Twice-Weekly High-Dose rHuEpo for the Treatment of Anemia in Patients with Low-Risk Myelodysplastic Syndromes

Latagliata, Roberto; Oliva, Esther N; Volpicelli, Paola; Carmosino, Ida; Breccia, Massimo; Vincelli, Iolanda Donatella; Alati, Caterina; Napoleone, Laura; Vozella, Federico; Nobile, Francesco; Alimena, Giuliana

doi:10.1159/000166864

Cited by 18 publications

(27 citation statements)

References 14 publications

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“… Latagliata et al () was assessed as high quality for erythroid response rate but low quality for erythroid response duration and time to erythroid response. …”

Section: Resultsmentioning

confidence: 99%

“…Overall, 11 publications reported time to erythroid response (Musto et al , ; Stasi et al , ; Mannone et al , ; Gabrilove et al , ; Latagliata et al , , ; Gotlib et al , ; Oliva et al , ; Villegas et al , ; Kelaidi et al , ; Pelizzari et al , ). Eight publications with data from 7 single‐arm studies of darbepoetin alfa reported a median time to response of 9 weeks (range, 4–31 weeks) (Musto et al , ; Stasi et al , ; Mannone et al , ; Gabrilove et al , ; Gotlib et al , ; Oliva et al , ; Villegas et al , ; Kelaidi et al , ).…”

Section: Resultsmentioning

confidence: 99%

“…Two publications reported time to response from single‐arm studies of short‐acting ESAs (Latagliata et al , , ). Both publications reported a median time to response of 7 weeks; however, it is unclear whether these articles reported data from separate studies.…”

Section: Resultsmentioning

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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“… Latagliata et al () was assessed as high quality for erythroid response rate but low quality for erythroid response duration and time to erythroid response. …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

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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“…21,22 In practice, anemic lower-risk MDS patients should start treatment with fixed doses, rather than weight-adjusted doses of ESAs. The optimal treatment doses are 30 000 to 80 000 U of EPO 23 and 150 to 300 mg of darbepoetin subcutaneous (SC) injection per week. 24 Provided endogenous EPO is measured and is below 500 U/L (see section to follow), treatment with ESAs should start in a timely manner, before transfusion-dependence is established, because the probability to respond is higher for early treated, transfusionindependent patients.…”

Section: Treatment Of Anemiamentioning

confidence: 99%

Treatment of low-risk myelodysplastic syndromes

Santini

2016

Hematology

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The majority of myelodysplastic syndrome (MDS) patients belong to the International Prognostic Scoring System (IPSS) and IPSS-revised (IPSS-R) lower-risk categories. Their precise diagnostics and prognostic stratification is often a challenge, but may ensure the optimization of therapy. The availability of diverse treatment options has significantly improved the quality of life and survival of this group of patients. Anemia is the most relevant cytopenia in terms of frequency and symptoms in lower-risk MDS, and may be treated successfully with erythropoietic stimulating agents, provided a careful selection is performed on the basis of IPSS-R, endogenous erythropoietin levels, and transfusion independence. Doses and duration of therapy of erythropoietic-stimulating agents (ESAs) are critical to determine efficacy. In case a patient fails ESA treatment, the available options may include lenalidomide (approved for del5q positive cases), hypomethylating agents, and a rather large number of experimental agents, whose clinical trials should be offered to a larger number of MDS patients. The choice for second-line treatment must take into account biologic, cytogenetic, and molecular-identified characteristics of individual patients, as well as frailty and comorbidities. Other cytopenias are less frequently presenting as isolated. Specific therapy for thrombocytopenia has been proposed in experimental clinical trials with thrombomimetic agents that have shown good efficacy, but raised some safety concern. Although neutropenia is targeted symptomatically with growth factor supportive care, the immunosuppressive treatments are indicated mainly for pancytopenic, hypoplastic lower-risk MDS; they are not widely used because of their toxicity, despite the fact that they may induce responses. Finally, hematopoietic stem cell transplant is the curative option also for lower-risk MDS and timing should be carefully evaluated, balancing toxicity and the possibility of survival advantage. Finally, even when considered suitable for lower-risk MDS, transplant application is limited to the rarer fit and younger MDS patient.

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“…This is quite paradoxical, as ESAs have been successfully employed in the treatment of anemia in MDS in the last 20 years. Many studies, actually with few randomized ones, have evaluated the efficacy and safety of various types, doses, and schedules of different ESAs [54][55][56][57][58][59]. Although different clinical response criteria have been applied along the years, results are consistent in indicating good activity in stimulation of erythropoiesis of MDS.…”

mentioning

confidence: 99%

Anemia as the Main Manifestation of Myelodysplastic Syndromes

Santini

2015

Seminars in Hematology

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Twice-Weekly High-Dose rHuEpo for the Treatment of Anemia in Patients with Low-Risk Myelodysplastic Syndromes

Cited by 18 publications

References 14 publications

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

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

Treatment of low-risk myelodysplastic syndromes

Anemia as the Main Manifestation of Myelodysplastic Syndromes

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