Meta-Analysis
doi: 10.1002/14651858.CD003407.pub5.
Erythropoietin or darbepoetin for patients with cancer
Affiliations
- PMID: 23235597
- PMCID: PMC8145276
- DOI: 10.1002/14651858.CD003407.pub5
Item in Clipboard
Meta-Analysis
Erythropoietin or darbepoetin for patients with cancer
Cochrane Database Syst Rev.
.
Abstract
Background: Anaemia associated with cancer and cancer therapy is an important clinical factor in the treatment of malignant diseases. Therapeutic alternatives are recombinant human erythropoiesis stimulating agents (ESAs) and red blood cell transfusions.
Objectives: To assess the effects of ESAs to either prevent or treat anaemia in cancer patients.
Search methods: This is an update of a Cochrane review first published in 2004. We searched the Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE and other databases. Searches were done for the periods 01/1985 to 12/2001 for the first review, 1/2002 to 04/2005 for the first update and to November 2011 for the current update. We also contacted experts in the field and pharmaceutical companies.
Selection criteria: Randomised controlled trials on managing anaemia in cancer patients receiving or not receiving anti-cancer therapy that compared the use of ESAs (plus transfusion if needed).
Data collection and analysis: Several review authors assessed trial quality and extracted data. One review author assessed quality assessment and extracted data, a second review author checked for correctness.
Main results: This update of the systematic review includes a total of 91 trials with 20,102 participants. Use of ESAs significantly reduced the relative risk of red blood cell transfusions (risk ratio (RR) 0.65; 95% confidence interval (CI) 0.62 to 0.68, 70 trials, N = 16,093). On average, participants in the ESAs group received one unit of blood less than the control group (mean difference (MD) -0.98; 95% CI -1.17 to -0.78, 19 trials, N = 4,715). Haematological response was observed more often in participants receiving ESAs (RR 3.93; 95% CI 3.10 to 3.71, 31 trials, N = 6,413). There was suggestive evidence that ESAs may improve Quality of Life (QoL). There was strong evidence that ESAs increase mortality during active study period (hazard ratio (HR) 1.17; 95% CI 1.06 to 1.29, 70 trials, N = 15,935) and some evidence that ESAs decrease overall survival (HR 1.05; 95% CI 1.00 to 1.11, 78 trials, N = 19,003). The risk ratio for thromboembolic complications was increased in patients receiving ESAs compared to controls (RR 1.52, 95% CI 1.34 to 1.74; 57 trials, N = 15,498). ESAs may also increase the risk for hypertension (fixed-effect model: RR 1.30; 95% CI 1.08 to 1.56; random-effects model: RR 1.12; 95% CI 0.94 to 1.33, 31 trials, N = 7,228) and thrombocytopenia/haemorrhage (RR 1.21; 95% CI 1.04 to 1.42; 21 trials, N = 4,507). There was insufficient evidence to support an effect of ESA on tumour response (fixed-effect RR 1.02; 95% CI 0.98 to 1.06, 15 trials, N = 5,012).
Authors' conclusions: ESAs reduce the need for red blood cell transfusions but increase the risk for thromboembolic events and deaths. There is suggestive evidence that ESAs may improve QoL. Whether and how ESAs affects tumour control remains uncertain. The increased risk of death and thromboembolic events should be balanced against the potential benefits of ESA treatment taking into account each patient's clinical circumstances and preferences. More data are needed for the effect of these drugs on quality of life and tumour progression. Further research is needed to clarify cellular and molecular mechanisms and pathways of the effects of ESAs on thrombogenesis and their potential effects on tumour growth.
Conflict of interest statement
Thomy Tonia, Annette Mettler, Nadège Robert, Olaf Weingart, Guido Schwarzer, Jerome Seidenfeld, Chris Hyde, Andreas Engert, Julia Bohlius: none known.
Figures
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study. If for a given study more than one reference was included we reported our judgement only for the main reference and left the other references of the same study empty.
Comparison 1 Haematologic response, Outcome 1 Haematological response ‐ overall.
Comparison 1 Haematologic response, Outcome 2 Haematologic response ‐ baseline Hb.
Comparison 1 Haematologic response, Outcome 3 Haematologic response ‐ different malignancies.
Comparison 1 Haematologic response, Outcome 4 Haematological response‐ age.
Comparison 1 Haematologic response, Outcome 5 Haematological response‐ age differentiated.
Comparison 1 Haematologic response, Outcome 6 Haematologic response ‐ different therapies.
Comparison 1 Haematologic response, Outcome 7 Haematologic response ‐ different therapies differentiated.
Comparison 1 Haematologic response, Outcome 8 Haematologic response ‐ epoetin versus darbepoetin.
Comparison 1 Haematologic response, Outcome 9 Haematologic response ‐ duration of ESA medication.
Comparison 1 Haematologic response, Outcome 10 Haematologic response ‐ iron supplementation.
Comparison 1 Haematologic response, Outcome 11 Haematologic response ‐ allocation concealment.
Comparison 1 Haematologic response, Outcome 12 Haematologic response ‐ masking.
Comparison 1 Haematologic response, Outcome 13 Haematologic response ‐ intention‐to treat.
Comparison 1 Haematologic response, Outcome 14 Haematologic response ‐ publication.
Comparison 1 Haematologic response, Outcome 15 Haematological response ‐ merged experimental arms.
Comparison 2 Change of haemoglobin level, Outcome 1 Change in Hb values ‐ overall.
Comparison 2 Change of haemoglobin level, Outcome 2 Change in Hb values ‐ baseline Hb.
Comparison 2 Change of haemoglobin level, Outcome 3 Change in Hb values ‐ different malignancies.
Comparison 2 Change of haemoglobin level, Outcome 4 Change in Hb values ‐ age.
Comparison 2 Change of haemoglobin level, Outcome 5 Change in Hb values ‐ age differentiated.
Comparison 2 Change of haemoglobin level, Outcome 6 Change in Hb values ‐ different therapies.
Comparison 2 Change of haemoglobin level, Outcome 7 Change in Hb values ‐ different therapies differentiated.
Comparison 2 Change of haemoglobin level, Outcome 8 Change in Hb values ‐ epoetin vs darbepoetin.
Comparison 2 Change of haemoglobin level, Outcome 9 Change in Hb values ‐ duration of ESA medication.
Comparison 2 Change of haemoglobin level, Outcome 10 Change in Hb values ‐ iron supplementation.
Comparison 2 Change of haemoglobin level, Outcome 11 Change in Hb values ‐ allocation concealment.
Comparison 2 Change of haemoglobin level, Outcome 12 Change in Hb values ‐ masking.
Comparison 2 Change of haemoglobin level, Outcome 13 Change in Hb values ‐ intention‐to‐treat.
Comparison 2 Change of haemoglobin level, Outcome 14 Change in Hb values ‐ publication.
Comparison 2 Change of haemoglobin level, Outcome 15 Change in Hb values ‐ experimental arms merged.
Comparison 2 Change of haemoglobin level, Outcome 16 Change in Hb values‐ sensitivity analysis.
Comparison 2 Change of haemoglobin level, Outcome 17 Change in Hb values ‐ publication sensitivity analysis excluding Henke 2003.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 1 Participants receiving red blood cell transfusions ‐ overall.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 2 Participants receiving red blood cell transfusions ‐ baseline Hb.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 3 Participants receiving red blood cell transfusions ‐ different malignancies.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 4 Participants receiving red blood cell transfusions ‐ age.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 5 Participants receiving red blood cell transfusions ‐ age differentiated.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 6 Participants receiving red blood cell transfusions ‐ different therapies.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 7 Participants receiving red blood cell transfusions ‐ different therapies differentiated.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 8 Participants receiving red blood cell transfusions ‐ epoetin versus darbepoetin.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 9 Participants receiving red blood cell transfusions ‐ duration of ESA medication.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 10 Participants receiving red blood cell transfusions ‐ iron supplementation.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 11 Participants receiving red blood cell transfusions ‐ allocation concealment.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 12 Participants receiving red blood cell transfusions ‐ masking.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 13 Participants receiving red blood cell transfusions ‐ intention‐to treat.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 14 Participants receiving red blood cell transfusions ‐ publication.
Comparison 3 Participants receiving red blood cell transfusions, Outcome 15 Participants receiving red blood cell transfusions ‐ first 4 weeks are....
Comparison 3 Participants receiving red blood cell transfusions, Outcome 16 Participants receiving red blood cell transfusions ‐ experimental arms merged.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 1 Number of RBC units transfused ‐ overall.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 2 Number of RBC units transfused ‐ baseline Hb.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 3 Number of RBC units transfused ‐ age differentiated.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 4 Number of RBC units transfused ‐ age.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 5 Number of RBC units transfused ‐ different malignancies.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 6 Number of RBC units transfused ‐ different therapies.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 7 Number of RBC units transfused ‐ different therapies differentiated.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 8 Number of RBC units transfused ‐ epoetin versus darbepoetin.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 9 Number of RBC units transfused ‐ duration of ESA medication.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 10 Number of RBC units transfused ‐ iron supplementation.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 11 Number of RBC units transfused ‐ allocation concealment.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 12 Number of RBC units transfused ‐ masking.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 13 Number of RBC units transfused ‐ intention‐to‐treat.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 14 Number of RBC units transfused ‐ publication.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 15 Number of RBC units transfused ‐ first 4 weeks are....
Comparison 4 Number of red blood cell units transfused per patient, Outcome 16 Number of RBC units transfused ‐ experimental arms merged.
Comparison 4 Number of red blood cell units transfused per patient, Outcome 17 Number of RBC units transfused ‐ age differentiated sensitivity analysis.
Comparison 5 Overall survival, Outcome 1 Overall survival ‐ overall.
Comparison 5 Overall survival, Outcome 2 Overall survival updated review (adjusted results).
Comparison 5 Overall survival, Outcome 3 Overall survival ‐ baseline Hb.
Comparison 5 Overall survival, Outcome 4 Overall survival ‐ different malignancies.
Comparison 5 Overall survival, Outcome 5 Overall survival ‐ age.
Comparison 5 Overall survival, Outcome 6 Overall survival ‐ age differentiated.
Comparison 5 Overall survival, Outcome 7 Overall survival ‐ different therapies.
Comparison 5 Overall survival, Outcome 8 Overall survival ‐ different therapies differentiated.
Comparison 5 Overall survival, Outcome 9 Overall survival ‐ epoetin vs darbepoetin.
Comparison 5 Overall survival, Outcome 10 Overall survival ‐ duration of ESA medication.
