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3342 Overview of French Routine Clinical Practice for the Management of Chemotherapy-Induced Anemia (CIA) with Biosimilar Epoetin Alfa in 563 Patients with Lymphoid Malignancies: A National Observational Study (The OncoBOS study)Clinically Relevant Abstract

Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron
Program: Oral and Poster Abstracts
Session: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III
Monday, December 7, 2015, 6:00 PM-8:00 PM
Hall A, Level 2 (Orange County Convention Center)

Lionel Karlin1*, Jean-Philippe Metges2*, Nataliya Khobta3*, Gilles Boschetti4*, Alain Toledano5*, Camille Aubron-Olivier6*, Domitille Fernet6* and Olivier Fitoussi7*

1Service d'Hématologie, Centre Hospitalier Lyon Sud, Pierre Bénite, France
2Institut de Cancérologie et d’Hématologie, CHU Morvan, Brest, France
3Centre Hospitalier de Castelluccio, Ajaccio, France
4Centre Hospitalier Lyon-Sud, Pierre Bénite, France
5Hôpital Américain de Paris, Neuilly Sur Seine, France
6Sandoz Biopharmaceuticals, Levallois-Perret, France
7Polyclinique Bordeaux Nord-Aquitaine, Bordeaux, France

Background. OncoBOS is a prospective, non-interventional study conducted in France to describe modalities of treatment with Binocrit® in routine clinical practice setting, for the correction of hemoglobin (Hb) in patients with CIA receiving chemotherapy (CT) for solid tumors, lymphoma or myeloma. This analysis focuses on patients with lymphoid malignancies (LM).

Patients & methods. Patient ≥18 years old with LM, CIA and eligible for treatment with Binocrit® were included. This analysis reports patients characteristics along with anemia-related data such as Hb outcomes, Binocrit® treatment characteristics and concomitant treatments received, at baseline, 3-4 weeks and 12 (± 1) weeks later. Factors associated with a Hb increase ≥2 g/dL in patients with LM were analyzed by means of univariate and multivariate analyses.

Results. 563 evaluable patients (302 males (53.6%), mean age 67.9 (SD 14.0) years were recruited from 34 sites, between September 2011 and July 2014. Non-Hodgkin lymphoma (NHL) (281 patients; 49.9%) and multiple myeloma (165 patients; 29.3%) were most prevalent. Among patients with NHL, 46.0% had a diffuse large B cell lymphoma, 11.5% a follicular lymphoma and 11.1% a mantle cell lymphoma. 62.5% of patients with NHL had a stage IV disease and bone marrow was involved by NHL in 45.2% of patients. A vast majority of patients (84.3%) suffering from multiple myeloma had a Durie-Salmon stage III myeloma. Mean baseline Hb was 9.5 (SD 1.0) g/dL, which increased by an average of 0.9 (SD 1.4) g/dL and 1.9 (SD 1.7) g/dL after 1 and 3 months, respectively. A Hb increase ≥1 g/dL was achieved by 51.3% of patients after 3-4 weeks of treatment with Binocrit®. About half of patients (53.0%) achieved a Hb increase ≥2 g/dL at week 12 (± 1). Patients received a mean Binocrit® dose of 31252.4 ± (SD 5815.9; median: 30000) UI once-weekly, over an average time span of 10.8 (SD 3.2; median: 13) weeks. Iron status (serum ferritin and transferrin saturation coefficient) was assessed in 29.1% of subjects at baseline. In total, 2.8% and 1.4% of patients concomitantly received oral or intravenous iron, respectively, during the follow-up period. 12.1% and 11.6% of patients received a folate supplementation at week 3-4 and 12, respectively. Moreover, 16.2% and 15.0% of patients received red blood cells transfusion over the 3-4 first weeks, and over the next 2 months, respectively. Over the treatment period, no treatment‐related adverse reaction was recorded. Factors negatively/positively associated with a Hb increase ≥2 g/dL (p<0.05) in the multivariate analysis were: prior radiotherapy [HR 0.16 (CI95% 0.04;0.64)] ; history of venous thrombotic disease [HR 1.93 (1.14;3.28)] ; administration of folate during the follow-up [HR 2.43 (1.69;3.49)] ; a Hb level < 8 or [8;10[ g/dL at inclusion [HR 3.04 (1.97;4.69) and HR 1.62 (1.25;2.11), respectively] ; 2 units of red blood cells received over the treatment period [HR 2.82 (1.91;4.16)].

Conclusions. This study indicates that in real-life clinical conditions Binocrit® increases effectively Hb, without any adverse drug reaction, in anemic patients with lymphoid malignancies, whatever chemotherapy received. The effect of treatment with Binocrit® is rapid, with mean hemoglobin increase of 0.9 (SD1.4) g/dL seen as early as 3 or 4 weeks following the start of therapy.

Disclosures: Karlin: Janssen: Honoraria ; BMS: Honoraria ; Amgen: Honoraria ; Sandoz: Honoraria , Membership on an entity’s Board of Directors or advisory committees ; Celgene: Honoraria . Metges: Sandoz: Consultancy . Khobta: Sandoz: Membership on an entity’s Board of Directors or advisory committees . Boschetti: Sandoz: Membership on an entity’s Board of Directors or advisory committees . Toledano: Sandoz: Membership on an entity’s Board of Directors or advisory committees . Aubron-Olivier: Sandoz: Employment . Fernet: Sandoz: Employment . Fitoussi: Sandoz: Membership on an entity’s Board of Directors or advisory committees .

*signifies non-member of ASH