This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks.
Study Type
OBSERVATIONAL
Enrollment
1,060
As prescribed by physician
Unnamed facility
Neuilly-sur-Seine, France
Percentage of Participants With Early Treatment Response: Day 28 to 42
Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.
Time frame: Day 28 to 42
Percentage of Participants With Early Treatment Response: Day 21 to 42
Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Time frame: Day 21 to 42
Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion
Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Time frame: Baseline up to Week 28
Mean Number of RBC Transfusions
Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.
Time frame: Baseline up to Week 28
Mean Number of RBC Units
Mean number of units was based on the number of participants with at least 1 RBC transfusion.
Time frame: Baseline up to Week 28
Time to First RBC Transfusions
Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.
Time frame: Baseline up to Week 28
Karnofsky Performance Status (KPS): Baseline
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KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Time frame: Baseline
KPS: Week 4 to 6
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Time frame: Week 4 to 6
KPS: Week 12 to 16
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Time frame: Week 12 to 16
KPS: Week 24 to 28
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Time frame: Week 24 to 28
Percentage of Participants With Professional Activity: Baseline
Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.
Time frame: Baseline
Percentage of Participants With At Least 1 Sick Leave
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Time frame: Week 4 Up to Week 28
Mean Number of Days of Sick Leave
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Time frame: Week 4 Up to Week 28
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline
Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Time frame: Baseline
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Time frame: Week 4 to 6
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Time frame: Week 12 to 16
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Time frame: Week 24 to 28
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Time frame: Baseline, Week 4 to 6
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Time frame: Baseline, Week 12 to 16
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Time frame: Baseline, Week 24 to 28
Mean Starting Dose of NeoRecormon® Injection
Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).
Time frame: Baseline
Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks
Time frame: Baseline
Percentage of Participants With Pre-specified Dose and Frequency of Injections
Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With Subcutaneous (SC) Route of Administration
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU
Time frame: Baseline up to Week 28
Percentage of Participants With Modifications of NeoRecormon® Regimen
All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.
Time frame: Baseline up to Week 28
Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment
Percentage of participants with at least 1 temporary discontinuation was reported.
Time frame: Baseline up to Week 28
Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment
Time frame: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28
Relative Percent Change in Hb Concentration From Baseline Over the Study Period
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28
Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL
Time frame: Baseline up to Week 28
Percentage of Participants With Adequate Iron Status
Criteria for adequate iron status included serum ferritin greater than (\>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)\> 20%.
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With Vitamins Prescription
Time frame: Week 4 to 6, Week 12 to 16, Week 24 to 48