Anemia
Conditions
Brief summary
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.
Interventions
DRUGEpoetin beta
Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) | Baseline, Month 4 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline, Month 4 | 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. |
| Percentage of Participants Who Required Blood Transfusions During the Study | Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4 | 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. |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NeoRecormon in Symptomatic Anemia Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study. | 1,167 |
| Total | 1,167 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Insufficient Therapeutic Response | 14 |
| Overall Study | Lost to Follow-up | 724 |
| Overall Study | Withdrawal Prior to Treatment | 1 |
Baseline characteristics
| Characteristic | NeoRecormon in Symptomatic Anemia |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 13 |
| Sex/Gender, Customized Female | 709 participants |
| Sex/Gender, Customized Male | 398 participants |
| Sex/Gender, Customized Unknown | 60 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 1,167 |
| serious Total, serious adverse events | 7 / 1,167 |
Outcome results
Primary
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).
Time frame: Baseline, Month 4
Population: All Participants Enrolled; only those who provided data at all study visits were included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NeoRecormon in Symptomatic Anemia | Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) | 14.58 g/L |
Comparison: The difference between Baseline and Month 4 was analyzed using the Wilcoxon signed-rank test.p-value: <0.0001Wilcoxon signed-rank test
Secondary
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.
Time frame: Baseline, Month 4
Population: All Participants Enrolled; only those who provided data at all study visits were included in the analysis. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants used in the denominator for each calculation (n) was based on the ECOG status at Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 0, EOT 0 (n=71) | 77.5 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 0, EOT 1 (n=71) | 19.7 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 0, EOT 2 (n=71) | 2.8 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 1, EOT 1 (n=168) | 67.3 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 1, EOT 2 (n=168) | 8.9 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 2, EOT 1 (n=33) | 48.5 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 2, EOT 2 (n=33) | 30.3 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 1, EOT 0 (n=168) | 23.8 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline 2, EOT 0 (n=33) | 21.2 percentage of participants |
Comparison: Overall (all categories combined) change from Baseline in ECOG performance status at Month 4 was analyzed using Wilcoxon signed-rank test.p-value: 0.001Wilcoxon signed-rank test
Secondary
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.
Time frame: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4
Population: All Participants Enrolled. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants who provided data for the analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NeoRecormon in Symptomatic Anemia | Percentage of Participants Who Required Blood Transfusions During the Study | Baseline to Month 1 (n=1073) | 4.1 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants Who Required Blood Transfusions During the Study | Month 1 to 2 (n=853) | 4.1 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants Who Required Blood Transfusions During the Study | Month 2 to 3 (n=650) | 3.8 percentage of participants |
| NeoRecormon in Symptomatic Anemia | Percentage of Participants Who Required Blood Transfusions During the Study | Month 3 to 4 (n=281) | 3.9 percentage of participants |