Recombinant human erythropoietin in very elderly patients with myelodysplastic syndromes: results from a retrospective study

Abstract

Myelodysplastic syndromes (MDS) are common in elderly patients. Recombinant human erythro-poietin (rHuEPO) has been widely used to treat anemia in lower risk MDS patients, but few data are known about rHuEPO treatment in the very elderly patient group. In order to investigate the role of rHuEPO treatment in terms of response, overall survival (OS), and toxicity in a very elderly MDS patient group, 93 MDS patients treated with rHuEPO when aged ≥80 years were selected among MDS cases enrolled in a retrospective multicenter study by the cooperative group Gruppo Romano Mielodisplasie (GROM) from Jan 2002 to Dec 2010. At baseline, median age was 82.7 (range 80-99.1) with a median hemoglobin (Hb) level of 9 g/dl (range 6-10.8). The initial dose of rHuEPO was standard (epoetin alpha 40,000 IU/week or epoetin beta 30,000 IU/week) in 59 (63.4 %) patients or high in 34 (36.6 %) (epoetin alpha 80,000 IU/week) patients. We observed an erythroid response (ER) in 59 (63.4 %) patients. No thrombotic event was reported. Independent predictive factors for ER were low transfusion requirement before treatment (p = 0.004), ferritin <200 ng/ml (p = 0.017), Hb >8 g/dl (p = 0.034), and a high-dose rHuEPO treatment (p = 0.032). Median OS from rHuEPO start was 49.3 months (95 % CI 27.5-68.4) in responders versus 30.6 months (95 % CI 7.3-53.8) in resistant patients (p = 0.185). In conclusion, rHuEPO treatment is safe and effective also in the very elderly MDS patients. However, further larger studies are warranted to evaluate if EPO treatment could be worthwhile in terms of quality of life and cost-efficacy in very old patients.

Response Assessment to Erythropoietin-Zeta (Epo-Alpha Biosimilar) Therapy in Low-Risk Myelodysplastic Syndromes

“…Moreover, Hb increase translates to the amelioration of the quality of life and the increased overall survival of these patients [ 2 , 35 , 36 , 37 ]. In our opinion, the fact that, after 24 weeks, 83% of our patients can reach this safety threshold is additional proof of the effectiveness of erythropoietin zeta in the treatment of low/int-1-risk MDS patients, in line with data from real-life experiences [ 38 , 39 ].…”

Predictive factors for anemia response to erythropoiesis‐stimulating agents in myelofibrosis

“…By contrast, the serum ferritin levels were found to discriminate the probability of anemia response in transfusion‐independent patients, which constituted the largest group in our series. Although there is no prior information on the potential influence of serum ferritin levels on the response to ESA treatment in MF, high ferritin levels have recently been associated with a lower probability of response to ESA in patients with myelodysplastic syndromes . With regard to the other two independent risk factors identified in multivariate analysis, female patients had also a higher response rate to ESA in two prior studies in MF, whereas the leukocyte counts were higher in anemia responders in one study, although such difference did not reach statistical significance.…”

A Systematic Literature Review of Predictors of Erythropoiesis-Stimulating Agent Failure in Lower-Risk Myelodysplastic Syndromes

“…Most studies were conducted in Europe (n = 24), and seven studies did not report the geographic location. Data sources were spread across nationwide registries, medical records in hospitals, Of the 38 studies identified (Table 2), one (3%) was a randomized controlled trial [22], three (8%) were non-randomized trials [23][24][25], 10 (26%) were single-arm trials [26][27][28][29][30][31][32][33][34][35], 15 (39%) were retrospective cohort studies [36][37][38][39][40][41][42][43][44][45][46][47][48][49][50], and four (11%) were prospective cohort studies [51][52][53][54]. One study (3%) was a compassionate, open-label, therapeutic trial [55], and four studies (11%) did not report the study design [56][57][58][59].…”

“…The median age of the study population ranged from 63.1 years [57] to 82.7 years [39], with 25 studies having patients with a median age of >70 years (Table 3). In the 33 studies that reported biological sex, 42% to 74% of participants were male.…”

“…One Italian study reporting results from multivariate analyses assessed ESA response at a threshold serum ferritin level of 200 ng/mL in patients who were receiving standarddose weekly epoetin alpha (40,000 IU) or epoetin beta (30,000 IU), or weekly high-dose epoetin alpha (80,000 IU), and reported an OR of 4.42, suggesting that patients below the 200 ng/mL threshold were more likely to respond to ESAs (95% CI: 1.3-15.1; p = 0.017, N = 59) [39] (Table S5).…”