Comparison 5 Overall survival, Outcome 11 Overall survival ‐ iron supplementation.
Comparison 5 Overall survival, Outcome 12 Overall survival ‐ publication.
Comparison 5 Overall survival, Outcome 13 Overall survival ‐ time‐to‐event or binary mortality data.
Comparison 5 Overall survival, Outcome 14 Overall survival ‐ allocation concealment.
Comparison 5 Overall survival, Outcome 15 Overall survival ‐ masking.
Comparison 5 Overall survival, Outcome 16 Overall survival ‐ intention‐to‐treat.
Comparison 5 Overall survival, Outcome 17 Overall survival ‐ follow up.
Comparison 5 Overall survival, Outcome 18 Overall survival ‐ follow up and design.
Comparison 5 Overall survival, Outcome 19 Overall survival‐ experimental arms merged.
Comparison 5 Overall survival, Outcome 20 Overall survival‐ experimental arms merged sens pos.
Comparison 5 Overall survival, Outcome 21 Overall survival‐ experimental arms merged sens neg.
Comparison 5 Overall survival, Outcome 22 Overall survival ‐ sensitivity analysis baseline Hb.
Comparison 5 Overall survival, Outcome 23 Overall survival ‐ sensitivity analysis iron supplementation.
Comparison 5 Overall survival, Outcome 24 Overall survival ‐ sensitivity analysis intention‐to‐treat.
Comparison 6 On‐study mortality, Outcome 1 On‐study mortality ‐ overall.
Comparison 6 On‐study mortality, Outcome 2 On‐study mortality ‐ baseline Hb.
Comparison 6 On‐study mortality, Outcome 3 On‐study mortality ‐ different malignancies.
Comparison 6 On‐study mortality, Outcome 4 On‐study mortality ‐ age.
Comparison 6 On‐study mortality, Outcome 5 On‐study mortality ‐ age differentiated.
Comparison 6 On‐study mortality, Outcome 6 On‐study mortality ‐ different therapies.
Comparison 6 On‐study mortality, Outcome 7 On‐study mortality ‐ different therapies differentiated.
Comparison 6 On‐study mortality, Outcome 8 On‐study mortality ‐ duration of ESA medication.
Comparison 6 On‐study mortality, Outcome 9 On‐study mortality ‐ epoetin vs darbepoetin.
Comparison 6 On‐study mortality, Outcome 10 On‐study mortality ‐ iron supplementation.
Comparison 6 On‐study mortality, Outcome 11 On‐study mortality ‐ publication.
Comparison 6 On‐study mortality, Outcome 12 On‐study mortality ‐ time‐to‐event or binary mortality data.
Comparison 6 On‐study mortality, Outcome 13 On‐study mortality ‐ allocation concealment.
Comparison 6 On‐study mortality, Outcome 14 On‐study mortality ‐ masking.
Comparison 6 On‐study mortality, Outcome 15 On‐study mortality ‐ intention‐to‐treat.
Comparison 6 On‐study mortality, Outcome 16 On‐study mortality ‐ sensitivity analysis ‐ follow‐up.
Comparison 6 On‐study mortality, Outcome 17 On‐study mortality ‐ sensitivity analysis experimental arms merged.
Comparison 6 On‐study mortality, Outcome 18 On‐study mortality ‐ sensitivity analysis intention‐to‐treat.
Comparison 6 On‐study mortality, Outcome 19 On‐study mortality ‐ sensitivity analysis excluding Leyland and Smith.
Comparison 7 Complete tumour response, Outcome 1 Complete tumour response.
Comparison 7 Complete tumour response, Outcome 2 Tumour‐response specific quality criteria.
Comparison 7 Complete tumour response, Outcome 3 Complete tumour response ‐ experimental study arms merged.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 1 Change in FACT‐Fatigue (13 items) ‐ overall.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 2 Change in FACT‐Fatigue sensitivity analysis‐ Tsuboi.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 3 Change in FACT‐F 13 ‐ baseline Hb.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 4 Change in FACT‐F 13 ‐ different malignancies.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 5 Change in FACT‐F 13 ‐ age.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 6 Change in FACT‐F 13 ‐ different therapies.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 7 Change in FACT‐F 13 ‐ different therapies differentiated.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 8 Change in FACT‐F 13 ‐ epoetin versus darbepoetin.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 9 Change in FACT‐F 13 ‐ duration of ESA medication.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 10 Change in FACT‐F 13 ‐ iron supplementation.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 11 Change in FACT‐F 13 ‐ allocation concealment.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 12 Change in FACT‐F 13 ‐ masking.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 13 Change in FACT‐F 13 ‐ intention‐to treat.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 14 Change in FACT‐F 13 ‐ publication.
Comparison 8 Change in FACT‐Fatigue 13, Outcome 15 Change in FACT‐F 13 ‐ type of data.
Comparison 9 Change in FACT‐An 20, Outcome 1 Change in FACT‐An (20 items) ‐ overall.
Comparison 9 Change in FACT‐An 20, Outcome 2 Change in FACT‐An 20 ‐ baseline Hb.
Comparison 9 Change in FACT‐An 20, Outcome 3 Change in FACT‐An 20 ‐ different malignancies.
Comparison 9 Change in FACT‐An 20, Outcome 4 Change in FACT‐An 20 ‐ age.
Comparison 9 Change in FACT‐An 20, Outcome 5 Change in FACT‐An 20 ‐ different therapies.
Comparison 9 Change in FACT‐An 20, Outcome 6 Change in FACT‐An 20 ‐ different therapies differentiated.
Comparison 9 Change in FACT‐An 20, Outcome 7 Change in FACT‐An 20 ‐ epoetin versus darbepoetin.
Comparison 9 Change in FACT‐An 20, Outcome 8 Change in FACT‐An 20 ‐ duration of ESA medication.
Comparison 9 Change in FACT‐An 20, Outcome 9 Change in FACT‐An 20 ‐ iron supplementation.
Comparison 9 Change in FACT‐An 20, Outcome 10 Change in FACT‐An 20 ‐ allocation concealment.
Comparison 9 Change in FACT‐An 20, Outcome 11 Change in FACT‐An 20 ‐ masking.
Comparison 9 Change in FACT‐An 20, Outcome 12 Change in FACT‐An 20 ‐ intention‐to treat.
Comparison 9 Change in FACT‐An 20, Outcome 13 Change in FACT‐An 20 ‐ publication.
Comparison 9 Change in FACT‐An 20, Outcome 14 Change in FACT‐An 20 ‐ data type.
Comparison 10 Change in FACT‐An Total 47, Outcome 1 Change in FACT‐An Total (47 items) ‐ overall.
Comparison 10 Change in FACT‐An Total 47, Outcome 2 Change in FACT‐An Total 47‐ sensitivity analysis.
Comparison 10 Change in FACT‐An Total 47, Outcome 3 Change in FACT‐An Total 47 ‐ baseline Hb.
Comparison 10 Change in FACT‐An Total 47, Outcome 4 Change in FACT‐An Total 47 ‐ different malignancies.
Comparison 10 Change in FACT‐An Total 47, Outcome 5 Change in FACT‐An Total 47 ‐ age.
Comparison 10 Change in FACT‐An Total 47, Outcome 6 Change in FACT‐An Total 47 ‐ different therapies.
Comparison 10 Change in FACT‐An Total 47, Outcome 7 Change in FACT‐An Total 47 ‐ different therapies differentiated.
Comparison 10 Change in FACT‐An Total 47, Outcome 8 Change in FACT‐An Total 47 ‐ epoetin versus darbepoetin.
Comparison 10 Change in FACT‐An Total 47, Outcome 9 Change in FACT‐An Total 47 ‐ duration of ESA medication.
Comparison 10 Change in FACT‐An Total 47, Outcome 10 Change in FACT‐An Total 47 ‐ iron supplementation.
Comparison 10 Change in FACT‐An Total 47, Outcome 11 Change in FACT‐An Total 47 ‐ allocation concealment.
Comparison 10 Change in FACT‐An Total 47, Outcome 12 Change in FACT‐An Total 47 ‐ masking.
Comparison 10 Change in FACT‐An Total 47, Outcome 13 Change in FACT‐An Total 47 ‐ intention‐to treat.
Comparison 10 Change in FACT‐An Total 47, Outcome 14 Change in FACT‐An Total 47 ‐ publication.
Comparison 10 Change in FACT‐An Total 47, Outcome 15 Change in Fact‐An Total 47 ‐ data type.
Comparison 10 Change in FACT‐An Total 47, Outcome 16 FACT‐An Total 47 ‐ merged experimental study arms.
Comparison 11 Thrombotic events, Outcome 1 Thrombotic events ‐ overall.
Comparison 11 Thrombotic events, Outcome 2 Thrombotic events ‐ baseline Hb.
Comparison 11 Thrombotic events, Outcome 3 Thrombotic events ‐ different malignancies.
Comparison 11 Thrombotic events, Outcome 4 Thrombotic events ‐ age.
Comparison 11 Thrombotic events, Outcome 5 Thrombotic events ‐ age differentiated.
Comparison 11 Thrombotic events, Outcome 6 Thrombotic events ‐ different therapies.
Comparison 11 Thrombotic events, Outcome 7 Thrombotic events ‐ different therapies differentiated.
Comparison 11 Thrombotic events, Outcome 8 Thrombotic events ‐ epoetin versus darbepoetin.
Comparison 11 Thrombotic events, Outcome 9 Thrombotic events ‐ duration of ESA treatment.
Comparison 11 Thrombotic events, Outcome 10 Thrombotic events ‐ iron supplementation.
Comparison 11 Thrombotic events, Outcome 11 Thrombotic events ‐ concealment of allocation.
Comparison 11 Thrombotic events, Outcome 12 Thrombotic events ‐ masking.
Comparison 11 Thrombotic events, Outcome 13 Thrombotic events ‐ intention‐to‐treat.
Comparison 11 Thrombotic events, Outcome 14 Thrombotic events ‐ publication.
Comparison 11 Thrombotic events, Outcome 15 Thrombotic events ‐ experimental arms merged.
Comparison 12 Hypertension, Outcome 1 Hypertension ‐ overall.
Comparison 12 Hypertension, Outcome 2 Hypertension ‐ merged experimental study arms.
Comparison 12 Hypertension, Outcome 3 Hypertension ‐ sensitivity analysis Dammacco.
Comparison 12 Hypertension, Outcome 4 Hypertension ‐ sensitivity analysis random effects.
