Randomized Comparison of Epoetin Alfa (40,000 U Weekly) and Darbepoetin Alfa (200 μg Every 2 Weeks) in Anemic Patients with Cancer Receiving Chemotherapy

Waltzman, Roger J.; Croot, C.; Justice, Glen; Fesen, Mark R.; Charu, Veena; Williams, Denise

doi:10.1634/theoncologist.10-8-642

Cited by 72 publications

(45 citation statements)

References 28 publications

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“…There was a lower percentage of patients transfused from baseline to the study end and by weeks of ESA therapy. The transfusion requirement by 4-weekly period on therapy showed a consistent difference: over the first 4 weeks on treatment, a transfusion was required by 8.6% of patients in the epoetin group and by 11.3% of patients given darbepoetin; in weeks 13-16, the corresponding figures were 4.8% and 7.4%, respectively (Table 2) [33].…”

Section: Thementioning

confidence: 85%

“…Oncologist ® There has been some suggestion that the type of ESA may also affect the transfusion requirement [33]. A randomized, open-label trial compared Hb response to once weekly epoetin alfa (Procrit ® ; Ortho Biotech Products, L.P., Raritan, NJ) with Hb response to darbepoetin alfa (Aranesp ® ; Amgen Inc., Thousand Oaks, CA) administered every 2 weeks in anemic patients receiving chemotherapy for their cancer [33].…”

Section: Thementioning

confidence: 99%

“…A randomized, open-label trial compared Hb response to once weekly epoetin alfa (Procrit ® ; Ortho Biotech Products, L.P., Raritan, NJ) with Hb response to darbepoetin alfa (Aranesp ® ; Amgen Inc., Thousand Oaks, CA) administered every 2 weeks in anemic patients receiving chemotherapy for their cancer [33]. In that study, a post hoc analysis showed that the overall number of units of transfusions from baseline to the end of the study was significantly lower for the epoetin alfa group (81) than for the darbepoetin alfa group (156) (p = .0587) [33]. There was a lower percentage of patients transfused from baseline to the study end and by weeks of ESA therapy.…”

Section: Thementioning

confidence: 99%

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Treatment Options for Anemia, Taking Risks into Consideration: Erythropoiesis-Stimulating Agents Versus Transfusions

Spano

Khayat

2008

The Oncologist

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Section: Thementioning

confidence: 85%

Section: Thementioning

confidence: 99%

Section: Thementioning

confidence: 99%

See 1 more Smart Citation

Treatment Options for Anemia, Taking Risks into Consideration: Erythropoiesis-Stimulating Agents Versus Transfusions

Spano

Khayat

2008

The Oncologist

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“…Moreover, EPO is certainly useful, not only for patients with renal failure but also for oncologic patients, [31,32] in which anaemia is due to the effect of both the tumoral mass and the heavy anti-blastic treatment. [33] High doses of EPO, in fact, together with growth factors like GM-CSF, can oppose the toxic effect of chemotherapy on bone marrow and improve the recovery of hematopoietic function. Nevertheless, a massive use of the hormone could lead to more significant side effects.…”

Section: Epo Therapy At Present Daymentioning

confidence: 99%

Experimental Models of Acute Renal Failure and Erythropoietin: What Evidence of a Direct Effect?

et al. 2007

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The kidney can achieve a structural and functional recovery after the damage induced by ischemia and reperfusion. This is due to the regeneration of epithelial tubular cells, the intervention of immature cells mainly localized in the medulla, and a small number of bone marrow-derived stem cells. In many instances, however, recovery is delayed or does not occur at all. The mechanisms allowing the renal cells to de-differentiate still need to be clarified in order to find a therapeutic approach that can amplify this ability and then stop the fibroid involution and the progression toward renal failure. Several authors have hypothesized a protective effect of EPO against ischemic and cytotoxic renal damage and observed that patients precociously treated with EPO showed a slower progression of renal failure. EPO has been demonstrated to have proliferative and anti-apoptotic effects in ischemia-reperfusion models in the brain and cell cultures. Moreover, EPO can mobilize stem cells and increase the plasmatic levels and the renal expression of VEGF. These effects seem to be dose-dependent and could be due to the activation of signal transduction systems, like Jak and STAT. In the presence of high doses of exogenous EPO or during the treatment with long-acting EPO-like molecules, non-specific receptors may be activated through a low-affinity link. Further investigations are needed to determine new therapeutic applications for EPO and other analogous hormones. Very long-acting molecules or molecules with cyto-protective but no erythropoietic effect may represent useful tools in the study of the molecular mechanisms underlying EPO's action and may have a rapid and safe therapeutic application.

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“…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).…”

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 Comparison of Epoetin Alfa (40,000 U Weekly) and Darbepoetin Alfa (200 μg Every 2 Weeks) in Anemic Patients with Cancer Receiving Chemotherapy

Abstract: Abstract

Cited by 72 publications

References 28 publications

Treatment Options for Anemia, Taking Risks into Consideration: Erythropoiesis-Stimulating Agents Versus Transfusions

Treatment Options for Anemia, Taking Risks into Consideration: Erythropoiesis-Stimulating Agents Versus Transfusions

Experimental Models of Acute Renal Failure and Erythropoietin: What Evidence of a Direct Effect?

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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