Weekly standard doses of rh-EPO are highly effective for the treatment of anemic patients with low-intermediate 1 risk myelodysplastic syndromes

Balleari, Enrico; Clavio, Marino; Arboscello, Eleonora; Bellodi, Andrea; Bruzzone, Andrea; Corso, Lisette Del; Lucchetti, Maria Vita; Miglino, Maurizio; Passalia, Caterina; Pierri, Ivana; Ponassi, Irene; Oneto, Caterina; Racchi, Omar; Scudeletti, Marco; Vignolo, L; Zoppoli, Gabriele; Gobbi, Marco; Ghio, Riccardo

doi:10.1016/j.leukres.2011.05.025

Cited by 15 publications

(17 citation statements)

References 25 publications

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“…Both these factors are clearly related to a poor response to rhEPO and possibly influenced the clinical outcome. Strictly selected MDS lower‐risk patients treated with SD had response rates equivalent to those observed with HD . The recent randomized trial comparing safety and efficacy of rhEPO with placebo in low‐risk MDS patients used weight‐adjusted doses of rhEPO, substantially equivalent to SD …”

Section: Discussionmentioning

confidence: 99%

Effects of different doses of erythropoietin in patients with myelodysplastic syndromes: A propensity score‐matched analysis

et al. 2019

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Background Erythropoiesis‐stimulating agents effectively improve the hemoglobin levels in a fraction of anemic patients with myelodysplastic syndromes (MDS). Higher doses (HD) of recombinant human erythropoietin (rhEPO) have been proposed to overcome suboptimal response rates observed in MDS patients treated with lower “standard doses” (SD) of rhEPO. However, a direct comparison between the different doses of rhEPO is lacking. Methods A cohort of 104 MDS patients treated with HD was retrospectively compared to 208 patients treated with SD in a propensity score‐matched analysis to evaluate hematological improvement‐erythroid (HI‐E) rate induced by the different doses of rhEPO. The impact of rhEPO doses on survival and progression to leukemia was also investigated. Results Overall HI‐E rate was 52.6%. No difference was observed between different rhEPO doses (P = .28) in matched cohorts; in a subgroup analysis, transfusion‐dependent patients and patients with higher IPSS‐R score obtained a higher HI‐E rate with HD, although without significant impact on overall survival (OS). Achievement of HI‐E resulted in superior OS. At univariate analysis, a higher HI‐E rate was observed in transfusion‐independent patients (P < .001), with a lower IPSS‐R score (P < .001) and lower serum EPO levels (P = .027). Multivariate analysis confirmed that rhEPO doses were not significantly related to HI‐E (P = .26). There was no significant difference in OS or progression to leukemia in patients treated with HD vs SD. Conclusion SD are substantially equally effective to HD to improve anemia and influencing survival in MDS patients stratified according to similar propensity to be exposed to rhEPO treatment.

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Section: Discussionmentioning

confidence: 99%

Effects of different doses of erythropoietin in patients with myelodysplastic syndromes: A propensity score‐matched analysis

et al. 2019

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“…ESAs are used to improve anemia, and many studies have demonstrated their effectiveness, sometimes combined with G-CSF [1][2][3][4][5][6][7][10][11][12]. According to these studies, major predictive factors for response are lower serum EPO levels and minimal requirement of red blood cell transfusion; consequently, serum EPO levels less than 500 IU/L have been widely accepted as a standard for high probability of response [13].…”

Section: Discussionmentioning

confidence: 99%

“…It has been reported that lower serum erythropoietin (EPO) levels, i.e., below 200 or 500 IU/L, are one of the favorable predictive factors for the efficacy of ESAs [1][2][3][4][5][6][7], but very little data are available about the distribution of serum EPO levels in Japanese MDS patients [8,9]. Therefore, we examined serum EPO in Japanese MDS patients, to estimate the proportion of patients to Abstract Erythropoiesis-stimulating agents (ESAs) are used to ameliorate anemia in lower-risk myelodysplastic syndromes (MDS).…”

Section: Introductionmentioning

confidence: 99%

Distribution of serum erythropoietin levels in Japanese patients with myelodysplastic syndromes