Comparison 12 Hypertension, Outcome 5 Hypertension ‐ sensitivity analysis without Rose.
Comparison 13 Thrombocytopenia or haemorrhage, Outcome 1 Thrombocytopenia ‐ overall.
Comparison 13 Thrombocytopenia or haemorrhage, Outcome 2 Thrombocytopenia ‐ merged experimental arms.
Comparison 13 Thrombocytopenia or haemorrhage, Outcome 3 Thrombocytopenia ‐ sensitivity analysis random effects.
Comparison 14 Rash, Outcome 1 Rash ‐ overall.
Comparison 14 Rash, Outcome 2 Rash ‐ merged experimental arms.
Comparison 15 Seizure, Outcome 1 Seizure ‐ overall.
Update of
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Erythropoietin or darbepoetin for patients with cancer.Cochrane Database Syst Rev. 2006 Jul 19;(3):CD003407. doi: 10.1002/14651858.CD003407.pub4. Cochrane Database Syst Rev. 2006. Update in: Cochrane Database Syst Rev. 2012 Dec 12;12:CD003407. doi: 10.1002/14651858.CD003407.pub5. PMID: 16856007 Updated.
References
References to studies included in this review
Aapro 2008 {published and unpublished data}
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- Aapro M, Barnadas A, Leonard RC, Marangolo M, Untch M. Effects of epoetin beta treatment in patients with metastatic breast cancer receiving chemotherapy. Results of the BRAVE trial. Breast Cancer Research and Treatment 2006; Vol. 100:abstract 6095.
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- Aapro M, Leonard RC, Barnadas A, Marangolo M, Untch M, Malamos N, et al. Effect of once‐weekly epoetin beta on survival in patients with metastatic breast cancer receiving anthracycline‐ and/or taxane‐based chemotherapy: Results of the Breast Cancer‐Anemia and the Value of Erythropoietin (BRAVE) Study. Journal of Clinical Oncology 2008;26(4):592‐8. - PubMed
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- Leonard RC, Aapro M, Chan S, Dirix LY, Mayordomo J, Reichert D, et al. Once weekly epoetin beta in patients with metastatic breast cancer receiving anthracycline‐ or taxane‐based chemotherapy. Annals of Oncology 2004;Vol. 15(Suppl 3):iii.50 (Abstract 188p).
Aapro 2008 IPD {published data only}
Abels 1993 {published and unpublished data}
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- Abels R. Erythropoietin for anemia in cancer patients. European Journal of Cancer 1993;29A(Suppl 2):2‐8. - PubMed
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- Abels R. Recombinant human erythropoietin in the treatment of the anaemia of cancer. Acta Haematologica 1992;87 (Suppl 1):4‐11. - PubMed
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- Abels RI, Larholt KM, Krantz KD, Bryant EC. Recombinant Human Erythropoietin (rHuEPO) for the treatment of the anemia of cancer. Oncologist 1996;1(3):140‐50. - PubMed
Abels 1993 IPD {published and unpublished data}
Abels 1993 J&J 2004 {published data only}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Antonadou 2001 {published data only}
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- Antonadou D, Cardamakis E, Puglisi M, Malamos N, Throuvalas N. Erythropoietin enhances radiation treatment efficacy in patients with pelvic malignancies. Final results of a randomized phase III study. Poster.
Aravantinos 2003 {published data only}
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- Aravantinos G, Linardou H, Makridaki D, Laiou E, Zafiropoulos A, Janninis J, et al. Recombinant human erythropoietin for platinum‐based chemotherapy‐induced anaemia: A single‐centre randomised study. Journal of B U On 2003;8(2):127‐32. [MEDLINE: ] - PubMed
Bamias 2003 {published data only}
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- Bamias A, Aravantinos G, Kalofonos C, Timotheadou N, Siafaka V, Vlahou I, et al. Prevention of anemia in patients with solid tumors receiving platinum‐based chemotherapy by recombinant human Erythropoietin (rHuEpo): a prospective, open label, randomized trial by the Hellenic Cooperative Oncology Group. Oncology 2003;64(2):102‐10. [MEDLINE: ] - PubMed
Blohmer 2011 {published and unpublished data}
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- Blohmer JU, Paepke S, Sehouli J, Boehmer D, Kolben M, Würschmidt F, et al. Randomized phase III trial of sequential adjuvant chemoradiotherapy with or without erythropoietin alfa in patients with high‐risk cervical cancer: results of the NOGGO‐AGO intergroup study. Journal of Clinical Oncology 2011;29(28):3791‐7. - PubMed
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- Blohmer JU, Wuerschmidt J, Petry K, Weise G, Sehouli J, Kimming R, et al. Results with sequential adjuvant chemo‐radiotherapy with vs. without epoetin alfa for patients with high‐risk cervical cancer: results of a prospective, randomized, open and controlled AGO and NOGGO‐intergroup study. Annals of Oncology. Vol. 15 Suppl 3. 2004.
Boogaerts 2003 {published and unpublished data}
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- Neorecormon (epoetin beta). Briefing package or the FDA Oncologic Advisory Committee Meeting, May 4, 2004 Vol. RO 205‐3859.
Boogaerts 2003 IPD {published and unpublished data}
Boogaerts Coiffier 2001 {published and unpublished data}
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- Coiffier B, Boogaerts M, Kainz C. Impact of epoetin beta on quality of life in patients with malignant disease. 6th Congress of the European Haematology Association. 2001:Abstract #194.
Carabantes 1999 {published data only}
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- Carabantes FJ, Benavides M, Trujillo R, Cobo M, Hebrero ML, Garcia S, et al. Epoetin alfa in the prevention of anemia in cancer patients undergoing platinum‐based chemotherapy (CT) (CT). A prospective randomized study. Proceedings of the American Society of Clinical Oncology 1999;18:596a. Abstract 2303.
Cascinu 1994 {published and unpublished data}
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- Cascinu S, Fedeli A, Ferro E, Fedeli SL, Catalano G. Recombinant human erythropoietin treatment in cisplatin‐associated anemia: a randomized, double‐blind trial with placebo. Journal of Clinical Oncology 1994;12:1058‐62. - PubMed
Case 1993 {published and unpublished data}
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- Abels RI, Larholt KM, Krantz KD, Bryant EC. Recombinant Human Erythropoietin (rHuEPO) for the treatment of the anemia of cancer. Oncologist 1996;1(3):140‐50. - PubMed
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- Case DC, Bukowski RM, Carey RW, Fishkin EH, Henry DH, Jacobson RJ, et al. Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy. Journal of the National Cancer Institute 1993;85(10):801‐6. - PubMed
Case 1993 IPD {published and unpublished data}
Case 1993 J&J 2004 {published data only}
-
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Cazzola 1995 {published and unpublished data}
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- Neorecormon (epoetin beta). Briefing package or the FDA Oncologic Advisory Committee Meeting, May 4, 2004 Vol. RO 205‐3859.
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- Cazzola M, Messinger D, Battistel V, Bron D, Cimino R, Enller‐Ziegler L, et al. Recombinant human erythropoietin in the anemia associated with multiple myeloma or non‐Hodgkin's lymphoma: dose finding and identification of predictors of response. Blood 1995;86(12):4446‐53. - PubMed
Cazzola 1995a {published and unpublished data}
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- Cazzola M, Messinger D, Battistel V, Bron D, Cimino R, Enller‐Ziegler L, et al. Recombinant human erythropoietin in the anemia associated with multiple myeloma or non‐Hodgkin's lymphoma: dose finding and identification of predictors of response. Blood 1995;86(12):4446‐53. - PubMed
Cazzola 1995b {published and unpublished data}
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- Cazzola M, Messinger D, Battistel V, Bron D, Cimino R, Enller‐Ziegler L, et al. Recombinant human erythropoietin in the anemia associated with multiple myeloma or non‐Hodgkin's lymphoma: dose finding and identification of predictors of response. Blood 1995;86(12):4446‐53. - PubMed
Cazzola 1995c {published and unpublished data}
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- Cazzola M, Messinger D, Battistel V, Bron D, Cimino R, Enller‐Ziegler L, et al. Recombinant human erythropoietin in the anemia associated with multiple myeloma or non‐Hodgkin's lymphoma: dose finding and identification of predictors of response. Blood 1995;86(12):4446‐53. - PubMed
Cazzola 1995d {published and unpublished data}
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- Cazzola M, Messinger D, Battistel V, Bron D, Cimino R, Enller‐Ziegler L, et al. Recombinant human erythropoietin in the anemia associated with multiple myeloma or non‐Hodgkin's lymphoma: dose finding and identification of predictors of response. Blood 1995;86(12):4446‐53. - PubMed
Cazzola 1995 IPD {published and unpublished data}
Chang 2005 {published and unpublished data}
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- Chang J, Couture F, Young S, McWatters KL, Lau CY. Once weekly epoetin alfa maintains hemoglobin, improves quality of life and reduces transfusion in breast cancer patients receiving chemotherapy. Journal of Clinical Oncology 2005;23(12):2597‐605. [MEDLINE: ] - PubMed
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- Chang J, Couture FA, Young SD, Lau CY, Lee McWatters K. Weekly administration of epoetin alfa improves cognition and quality of life in patients with breast cancer receiving chemotherapy. Supportive Cancer Therapy 2004;2(1):52‐8. - PubMed
Chang 2005 IPD {published and unpublished data}
Charu 2007 {published and unpublished data}
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- Charu V, Belani CP, Gill AN, Bhatt M, Ben‐Jacob A, Tomita D, et al. A controlled, randomized, open‐label study to evaluate the effect of every‐2‐week darbepoetin alfa for anemia of cancer. Annual Meeting Proceedings of the American Society of Clinical Oncology 2004:abstract 8084.
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- Charu V, Belani CP, Gill AN, Bhatt M, Tomita D, Rossi G, et al. Efficacy and safety of every‐2‐week darbepoetin alfa in patients with anemia of cancer: a controlled, randomized, open‐label phase II trial. Oncologist 2007;12(6):727‐37. - PubMed
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- Charu V, Saidman B, Ben‐Jacob A, Justice GR, Maniam AS, Rearden T, et al. Improvements in fatigue are associated with early treatment with darbepoetin alfa every 3 weeks in anemic patients receiving chemotherapy. The Journal of Supportive Oncology 2005;3(2 Suppl 1):14‐5.
Charu 2007 Amgen 2007 {published data only}
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- Amgen Inc with contributions from Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Safety of Erythropoiesis‐Stimulating Agents (ESAs) in Oncology). Background information for Oncologic Drugs Advisory Committee 10 May 2007.
