ITACA: A new validated international erythropoietic stimulating agent‐response score that further refines the predictive power of previous scoring systems

Buckstein, Rena; Balleari, Enrico; Wells, Richard A.; Sanna, Alessandro; Salvetti, Chiara; Crisà, Elena; Allione, Bernardino; Danise, Paolo; Finelli, Carlo; Clavio, Marino; Poloni, Antonella; Salvi, Flavia; Cilloni, Daniela; Olíva, Esther Natalie; Musto, Pellegrino; Houston, Brett L.; Zhu, Nancy; Geddes, Michelle; Leitch, Heather A.; Leber, Brian; Sabloff, Mitchell; Nevill, Thomas J.; Yee, Karen; Storring, John M.; Francis, Janika; Maurillo, Luca; Latagliata, Roberto; Spiriti, Maria Antonietta Aloe; Andriani, Alessandro; Piccioni, Anna Lina; Fianchi, Luana; Fenu, Susanna; Gumenyuk, Svitlana; Buccisano, Francesco

doi:10.1002/ajh.24842

Cited by 22 publications

(26 citation statements)

References 38 publications

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“…Notably, when the strict interpretation of these criteria was relaxed, the observed response rate in the studies increased from 15% to 24% in ARCADE (Platzbecker et al , ) and from 32% to 46% in EPOANE3021 (Fenaux et al , ). Similar support for the use of other criteria for measuring erythroid response has been provided from other ESA studies (Buckstein et al , ; Houston et al , ).…”

Section: Discussionsupporting

confidence: 64%

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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Section: Discussionsupporting

confidence: 64%

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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“…Based on the most influential predictive factors discussed above, various groups have proposed scoring systems to predict hematologic response to ESAs with or without G-CSF among patients with MDS (Table 2) [39,56,60,61]. These all include sEPO levels, although the cutoffs and scores vary between systems.…”

Section: Scoring Systems Predictive Of Hematologic Response To Esas Amentioning

confidence: 99%

“…The earliest system additionally included only transfusion need [39]. Later systems [56,60,61] included either IPSS-R or IPSS risk levels. Response rates for the most favorable scores are 74-85%, falling to 7-23% for the least favorable scores ( Table 2).…”

Section: Scoring Systems Predictive Of Hematologic Response To Esas Amentioning

confidence: 99%

“…However, the lack of significance was likely due to a lack of power as all the required variables (ferritin, sEPO, and IPSS-R) were only available in 92 patients. Buckstein et al [60], who designed the Italy-Canada (ITACA) score, also tested the Nordic, European, and MDS-CAN ESA scores (Table 2), but in much larger numbers of patients (n = 846, 524, and 702, respectively). They reported response rates of 68-78% for the best categories, falling to 20-38% for the worst categories for these three scores, suggesting that all of them could be very beneficial in predicting response to ESAs.…”

Section: Scoring Systems Predictive Of Hematologic Response To Esas Amentioning

confidence: 99%

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The prognostic value of serum erythropoietin in patients with lower-risk myelodysplastic syndromes: a review of the literature and expert opinion

et al. 2019

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Myelodysplastic syndromes (MDS) are hematopoietic stem cell malignancies associated with an erythroid maturation defect, resulting in anemia. Treatments for MDS include erythropoiesis-stimulating agents (ESAs). The identification of prognostic markers is important to help predict response and improve outcomes. Various scoring systems have been developed to help predict response to ESAs. Despite limitations in its assessment, serum erythropoietin (sEPO) level is an important predictor of hematologic response to ESAs in patients with lower-risk MDS. Numerous studies have reported significantly lower sEPO levels among responders versus non-responders. Furthermore, treatment response is significantly more likely among those with sEPO levels below versus those above various cutoffs. Other prognostic indicators for response to ESAs include lower transfusion requirement, fewer bone marrow blasts, higher hemoglobin, lower serum ferritin, lower-risk MDS, and more normal cytogenetics. Studies of other MDS therapies (e.g., lenalidomide and luspatercept) have also reported that lower sEPO levels are indicative of hematologic response. In addition, lower sEPO levels (up to 500 IU/L) have been included in treatment algorithms for patients with lower-risk MDS to define whether ESAs are indicated. Lower sEPO levels are predictive of hematologic responseparticularly to ESAs. Further, clinical trials should use sEPO thresholds to ensure more homogeneous cohorts.

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“…(71) Además de prolongar la supervivencia, los AEE mejoran significativamente la calidad de vida(63,67,72) y no incrementan el riesgo de LMA (63,65,67,70). En cuanto a los factores que influyen en la respuesta a los AEE, se han identificado de manera bastante unánime algunas variables, como los niveles de EPO endógena, la dependencia transfusional y el IPSS (66,67,69,73,74). Se ha observado que cuanto más altos son los niveles de EPO endógena, menor es la probabilidad de respuesta a los AEE, y viceversa, ya que niveles altos de EPO revelarían una respuesta insuficiente a la misma, a pesar de una secreción adecuada; por el contrario, los pacientes con niveles desproporcionadamente bajos en relación al grado de anemia podrían beneficiarse de dicho tratamiento(75).…”

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Impacto de las mutaciones somáticas en pacientes con síndromes mielodisplásticos sometidos a distintas modalidades de tratamiento

Berrocal¹,

Carlos²

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ITACA: A new validated international erythropoietic stimulating agent‐response score that further refines the predictive power of previous scoring systems

Abstract: ITACA is an internally-validated predictive SS of ESA response in real-life 'good risk' MDS patients derived from a large international dataset that surpasses others. The incorporation of biologic markers to better identify non-responders is still needed.

Cited by 22 publications

References 38 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

The prognostic value of serum erythropoietin in patients with lower-risk myelodysplastic syndromes: a review of the literature and expert opinion

Impacto de las mutaciones somáticas en pacientes con síndromes mielodisplásticos sometidos a distintas modalidades de tratamiento

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