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Intravenous Iron Supplementation for the Treatment of Chemotherapy-Induced Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Buchrits S, Itzhaki O, Avni T, Raanani P, Gafter-Gvili A
Journal of clinical medicine. 2022;11(14)
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Abstract
BACKGROUND The pathophysiology of cancer-related anemia is multifactorial, including that of chemotherapy-induced anemia (CIA). The guidelines are not consistent in their approach to the use of intravenous (IV) iron in patients with cancer as part of the clinical practice. MATERIALS AND METHODS All randomized controlled trials that compared IV iron with either no iron or iron taken orally for the treatment of CIA were included. We excluded trials if erythropoiesis-stimulating agents (ESAs) were used. The primary outcome was the percentage of patients requiring a red blood cell (RBC) transfusion during the study period. The secondary outcomes included the hematopoietic response (an increase in the Hb level by more than 1 g/dL or an increase above 11 g/dL), the iron parameters and adverse events. For the dichotomous data, risk ratios (RRs) with 95% confidence intervals (Cis) were estimated and pooled. For the continuous data, the mean differences were calculated. A fixed effect model was used, except in the event of significant heterogeneity between the trials (p < 0.10; I(2) > 40%), in which we used a random effects model. RESULTS A total of 8 trials published between January 1990 and July 2021 that randomized 1015 patients fulfilled the inclusion criteria. Of these, 553 patients were randomized to IV iron and were compared with 271 patients randomized to oral iron and 191 to no iron. IV iron decreased the percentage of patients requiring a blood transfusion compared with oral iron (RR 0.72; 95% CI 0.55-0.95) with a number needed to treat of 20 (95% CI 11-100). IV iron increased the hematopoietic response (RR 1.23; 95% CI 1.01-1.5). There was no difference with respect to the risk of adverse events (RR 0.97; 95% CI 0.88-1.07; 8 trials) or severe adverse events (RR 1.09; 95% CI 0.76-1.57; 8 trials). CONCLUSIONS IV iron resulted in a decrease in the need for RBC transfusions, with no difference in adverse events in patients with CIA. IV iron for the treatment of CIA should be considered in clinical practice.
PICO Summary
Population
People with chemotherapy induced anaemia enrolled in randomised controlled trials (RCTs), and identified by systematic review (n= 1,015, 8 RCTs).
Intervention
Intravenous [IV] iron (n= 553).
Comparison
Oral iron (n= 271), or no iron (n= 191).
Outcome
IV iron decreased the percentage of patients requiring a blood transfusion compared with oral iron (Risk ratio [RR] 0.72; 95% confidence interval [CI] 0.55-0.95) with a number needed to treat of 20 (95% CI 11-100). IV iron increased the hematopoietic response (RR 1.23; 95% CI 1.01-1.5). There was no difference with respect to the risk of adverse events (RR 0.97; 95% CI 0.88-1.07; 8 trials) or severe adverse events (RR 1.09; 95% CI 0.76-1.57; 8 trials).
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2.
Randomized, double-blind, placebo-controlled, multicenter study evaluating epoetin alfa versus placebo in anemic patients with IPSS Low- Int1 risk MDS
Fenaux P, Santini V, Aloe Spiriti MA, Giagounidis A, Schlag R, Radinoff A, L Gercheva-Kyuchukova L, Anagnostopoulos A, E Oliva E, Symeonidis A, et al
Haematologica. 2016;101((s1)):71.. p248.
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3.
Low-dose fludarabine with or without darbepoetin alfa in patients with chronic lymphocytic leukemia and comorbidity: primary results of the CLL9 trial of the German CLL Study Group
Goede V, Busch R, Bahlo J, Chataline V, Kremers S, Muller L, Reschke D, Schlag R, Schmidt B, Vehling-Kaiser U, et al
Leukemia & Lymphoma. 2016;57((3)):596-603.
Abstract
This study was planned as a phase 3 trial to investigate low-dose fludarabine with or without darbepoetin alfa in older patients with previously untreated or treated chronic lymphocytic leukemia (CLL) and comorbidity. Due to slow recruitment, the study was terminated prematurely after accrual of 97 patients who, on average, were 74 years old and had a cumulative illness rating scale (CIRS) total score of 5. We report toxicity and efficacy of the study treatment. Grade 3-5 neutropenia and infection were observed in 25% and 10% of patients, respectively. Response was seen in 73% (5% complete remissions). Median event-free and overall survival was 12.2 and 44.8 months, respectively. No differences in outcome were found for patients treated with versus without darbepoetin alfa. In subjects with progressive/recurrent CLL during or after study treatment, overall survival was similar for patients receiving chemotherapy versus chemoimmunotherapy as salvage treatment.
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A Bayesian, phase II randomized trial of extracorporeal photopheresis (ECP) plus steroids versus steroids-alone in patients with newly diagnosed acute graft vs. host disease (GVHD): the addition of ECP improves GVHD response and the ability to taper steroids
Alousi AM, Bassett R, Chen J, Overman BJ, Hosing CM, Popat UR, Shpall EJ, Nieto Y, Qazilbash MH, Khouri1 IF, et al
Blood. 2015;126((23)): Abstract No. 854.