Charu 2007 IPD {published data only}
Christodoulou 2009 {published data only}
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- Christodoulou C, Dafni U, Aravantinos G, Koutras A, Samantas E, Karina M, et al. Effects of epoetin‐alpha on quality of life of cancer patients with solid tumors receiving chemotherapy. Anticancer Research 2009;29:693‐702. - PubMed
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Dammacco 2001 {published and unpublished data}
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- Dammacco F, Castoldi G, Rodjer S. Efficacy of epoetin alfa in the treatment of anaemia of multiple myeloma. British Journal of Haematology 2001;113(1):172‐9. - PubMed
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Dammacco 2001 IPD {published and unpublished data}
Dammacco 2001 J&J 2004 {published data only}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Debus 2006 IPD {published and unpublished data}
Debus 2006 J&J 2004 {published and unpublished data}
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- Debus J, Hindermann S, Morr H, Mezger J, Sebastian M, Angermund R, et al. Epoetin alfa (EPO) and survival in patients with non‐resectable NSCLC ‐ Interim results. Lung Cancer 2005; Vol. 49, issue Suppl 3:S57.
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Debus 2006 J&J 2007 {published data only}
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- Debus J, Hindermann S, Morr H, Mezger J, Sebastian M, Angermund R, et al. Epoetin alfa (EPO) and survival in patients with non‐resectable NSCLC ‐ Interim results. Lung Cancer 2005; Vol. 49, issue Suppl 3:S57.
Del Mastro 1997 {published and unpublished data}
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- Mastro L, Venturini M, Lionetto R, Garrone O, Melioli G, Pasquetti W, et al. Randomized phase III trial evaluating the role of erythropoietin in the prevention of chemotherapy‐induced anemia. Journal of Clinical Oncology 1997;15(7):2715‐21. - PubMed
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- Dunphy FR, Harrison BR, Dunleavy TL, Rodriguez JJ, Hilton JG, Boyd JH. Erythropoietin reduces anemia and transfusions. Cancer 1999;86:1362‐7. - PubMed
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- Engert A, Borchmann P, Fuchs M, Josting A, Haverkamp H, Diehl V. Prospetively randomized placebo‐controlled trial of epoetin‐alfa in patients with advanced‐stage Hodgking lymphoma: final analysis of the GHSG HD15‐EPO trial. Blood ASH Annual Meeting Abstracts 2008;112:2598.
Engert 2010 {published data only}
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- Engert A, Josting A, Haverkamp H, Villalobos M, Lohri A, Sökler M, et al. Epoetin alfa in patients with advanced‐stage Hodgkin's lymphoma: results of the randomized placebo‐controlled GHSG HD15EPO trial. Journal of Clinical Oncology 2010;28(13):2239‐45. - PubMed
EPO‐GER‐20 IPD {published and unpublished data}
EPO‐INT‐1 IPD {published data only}
EPO‐INT‐1 J&J 2004 {published and unpublished data}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
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- Luksenburg H, Weir A, Wager R. EPO‐INT‐1: Safety Concerns Associated with Aranesp (darbepoetin alfa) Amgen, Inc. and Procrit (epoetin alfa) Ortho Biotech, L.P., for the Treatment of Anemia Associated with Cancer Chemotherapy. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Oncologic Drugs Advisory Committee, Rockville (MD), USA, 2004; Vol. http://www.fda.gov/ohrms/dockets/ac/04/briefing/4037b2_04.pdf [date of last access March 27, 2009].
EPO‐INT‐3 IPD {published data only}
EPO‐INT‐3 J&J 2004 {published and unpublished data}
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- A placebo controlled study on the effect of r‐HeUPO in patients with malignancy receiving chemotherapy.Study: CR005923. Raritan, NJ: RW Johnson Pharmaceutical Research Institute 1998.
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
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- Luksenburg H, Weir A, Wager R. EPO‐INT‐3: Safety Concerns Associated with Aranesp (darbepoetin alfa) Amgen, Inc. and Procrit (epoetin alfa) Ortho Biotech, L.P., for the Treatment of Anemia Associated with Cancer Chemotherapy. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Oncologic Drugs Advisory Committee Rockville (MD), USA, 2004; Vol. http://www.fda.gov/ohrms/dockets/ac/04/briefing/4037b2_04.pdf [date of last access March 27, 2009].
Fujisaka 2011 {published data only}
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- Yoshizaki A, Kumagai S, Sugiyama T, Goto I, Saito H, Ariyoshi Y, Saijo N, Ohashi Y. A phase III, randomized, double‐blind placebo‐controlled study of epoetin beta in lung and gynecological cancer receiving platinum‐based chemotherapy: Japan Erythropoietin Study Group. Annals of Oncology 2010;21(S8):viii385.
Gebbia 2003 {published data only}
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- Gebbia V, Marco P, Citarrella P. Systemic chemotherapy in elderly patients with locally advanced and/or inoperable squamous cell carcinoma of the head and neck: impact of anemia and role of recombinant human erythropoietin. Critical Reviews in Oncology/Hematology 2003;48:49‐55. - PubMed
Gordon 2008 {published and unpublished data}
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- Gordon D, Nichols G, Ben‐Jacob A, Tomita D, Lillie T, Miller C. Treating anemia of cancer with every‐4‐week darbepoetin alfa: Final efficacy and safety results from a phase II, randomized, double‐blind, placebo‐controlled study. Oncologist 2008;13(6):715‐24. - PubMed
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- Gordon DH, Nichols G, Ben‐Jacob A, Lam H, Lillie T, Miller C. Treating anemia of cancer with darbepoetin alfa administered every 4 weeks: Final results from a phase 2, randomized, double‐Blind, placebo‐controlled study in cancer patients not receiving chemotherapy and/or radiotherapy. Blood 2006; Vol. 108, issue 11 Suppl:abstract 1304.
Gordon 2008 IPD {published data only}
Goss 2005 {published and unpublished data}
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- Goss G, Feld R, Bezjak A, Perry G, Melosky B, Smith C, et al. Impact of maintaining Hb with epoetin alfa on time to progression (TTP), overall survival (OS), quality of life (QOL) and transfusion reduction in limited disease SCLC patients. Lung cancer 2005; Vol. 49, issue Suppl 2:S53.
Goss 2005 FDA 2004 {published data only}
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- Luksenburg H, Weir A, Wager R. Safety Concerns Associated with Aranesp (darbepoetin alfa) Amgen, Inc. and Procrit (epoetin alfa) Ortho Biotech, L.P., for the Treatment of Anemia Associated with Cancer Chemotherapy. FDA Briefing Document May 4, 2004 Oncologic Drugs Advisory Committee.
Goss 2005 IPD {published data only}
Goss 2005 J&J 2004 {published and unpublished data}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD Report Date: 30 MARCH 2004.
Grote 2005 {published and unpublished data}
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- Grote T, Yeilding AL, Castillo R, Butler D, Fishkin E, Henry DH, et al. Efficacy and safety analysis of epoetin alfa in patients with small‐cell lung cancer: a randomized, double‐blind, placebo‐controlled trial. Journal of Clinical Oncology 2005;23(36):9377‐86. - PubMed
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- Luksenburg H, Weir A, Wager R. Safety Concerns Associated with Aranesp (darbepoetin alfa) Amgen, Inc. and Procrit(epoetin alfa) Ortho Biotech, L.P., for the Treatment of Anemia Associated with Cancer Chemotherapy. FDA Briefing Document May 4, 2004 Oncologic Drugs Advisory Committee.
Grote 2005 IPD {published data only}
Grote 2005 J&J 2004 {published and unpublished data}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Gupta 2009 {published data only}
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- Gupta S, Singh P, Bisht S, Bhatt M, Pant M, Gupta R, et al. Recombinant human erythropoietin in patients of advanced Cancer treated "by chemoradiotherapy". Landes Bioscience 2009;8(1):13‐7. - PubMed
Hedenus 2002 {published data only}
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- Hedenus M, Hansen S, Taylor K, Arthur C, Emmerich B, Dewey C, et al. Randomized, dose‐finding study of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. British Journal of Haematology 2002;119(1):79‐86. [MEDLINE: ] - PubMed
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- Hedenus M, Hansen S, Taylor K, Arthur C, Emmerich B, Dewey C, et al. Randomized, dose‐finding study of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. British Journal of Haematology 2002;119(1):79‐86. [MEDLINE: ] - PubMed
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- Hedenus M, Hansen S, Taylor K, Arthur C, Emmerich B, Dewey C, et al. Randomized, dose‐finding study of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. British Journal of Haematology 2002;119(1):79‐86. [MEDLINE: ] - PubMed
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- Hedenus M, Hansen S, Taylor K, Arthur C, Emmerich B, Dewey C, et al. Randomized, dose‐finding study of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. British Journal of Haematology 2002;119(1):79‐86. [MEDLINE: ] - PubMed
Hedenus 2003 {published and unpublished data}
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- Amgen Inc. Aranesp® (darbepoetin alfa) safety. Oncologic Drugs Advisory Committee, 4 May 2004.
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- Hedenus M, Adriansson M, San Miguel J, Kramer MH, Schipperus MR, Juvonen E, et al. Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double‐blind, placebo‐controlled study. British Journal of Haematology 2003;122(3):394‐403. - PubMed
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- Hedenus M, Brandberg Y, Molostova V, Iosova G, Abdulkadyrov K, Messinger D, et al. Efficacy of epoetin beta in treating the anaemia of cancer in patients with haematological malignancies. Proceedings of the 6th Congress of the European Haematology Association 2001:abstract 190.
Hedenus 2003 FDA 2007 {published and unpublished data}
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- 20000161. Continuing reassessment of the risks of erythropoiesis‐stimulating agents (ESAs) administered for the treatment of anemia associated with cancer chemotherapy. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Oncologic Drugs Advisory Committee, Rockville (MD), USA, 2007; Vol. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007‐4301b2‐02‐ FDA.pdf.
