Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents in Patients with Cancer

Juneja, Vinni; Keegan, Patricia; Gootenberg, Joseph E.; Rothmann, Mark D.; Shen, Yuan Li; Lee, Ki Young; Weiss, Karen D.; Pazdur, Richard

doi:10.1158/1078-0432.ccr-07-1872

Cited by 33 publications

(27 citation statements)

References 14 publications

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“…In March 2007, the FDA modified the label to include a black box warning describing the thromboembolic and mortality risks associated with ESA use targeted to hemoglobin levels Ն12 g/dl [22,23]. Physicians were advised to administer the lowest ESA dose sufficient to avoid transfusions.…”

Section: Introductionmentioning

confidence: 99%

Impact of Safety Concerns and Regulatory Changes on the Usage of Erythropoiesis-Stimulating Agents and RBC Transfusions

Vadhan‐Raj¹,

Zhou²,

Sizer³

et al. 2010

The Oncologist

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Purpose. Safety concerns raised in the recent oncology trials with erythropoiesis-stimulating agents (ESAs) have led to regulatory restrictions on their use. We wished to determine the impact of these changes on the use of ESAs and RBC transfusions. Conclusions. Recent ESA safety concerns and regulatory restrictions have significantly decreased ESA use. The lack of a significant impact on transfusions may be related to a lower hemoglobin threshold used to initiate ESAs or treatment of patients less likely to respond. The Oncologist

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Section: Introductionmentioning

confidence: 99%

Impact of Safety Concerns and Regulatory Changes on the Usage of Erythropoiesis-Stimulating Agents and RBC Transfusions

Vadhan‐Raj¹,

Zhou²,

Sizer³

et al. 2010

The Oncologist

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“…The Oncologic Drug Advisory Committee (USA) has indicated that there are insufficient data from adequate and well-controlled studies designed to assess the effects on survival or tumor promotion, and employ the recommended doses of erythropoiesis-stimulating agents (17). In addition, the United States Food and Drug Administration issued a warning against erythropoiesis-stimulating agents for patients with chemotherapy-associated anemia (18).…”

Section: Introductionmentioning

confidence: 99%

Effect of erythropoietin on human tumor growth in xenograft models

Kataoka¹,

Moriya²,

Moriguchi³

et al. 2009

Mol Med Rep

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Abstract. recombinant human erythropoietin (rhePo) has been used in the eu and the united States for the treatment of anemia in cancer patients after myelosuppressive chemotherapy or radiotherapy. However, several conflicting results have been reported concerning the detrimental effect of rhEPO on survival benefit in cancer patients. In experimental studies, contradictory results were also reported in in vitro tumor cell proliferation studies and in vivo tumor growth studies using tumor cells expressing EPO-receptor (EPO-R). Therefore, we tried to clarify the effect of epoetin β, a product of rhEPO, on tumor growth in xenograft models using five ePo-r-positive human cancer cell lines, namely the McF7 breast, 786-O renal, SCH gastric, A549 lung and SK-OV-3 ovarian cancer cell lines. epoetin β was administered once a week for 3 weeks at doses of 1,000, 3,000 and 10,000 IU/kg in accordance with the clinical administration schedule and dosages. As a result, no enhancement of tumor growth from the administration of epoetin β was observed in any of the xenograft models throughout the experiment duration. The effect of epoetin β on the antitumor activity of bevacizumab, an anti-angiogenic agent, was additionally examined using A549 and MCF7 xenograft models, since rhEPO reportedly stimulates tumor neovascularization. epoetin β showed no significant effect on the antitumor activity of bevacizumab in either xenograft model. These findings suggest that epoetin β is not involved in in vivo tumor growth promotion.

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“…Although this systematic review did not highlight an increase in mortality or thrombotic events in the intervention groups, there have been a number of trials that have reported an increase in thrombotic events, decreased survival and poor tumour control following administration of erythropoeisis stimulating agents in cancer patients, particularly if it is given in conjunction with chemotherapy regimens [17,18].…”

Section: Discussionmentioning

confidence: 88%

Single Dose Preoperative Administration of Intravenous Iron Corrects Iron Deficiency Anaemia in Colorectal Cancer

Ng¹

2010

J Blood Disord Transfus

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Preoperative iron defi ciency anaemia (IDA) is common and associated with poor postoperative outcomes. Standard treatment includes allogenic blood transfusion or oral iron supplementation, but new intravenous iron strategies have shown promise in the perioperative setting. We aim to assess the feasibility and effect of a single dose of intravenous iron in treating preoperative colorectal cancer related anaemia.We performed an open labelled phase I uncontrolled trial. Patients with a diagnosis of colorectal cancer and biochemically proven IDA received intravenous iron a minimum of 14 days prior to surgery. Blood parameters including haemoglobin values were measured at pre-dose and preoperative time points.Eight of the ten patients responded to intravenous iron supplementation with a mean preoperative rise in haemoglobin of 1.1 g/dl (p=0.036). Ferritin levels rose by a mean of 523.4ng/ml across the ten patients. No adverse events occurred in any of the trial patients.This trial demonstrates that intravenous iron is both a feasible and effective treatment for IDA in anaemic colorectal cancer patients. However two patients did not respond to treatment, highlighting the need to identify biochemical markers which will accurately predict the underlying cause for anaemia and response to treatment.

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Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents in Patients with Cancer

Abstract: Purpose: Erythropoiesis-stimulating agents (ESA) are approved for the treatment of anemia in patients with nonmyeloid malignancies whose anemia is due to the effect of concomitantly administered chemotherapy. Since the 1993 approval of epoetin alfa in patients with cancer,

Cited by 33 publications

References 14 publications

Impact of Safety Concerns and Regulatory Changes on the Usage of Erythropoiesis-Stimulating Agents and RBC Transfusions

Impact of Safety Concerns and Regulatory Changes on the Usage of Erythropoiesis-Stimulating Agents and RBC Transfusions

Effect of erythropoietin on human tumor growth in xenograft models

Single Dose Preoperative Administration of Intravenous Iron Corrects Iron Deficiency Anaemia in Colorectal Cancer

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