Randomized, Double-Blind, Active-Controlled Trial of Every-3-Week Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia

Canon, Jean-Luc; Vansteenkiste, Johan; Bodoky, G.; Mateos, María Victoria; Bastit, Laurent; Ferreira, Irene; Rossi, G.; Amado, Rafael G.

doi:10.1093/jnci/djj053

Cited by 94 publications

(71 citation statements)

References 37 publications

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“…A recent large phase III randomised study compared DA weekly vs. Q3W in patients with non-myeloid malignancies treated for CIA [5]. Q3W dosing of DA proved to be noninferior to weekly in terms of efficacy (Hb endpoints, RBC transfusion rates and impact on QoL), and the adverse event profile was similar in both arms.…”

Section: Discussionmentioning

confidence: 99%

“…Evolution of Hb over time was analysed with Kaplan-Meier analysis. Similar to the analyses conducted in phase III randomised study [5], Hb endpoints were reported using all available Hb values and also disregarding Hb values within 28 days after any transfusion. Results were reported as Kaplan-Meier rates after 12 weeks of therapy.…”

Section: Methodsmentioning

confidence: 99%

“…The most recent publication [4] also mentions less frequent administration schedules, such as darbepoetin alfa (DA) once every 3 weeks (Q3W). DA is an ESA with a long plasma half life [7], thereby suitable for administration with extended dosing intervals, without loss of efficacy-as recently shown in a large phase III randomised study [5]-and for synchronisation with frequently used Q3W chemotherapy regimens [6].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Observational Aranesp® Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa

Pat¹,

Anrys²,

Verhulst

et al. 2008

Support Care Cancer

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Observational Aranesp® Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa

Pat¹,

Anrys²,

Verhulst

et al. 2008

Support Care Cancer

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“…Extended dosing was shown to have comparable efficacy and safety profiles to QW dosing with respect to raising Hb levels, 19,20 and reducing RBC transfusion requirements. [21][22][23][24] Importantly, the administration of DA Q3W represented an opportunity to synchronize ESA treatment with many chemotherapy regimens in clinical practice. 25 Chemotherapy has a myelosuppressive effect and as bone marrow had a hypothesized role in ESA clearance, the question was raised as to whether the efficacy of DA was different when administered synchronously or asynchronously with chemotherapy.…”

Section: Early 1990s To Mid-2000s: Developmentmentioning

confidence: 99%

Managing chemotherapy induced anemia with darbepoetin alfa and other erythropoiesis stimulating agents: a nurse's perspective

Derbyshire¹,

Thain²

2013

NRR

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Chemotherapy induced anemia (CIA) is a frequent complication of anticancer treatment, but often remains untreated. The main presenting symptom of CIA is fatigue, and this can have profound implications upon chemotherapy treatment compliance and patients' quality of life (QoL). Nevertheless, a tendency has been seen in both patients and physicians to underestimate the consequences of fatigue. As nurses are taking on greater responsibilities for identifying, monitoring, and in some cases even treating CIA, it is important that they have a clear understanding of the treatment options at their disposal. Erythropoiesis stimulating agents (ESAs) have been available as a tool for the treatment of CIA for many years. However, the vast majority of literature on this topic has been targeted towards physicians. Hence, the purpose of this review is to summarize the key ESA studies, with an emphasis on material that is of interest to the nursing community. Herein we present a brief chronological review of the development of ESAs to illustrate how the currently available treatment options for anemia arose. For conciseness, darbepoetin alfa (DA) has been used as a model to represent all ESAs; however, important findings from studies of other ESAs have also been included for completeness. We also discuss the management of CIA, based on the available literature and our experience of routine clinical practice in the UK. In conclusion, CIA is important in the context of maintaining QoL in patients undergoing chemotherapy and its effective management needs to be considered as part of their holistic care. Available studies show that ESA treatment can decrease fatigue levels and reduce the need for transfusions. ESAs, such as DA, may therefore be an important treatment option for patients with CIA. DA is well tolerated when used according to current recommendations, can be synchronized with chemotherapy cycles, and can also be self-administered.