Hedenus 2003 IPD {published and unpublished data}
Henke 1999 {published data only}
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- Henke M, Guttenberger R, Barke A, Pajonk F, Potter R, Frommhold H. Erythropoietin for patients undergoing radiotherapy: a pilot study. Radiotherapy and Oncology 1999;50(2):185‐90. - PubMed
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- Henke M, Guttenberger R, Barke A, Pajonk F, Potter R, Frommhold H. Erythropoietin for patients undergoing radiotherapy: a pilot study. Radiotherapy and Oncology 1999;50(2):185‐90. - PubMed
Henke 1999b {published data only}
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- Henke M, Guttenberger R, Barke A, Pajonk F, Potter R, Frommhold H. Erythropoietin for patients undergoing radiotherapy: a pilot study. Radiotherapy and Oncology 1999;50(2):185‐90. - PubMed
Henke 1999c {published data only}
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- Henke M, Guttenberger R, Barke A, Pajonk F, Potter R, Frommhold H. Erythropoietin for patients undergoing radiotherapy: a pilot study. Radiotherapy and Oncology 1999;50(2):185‐90. - PubMed
Henke 2003 {published and unpublished data}
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- Henke M, Laszig R, Ruebe C, Schaefer U, Haase KD, Schilcher B, et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double‐blind, placebo‐controlled trial. Lancet 2003;362:1255‐60. - PubMed
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Henke 2003 IPD {published and unpublished data}
Henke 2003 Roche 2004 {published data only}
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- Neorecormon (epoetin beta). Briefing package or the FDA Oncologic Advisory Committee Meeting, May 4, 2004 Vol. RO 205‐3859.
Henry 1995 {published and unpublished data}
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- Abels RI, Larholt KM, Krantz KD, Bryant EC. Recombinant Human Erythropoietin (rHuEPO) for the treatment of the anemia of cancer. Oncologist 1996;1(3):140‐50. - PubMed
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Henry 1995 IPD {published and unpublished data}
Henry 1995 J&J 2004 {published data only}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Hernandez 2009 {published and unpublished data}
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- Hernandez. Randomized, double‐blind, placebo‐controlled trial of every‐3‐week darbepoetin alfa 300 micrograms for treatment of chemotherapy‐induced anemia. Current Medical Research and Opinion 2009;25(9):2109‐20. - PubMed
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Hernandez 2009 IPD {published and unpublished data}
Hoskin 2009 {published data only}
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- Hoskin P, Robinson M, Slevin N, Morgan D, Harrington K, Gaffney C. Effect of Epoetin Alfa on Survival and Cancer Treatment‐Related Anemia and Fatigue in Paatients Receiving Radical Radiotherapy With Curative Intent for Head and Neck Cancer. Journal of Clinical Oncology 2009;27(34):5751‐5756. - PubMed
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Hoskin 2009 GBR‐7 FDA 04 {published data only}
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- Luksenburg H, Weir A, Wager R. EPO‐GBR‐7: Safety Concerns Associated with Aranesp (darbepoetin alfa) Amgen Inc. and Procrit (epoetin alfa) Ortho Biotech L.P., for the Treatment of Anemia Associated with Cancer Chemotherapy. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Oncologic Drugs Advisory Committee, Rockville (MD), USA, 2004; Vol. http://www.fda.gov/ohrms/dockets/ac/04/briefing/4037b2_04.pdf [date of last access March 27, 2009].
Hoskin 2009 IPD {published data only}
Hoskin 2009 J&J 2004 {published data only}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Huddart 2002 {published and unpublished data}
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- Huddart RA, Welch RS, Chan S, Perren T, Atkinson R. A prospective randomised comparative‐group evaluation of epoetin alfa for the treatment of anaemia in UK cancer patients receiving platinum‐based chemotherapy. Annals of Oncology 2002;13 (Suppl 5):177. [MEDLINE: ]
Huddart 2002 IPD {published and unpublished data}
Iconomou 2003 {published data only}
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- Iconomou G, Koutras A, Rigopoulos A, Vagenakis AG, Kalofonos HP. Effect of recombinant human erythropoietin on quality of life in cancer patients receiving chemotherapy: results of a randomized, controlled trial. Journal of Pain & Symptom Management 2003;25(6):512‐8. [MEDLINE: ] - PubMed
Italian 1998 {published and unpublished data}
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- Italian Cooperative Study Group For rHuEpo In Myelodysplastic Syndromes. A randomized double‐blind placebo‐controlled study with subcutaneous recombinant human erythropoietin in patients with low‐risk myelodysplastic syndromes. British Journal of Haematology 1998;103:1070‐4. - PubMed
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- Katakami N, Nishiwaki Y, Fujiwara Y, Tsuboi M, Takeda K, Nakanishi T, et al. Randomized, double‐blind, placebo‐controlled phase III study of weekly administration of darbepoetin alfa (DA) in anemic patients with lung or gynecologic cancer receiving platinum‐containing chemotherapy. Annals of Oncology 2008;19(S8):viii277‐viii278.
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- Katsumata N, Fujiwara Y, Katakami N, Nishiwaki Y, Tsuboi M, Takeda K, et al. Randomized, double‐blind, placebo‐controlled phase III study of weekly administration of darbepoetin alfa in anemic patients with lung or gynecologic cancer receiving platinum‐containing chemotherapy. Vox Sanguinis 2009;97(S1):58.
Kotasek 2002 {published and unpublished data}
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- Kotasek D, Albertsson M, Mackey J, Darbepoetin Alfa 980291 Study Group. Randomized, double‐blind, placebo‐controlled, dose‐finding study of darbepoetin alfa administered once every 3 (Q3W) or 4 (Q4W) weeks in patients with solid tumors. Proceedings of the American Society of Clinical Oncology 2002; Vol. 21:356a.
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- Kotasek D, Albertsson M, Mackey J, Steger G, Rossi G, O'Byne J, et al. Once per cycle dosing of darbepoetin alfa is feasible in anemic cancer patients receiving chemotherapy. Annals of Oncology 2002; Vol. 13, issue Suppl 5:170.
Kotasek 2002 IPD {published data only}
Kotasek 2003 {published and unpublished data}
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- Kotasek D, Berg R, Poulsen E, Colowick A. Randomized, double‐blind, placebo controlled, phase I/II dose finding study of ARANESP (TM) administered once every three weeks in solid tumor patients. Blood 2000; Vol. 96, issue 11:abstract 1268.
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- Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double‐blind, placebo‐controlled, randomised study. European Journal of Cancer 2003;39(14):2026‐34. [MEDLINE: ] - PubMed
Kotasek 2003a {published and unpublished data}
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- Kotasek D, Berg R, Poulsen E, Colowick A. Randomized, double‐blind, placebo controlled, phase I/II dose finding study of ARANESP (TM) administered once every three weeks in solid tumor patients. Blood 2000; Vol. 96, issue 11:abstract 1268.
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- Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double‐blind, placebo‐controlled, randomised study. European Journal of Cancer 2003;39(14):2026‐34. [MEDLINE: ] - PubMed
Kotasek 2003b {published and unpublished data}
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- Kotasek D, Berg R, Poulsen E, Colowick A. Randomized, double‐blind, placebo controlled, phase I/II dose finding study of ARANESP (TM) administered once every three weeks in solid tumor patients. Blood 2000; Vol. 96, issue 11:abstract 1268.
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- Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double‐blind, placebo‐controlled, randomised study. European Journal of Cancer 2003;39(14):2026‐34. [MEDLINE: ] - PubMed
Kotasek 2003c {published and unpublished data}
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- Kotasek D, Berg R, Poulsen E, Colowick A. Randomized, double‐blind, placebo controlled, phase I/II dose finding study of ARANESP (TM) administered once every three weeks in solid tumor patients. Blood 2000; Vol. 96, issue 11:abstract 1268.
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- Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double‐blind, placebo‐controlled, randomised study. European Journal of Cancer 2003;39(14):2026‐34. [MEDLINE: ] - PubMed
Kotasek 2003d {published and unpublished data}
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- Kotasek D, Berg R, Poulsen E, Colowick A. Randomized, double‐blind, placebo controlled, phase I/II dose finding study of ARANESP (TM) administered once every three weeks in solid tumor patients. Blood 2000; Vol. 96, issue 11:abstract 1268.
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- Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double‐blind, placebo‐controlled, randomised study. European Journal of Cancer 2003;39(14):2026‐34. [MEDLINE: ] - PubMed
Kotasek 2003e {published and unpublished data}
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- Kotasek D, Berg R, Poulsen E, Colowick A. Randomized, double‐blind, placebo controlled, phase I/II dose finding study of ARANESP (TM) administered once every three weeks in solid tumor patients. Blood 2000; Vol. 96, issue 11:abstract 1268.
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- Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double‐blind, placebo‐controlled, randomised study. European Journal of Cancer 2003;39(14):2026‐34. [MEDLINE: ] - PubMed
Kotasek 2003f {published and unpublished data}
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- Kotasek D, Berg R, Poulsen E, Colowick A. Randomized, double‐blind, placebo controlled, phase I/II dose finding study of ARANESP (TM) administered once every three weeks in solid tumor patients. Blood 2000; Vol. 96, issue 11:abstract 1268.
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- Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double‐blind, placebo‐controlled, randomised study. European Journal of Cancer 2003;39(14):2026‐34. [MEDLINE: ] - PubMed
Kotasek 2003 IPD {published and unpublished data}
Krzakowski 2008 {published data only}
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- Krzakowski M, DYNEPO Oncology Study Group. Epoetin delta: efficacy in the treatment of anaemia in cancer patients receiving chemotherapy. Clinical Oncology 2008;20:705‐13. - PubMed
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- Kunikane H, Watanabe K, Fukuoka M, Saijo N, Furuse K, Ikegami H, et al. Double‐blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy‐induced anemia in patients with non‐small cell lung cancer. International journal of clinical oncology 2001;6:296‐301. - PubMed
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- Kunikane H, Watanabe K, Fukuoka M, Saijo N, Furuse K, Ikegami H, et al. Double‐blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy‐induced anemia in patients with non‐small cell lung cancer. International journal of clinical oncology 2001;6:296‐301. - PubMed
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- Kunikane H, Watanabe K, Fukuoka M, Saijo N, Furuse K, Ikegami H, et al. Double‐blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy‐induced anemia in patients with non‐small cell lung cancer. International journal of clinical oncology 2001;6:296‐301. - PubMed
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Leyland‐Jones 2005 IPD {published and unpublished data}
Littlewood 2001 {published and unpublished data}
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Littlewood 2001 IPD {published and unpublished data}
Littlewood 2001 J&J 2004 {published data only}
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Machtay 2007 {published and unpublished data}
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Machtay 2007 IPD {published and unpublished data}
Milroy 2003 IPD {published data only}
Milroy 2011 {published data only}
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ML17620 2006 {published data only}
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Moebus 2007 {published and unpublished data}
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Moebus 2007 IPD {published data only}
Moebus 2007 J&J 2007 {published and unpublished data}
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O'Shaughnessy 2005 {published and unpublished data}
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O'Shaugnessy 2005 IPD {published and unpublished data}
OBE/EPO‐INT‐03 IPD {published and unpublished data}
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Oberhoff 1998 IPD {published and unpublished data}
Osterborg 1996 {published and unpublished data}
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Osterborg 2002 {published and unpublished data}
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Osterborg 2002 IPD {published and unpublished data}
Overgaard 2009 {published data only}
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P‐174 J&J 2004 {published and unpublished data}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
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Quirt 1996 IPD {published and unpublished data}
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Razzouk 2004 {published data only}
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Rose 1994 IPD {published and unpublished data}
Rose 1994 J&J 2004 {published data only}
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Thatcher 1999b {published and unpublished data}
Thatcher 1999 IPD {published and unpublished data}
Thomas 2002 {published and unpublished data}
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Thomas 2002 IPD {published data only}
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Throuvalas 2000 {published and unpublished data}
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- Throuvalas NA, Antonadou D, Boufi M, Lavey R Malamos N. Erythropoietin decreases transfusion requirements during radiochemotherapy. Proceedings of the American Society of Clinical Oncologists 2000;19:Abstract 1558.
