Epoetin biosimilars in the management of chemotherapy-induced anemia in elderly patients: A subanalysis of the ORHEO study.

Abstract

e20513 Background: Chemotherapy-induced anemia (CIA) treatment requires transfusion, or epoietin administration. Elderly patients (pts) may experience severe complications from CIA, with fatigue and cardiovascular events. Methods: ORHEO (place of biOsimilaRs in the therapeutic management of anemia secondary to chemotherapy in HaEmatology and Oncology) was a post-marketing, observational, prospective, multicentric study. Adult CIA (Hb<110g/l) pts with solid tumors, lymphomas or myelomas and eligible for epoetin alpha biosimilar (EAB) treatment were included to receive EAB according to drugs approval recommendations. Recorded data included demographics, performance status, blood count and iron load profile. Safety (NCI-CTC V2.0) and efficacy were also assessed. The primary study endpoint was the rate of responders (defined as increase in Hb levels to 100 g/l or at least 10 g/l since inclusion visit, or reaching target Hb set at start of study, without any blood transfusions in the 3 weeks prior to measurement) at +3 months (M+3). Other endpoints included safety, patterns of treatment interruption and rate of responders at +6 months (M+6). Here we present data for the elderly (>= 70 years old) pts. Results: 1,009 pts (54.3% male, 45.7% female) >= 70 y.o. were included in this analysis. Median age was 77 y, range [70-93]. At baseline, 36.3, 57.8 and 3.4% of pts had respectively grade 1, 2 and 3 anemia. Iron supplementation was given in 9.9 (oral) and 16.0% (IV) of pts. At M+3, 84.0% of pts were responders (IC95% 81.4-86.3). Moreover, respectively 241 pts (23.8%) and 139 pts (13.7%) had stopped EAB permanently or temporarily, mainly because of efficacy (45.2 and 79.1% respectively); other reasons were side-effects (2.9 and 0.7% respectively), lack of efficacy (7.0 and 4.3%), and unspecified reason (44.8 and 15.8%). Similar results were observed at M+6 with 86.8% of responders. 17.0% of pts reported side effects (all grades); the most frequent were thromboembolic events (4.5%). No EAB-related death was reported. 94.6% of pts reported being satisfied with EAB therapy at M+3 and M+6 and willing to restart if needed. Conclusions: EAB therapy is efficacious on CIA management in elderly pts with low toxicity.