeks 3 to 4, and 77.6% at week 12. An increase of hemoglobin ≥2 g/dL was achieved by 17.9% and 47.4% of patients at the same time points, respectively. The mean dose of HX575 was 31,458 IU/week. Patients received a median HX575 dose of 30,000 IU/week, and only 4 (4.2%) of the 96 patients required a dose increase. Two patients required a blood transfusion at weeks 3 to 4, and only 1 blood transfusion was required at week 12. No treatment-related adverse events were recorded.