Tjulandin 2010 {published data only}
Tjulandin 2010a {published data only}
Tjulandin 2010b {published data only}
Tjulandin 2011 {published data only}
-
- Buchner A, Bias P. Epoetin theta shows efficacy and safety in a placebo controlled, randomized phase III study in cancer patients receiving non‐platinum chemotherapy. Onkologie 2009;32(Supplement 4):88, Abstract V348.
Tsuboi 2009 {published data only}
-
- Tsuboi M, Ezaki K, Tobinai K, Ohashi Y, Saijo N. Weekly administration of epoetin beta for chemotherapy‐induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double‐blind, placebo‐controlled study. Japanese Journal of Clinical Oncology 2009;39(3):163‐8. - PubMed
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- Watanabe M, Ezaki K, Tobinai K, Tsuboi M, Ohashi Y, Hirashima K, et al. A multicenter phase III randomized, double‐blind placebo‐controlled study of Epoetin beta administered once‐weekly for chemotherapy induced anemia (CIA) in cancer patients: Japan Erythropoietin Study Group. Annals of Oncology 2006; Vol. 17, issue Suppl 9:294.
Untch 2008 IPD {published data only}
Untch 2011_1 {published data only}
-
- Untch M, Fasching PA, Konecny GE, Koch F, Conrad U, Fett W, Kurzeder C, et al. PREPARE trial: A randomized phase III trial comparing preoperative, dose‐dense, dose‐intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard‐dosed epirubicin/cyclophosphamide followed by paclitaxel (plus or minus) darbepoetin alfa in primary breast cancer‐results at the time of surgery. Annals of Oncology 2011;22(9):1988‐98. - PubMed
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- Untch M, Fascing PA, Bauernfeind I, Conrad U, Camara O, Fett W, et al. PREPARE trial. A randomized phase III trial comparing preoperative, dose‐dense, dose‐intensified chemotherapy with epirubicin, paclitaxel and CMF with a standard dosed epirubicin/cyclophosphamide followed by paclitaxel +/‐ darbepoetin alfa in primary breast cancer: A preplanned interim analysis of efficacy at surgery. Journal of Clinical Oncology 2008; Vol. 26, issue Suppl:abstract 517.
Untch 2011_2 {published data only}
-
- Untch M, Fascing PA, Bauernfeind I, Conrad U, Camara O, Fett W, et al. PREPARE trial. A randomized phase III trial comparing preoperative, dose‐dense, dose‐intensified chemotherapy with epirubicin, paclitaxel and CMF with a standard dosed epirubicin/cyclophosphamide followed by paclitaxel +/‐ darbepoetin alfa in primary breast cancer: A preplanned interim analysis of efficacy at surgery. Journal of Clinical Oncology 2008; Vol. 26, issue Suppl:abstract 517.
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- Untch M, Minckwitz G, Konecny GE, Conrad U, Fett W, Kurzeder C, et al. PREPARE trial: A randomized phase III trial comparing preoperative, dose‐dense, dose‐intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard‐dosed epirubicin/cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer‐outcome on prognosis. Annals of Oncology 2011;22(9):1999‐2006. [69960] - PubMed
Vansteenkiste 02 FDA 2004 {published and unpublished data}
-
- Luksenburg H, Weir A, Wager R. Safety Concerns Associated with Aranesp(darbepoetin alfa) Amgen, Inc. and Procrit(epoetin alfa) Ortho Biotech, L.P., for the Treatment of Anemia Associated with Cancer Chemotherapy. FDA Briefing Document May 4, 2004 Oncologic Drugs Advisory Committee.
Vansteenkiste 2002 {published and unpublished data}
-
- Amgen Inc. Aranesp® (darbepoetin alfa) safety. Oncologic Drugs Advisory Committee, 4 May 2004.
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- Kallich JD, Tchekmedyian NS, Damiano AM, Shi J, Black JT, Erder MH. Psychological outcomes associated with anemia‐related fatigue in cancer patients. Oncology (Huntingt) 2002;16(9 Suppl 10):117‐24. - PubMed
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- Pirker R, Vansteenkiste J, Gateley J, Yates P, Colowick A, Musil J. A phase 3, double‐blind, placebo‐controlled, randomized study of novel erythropoiesis stimulating protein (NESP) in patients undergoing platinum treatment for lung cancer. Proceedings of the American Society of Clinical Oncology 2001; Vol. 20:abstract 1572.
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- Tchekmedyian NS, Kallich J, McDermott A, Fayers P, Erder MH. The relationship between psychologic distress and cancer‐related fatigue. Cancer 2003;98(1):198‐203. - PubMed
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- Tchekmedyian S, Glaspy J, Colowick A, Tomita D, Rossi G. Effect of darbepoetin alfa and recombinant human erythropoietin (rHuEPO) on early hemoglobin (Hb) changes in anemic cancer patients (pts). Annals of Oncology 2002; Vol. 13, issue Suppl 5:184.
Vansteenkiste 2002 IPD {published and unpublished data}
Welch 1995 {published data only}
-
- James RD, Wilkinson PM, Belli F, Welch R, Cowan R. Recombinant human erythropoietin in patients with ovarian carcinoma and anaemia secondary to cisplatin and carboplatin chemotherapy: preliminary results. Acta Haematologica 1992;87 (Suppl 1):12‐5. - PubMed
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- Welch RS, James RD, Wilkinson PM, et al. Recombinant human erythropoietin and platinum‐based chemotherapy in advanced ovarian cancer. Cancer Journal of the Scientific American 1995;1(4):261. - PubMed
Wilkinson 2006 {published and unpublished data}
Wilkinson 2006 IPD {published data only}
Winquist 2009 {published data only}
-
- Winquist E, Julian JA, Moore MJ, Nabid A, Sathya J, Wood L, et al. Randomized, double‐blind, placebo‐controlled trial of epoetin alfa in men with castration‐resistant prostate cancer and anemia. Journal of Clinical Oncology 2009;27(4):644‐6. - PubMed
Witzig 2005 {published and unpublished data}
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- Dicato M, Vercammen E, Liu KL, Xiu LX, Bowers P. Relationship of body weight to efficacy of a fixed‐dose regimen of epoetin alfa vs placebo in anemic cancer patients. Haematologica 2005; Vol. 90, issue Suppl 2:abstract 0077.
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- Witzig TE, Silberstein PT, Loprinzi CL, Sloan JA, Novotny PJ, Mailliard JA, et al. Phase III, randomized, double‐blind study of epoetin alfa versus placebo in anemic patients with cancer undergoing chemotherapy. Journal of Clinical Oncoogy 2005;23(12):2606‐17. [MEDLINE: ] - PubMed
Witzig 2005 IPD {published and unpublished data}
Witzig 2005 J&J 2004 {published data only}
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- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Background information for Oncologic Drugs Advisory Committee Meeting, Safety of Erythropoietin Receptor Agonists (ERAs) in Patients with Cancer. Johnson and Johnson briefing document for FDA/ODAC hearing May 4, 2004; Gaithersburg, MD, Report Date: 30 MARCH 2004.
Wright 2007 {published and unpublished data}
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- Luksenburg H, Weir A, Wager R. EPO‐CAN‐20: Safety Concerns Associated with Aranesp (darbepoetin alfa) Amgen Inc and Procrit (epoetin alfa) Ortho Biotech L.P. for the Treatment of Anemia Associated with Cancer Chemotherapy. Oncologic Drugs Advisory Committee, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville (MD), USA, 2004; Vol. http://www.fda.gov/ohrms/dockets/ac/04/briefing/4037b2_04.pdf [date of last access March 27, 2009].
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- Wright JR, Ung YC, Julian JA, Pritchard KI, Whelan TJ, Smith C, et al. Randomized, double‐blind, placebo‐controlled trial of erythropoietin in non‐small‐cell lung cancer with disease‐related anemia. Journal of Clinical Oncology 2007;25(9):1027‐32. - PubMed
Wright 2007 IPD {published data only}
Wurnig 1996 {published data only}
-
- Wurnig C, Windhager R, Schwameis E, Kotz R, Zoubek A, Stockenhuber F, et al. Prevention of chemotherapy‐induced anemia by the use of erythropoietin in patients with primary malignant bone tumors (a double‐blind, randomized, phase III study). Transfusion 1996;36(2):155‐9. - PubMed
References to studies excluded from this review
Aagaard 2010 {published data only}
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- Aagaard AW, Purdy S, Philpott S. Review, Approval, and Marketingof Biosimilars in the United StatesPart 1: Safety and Regulatory Issues. BioProcess International 2010;8(11):12‐20.
Aapro 2009 {published data only}
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- Aapro M, Osterwalder B, Scherhag A, Burger HU. Epoetin‐beta treatment in patients with cancer chemotherapy‐induced anaemia: the impact of initial haemoglobin and target haemoglobin levels on survival, tumour progression and thromboembolic events. British Journal of Cancer 2009;101(12):1961‐71. - PMC - PubMed
Abdelrazik 2007 {published data only}
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- Abdelrazik N, Fouda M. Once weekly recombinant human erythropoietin treatment for cancer‐induced anemia in children with acute lymphoblastic leukemia receiving maintenance chemotherapy: A randomized case‐controlled study. Hematology 2007;12(6):533‐41. - PubMed
Abraham 2011 {published data only}
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- Abraham J. Eribulin in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. Community Oncology 2011;8(1):15‐7.