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Erythropoietin therapy after allogeneic hematopoietic cell transplantation: a prospective, randomized trial
Jaspers A, Baron F, Willems E, Seidel L, Hafraoui K, Vanstraelen G, Bonnet C, Beguin Y
Blood. 2014;124((1):):33-41.
Abstract
We conducted a prospective randomized trial to assess hemoglobin (Hb) response to recombinant human erythropoietin (rhEPO) therapy after hematopoietic cell transplantation (HCT). Patients (N = 131) were randomized (1:1) between no treatment (control arm) or erythropoietin at 500 U/kg per week (EPO arm). Patients were also stratified into 3 cohorts: patients undergoing myeloablative HCT with rhEPO to start on day (D)28, patients given nonmyeloablative HCT (NMHCT) with rhEPO to start on D28, and patients also given NMHCT but with rhEPO to start on D0. The proportion of complete correctors (ie, Hb >13 g/dL) before D126 posttransplant was 8.1% in the control arm (median not reached) and 63.1% in the EPO arm (median, 90 days) (P < .001). Hb levels were higher and transfusion requirements decreased (P < .001) in the EPO arm, but not during the first month in the nonmyeloablative cohort starting rhEPO on D0. There was no difference in rates of thromboembolic events or other complications between the 2 arms. This is the first randomized trial to demonstrate that rhEPO therapy hastens erythroid recovery and decreases transfusion requirements when started one month after allogeneic HCT. There was no benefit to start rhEPO earlier after NMHCT. 2014 by The American Society of Hematology.
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Long-term survival in patients receiving rhEPO following allogeneic hematopoietic cell transplantation
Jaspers A, Baron F, Willems E, Seidel L, Hafraoui K, Bonnet C, Beguin Y
Haematologica. 2014;99((S1):):168.. Abstract No. P507.
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7.
Darbepoetin-alfa and intravenous iron administration after autologous hematopoietic stem cell transplantation: A prospective multicenter randomized trial
Beguin Y, Maertens J, De Prijck B, Schots R, Seidel L, Bonnet C, Hafraoui K, Willems E, Vanstraelen G, Servais S, et al
American Journal of Hematology. 2013;88((12):):990-6.
Abstract
We conducted a randomized study analyzing the impact of darbepoetin alfa (DA) administration with or without intravenous (i.v.) iron on erythroid recovery after autologous hematopoietic cell transplantation (HCT). Patients were randomized between no DA (Arm 1), DA 300 mug every 2 weeks starting on Day 28 after HCT (Arm 2), or DA plus i.v. iron 200 mg on Days 28, 42, and 56 (Arm 3). The proportion achieving complete hemoglobin (Hb) response within 18 weeks (primary end point) was 21% in Arm 1 (n=24), 79% in Arm 2 (n=25), and 100% in Arm 3 (n=23; P<0.0001). Erythropoietic response was shown to be significantly higher in Arm 3 (n=46) than in Arm 2 (n=50; P=0.008), resulting in lower DA use, reduced drug costs, and improved quality of life scores, but the effect on transfusions was not significant. In multivariate analysis, DA administration (P<0.0001), i.v. iron administration (P=0.0010), high baseline Hb (P<0.0001), and low baseline creatinine (P=0.0458) were independently associated with faster achievement of complete Hb response. In conclusion, DA is highly effective to ensure full erythroid reconstitution after autologous HCT when started on Day 28 post-transplant. I.v. iron sucrose further improves erythroid recovery. Am. J. Hematol. 88:990-996, 2013. 2013 Wiley Periodicals, Inc. Copyright 2013 Wiley Periodicals, Inc.
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8.
Intravenous ferric carboxymaltose as sole anemia therapy in patients with lymphoid malignancies, chemotherapy-induced anemia and functional iron deficiency
Hedenus M, Karlsson T, Ludwig H, Felder M, Roubert B, Birgegard G
Blood. 2013;122((21):):3439.
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Prognostic factors of response and survival to azacitidine (AZA) +/- EPO in RBC transfusion dependent (TD) IPSS low and Int-1 (LR) MDS resistant to EPO, with particular emphasis of genetic lesions: a study by the GFM
Thepot S, Ben Abdelali R, Chevret S, Renneville A, Beyne Rauzy O, Prebet T, Park S, Stamatoullas A, Guerci-Bresler A, Cheze S, et al
Blood. 2013;122((21):):658.
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10.
Erythropoietin alpha vs biosimilar erythropoietin alpha plus lipofer and B12 and folates in patients with refractory anemia. two center prospectic study abstract
Giordano G, Mondello P, Tambaro1 R, Perrotta N, DÆAmico F, Sticca G, Di Falco C
Haematologica. 2012;97((S1):):142. Abstract No. 0353.