PO023 High dose of r-EPO (40,000 IU) once a week is highly effective in a selected cohort of MDS patients with basal EPO level &lt;250mu/ml, IPSS score ≤1.5 and low transfusional need

Pierri, Isabella Gonçalves; Balleari, Enrico; Olcese, Francesca; Passalia, Caterina; Calvia, A.; Clavio, Marino; Varaldo, Riccardo; Miglino, Maurizio; Ballerini, Filippo; Canepa, Letizia; Ghiggi, Chiara; Vignolo, L; Ghiso, Anna; Ghio, Riccardo; Gobbi, Marco

doi:10.1016/s0145-2126(07)70253-9

Cited by 2 publications

(5 citation statements)

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“…Specifically, multicenter studies of epoetin-treated patients with MDS revealed response rates of approximately 30%-50% with durations of 12-24 months [ 1 , 6 , 15 , 16 , 17 , 18 , 19 , 20 , 21 ], while single-arm darbepoetin alfa studies reported durations of response ranging from 1 to 36 months [ 17 , 22 , 23 , 24 ]. Prospective observational studies also revealed similar response rates for patients treated with epoetin alfa and darbepoetin alfa, despite differences in median response durations obtained with epoetin alfa (7.5-15 months) and darbepoetin alfa (9.7 months) [ 1 , 25 , 26 , 27 ].…”

Section: Discussionmentioning

confidence: 86%

Long-Term Efficacy of Erythropoiesis-Stimulating Agents in Patients with Low-Risk or Intermediate-1-Risk Myelodysplastic Syndrome: Multicenter Real-Life Data

Ak¹,

Gedük²,

Açar³

et al. 2023

Tjh

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Objective: This study was undertaken to evaluate the long-term clinical efficacy of epoetin alfa and darbepoetin alfa in patients with myelodysplastic syndrome (MDS) in a real-life setting. Materials and Methods: A total of 204 patients with low-risk or intermediate-1-risk MDS who received epoetin alfa or darbepoetin alfa were included. Hemoglobin levels and transfusion needs were recorded before treatment and at 12 months, 24 months, 36 months, and 48 months of treatment. Results: At the 36-month (p=0.025) and 48-month (p=0.022) visits, epoetin alfa yielded significantly higher hemoglobin levels compared to darbepoetin alfa. Transfusion needs were also significantly lower with epoetin alfa compared to darbepoetin alfa at 24 months (p=0.012) and in the low-risk group compared to the intermediate-risk group at 24 months (p=0.018), 36 months (p=0.025), and 48 months (p<0.001). Treatment response rates at the 24-month, 36-month, and 48-month visits in the epoetin alfa (43.0%, 33.6%, and 27.1%), darbepoetin alfa (29.9%, 22.7%, and 16.5%), low-risk (39.3%, 30.0%, and 26.0%), and intermediate-risk (29.6%, 24.1%, and 11.1%) groups were lower than those obtained at 12 months, and the values differed significantly for the 36-month and 48-month visits with values ranging from p<0.05 to p<0.001. Conclusion: This real-life long-term ESA extension study investigated the clinical efficacy of epoetin alfa and darbepoetin alfa for up to 48 months, revealing that treatment efficacy reached a plateau starting from the 24 th month of therapy with a continuing decrease in treatment response rates regardless of treatment type, risk status, or gender. Nonetheless, significantly higher hemoglobin levels and marked improvement in transfusion needs were evident in epoetin-treated patients compared to darbepoetin-treated patients and in the low-risk group compared to the intermediate-risk group.

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Section: Discussionmentioning

confidence: 86%

Long-Term Efficacy of Erythropoiesis-Stimulating Agents in Patients with Low-Risk or Intermediate-1-Risk Myelodysplastic Syndrome: Multicenter Real-Life Data

Ak¹,

Gedük²,

Açar³

et al. 2023

Tjh

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“…By comparison, two studies evaluating short‐acting ESAs reported 65·5% and 76·0% response rates at 12 weeks and 6 months, respectively (Balleari et al , ; Pelizzari et al , ). The remaining two prospective observational studies did not use the IWG criteria; however, they reported response rates of 52·6% (Economopoulos et al , ) and 73·9% (Pierri et al , ). Similarly, Giraldo et al () reported an overall response rate of 55% with darbepoetin alfa at 16 weeks.…”

Section: Resultsmentioning

confidence: 99%

“…As was seen with time to response, Latagliata et al (, ) reported median duration of response (10 and 19 months, respectively) for single‐arm studies of short‐acting ESAs. For prospective observational studies of either darbepoetin alfa or other ESAs, response rates were similar for patients treated with epoetin alfa and darbepoetin alfa, although the median response duration was longer for darbepoetin alfa (39·1 vs. 21·9 weeks with placebo) (Sekeres et al , ), and was 15 months with epoetin alfa (Pierri et al , ). Mele et al () was the only non‐specified observational study that evaluated duration of response following epoetin alfa administration and reported a median duration of 7·5 months.…”

Section: Resultsmentioning

confidence: 99%

“…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: 94%

“…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%

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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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PO023 High dose of r-EPO (40,000 IU) once a week is highly effective in a selected cohort of MDS patients with basal EPO level <250mu/ml, IPSS score ≤1.5 and low transfusional need

Cited by 2 publications

References 0 publications

Long-Term Efficacy of Erythropoiesis-Stimulating Agents in Patients with Low-Risk or Intermediate-1-Risk Myelodysplastic Syndrome: Multicenter Real-Life Data

Long-Term Efficacy of Erythropoiesis-Stimulating Agents in Patients with Low-Risk or Intermediate-1-Risk Myelodysplastic Syndrome: Multicenter Real-Life Data

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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