Adamson 2009 {published data only}
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- Adamson JW. Erythropoietic‐stimulating agents: the cancer progression controversy and collateral damage to the blood supply.[comment]. Transfusion 2009;49(5):824‐6. - PubMed
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- Alexopoulos CG KA. A randomized comparison of rHuEPO with darbepoetin for cancer related anemia. Annals of Oncology. 2004; Vol. 15 Suppl 3.
Anonymous 2007 {published data only}
Anthony 2011 {published data only}
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- Anthony LB, Gabrail NY, Ghazal H, Woytowitz DV, Flam MS, Drelichman A, et al. IV iron sucrose for cancer and/or chemotherapy‐induced anemia in patients treated with erythropoiesisstimulating agents. Community Oncology 2011;8(6):270‐8.
Arcasoy 2010 {published data only}
Arslan 2004 {published data only}
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Auerbach 2004 {published data only}
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Australian 2010 {published data only}
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Aziz 2001 {published data only (unpublished sought but not used)}
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- Aziz K, Hashem T, Mobarek N, Bary N, Ghoneimy I, Haddad S. Does recombinant human erythropoietin improve the outcome of radiation therapy in head and neck cancer Patients. Proceedings of ASTRO. 2001; Vol. Abstract #2274.
Barosi 1998 {published data only}
Barosi 2011 {published data only}
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Beggs 2003 {published data only}
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- Beggs VL, Disalvo WM, Meyer LP, Gragnev KH, Gibson JJ, Hoopes PJ, et al. Fatigue and plasma cytokines in a randomized double‐blind placebo‐controlled trial of epoetin alfa in patients undergoing combined modality therapy for unreseactable non‐small cell lung cancer (NSCLC). Proceedings of the American Society of Clincal Oncology. 2003; Vol. 22:733.
Bell 2008 {published data only}
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- Bell D, Grimes D, Gurney H, Dalley D, Blackwell T, Fox R, et al. Outcomes and predicting response in anaemic chemotherapy patients treated with epoetin alfa. A multicentre, 4‐month, open‐label study in Australia and New Zealand. Internal Medicine Journal 2008;38(10):751‐7. - PubMed
Bessho 1997 {published data only}
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- Bessho M, Hirashima K, Asano S, Ikeda Y, Ogawa N, Tomonaga M, et al. Treatment of the anemia of aplastic anemia patients with recombinant human erythropoietin in combination with granulocyte colony‐stimulating factor: a multicenter randomized controlled study. Multicenter Study Group. European Journal of Haematology 1997;58(4):265‐72. - PubMed
Bindi 2004 {published data only}
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- Bindi M, Montemaggi M, Sabatino M, Paolelli LPR, Morelli R, Piazza D, et al. Reticulocytes can represent an early indicator of te erythropoietic response to darbepoetin alfa in the anemia by chemotherapy. Journal of Clinical Oncology. 2004; Vol. 22, issue 14S:#8245.
Blayney 2003 {published data only}
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- Blayney D, Fesen M, Mirtsching BC, Katz D, Tomita D. Every‐2‐Week Darbepoetin Alfa improves hemoglobin in anemic patients with cancer undergoing chemotherapy: A stratified analysis by tumor type. Blood 2003; Vol. 102 (11):abstract 3779.
Boccia 2007 {published data only}
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- Boccia R, Lillie T, Tomita D, Balducci L. The effectiveness of darbepoetin alfa administered every 3 weeks on hematologic outcomes and quality of life in older patients with chemotherapy‐induced anemia. Oncologist. 2007;12(1083‐7159 (Print), 1083‐7159 (Linking), 5):584‐93. - PubMed
Borg 2008 {published data only}
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- Borg S, Glenngard AH, Osterborg A, Persson U. The cost‐effectiveness of treatment with erythropoietin compared to red blood cell transfusions for patients with chemotherapy induced anaemia: a Markov model. Acta Oncologica 2008;47(6):1009‐17. - PubMed
Borget 2008 {published data only}
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- Borget I, Chouaid C, Demarteau N, Annemans L, Pujol JL. [Cost‐effectiveness of darbepoetin alpha in an every‐3‐weeks schedule]. [French]. Bulletin du Cancer 2008;95(4):465‐73. - PubMed
Bowen 2004 {published data only}
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- Bowen D, Hyslop A, Keenan N, Groves M, Culligan D, Johnson P, et al. Prediction of response to recombinant erythropoietin plus granulocyte‐colony stimulating factor following a single subcutaneous bolus in patients with myelodysplastic syndromes; a randomised placebo controlled study. ASH Annual Meeting Abstracts 2004;104(11):1435.
Brower 2008 {published data only}
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- Brower V. ESAs further restricted, but debate continues. Journal of the National Cancer Institute 2008;100(19):1344‐51. - PubMed
Buchler 2011 {published data only}
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- Buchler T. [Therapeutic equivalence and effectiveness of Binocrit (HX575) in patients with anemia caused by chemotherapy]. [Czech]. Klinicka Onkologie 2011;24(2):147‐148. - PubMed
Buyukpamukcu 2002 {published data only}
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- Buyukpamukcu M, Varan A, Kutluk T, Akyuz C. Is epoetin alfa a treatment option for chemotherapy‐related anemia in children?. Medical and Pediatric Oncology 2002;39(4):455‐8. - PubMed
Cabanillas 2012 {published data only}
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- Cabanillas ME, Kantarjian H, Thomas DA, Mattiuzz GN, Rytting ME, Bruera E, et al. Epoetin alpha decreases the number of erythrocyte transfusions in patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, and Burkitt leukemia/lymphoma: results of a randomized clinical trial. Cancer 2012;118(3):848‐55. - PMC - PubMed
Candelaria 2005 {published data only}
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- Candelaria M, Cetina L, Duenas‐Gonzalez A. Anemia in cervical cancer patients: implications for iron supplementation therapy. Medical Oncology 2005;22(2):161‐8. - PubMed
Canon 2006 {published data only}
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- Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, et al. Randomized, double‐blind, active‐controlled trial of every‐3‐week darbepoetin alfa for the treatment of chemotherapy‐induced anemia. Journal of the National Cancer Institute 2006;98(4):273‐84. - PubMed
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- Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, et al. Results of a randomised, double‐blind, active‐controlled trial of darbepoetin alfa administered once every 3 weeks for the treatment of anaemia in patients receiving multicycle chemotherapy. Haematologica 2005; Vol. 90, issue Suppl 2:abstract 471.
Canon 2011 {published data only}
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- Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, et al. Transfusion risk in cancer patients with chemotherapy‐induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus (greater‐than or equal to)10 g/dL: an exploratory analysis of a phase 3 trial. Medical Oncology 2011;xx:1‐9. - PubMed
Caravita 2009 {published data only}
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- Caravita T, Siniscalchi A, Montanaro M, Niscola P, Stasi R, Amadori S, et al. High‐dose epoetin alfa as induction treatment for severe anemia in multiple myeloma patients. International Journal of Hematology 2009;90(2):270‐2. - PubMed
Casadevall 2004 {published data only}
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- Casadevall N, Durieux P, Dubois S, Hemery F, Lepage E, Quarre MC, et al. Health, economic, and quality‐of‐life effects of erythropoietin and granulocyte colony‐stimulating factor for the treatment of myelodysplastic syndromes: a randomized, controlled trial. Blood 2004;104(2):321‐7. [MEDLINE: ] - PubMed
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- Casadevall N, Lepage E, Durieux P, Dubois S, Dreyfus F, Quarre MC, et al. Erythropoietin (RHUEPO) plus G‐CSF in the treatment of anemia in myelodysplastic syndromes (MDS): results of a randomised trial with impact on quality of life and costs. The Hematology Journal 2001, issue Suppl 1:abstract 687.
Cazzola 2003 {published data only}
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- Cazzola M, Beguin Y, Kloczko J, Spicka I, Coiffier B. Once‐weekly epoetin beta is highly effective in treating anaemic patients with lymphoproliferative malignancy and defective endogenous erythropoietin production. British Journal of Haematology 2003;122(3):386‐93. - PubMed
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- Cazzola M, Coiffier B, Kloczko J, Spika I. Once weekly NeoRecormon® (epoetin beta) for the treatment of anemia associated with lymphoproliferative malignancies: results of the NOW (NeoRecormon® once weekly) study. Hematology Journal 2002, issue 3 Suppl 1:abstract 0182.
Chan 1995 {published data only}
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- Chan AT, Leung WT, Lin J, Yeo W, Johnson PJ. Recombinant human erythropoietin for anaemia in Chinese cancer patients on chemotherapy. Clinical Oncology (Royal College of Radiologists) 1995;7(4):272. - PubMed
Cheng 2009 {published data only}
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- Cheng Z, Wu JL, Chen JF. Clinical observation on the treatment of male neoplastic anemia with Yixuesheng capsule combined with recombination human erythropoietin. Chinese Journal of Integrative Medicine 2009;15(1):63‐5. - PubMed
Christodoulakis 2005 {published data only}
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- Christodoulakis M, Tsiftsis DD, Hellenic Surgical Oncology Perioperative EPO Study Group. Preoperative epoetin alfa in colorectal surgery: a randomized, controlled study. Annals of Surgical Oncology 2005;12(9):718‐25. - PubMed
Coiffier 2006 {published data only}
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- Coiffier B, Boogaerts M, Aapro M, Hayward C, Burger HU. Effect of treatment with epoetin Beta on thromboembolic events in anemic patients with cancer: a metaanalysis. Supportive Cancer Therapy 2006;4(1):49‐55. - PubMed
Coleman 2009 {published data only}
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- Coleman EA, Anaissie EJ, Kennedy RL, Lockhart KD, Stewart CB, Bailey C. Predictors of deep vein thrombosis (DVT) in newly diagnosed multiple myeloma (MM) patients with and without prophylactic recombinant erythropoietin (EPO) therapy. Journal of Clinical Oncology 2009;27(15):9554.
Crawford 1997 {published data only}
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- Crawford J, Blackwell S, Shoemaker D, Pupa MR, Sparrow T, Herndon J, et al. Prevention of chemotherapy‐related anemia by recombinant human erythropoietin (EPO) in patients with small cell lung cancer receiving cyclophosphamide, doxorubicin, and etoposide (CAE) chemotherapy with G‐CSF support. Lung Cancer 1997;18 Suppl 1:205.
Crawford 2003 {published data only}
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- Crawford J, Robert F, Perry M, Belani CP, Sarokhan B. Epoetin alfa 40,000 u once weekly maintains hemoglobin in advanced non‐small‐cell lung cancer patients receiving first‐line chemotherapy. Proceedings of the American Society of Clinical Oncology. 2003; Vol. 22:628.
