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Observational data on the clinical benefit of epoetin beta in cancer patients with anemia

Date

09 Oct 2016

Session

Poster display

Presenters

Jean-Philippe Spano

Citation

Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390

Authors

J. Spano1, F. Barlesi2, K. Pestel3, D. Pau4, C. Dauriac5

Author affiliations

  • 1 Medical Oncology, Pitié-Salpêtrière Hospital, 75013 - Paris/FR
  • 2 Multidisciplinary Oncology And Therapeutic Innovations, Aix Marseille University; Assistance Publique Hôpitaux de Marseille, 13915 - Marseille/FR
  • 3 Medical Affairs, Roche S.A.S., Boulogne-Billancourt/FR
  • 4 Clinical Operations, Roche S.A.S., Boulogne-Billancourt/FR
  • 5 Hematology, Pontchaillou Hospital, 35033 - Rennes/FR
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Resources

Background

Anemia is a frequent complication of chemotherapy that can reduce quality of life as well as the anti-cancer efficacy of treatment.

Methods

Two prospective observational studies have investigated, in a real-life setting, the efficacy and safety of epoetin beta in treatment of chemotherapy-induced anemia. The FAST study (ML22733 [NCT01168349]) included patients in France receiving chemotherapy for solid tumors or hematologic malignancies for whom the treating physician had prescribed epoetin beta, with 24–28-week follow-up. The ML25362 study (NCT01716559) included patients in Hungary receiving chemotherapy for non-myeloid malignancies and presenting with symptomatic anemia, with 16-week follow-up.

Results

In the FAST study, 1055 patients were enrolled and 979 (528 [54%] female, mean age 65 years) were evaluable for efficacy, including 677 with solid tumors and 302 with hematologic malignancies. The starting dose of epoetin beta was 30,000 IU in >90% of patients. Mean hemoglobin (Hb) was 9.7 ± 0.9 g/dL at the start of treatment, rising to 11.5 ± 1.5 g/dL by week 24–28. In patients with solid tumors, mean Hb increased from 9.8 ± 0.8 g/dL to 11.3 ± 1.4 g/dL and in those with hematologic malignancies from 9.5 ± 1.1 g/dL to 11.8 ± 1.6 g/dL. The proportion of patients experiencing at least one physical sign of anemia reduced from 95% to 77% (solid tumors) and from 97% to 70% (hematologic malignancies) during the study, the proportion reporting fatigue decreasing from 91% to 68% (solid tumors) and 87% to 66% (hematologic malignancies). 186 patients (19%) received at least one red blood cell transfusion. Thromboembolic events were seen in 13 patients (1%) (5 deep vein thrombosis, 7 pulmonary embolism, 1 arterial thrombosis). In ML25362, 160 patients (87 [54%] female, mean age 63 years) were treated with a starting dose of 30,000 IU epoetin beta. Mean Hb increased from 9.1 ± 0.1 g/dL at baseline to 10.7 ± 0.2 g/dL at week 8 and 10.8 ± 0.2 g/dL at week 16. 38 patients (24%) received at least one red blood cell transfusion. In both studies, safety was consistent with the known profile of epoetin beta in this population.

Conclusions

The data from both studies confirm the efficacy and safety of epoetin beta in the treatment of chemotherapy-induced anemia in a real-world setting.

Clinical trial identification

NCT01168349, NCT01716559

Legal entity responsible for the study

Roche S.A.S.

Funding

F. Hoffmann-La Roche

Disclosure

J-P. Spano: Consultancy and Advisory Board membership for F. Hoffmann-La Roche. K. Pestel, D. Pau: Employed by Roche S.A.S. All other authors have declared no conflicts of interest.

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