Randomized, Multicenter, Controlled Trial Comparing the Efficacy and Safety of Darbepoetin Alfa Administered Every 3 Weeks With or Without Intravenous Iron in Patients With Chemotherapy-Induced Anemia

Bastit, Laurent; Vandebroek, A.; Altıntaş, Sevilay; Gaede, Bernd; Pintér, Tamás; Sütö, Tamás; Mossman, T.; Smith, K.; Vansteenkiste, Johan

doi:10.1200/jco.2006.10.4620

Cited by 192 publications

(193 citation statements)

References 27 publications

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“…Patients receiving IV iron had larger increases in hemoglobin levels, and hemoglobin response occurred earlier compared with patients not receiving IV iron. This is consistent with findings from other studies that have reported significant improvements in hemoglobin levels for patients receiving ESA therapy in combination with IV iron in the CIA setting [17][18][19][20][21]. In the present study, RBC transfusions were not different for the IV iron usage groups, consistent with findings from most studies evaluating iron usage in CIA patients [17,[19][20][21].…”

Section: Discussionsupporting

confidence: 93%

“…In the present study, RBC transfusions were not different for the IV iron usage groups, consistent with findings from most studies evaluating iron usage in CIA patients [17,[19][20][21]. Notably, the study by Bastit et al [18] showed a significant decrease in number of transfusions in the IV iron group compared with the no IV iron group. Inconsistent results were observed for achieving target hemoglobin and achieving hematopoietic response when data were stratified by baseline serum ferritin (<100 ng mL 21 vs. 100 ng mL 21 ), reinforcing the observation that serum ferritin is a poor predictor of response to IV iron, as show in previous studies [26].…”

Section: Discussionsupporting

confidence: 91%

“…Anaphylactoid reactions were reported in two patients after administration of IV iron, both of whom recovered uneventfully without hospitalization. The report of these anaphylactoid reactions in response to LMW iron is surprising and has not been observed in a number of similar studies [17][18][19]21,27]. No other safety signal was reported when darbepoetin alfa was dosed concurrently with IV iron in this population.…”

Section: Discussionmentioning

confidence: 64%

“…Several studies have shown that IV iron supplementation during ESA therapy in the CIA setting is well tolerated and increases treatment response [17][18][19][20][21]. In a Phase 3 study in CIA patients receiving darbepoetin alfa 500 lg Q3W, IV iron administered as iron-sucrose increased the hematopoietic response rate (proportion of patients achieving hemoglobin 12 g dL 21 or hemoglobin increase of 2 g dL 21 ) and lowered incidence of RBC transfusions [18].…”

Section: Introductionmentioning

confidence: 99%

“…In a Phase 3 study in CIA patients receiving darbepoetin alfa 500 lg Q3W, IV iron administered as iron-sucrose increased the hematopoietic response rate (proportion of patients achieving hemoglobin 12 g dL 21 or hemoglobin increase of 2 g dL 21 ) and lowered incidence of RBC transfusions [18]. This was the first study to show a statistically significant reduction in RBC transfusion needs for ESA-treated patients receiving IV iron versus ESA-treated patients not receiving IV iron (9% vs. 20%, P 5 0.005).…”

Section: Introductionmentioning

confidence: 99%

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Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia

Auerbach

Silberstein

Webb³

et al. 2010

American J Hematol

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This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 μg with or without intravenous (IV) iron in treating anemia in patients receiving multicycle chemotherapy. This Phase 2, double‐blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 μg (n = 62), darbepoetin alfa 300 μg plus IV iron (n = 60), darbepoetin alfa 500 μg (n = 60), or darbepoetin alfa 500 μg plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ≤10 g dL−1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (≥11 g dL−1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT‐F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin (75 and 78%, respectively); Kaplan–Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82%) than not receiving IV iron (72%) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit, while added IV iron improved treatment response in these patients. Am. J. Hematol., 2010. © 2010 Wiley‐Liss, Inc.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 64%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia

Auerbach

Silberstein

Webb³

et al. 2010

American J Hematol

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Risk of Infection Associated With Administration of Intravenous Iron

et al. 2021

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IMPORTANCEIntravenous iron is recommended by many clinical guidelines based largely on its effectiveness in reducing anemia. However, the association with important safety outcomes, such as infection, remains uncertain. OBJECTIVE To examine the risk of infection associated with intravenous iron compared with oral iron or no iron. DATA SOURCES Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials (RCTs) from 1966 to January 31, 2021. Ongoing trials were sought from ClinicalTrials.gov, CENTRAL, and the World Health Organization International Clinical Trials Search Registry Platform. STUDY SELECTION Pairs of reviewers identified RCTs that compared intravenous iron with oral iron or no iron across all patient populations, excluding healthy volunteers. Nonrandomized studies published since January 1, 2007, were also included. A total of 312 full-text articles were assessed for eligibility. DATA EXTRACTION AND SYNTHESIS Data extraction and risk of bias assessments were performed according to the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) and Cochrane recommendations, and the quality of evidence was assessed using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach. Two reviewers extracted data independently. A random-effects model was used to synthesize data from RCTs. A narrative synthesis was performed to characterize the reporting of infection. MAIN OUTCOMES AND MEASURESThe primary outcome was risk of infection. Secondary outcomes included mortality, hospital length of stay, and changes in hemoglobin and red blood cell transfusion requirements. Measures of association were reported as risk ratios (RRs) or mean differences.RESULTS A total of 154 RCTs (32 920 participants) were included in the main analysis. Intravenous iron was associated with an increased risk of infection when compared with oral iron or no iron (RR, 1.17; 95% CI, 1.04-1.31; I 2 = 37%; moderate certainty of evidence). Intravenous iron also was associated with an increase in hemoglobin (mean difference, 0.57 g/dL; 95% CI, 0.50-0.64 g/dL; I 2 = 94%) and a reduction in the risk of requiring a red blood cell transfusion (RR, 0.93; 95% CI, 0.76-0.89; I 2 = 15%) when compared with oral iron or no iron. There was no evidence of an effect on mortality or hospital length of stay. (continued) Key Points Question In patients who require treatment with intravenous iron, what is the evidence that this intervention increases the risk of developing a new infection? Findings In this systematic review and meta-analysis of 154 randomized clinical trials that included 32 920 participants, intravenous iron was associated with an increased risk of infection. Meaning The results of this study suggest that, despite broad advocacy in clinical guidelines, intravenous iron may increase the risk of infection, which must be balanced with the potential benefits of treating anemia and reducing blood transfusion requirements.

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Role of iron supplementation to erythropoiesis stimulating agents in the management of chemotherapy-induced anemia in cancer patients

Mhaskar

Wao

Miladinović

et al. 2012

Cochrane Database of Systematic Reviews

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Randomized, Multicenter, Controlled Trial Comparing the Efficacy and Safety of Darbepoetin Alfa Administered Every 3 Weeks With or Without Intravenous Iron in Patients With Chemotherapy-Induced Anemia

Abstract: Addition of IV iron to darbepoetin alpha Q3W in patients with chemotherapy-induced anemia was well tolerated, resulting in an improved hematopoietic response rate and lower incidence of transfusions compared with darbepoetin alpha alone.

Cited by 192 publications

References 27 publications

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia

Risk of Infection Associated With Administration of Intravenous Iron

Role of iron supplementation to erythropoiesis stimulating agents in the management of chemotherapy-induced anemia in cancer patients

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