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- Crawford J, Robert F, Perry M, Belani CP, Sarokhan B. Epoetin alfa 40,000 u once weekly maintains hemoglobin in advanced non‐small‐cell lung cancer patients receiving first‐line chemotherapy. Proceedings of the American Society of Clinical Oncology 2003;22:628, abstract 2527.
Crawford 2007 {published data only}
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- Crawford J, Robert F, Perry MC, Belani C, Williams D, Anemia Prevention in NSCLC Group. A randomized trial comparing immediate versus delayed treatment of anemia with once‐weekly epoetin alfa in patients with non‐small cell lung cancer scheduled to receive first‐line chemotherapy. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2007;2(3):210‐20. - PubMed
Cremieux 2003 {published data only}
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- Cremieux P, Greenberg P, Piech CT. Epoetin alfa is more effective and less costly relative to darbepoetin alfa in lung cancer patients receiving treatment for chemotherapy‐induced anemia [abstract no. 2248]. Proceedings of the American Society of Clinical Oncology. 2003; Vol. 22:2248.
Dahl 2008 {published data only}
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- Dahl NV, Henry DH, Coyne DW. Thrombosis with erythropoietic stimulating agents‐does iron‐deficient erythropoiesis play a role?. Seminars in Dialysis 2008;21(3):210‐1. - PubMed
Daneryd 1998 {published data only}
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- Daneryd P, Svanberg E, Körner U, Lindholm E, Sandström R, Brevinge H, et al. Protection of metabolic and exercise capacity in unselected weight‐losing cancer patients following treatment with recombinant erythropoietin: a randomized prospective study. Cancer Research 1998;58:5374‐9. - PubMed
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- Lindholm E, Daneryd P, Korner U, Hyltander A, Fouladiun M, Lundholm K. Effects of recombinant erythropoietin in palliative treatment of unselected cancer patients. Clinical Cancer Research 2004;10(20):6855‐64. - PubMed
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- Lonnroth C, Svensson M, Wang W, Korner U, Daneryd P, Nilsson O, et al. Survival and erythropoietin receptor protein in tumours from patients randomly treated with rhEPO for palliative care. Medical Oncology 2008;25(1):22‐9. - PubMed
Dannemann 2004 {published data only}
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- Dannemann B, Wacholtz M, Lau H, Cheung W. Pharmacokinetics (PK) and pharmacodynamics (PD) of epoetin alfa in cancer patients with anemia receiving cyclic chemotherapy. Journal of Clinical Oncology 2004; Vol. 22, issue 14s:775, abstract 8203.
Demetri 1998 {published data only}
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- Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality‐of‐life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: Results from a prospective community oncology study. Journal of Clinical Oncology 1998;16:3412‐25. - PubMed
Dicato 2011 {published data only}
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- Dicato M. Erythropoiesis‐stimulating agents: The present situation. Clinical and Translational Oncology 2011;13(5):287‐8. - PubMed
Dronca 2008 {published data only}
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- Dronca RS, Steensma DP. VTE and mortality associated with erythropoiesis‐stimulating agents in cancer‐associated anemia.[comment]. Nature Clinical Practice Oncology 2008;5(9):504‐5. - PubMed
Dusenbery 1994 {published data only}
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- Dusenbery KE, McGuire WA, Holt PJ, Carson LF, Fowler JM, Twiggs LB. Erythropoietin increases hemoglobin during radiation therapy for cervical cancer. International Journal of Radiation Oncology, Biology, Physics 1994;29(5):1079‐84. - PubMed
Elsaid 2001 {unpublished data only}
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- Elsaid A, Farouk M. Significance of anemia and role of erythropoietin in radiation induced mucositis in head and neck cancer patients. International Journal of Radiation Oncology Biology Physics 2001; Vol. 51, issue 3 Suppl 1:368.
Fagnoni 2005 {published data only}
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- Fagnoni P, Limat S, Chaigneau L, Guardiola E, Briaud S, Schmitt B, et al. Clinical and economic impact of epoetin in adjuvant‐chemotherapy for breast cancer. Support.Care Cancer 2006;14(0941‐4355 (Print), 0941‐4355 (Linking), 10):1030‐7. - PubMed
Ferrero 2009 {published data only}
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- Ferrero D, Darbesio A, Giai V, Genuardi M, Dellacasa CM, Sorasio R, et al. Efficacy of a combination of human recombinant erythropoietin + 13‐cis‐retinoic acid and dihydroxylated vitamin D3 to improve moderate to severe anaemia in low/intermediate risk myelodysplastic syndromes. British Journal of Haematology 2009;144(3):342‐9. - PubMed
Franchi 2008 {published data only}
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- Franchi F, Pastore C, Nigita G, Seminara P. Darbepoetin in the control of cancer‐related anaemia. Clinical & Experimental Medicine 2008;8(4):225‐7. - PubMed
Freeman 2006 {published data only}
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- Freeman III BB, Hinds P, Iacono LC, Razzouk BI, Burghen E, Stewart CF. Pharmacokinetics and pharmacodynamics of intravenous epoetin alfa in children with cancer. Pediatric Blood & Cancer 2006;47(5):572‐9. - PubMed
Fujisaka 2004 {published data only}
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- Fujisaka Y, Tamura T, Ohe Y, Kunitoh H, Sekine I, Yamamoto N, et al. Pharmacokinetics and pharmacodynamics of weekly epoetin beta in lung cancer patients. Japanese Journal of Clinical Oncology 2006;36(8):477. - PubMed
Gabrilove 2001 {published data only}
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- Gabrilove JL, Cleeland CS, Livingston RB, Sarokhan B, Winer E, Einhorn LH. Clinical evaluation of once‐weekly dosing of epoetin alfa in chemotherapy patients: improvements in hemoglobin and quality of life are similar to three‐times‐weekly dosing. Journal of Clinical Oncology 2001;19(11):2875‐82. - PubMed
Garton 1995 {published data only}
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- Garton JP, Gertz MA, Witzig TE, Greipp PR, Lust JA, Schroeder G, et al. Epoetin alfa for the treatment of the anemia of multiple myeloma. A prospective, randomized, placebo‐controlled, double‐blind trial. Archives of Internal Medicine 1995;155:2069‐74. - PubMed
Gascon 2008 {published data only}
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- Gascn P. Safety update on erythropoiesis‐stimulating agents: Trials within and outside the accepted indications. unknown AM 2008;13(SUPPL. 3):4‐10. - PubMed
Gebbia 1992 {published data only}
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- Gebbia V, Gebbia N, Testa A, Valenza R, Borsellino N, Rausa L. Subcutaneous recombinant human erythropoietin prevents chemotherapy‐related anemia in patients with advanced cancer. International Journal of Oncology 1992;1:341‐5. - PubMed
Glaser 1999 {published data only}
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- Glaser C, Millesi W, Wanschitz F, Schull B, Lang S, Leitha T, et al. R‐HuErythropoietin treatment increases efficacy of neo‐adjuvant radiochemotherapy and improves cancer free survival of patient with oral squamous cell carcinoma: a 17 months follow‐up. ASCO 1999;Meeting Abstract:Abstract 1543.
Glaser 2001 {published data only}
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- Glaser CM, Millesi W, Kornek GV, Lang S, Schull B, Watzinger F, et al. Impact of hemoglobin level and use of recombinant erythropoietin on efficacy of preoperative chemoradiation therapy for squamous cell carcinoma of the oral cavity and oropharynx. International Journal of Radiation Oncology, Biology, Physics 2001;50(3):705‐15. - PubMed
Glaspy 1997 {published data only}
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- Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan‐Raj S. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Journal of Clinical Oncology 1997;15:1218‐34. - PubMed
Glaspy 2001 {published data only}
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- Glaspy J, Jadeja JS, Justice G, Kessler J, Richards D, Schwartzberg L, et al. A dose‐finding and safety study of novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia in patients receiving multicycle chemotherapy. British Journal of Cancer 2001;84 Suppl 1:17‐23. - PMC - PubMed
Glaspy 2002 {published data only}
Glaspy 2002b {published data only}
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- Glaspy JA, Tchekmedyian NS. Darbepoetin alfa administered every 2 weeks alleviates anemia in cancer patients receiving chemotherapy. Oncology (Huntingt) 2002;16(10 Suppl 11):23‐9. - PubMed
Glaspy 2003 {published data only}
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- Glaspy JA, Jadeja JS, Justice G, Fleishman A, Rossi G, Colowick AB. A randomized, active‐control, pilot trial of front‐loaded dosing regimens of darbeopetin‐alfa for the treatment of patients with anemia during chemotherapy for malignant disease. Cancer 2003;97:1312‐20. - PubMed
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- Glaspy J, Henry D, Patel R, Tchekmedyian S, Applebaum S, Berdeaux D, et al. Effects of chemotherapy on endogenous erythropoietin levels and the pharmacokinetics and erythropoietic response of darbepoetin alfa: A randomised clinical trial of synchronous versus asynchronous dosing of darbepoetin alfa. European Journal of Cancer 2005;41(8):1140‐9. - PubMed
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- Glaspy J, Jadeja J, Justice G, Fleishman A, Rossi G, Colowick A. Optimizing the management of anemia in patients with cancer: a randomized, active‐controlled, study investigating the dosing of darbepoetin alfa. Hematology Journal 2002:abstract 0109.
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- Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate (FG) for increasing response to epoetin (EPO) in patients with anemia of cancer chemotherapy results of a multicenter, randomized trial. Blood 2004; Vol. 104, issue 11 Pt 2:10b, abstract 3696.
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- Henry DH, Gordan LN, Charu V, Wilhelm FE, Williams D, Xie J, et al. Randomized, open‐label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy‐induced anemia. Current Medical Research & Opinion 2006;22(7):1403‐13. - PubMed
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- Schwartzberg L, Yee L, Charu V, Tomita D, Rossi G, Senecal F. Comparable efficacy and safety of darbepoetin alfa 200 mug every 2 weeks and epoetin alfa 40,000 U weekly in patients with breast cancer: Results of a randomized comparison. The Journal of Supportive Oncology 2005;3(2 Suppl 1):30‐1.
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Scott 2002 {published data only}
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Varan 1999 {published data only (unpublished sought but not used)}
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Wauters 2006 {published data only}
WHO 2011 {published data only}
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Blackstock {unpublished data only}
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Chapman 2004 {unpublished data only}
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