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“…Once-weekly (Q1W) administration with all ESAs has become the preferred treatment modality (6,7). Darbepoetin α has also been licensed for use once every 3 weeks (Q3W) in cancer patients with chemotherapy-induced anemia (8). Continuous erythropoietin receptor activator (C.E.R.A.)…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic and pharmacodynamic profiles of subcutaneous administration of continuous erythropoietin receptor activator in lung cancer patients with anemia induced by chemotherapy

Takahashi¹,

Yamamoto²,

Tamura

et al. 2011

Oncology Letters

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Abstract. Continuous erythropoietin receptor activator (C.E.R.A.) is an innovative erythropoiesis-stimulating agent with unique erythropoietin receptor activity and a prolonged half-life. C.E.R.A. is currently in development for the correction of anemia and stable hemoglobin (Hb) control at extended administration intervals in patients with cancer who are receiving chemotherapy. The purpose of this pharmacological study was to evaluate the pharmacokinetic (PK), pharmacodynamic (PD) and safety profiles of C.E.R.A. administered subcutaneously once every 3 weeks (Q3W) in lung cancer patients with anemia induced by chemotherapy. This open-label, multicenter study recruited 46 patients. Entry Hb levels were not more than 11.0 g/dl. Five dose levels of C.E.R.A. (2.1, 4.2, 6.3, 9 and 12 µg/kg) were tested in sequential cohorts of 8-11 patients for 12 weeks. The mean values for C.E.R.A half-life ranged from 143 to 247 h. The maximum serum concentration (C max ) following the first administration of C.E.R.A. increased in proportion to the dose. The increase of Hb levels occurred in a dose-dependent manner. No serious adverse events reported as being related to C.E.R.A. were observed during the study period. Thrombovascular events were not observed in any patient. Anti-C.E.R.A antibodies were not detected in any patient. Thus, this pharmacological study confirmed the long half-life of C.E.R.A., thereby supporting subcutaneous administration of C.E.R.A. at the Q3W interval. PK and PD parameters demonstrated dose-proportionality over the range of doses tested in this study. Additionally, C.E.R.A. was generally well tolerated. IntroductionErythropoiesis-stimulating agents (ESAs) are commonly used to treat chemotherapy-induced anemia. The administration of these agents has been shown to be effective for treating anemia in patients who undergo chemotherapy. These agents are effective as they increase hemoglobin (Hb) concentrations and reduce or eliminate the need for red blood cell (RBC) transfusions, thus improving quality of life (QoL) (1-3). In anemic patients with cancer, ESAs were initially administered 3 times weekly, a schedule that had already proved effective in patients with renal anemia (4,5). Once-weekly (Q1W) administration with all ESAs has become the preferred treatment modality (6,7). Darbepoetin α has also been licensed for use once every 3 weeks (Q3W) in cancer patients with chemotherapy-induced anemia (8). Continuous erythropoietin receptor activator (C.E.R.A.) is an innovative agent with a prolonged half-life compared with that of epoetin α and epoetin β in healthy volunteers, and darbepoetin α in patients with peritoneal dialysis (9). C.E.R.A. is a chemically synthesized continuous erythropoietin receptor activator that differs from erythropoietin through the integration of amide bonds between amino groups and methoxy polyethylene glycolsuccinimidyl butanoic acid (10,11). It has been developed to provide correction of anemia and to control Hb levels at extended administration intervals in patients with CKD...

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Randomized, Double-Blind, Active-Controlled Trial of Every-3-Week Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia

Abstract: Patients with chemotherapy-induced anemia can safely and effectively be treated with 500 microg of darbepoetin alfa every 3 weeks.

Cited by 94 publications

References 37 publications

Observational Aranesp® Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa

Observational Aranesp® Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa

Managing chemotherapy induced anemia with darbepoetin alfa and other erythropoiesis stimulating agents: a nurse's perspective

Pharmacokinetic and pharmacodynamic profiles of subcutaneous administration of continuous erythropoietin receptor activator in lung cancer patients with anemia induced by chemotherapy

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Randomized, Double-Blind, Active-Controlled Trial of Every-3-Week Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia

Abstract: Patients with chemotherapy-induced anemia can safely and effectively be treated with 500 microg of darbepoetin alfa every 3 weeks.

Cited by 94 publications

References 37 publications

Observational Aranesp® Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa

Observational Aranesp® Survey to Investigate the Q3W Schedule (OASIS): a prospective observational study of treatment of chemotherapy-induced anaemia with every 3 weeks darbepoetin alfa

Managing chemotherapy induced anemia with darbepoetin alfa and other erythropoiesis stimulating agents: a nurse&#39;s perspective

Pharmacokinetic and pharmacodynamic profiles of subcutaneous administration of continuous erythropoietin receptor activator in lung cancer patients with anemia induced by chemotherapy

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Managing chemotherapy induced anemia with darbepoetin alfa and other erythropoiesis stimulating agents: a nurse's perspective