Suzuki

Ohmine

et al. 2014

Int J Hematol

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Erythropoiesis-stimulating agents (ESAs) are used to ameliorate anemia in lower-risk myelodysplastic syndromes (MDS). Serum erythropoietin (EPO) level <500 IU/L is widely accepted as a major predictive factor for response to ESAs. However, few data about EPO levels in the Japanese population are available. We therefore evaluated distribution of serum EPO levels in Japanese patients with MDS. Forty-three cases were analyzed; 30 were classified as lower-risk MDS (low or intermediate-1 by the international prognostic scoring system). Twenty-two cases were transfusion dependent. The overall median hemoglobin level was 7.7 g/dL. The median value of serum EPO was 254 IU/L (range: 16.4-23,000). Serum EPO levels had a strong inverse correlation with hemoglobin levels, and a significantly larger proportion of patients showed high EPO levels (>500 IU/L) in the transfusion-dependent group. In the higher-risk group, no significant correlation between EPO and hemoglobin was observed. Regression analyses showed that serum EPO of 500 IU/L corresponds to 8.29 g/dL of hemoglobin in lower-risk MDS. The results indicate that patients with hemoglobin levels of 8.0 g/dL or more, who are still transfusion independent, may be good candidates for ESA treatment.

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“…A prospective observational study compared median survival between darbepoetin alfa and epoetin alfa; reported survival was 28Á8 months with darbepoetin alfa compared with 21Á6 months with epoetin alfa (Sekeres et al, 2015). Moreover, in 3 prospective observational studies of short-acting ESAs, survival rates at varying time points (from 12 weeks to 6 months) were consistent across studies and ranged from 88Á9% to 90Á5% (Pierri et al, 2007;Balleari et al, 2011;Pelizzari et al, 2016). Lastly, in a retrospective observational study of darbepoetin alfa, no significant difference in time to death was observed between epoetin alfa and darbepoetin alfa (hazard ratio [HR], 0Á99; 95% confidence interval [CI], 0Á63-1Á53) (Kelaidi et al, 2013b).…”

Section: Nrmentioning

confidence: 93%

“…Progression to AML was not reported between arms for the prospective observational study of darbepoetin alfa; however, median time to AML transformation was reported for the whole population (17Á4 months) (Sekeres et al, 2015). All 4 prospective observational studies of short-acting ESAs reported rates of AML progression ranging from 0% to 14Á3% when considering the entire patient population of each study over time points from 12 weeks to 33 months (Pierri et al, 2007;Balleari et al, 2011;Pelizzari et al, 2016). However, Economopoulos et al (1999) reported a higher risk of progression (50%) in a subgroup of patients who had refractory anaemia with excess blasts, who are known to be at higher clinical risk for AML progression (Economopoulos et al, 1999).…”

Section: Nrmentioning

confidence: 99%

Clinical effectiveness and safety of erythropoietin‐stimulating agents for the treatment of low‐ and intermediate‐1−risk myelodysplastic syndrome: a systematic literature review

et al. 2018

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Summary Many patients with lower‐risk myelodysplastic syndrome (MDS) experience anaemia, which has negative consequences. Erythropoiesis‐stimulating agents (ESAs) and their biosimilars are used to treat anaemia in MDS and, currently, epoetin alfa and darbepoetin alfa are commonly used and recommended by clinical guidelines. To better understand the evidence available on the use of ESAs for anaemia in lower‐risk MDS, we conducted a systematic literature review to identify randomized and nonrandomized prospective studies reporting on clinical efficacy/effectiveness, patient‐reported quality of life (QoL), and safety. We extended our review to include retrospective studies for darbepoetin alfa specifically and to ascertain the feasibility of completing an indirect network meta‐analysis comparing epoetin and darbepoetin alfa. Overall, 53 articles reporting on 35 studies were included. The studies indicated a clinical benefit of ESAs, with benefits observed across key clinical outcomes. ESAs showed consistent improvement in erythroid response rates (ESA‐naïve, 45–73%; previous ESA exposure, 25–75%) and duration of response. Comparative studies demonstrated similar progression to acute myeloid leukaemia and several showed improved overall survival and QoL. Limited safety concerns were identified. This analysis confirmed ESA therapy should be the foremost first‐line treatment of anaemia in most patients with lower‐risk MDS who lack the 5q deletion.

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Weekly standard doses of rh-EPO are highly effective for the treatment of anemic patients with low-intermediate 1 risk myelodysplastic syndromes

Cited by 15 publications

References 25 publications

Effects of different doses of erythropoietin in patients with myelodysplastic syndromes: A propensity score‐matched analysis

Effects of different doses of erythropoietin in patients with myelodysplastic syndromes: A propensity score‐matched analysis

Distribution of serum erythropoietin levels in Japanese patients with myelodysplastic syndromes

Clinical effectiveness and safety of erythropoietin‐stimulating agents for the treatment of low‐ and intermediate‐1−risk myelodysplastic syndrome: a systematic literature review

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