An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy

This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin beta

• Study Type: Observational
• Enrollment (Actual): 1167

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1125
  • Budapest, Hungary, 1122
  • Budapest, Hungary, 1083
  • Budapest, Hungary, 1145
  • Budapest, Hungary, 1088
  • Budapest, Hungary, 1082
  • Budapest, Hungary, 1085
  • Budapest, Hungary, 1106
  • Budapest, Hungary, 1097
  • Budapest, Hungary, 1529
  • Budapest, Hungary, 1076
  • Budapest, Hungary, 1031
  • Debrecen, Hungary, 4032
  • Debrecen, Hungary, 4012
  • Debrecen, Hungary, H-4031
  • Deszk, Hungary, 6772
  • Dunaujvaros, Hungary, 2400
  • Eger, Hungary, 3300
  • Farkasgyepu, Hungary, 8582
  • Gyor, Hungary, 9024
  • Gyula, Hungary, 5700
  • Kaposvar, Hungary, 7400
  • Kecskemet, Hungary, 6000
  • Miskolc, Hungary, 3529
  • Miskolc, Hungary, 3501
  • Mosdos, Hungary, 7257
  • Nyíregyháza, Hungary, 4400
  • Pecs, Hungary, 7624
  • Pecs, Hungary, 7635
  • Pecs, Hungary, 7623
  • Salgótarján, Hungary, 3100
  • Szeged, Hungary, 6720
  • Szekesfehervar, Hungary, 8000
  • Szekesfehervar, Hungary, 8001
  • Szekszard, Hungary, 7100
  • Szolnok, Hungary, 5004
  • Szolnok, Hungary, 5007
  • Szombathely, Hungary, 9700
  • Székesfehérvár, Hungary, 8000
  • Tatabánya, Hungary, 2800
  • Torokbalint, Hungary, 2045
  • Veszprem, Hungary, 8200
  • Zalaegerszeg, Hungary, 8900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with symptomatic anemia due to malignancies will be included.

Description

Inclusion Criteria:

• Adults greater than or equal to (≥) 18 years of age
• Participants with solid tumors or lymphoproliferative disease
• Participants receiving chemotherapy
• Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (<) 11 g/dL or 6.83 millimoles per liter (mmol/L)
• ECOG performance status of 0, 1, or 2

Exclusion Criteria:

• Resistant hypertension
• Acute chronic bleeding within 3 months prior to study
• Iron deficiency that is unmanageable prior to study
• Hypersensitivity to the active substance or any of the excipients of the product
• Pregnant or breastfeeding women
• Epoetin treatment within 6 months prior to study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NeoRecormon in Symptomatic Anemia; Participants with symptomatic anemia who are receiving epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics will be observed for 4 months. Treatment must be selected at the discretion of the prescriber prior to enrollment and will not be chosen by the Sponsor in this non-interventional study.	Drug: Epoetin beta; Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.; Other Names: NeoRecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)	The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).	Baseline, Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT	ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as "Baseline 0, EOT 2". Transition to a lower performance status indicates improved/increased independence.	Baseline, Month 4
Percentage of Participants Who Required Blood Transfusions During the Study	The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.	Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: March 8, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (Estimate): March 12, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML21420